QMS for Laboratories Testing and Calibration ISO 17025

GUIDANCE ON

QUALITY QU ALITY MANAGEMENT

SYSTEMS FOR LAB LABOR ORA ATORIES TESTING AND CALIBRATION (ISO/IEC 17025)

Prepared by the Caribbean Laboratory Accreditation Services (CLAS) An European Union Funded Project

“Obstacles are what you see when you take your eyes off the goal” November 2010 Edition 1

Q UAL  UAL IT Y MANAGEMENT SYS SYST  T EM EM GUIDANCE GUIDANCE

PREAMBLE This document is a consolidation of information information and resources on the process of Developing a Qualityy Management Qualit Management Syst System em for Testing Testing Laboratori Laboratories. es. Many resource resourcess were were consulted consulted in  preparation of the guide, and therefore contributed to its completion. Laboratories should understand that there are many ways of accomplishing the goal of Accreditation and producing a reliable output and therefore do not restrict themselves or their staff only to what pertains herein. The development of this manual on “Quality “Quality Management systems for Laboratories” was supported by the European Union through the 9th EDF Funded Caribbean Laboratory Accreditation Services Services Project implemented by the CARICOM Regional Organisation for Standards and Quality (CROSQ). This guidance manual is not used for commercial purposes.

For further information, i nformation, please contact  contact : 

CARICOM CARICO M Region Regional al Organisatio Organis ation n for f or Standards Standard s and Quality Qualit y (CROS (CROSQ)  Q)  nd  2  Floor Nicholas Nichol as House  House  29-30 29 -30 Broad Street  Bridgetown  Barbados,, W.I. Barbados W.I. www.crosq.org  [email protected] 

Authors  Giselle Guevara, BSc., MPhil, MBA Project Coordinator  9th EDF Funded Caribbean Laboratory Accreditation Services Services Project (CLAS) CROSQ Bridgetown Barbados Ing. Manfred Kindler   Accreditation Expert and Consultant Kindlerr Intern Kindle International ational Divi Division sion Berlin, Germany [email protected]

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Q UAL  UAL IT Y MANAGEMENT SYS SYST  T EM EM GUIDANCE GUIDANCE

PREAMBLE This document is a consolidation of information information and resources on the process of Developing a Qualityy Management Qualit Management Syst System em for Testing Testing Laboratori Laboratories. es. Many resource resourcess were were consulted consulted in  preparation of the guide, and therefore contributed to its completion. Laboratories should understand that there are many ways of accomplishing the goal of Accreditation and producing a reliable output and therefore do not restrict themselves or their staff only to what pertains herein. The development of this manual on “Quality “Quality Management systems for Laboratories” was supported by the European Union through the 9th EDF Funded Caribbean Laboratory Accreditation Services Services Project implemented by the CARICOM Regional Organisation for Standards and Quality (CROSQ). This guidance manual is not used for commercial purposes.

For further information, i nformation, please contact  contact : 

CARICOM CARICO M Region Regional al Organisatio Organis ation n for f or Standards Standard s and Quality Qualit y (CROS (CROSQ)  Q)  nd  2  Floor Nicholas Nichol as House  House  29-30 29 -30 Broad Street  Bridgetown  Barbados,, W.I. Barbados W.I. www.crosq.org  [email protected] 

Authors  Giselle Guevara, BSc., MPhil, MBA Project Coordinator  9th EDF Funded Caribbean Laboratory Accreditation Services Services Project (CLAS) CROSQ Bridgetown Barbados Ing. Manfred Kindler   Accreditation Expert and Consultant Kindlerr Intern Kindle International ational Divi Division sion Berlin, Germany [email protected]

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This Manual is dedicated to my colleague and dear friend Bertha Munguia

 Ackn  Ac know owled ledgem gement entss The Authors are most grateful to the several persons who provided support, very useful input, feedback and gave generously of their time in the the development and production of this document. We especially wish to thank those colleagues who reviewed the Manual and paused in their busy schedule to provide incisive comments, comment s, helpful tips and stimulating stimulating input. Thank you for everyone who provided provided examples and ideas for the content of this manual, sometimes without even knowing you were helping. We are truly thankful and wish to recognise the contributions of Valerie Wilson and Wendy Kitson-Piggott as Technical Editors, Michael Seepersaud, CROSQ-IDB Project Manager for assisting with the manual publication. Thanks to Manfred Kindler who provided useful technical information, invaluable feedback and assistance, assist ance, in the preparation preparation and compilation compilation of this this mater material. ial. We wish to thank CROSQ, the CARICOM Secretariat and the European Union funded CISP Project for their contribution to the production of this guide. Preparation and Editing of this this manual was a long and precise task and we therefore wish to extend our special gratitude to all who assisted and facilitated the process.

Produced and Printed with support from the European Union under the 9th EDF Fund

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Table of Contents FOREWORD.......... ........................................ FOREWORD.............................. ....................................... ....................................... ........................................ ....................................... ....................... .... 6 CHAPTER 1 LABORATORY QUALITY FUNDAMENTALS .................................................. 7 1.1 INTRODUCTION .................................................... ..................................................................................................... ................................................. 7 1.2 QUALITY TERMS AND DEFINITIONS ..................................................................... 8 1.3  ACCREDITA  ACCREDITATION TION vs. vs . CERTIFICATION ......................................................... ................................................................. ........ 11 1.4 QUALITY MANAGEMENT SYSTEM .................................................... ...................................................................... .................. 13 1.5 DOCUMENT HIERARCHY ........................................................ .................................................................................... ............................ 14 1.6  A STEPWISE APPROACH TO DEVELOPING DEVEL OPING A QMS  ............................................ 17 1.7  ACTION PLANNING PL ANNING USING THE MIL ESTONES .................................................... 20 1.8 CONTINUOUS QUALITY IMPROVEMENT ..................................................... ............................................................. ........ 22 1.9 DOCUMENTATION DOCUME NTATION PLAN PLA N ......................................................... ..................................................................................... ............................ 29 CHAPTER 2 ELEMENTS OF THE QUALITY MANAGEMENT SYSTEM .............................. 35 2.1 THE QUALITY PLAN ...................................................... ............................................................................................ ...................................... 35 2.2 STRUCTURING YOUR QUALITY MANAGEMENT SYSTEM ................................... 37 2.3 THE QUALITY POLICY STATEMENT .................................................. .................................................................... .................. 38 2.4 THE QUALITY MANUAL ................................................. ....................................................................................... ...................................... 39 2.5 DOCUMENT CONTROL .................................................. ........................................................................................ ...................................... 42 2.6 RECORDS .................................................. ........................................................................................................... ......................................................... 46 CHAPTER 3 PROCEDURES ...................................................... ............................................................................................ ...................................... 47 3.1 PROCEDURE MANUAL .................................................. ........................................................................................ ...................................... 47 3.2 OVERVIEW OF PROCEDURE WRITING ........................................................ ................................................................ ........ 47 3.3  ADVICE FOR WRITING PROCEDURES ................................................................ 48 3.4  ADMINISTRA  ADMINISTRATIVE TIVE PROCEDURE OUTLINE ................................................... ........................................................... ........ 49 3.5 OVERVIEW OF TECHNICAL PROCEDURES (SOPs) ............................................. 53 3.6 DOCUMENTATION CHECKLIST ......................................................... ........................................................................... .................. 57 3.7 USE OF FLOW DIAGRAMS ...................................................... .................................................................................. ............................ 58 CHAPTER 4 FAQs in LABORATORY QUALITY ....................................................... ............................................................... ........ 61 CHAPTER 5 APPENDICES ........................................................ .............................................................................................. ...................................... 67 REFERENCE DOCUMENTS ...................................................... ............................................................................................ ...................................... 85

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Q UAL IT Y MANAGEMENT SYST EM GUIDANCE List of Figures Figure 1 Summary of th e Applic ation Pro cess tow ards Ac creditati on ....................................12 Figure 2 Process Appr oach to Laborato ry Quality Management..............................................13 Figure 3 Docu ment Hierarc hy ......................................................................................................15 Figure 4 Implement ing a Quality Management System .............................................................16 Figure 5 The Twent y Mileston es su mmaris ed ............................................................................18 Figure 6 Milest one 1: Quality Polici es ........................................................................................20 Figure 7 Milest one 2: Managemen t.............................................................................................21 Figure 8 Example of Responsib ili ty Matrix for train ing .............................................................21 Figure 9 Hou se of Acc redit atio n ..................................................................................................17 Figure 10 The PDCA Mod el fo r QMS Impr ovement ....................................................................24 Figure 11 Example of a Quality Plan ...........................................................................................25 Figure 12 Diag ram of QMS Proces s Ac tiv ities............................................................................28 Figure 13 Docu ment atio n plan .....................................................................................................29 Figure 14 Qu ality Plan Outline .....................................................................................................36 Figure 15 Doc umentat ion Status .................................................................................................38 Figure 16 Example of Table of Cont ents for Manual .................................................................41 Figure 17 Example of Quality Manual Amendment table...........................................................42 Figure 18 Examp le of Master list (Docu ment cont rol lo g) .........................................................43 Figure 19 Example of Header/Footer combination.....................................................................44 Figure 20 Example of a Header ....................................................................................................44 Figure 21 Example of a Foot er .....................................................................................................44 Figure 22 Examp le of Docu ment c ont rol n otes ..........................................................................45 Figure 23 Example Header/Footer with Document cont rol note ...............................................45 Figure 24 Example of Record Managem ent Database ...............................................................46 Figure 25. The P’s of Proced ure wr iti ng ......................................................................................48 Figure 26. Docu ment atio n Checkli st for th e QMS Program ......................................................57 Figure 27 Flowcharting Log ic ......................................................................................................59 Figure 28 Flow chart sym bol s .......................................................................................................60 List of Appendices  Appen dix 1 Su mmary of Clau ses in ISO/IEC 17025............................................................. 67  Appen dix 2 L ist o f Policies in ISO/IEC 17025 ...................................................................... 70  Appen dix 3 L ist o f Procedu res in ISO/IEC 17025 ................................................................ 71  Appen dix 4 L ist o f “ SHALLs” in ISO/IEC 17025 .................................................................. 73  Appen dix 5 Do cu ment Co ntrol Ch eck lis t ............................................................................ 78  Appen dix 6 Examp le of a Flow chart ................................................................................... 79  Appen dix 7 Ch ecklist fo r revi ewing Quality Man agement System Imp lem ent ation ............. 80

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Q UAL IT Y MANAGEMENT SYST EM GUIDANCE FOREWORD

L

aboratory accreditation is a formal process that recognizes the technical competence of a laboratory to perform specific tests or calibrations. Accreditation requires laboratories to maintain a documented quality management system (QMS) and personnel who are qualified and authorized to perform tasks related to the scope of accreditation. The added value of accreditation far outweighs the necessary investment in human resources, finances and time, since it is an independent method of monitoring laboratory competence and performance, and assures the validity of results disseminated to users. One very critical benefit of laboratory accreditation is that it provides assurance to trading partners that an exporting country is competent to test or inspect to the trading partners’ requirements, while at the same time addressing and assuring compliance with the World Trade Organisation’s (WTO) Technical Barriers to Trade (TBT) Agreement. The CLAS PROJECT (2008-2010) has sought to develop a framework that would facilitate co-ordination of regional laboratory accreditation in a manner that would leverage regional capacity and harmonize accreditation processes and procedures used across the Caribbean region while also addressing the need for regional accreditation services to be cost-effective and internationally accepted. It was envisioned that CLAS would create a platform for: •

• • •

Strengthening regional communication through providing a mechanism for negotiation and consensus building Building the relevant human resource capacity Forging strong linkages and relationships among regional stakeholders Enabling the smaller countries of the region to participate in and more easily access expertise and services to support their accreditation efforts.

Overall it strengthened and improved regional capacity for the continued functioning of the Laboratory  Accreditation infrastructure. More specifically, CLAS provided: • Assistance and support for the coordination of activities of the national accreditation bodies in the region, aimed at avoiding duplication and promoting transfer of knowledge; and ensuring an internationally recognized accreditation infrastructure in the Caribbean; • Interaction among the National Accreditation Focal points (NAFPs) for multiplication of benefits; • Access to international expertise by the NAFPs; • Access to proficiency testing programs by the NAFPs; • Access to training programs for Labs and Assessors; •A structure to uphold the principles of Cross frontier Accreditation (ILAC G21) and ensure that confidence in the Caribbean Accreditation infrastructure is not eroded by extra-regional  Accreditation Bodies. This manual has been developed to support the development of laboratory quality management systems in regional laboratories and to build regional capacity to meet accreditation requirements.

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CHAPTER 1 LABORATORY QUALITY FUNDAMENTALS  1.1

INTRODUCTION

The International Standards ‘ISO/IEC 17025 - General Requirements for the Competence of Testing and Calibration Laboratories’  and ‘ISO 15189 – Medical Laboratories – Particular Requirements for Quality and Competence’ both respectively state that a laboratory shall establish, implement and maintain a quality system appropriate to the scope of its activities including the type, range and volume of testing and/or calibration activities it undertakes Laboratory Accreditation is the formal recognition of a laboratory’s technical competency to perform specific tests, types of tests or calibrations. ISO/IEC 17025 and ISO 151891 requirements are recognised internationally as defining and incorporating essential elements of a quality management system for laboratories (ref: Appendix 1). The requirements for each stage of the quality improvement process are described in the various clauses of the ISO/IEC 17025 and ISO 151892. Achieving compliance with the ISO/IEC 17025 and/or ISO 15189 Standard can be achieved in a stepwise manner that ensures efficient use of resources. Essential components of these standards include the following: •

•

 A laboratory that operates within a Quality Management System (QMS) will have a single QUALITY MANUAL (ref: Section 2.4) hereafter referred to as ‘the Manual’, that contains the documented policies for the laboratory and either includes or refers to the processes, procedures and forms used by laboratory staff to implement the QMS throughout all the disciplines in the laboratory.  A laboratory shall periodically and in accordance with a predetermined schedule and procedure, conduct internal audits of its activities to verify that its operations continue to comply with the requirements of the quality system and the Standard (ISO 17025/15189 clause 4.14).

Some laboratories have significant gaps in the required QMS documentation and as such implementation of the QMS can at first appear to be a daunting task. However, if everyone in the laboratory can be motivated and involved the task usually becomes easier. The Manual not only serves as a guide for laboratory quality improvement but can also serve as a training manual for new and existing staff because it outlines all the processes and procedures that must be executed in the laboratory. Additionally, by describing all of the laboratory’s processes and procedures, the Manual allows laboratory staff to accurately identify the resources required for the laboratory’s operations.

1

This document references the ISO/IEC 17025:2005 –General Requirements for the competence of Testing and Calibration Laboratories 2 Please note that wherever “Clause” is mentioned in this document, it refers to a Clause of the ISO/IEC 17025 Standard

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In designing a quality plan (Figures 11 & 14), the laboratory establishes clear quality objectives that ensure compliance with requirements of relevant regulatory authorities, clients and/or accreditation bodies. The quality plan is intended to ensure that implementation of the QMS is efficient and costeffective. The guidelines given in this publication are of a general nature. The complexity of a QMS depends on the size, scope and organizational structure of the laboratory and many of the processes and procedures described in this publication can be implemented in a simplified manner. In order to master the process of Quality Management System implementation you must first understand some related key concepts and definitions. These are described in the following section. Note Essential areas of focus in your QMS include: org anisation, personnel, equipment, purchasing and inventory, process control, documents and records, information management, occurrence management, internal and external assessment, process improvement, facilities and safety, customer service

1.2

QUALITY TERMS AND DEFINITIONS

a. Quality Management System  A program developed to support efficient and effective, high quality and appropriate laboratory services (e.g. accurate and precise results, appropriate test selection, timely reporting, and correct interpretation of results, clinical usefulness, and recommendations for further tests). Comprehensive and coordinated efforts (policies, processes and procedures) designed to meet quality objectives, to direct and control an organization with regard to quality. The system is comprised of the Quality Manual (Quality Policy, General policies, Organisational Chart, etc), Administrative Procedures, Technical Procedures and Technical and Quality Records. b. Policy Statement describing what is done and why. c. Process Series of inter-related steps involved in an activity or examination that uses resources and is managed to transform inputs into outputs. Processes may often be linked since the output of one process is often the input to the next. Rarely is there a process that is not linked to some other.

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d . Pro ced ure Written work instructions that specify the way to carry out a step in the process, an activity or examination. Procedures describe in detail exactly how one individual should perform an activity. e. Record  Any information that produces evidence (e.g. requisitions, examination results and reports, instrument printouts, laboratory workbooks and worksheets, accession records, calibration records, quality control records, records of audits, complaints and action taken, external quality assessment records, instrument maintenance records, incident/accident reports, staff training and competency records, personnel records). f.Document  Any information that provides information (e.g. instructions including policy statements, textbooks, reference intervals and their origins, procedures, specifications, calibration tables, charts, posters, notices, memoranda, plans, software, drawings, regulations and standards). g. Document Control Is a system to regulate the handling and management (including archiving, storing and destruction) of documents containing information that communicates policies, processes, procedures as well as records. Usually pertains to documents that are part of the quality management system h. Audit Systematic and independent examination to determine whether quality activities and related results comply with planned arrangements and whether these arrangements are implemented effectively and are suitable to achieve the objectives. Note: In this document the term “Internal Audit” is used to emphasize that the audit is done by the organization itself  i. Audit scope The extent and boundaries of an audit. Usually established before the audit process begins  j. Audit p lan Description of the activities and arrangements for an audit k. Management review  A formal evaluation by top management of the status and adequacy of the quality system in relation to quality policy and objectives l. Quality management That aspect of the overall management function that determines and implements the quality policy

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m. Quality manager  The staff member (by whatever title) who has responsibility for the laboratory’s quality system, its development, maintenance and ensuing implementation and who, in this capacity, reports directly to top management. n. Quality auditor  Person qualified to perform quality audits o . Ob ser vat io n  A statement of fact made during an audit and substantiated by objective evidence. p. Objective evidence Qualitative or quantitative information, records or statements of fact pertaining to the quality of an item or service or to the existence and implementation of a quality system element, which is based on observation, measurement or test and which can be verified. q . A ud it f in di ng s Results of the evaluation of the collected audit evidence against specified audit criteria. r.Nonconformity The non fulfillment of specified requirements. s. Corrective Action  An action taken to eliminate the causes of an existing nonconf ormity, defect or other undesirable situation, to prevent recurrence t.Preventive Action  An action taken to eliminate the cause of a po tentially undesirable result u. Continuous Quality Improvement The use of incremental and breakthrough quality management techniques to constantly improve processes, products, or services provided to internal and external customers and thus achieve higher levels of customer satisfaction v. Quality Improvement Plan  A written description of the organization’s quality improvement program that has been approved by the management and is then periodically reviewed and updated, as necessary.

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1.3

ACCREDITATION vs. CERTIFICATION

Laboratory accreditation requires the use of criteria specifically developed to determine technical competence. These criteria are based on the international standards ISO/IEC 17025 and ISO 15189, for Testing/Calibration and Medical Laboratories respectively. Accreditation bodies, through specialist technical assessors, use these standards to conduct a thorough evaluation of all factors relevant to the laboratory’s competence and aim to ensure the laboratory’s test data are accurate and reliable. The ISO 9001 standard is widely used in manufacturing and service organizations to evaluate their system for managing the quality of their product or service. The ISO 9001, however, does NOT assess the technical competence of the organisation’s operations. This standard is thus used for certification and cannot be used for accreditation of laboratories. Note While laboratories may be certified to ISO 9001, such certification does not make any statement about the technical competence of a laboratory as this standard does not contain technical requirements for laboratory personnel and operations 3

Why Is a Laboratory’s Technical Competence Critical?

Because it is important for laboratories to: Minimise Risk In the world today, customers seek reassurance that the products, materials or services they produce or purchase meet their expectations or conform to specific requirements. This often means the product is sent to a laboratory to determine its characteristics against a standard or a specification. For the manufacturer or supplier, choosing a competent laboratory minimizes the risk of producing or supplying a faulty product.  Avoid Ex pensive Ret esting Testing of products and materials can be expensive and time consuming, even when they are done correctly the first time. If not done correctly, then the cost and time involved can be even higher if the product has failed to meet specifications or expectations and re-testing is required. This can negatively impact the reputation of a supplier or manufacturer. Additionally, the supplier can also be held liable for any failure of the product, particularly if it involves public safety or financial loss to a client. Choosing a competent laboratory thus minimises the chance of retesting being required, increase in operational costs and/or exposure to legal action.

3

See ISO CASCO Communiqué on Accreditation vs. Certification and ILAC Publication on Laboratory Accreditation or ISO 9001 Certification (www.ilac.org.tt)

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How does a Laboratory Apply for Accreditation? 

Figure 1 summarises the steps in the accreditation process from the pre-audit visit to the final award of the accreditation certificate.

Figure 1 Summary of the Application Process towards Accreditation Accreditation Body Pre-Audit External Audit by pre-Assessment Visit with Experts from  Accreditation Body Corrective actions completed

Application to Accreditation Body Complete Application process for Accreditation to ISO/IEC 17025

Accreditation Body Document Review – On-site Visit Review of Documents forwarded by laboratory previously On site Assessment by Assessor team

Laboratory Corrective Actions Cause Analysis – identify the source of Non conformances and Confirm Corrective Actions

Accreditation  Accreditation Body -Vote on Accreditation Decision Lab - Receipt of Accreditation Certificate

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1.4

QUALITY MANAGEMENT SYSTEM 

Laboratory management, tasked with the responsibility for developing the QMS, must define the policies under which the laboratory will operate. These policies are operationalised by defining the processes and procedures (specific actions) that describe what must be done to implement the policies (Appendix 2). Many laboratories may already be adhering to the best technical and management practices and may only need to now document these practices. Some laboratories may already have all or most of the documentation they need and all that is required is collation, rationalization, and organization of the existing documentation with possibly some additional documentation of the general administrative procedures (e.g. document control, purchasing of supplies, retention of records, etc). What is a Quality Management System (QMS)? 

The procedures (activities, mechanisms, actions) that a laboratory uses to achieve and demonstrate control over its system constitute the Quality Management System (QMS). Every QMS is driven by an overarching quality policy (philosophy) from which a series of connected processes and procedures are derived. These define the resources needed to provide the desired laboratory outputs. The QMS outlines the inputs needed to produce the desired laboratory outputs as well as the processes and procedures that transform these inputs into outputs. The laboratory’s input-output relationships are thus connected through the laboratory’s processes and procedures and collectively shape the laboratory’s quality system (Figure 2). The decision to implement a QMS has to be made by top management since management’s commitment is essential for the implementation and successful maintenance of the system. The design and implementation of a QMS will vary depending on the type, size and output of the laboratory with each one having its own objective. The QMS is often designed to align with the requirements of an international standard. For laboratories, the standard commonly used is either the ISO 17025 or ISO 15189. Figure 2 Process Approach to Laboratory Quality Management

INPUT

PROCESS

OUTPUT

Personnel

Critical process necessary to provide reliable output

Product or Service

Environment Methods Equipment Materials

Internal or External Customer

Satisfied or Dissatisfied

Measures of performance (Time, quantity, quality)

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What are Quality Objecti ves? 

In order for a QMS to be effective, its quality objectives must be clearly defined and must reflect the laboratory’s overall service objectives. Objectives must also be practical, able to be regularly reviewed and measured for effectiveness. All laboratory staff must be familiarized with these quality objectives. Ongoing adjustments must be made to reflect major changes to the laboratory and its practices. What are Quality Documents? 

 A QMS consists of documented policies, processes and procedures for establishment and effective implementation of the system, as well as records to provide evidence that the system is in compliance. Key documents include the Quality Manual (which includes the quality policy or philosophy of the laboratory and general policies); administrative and technical procedures (specific work instructions), Test Methods (SOP’s), and te chnical and quality records (proof).

1.5 DOCUMENT HIERARCHY

Figure 3 illustrates a typical document hierarchy. It shows that the laboratory must first establish the Quality Policy (philosophy) for the organization, followed by the development of the more general policies that reflect the overarching goals for every area of the laboratory’s operations (a list of policies from ISO/IEC 17025 are referenced at Appendix 2). Although very important, these policies can be stated in a relatively simple way.  Administrative or operational processes and procedures that your organization performs to achieve the goals or objectives expressed in the quality policies are then developed in addition to the documentation of technical procedures that describe the specific analytical work performed in your laboratory. These documents outline “how” you do things in your laboratory. Finally the document hierarchy includes all the forms and records that are used to document the results and activities of day-to-day operations. Records can be classified as either Quality or Technical records, and as such the retention times and instructions for archiving both categories should be documented. It is these records that are used as documented evidence of the work and represent the proof of compliance with the standard’s requirements. All of these documents collectively comprise the laboratory’s QMS documentation. The laboratory’s safety management system, which will include policies, procedures and records, can also be integrated into the Quality Management system.

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Figure 3 Document Hierarchy

What are t he Benefits of a QMS?  • • • • • • • • •

Increases operational efficiency and productivity Provides a system to enable control of all processes Reduces costs and risks/errors Provides ability to identify improvement opportunities Provides employee participation and motivation of human resources Increases customer satisfaction  Allows effective and efficient use of resources Provides flexibility and ability to respond to market opportunities Increases competitiveness and industry reputation

Implementing a Quality Management System –who does what? 

Successfully implementing a laboratory QMS needs careful planning, detailed identification of tasks and clear guidance on the roles and responsibilities of the key stakeholders. Figure 4 details the critical roles and responsibilities of management, the quality manager and the quality team.

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Figure 4 Implementing a Quality Management System Responsibility • •

Management

• •

• • •

Management/QM/QT

• •

• •

QM/QT

• •

• •

QM/QT/Management

•

•

Management

• • • •

QM/QT •

• •

Management

• • • • •

QM/QT/Management

• •

Tasks Set objectives and goals of the QMS  App oint a Qualit y Manager (QM) or Quali ty Team (QT) to develop and maintain the QMS Set tim elines and project scope  All ocat e reso urc es requi red for t he development, i mpl ementatio n and on-go ing management of the system Inform all staff and seek participation from all l evels Decide if a consultant is required for the project Prepare a project plan an allocate resources Develop a budget based on equipment, tr aining, time and personnel required Seek approval from management to procure required resources and execute training  Ass ess metho d fo r do cumenti ng t he QMS Design templates and documentation Set tim elines for the various tasks Schedule individual departments and positions for development of policies and procedures Develop QMS policies to reflect laboratory objectives Start to develop procedures and work instructions (SOPs) with each department Report to management any risks and improvement opportunities that have been found Document any Quality Corrective Action Requests that might be identified (identified risk areas that r equire management attention and impro vements)  App rov e and issu e the QMS Operate the QMS for a minimum period of 3 months Carry out initial audits to ensure documentation matches processes Ensure that “you do what you say you do”. If any deficiencies are found change processes or QMS to r eflect what is actually done  Ass ess t he eff ecti veness of the QMS and implem ent any c hanges that m igh t b e required. Undertake management review of the QMS  Adj ust reso urc e requirement s Decide if accreditation assessment is required Set accreditation assessment timelines  App oint Accredi tati on B ody Continue to audit, review and assess the QMS at the agreed time intervals Continue to assess risk areas and identify improvement opportunit ies Continue to review policies and p rocedures and make amendments as required Continue to measure effectiveness of QMS to the overall laboratory performance

The ISO standards mention “shall” where it requires the laboratory to perform an activity without question (i.e. all requirements that begin with shall are mandatory). Additionally, it mentions Policy and Procedure wherever one of these documents is required. Where it does not require a documented procedure, the standard may ask that the laboratory implement an activity. Page 16 of 85

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Naturally, if an activity is performed, records of its performance will be produced in a number of different ways. Probably you will find that the most difficult task in implementing your QMS is ensuring that all these activities are documented in one form or another and the records can be retrieved when necessary. Note  As stated in the stand ard , the establ is hm ent and effectiv e im pl emen tatio n of the QMS Pro ced ur es requires them to be documented. Quality Management System documents may be kept in various forms, such as written on paper, in electronic format, photographic, or in any other media

1.6

A STEPWISE APPROACH TO DEVELOPING A QMS 

HOUSE OF ACCREDITATION 

(Model developed by Manfred Kindler, Berlin, Germany)

The following diagram illustrates how the 20 milestones can be put together in a systematic pathway to achieve the desired endpoint, i.e. Accreditation for your laboratory. Let us picture a house in which the policies are the foundation of the house, and the walls are comprised of the documents and activities which make up the Management and Technical requirements of the standard. The roof is the final pinnacle in the effort towards the achievement of accreditation. The house is complete only after each brick has been laid. Figure 5 House of Accreditation

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THE 20 MILESTONES FOR TESTING LABORATORIES 

(Model developed by Manfred Kindler, Berlin, Germany4)

Successful implementation of a QMS requires a structured and strategic approach. One such approach entitled ‘The Twenty Milestones to Accreditation” is outlined in Figure 6. These milestones present a stepwise approach that can be used to develop and implement a Quality Management System and represent the actions you would undertake prior to applying for  Accreditation. The achievement of each milestone should signal the development and completion of that particular aspect of the QMS. A timeline chart can be drawn using the milestones against the estimated time allocated to conducting the activities. As each is completed it can be ticked off (see example below). Figure 6 The Twenty Milestones summarized 1.

Policies • • • • • •

2.

Man ag em en t • • • •

3.

Legal status established Quality policy developed and documented Quality goals agreed and documented Quality Indicators determined and documented General Policies developed and documented Quality Plan developed and documented

Conflict of Interest Analysis conducted Commitments fr om Top Management Technical (testing s taff) responsibiliti es developed and documented Technical and Quality Responsibilities/Job Descriptions developed and doc umented

Scope Descriptio n of Scope of tests for Accreditation Procedures/Equipment/Personnel identifi ed for test scope Inventory of all Requirements for testing do cumented • • •

4.

Quality System Quality Manual Structure developed Continuous Quality Improvement plan developed • •

5.

Pr ocedu res  Adm inist rati ve Work Proc edures dev elop ed and d ocu mented Process for Control of Documents developed Records identif ied and filed • • •

6.

Tes t Met ho ds Instructions f or Equipment operation documented Examinations documented • •

4

Kindler International Division – [email protected]

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7.

Sampl ing Instructions for Pre-Analysis pr ocesses and procedures documented Sampling procedures developed, and Sampling pl an and processes documented • •

8.

Review Requests, Tenders and Contracts Review Quality Manual Review Requests and Contracts Identify Process and procedures for Advisors Evaluation of Subcontracting laboratories • • • •

9.

Qu al it y Co nt ro l Reference Methods developed and documented Internal and External Quality Control pro cesses established • •

10. Validation Verification Procedures developed and documented Validation o f new or modified Test Procedures documented • •

11. Work Conditions  Accomm odat ion con dit ion s doc umented and mo nit ored Faciliti es evaluated for suitabilit y Work Environment monitored • • •

12. Literature Review of current Standards Research current Scientific Literature • •

13. Traceability Check of Test Equipment Calibration of Equipment Reference Materials purchased and used • • •

14. Uncertainty Training in Estimation of Measurement Uncertainty Calculation of Uncertainties • •

15. Training Job Descriptions documented Plan and Implement Staff conti nuing education • •

16. Monitoring Monitoring System developed Internal Audit plan and Schedule developed • •

17. Internal Audit Training of Auditors Internal Audit conducted  Aud it Report prepared and evaluated • • •

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Q UAL IT Y MANAGEMENT SYST EM GUIDANCE 18. Complaints Complaint Management syst em implemented Root Cause Analysis procedure impl emented Corrective Action pro cedure implemented Preventive Acti on pro cedure implemented • • • •

19. Review Documents Internal Review of Quality Documentation (Final review) Review Manual, Procedures, Forms, Lists, Technical and Quality Records • •

20. Management Review Management Review conducted, Corrective Action pl an implemented Implementation and Control of Plan for Effectiveness • • •

END OF THE SYSTEMS DEVELOPMENT PROCESS 

1.7

ACTION PLANNING USING THE MILESTONES 

Each of the twenty milestones can be broken down into the steps of an action plan, where each action must end in a tangible result. In Figures 7 and 8 that follow, Milestone 1 and 2, for example, are broken down into a series of 10 achievable steps with related laboratory and management staff responsibilities. Each step yields a distinct result and responsibilities for achieving the result at each step can be assigned to different persons. The responsibility matrix (Figure 9) can be used to determine what each person’s role is at each step.

Figure 7 Milestone 1: Quality Policies

Step 1 2 3 4 5 6 7 8 9 10

 Action

HL

Legal Status E Decide about Policy E Define Objectives D Determine Indicators D Create monitoring lists D General management D Policies General Technical Policies E Design Quality Plan E Issue Quality Records C Quality Report C

QM

TM

P P E E P E

P P P P E P

P P P P P P

P P P P P P

(Company) Registration Quality Policy List of Objectives List of Indictors Monitoring Procedure Management policies

C C E E

D P P P

P P P P

P P P I

Technical Policies Quality Plan Quality Records Report

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EP

SEC

Resu lts

Q UAL IT Y MANAGEMENT SYST EM GUIDANCE

Figure 8 Milestone 2: Management

Step

 Action

HL

QM

TM

EP

SEC

Resu lts

1 2

Introduction Workshop Conflict Analysis

D D

E E

P P

P P

P P

3 4 5

Organisational Structure D Management Commitment D Clinical interpretation D Responsibility Technical Responsibility D Quality Responsibility D Job Descriptions D Final Check C Final Report C

E E P

P P E

P P P

P P P

 Agend a and Min utes Structure, Process, Outcome Analysis, Risk Matrix Organisation Chart Commitments in writing List of Responsibilities

P E E E E

E P P P P

P P P P P

P P P P I

List of Responsibilities List of Responsibilities CVs, Job Descriptions Checklist Milestones Report

6 7 8 9 10

Responsibili ty Matrix The following matrix is very useful for highlighting the responsible persons and the necessary activities which must be performed in the normal conduct of daily operations for the laboratory. The matrix can be used on its own or integrated into a procedure to illustrate the responsibilities needed for effective implementation Figure 9 Example of Responsibility Matrix for training  Acti vi ty  Asses sm ent of train in g n eeds Creation of a training plan Interview of employees about training  Appr ov in g the t rai ni ng pl an Orientation o f new s taff  Technical training and exchange of experiences (seminar, staff experiences) Control of training activities

Key HL – Head of Lab QM – Quality Manager TM – Technical Manager EP – Employee Sec – Secretary

HL

QM

TM

D D P D/E D D

P E P I E P

E I E C P E

D/E

P

C

E - Execute P - Perform/Develop activities C – Cooperate/Assist D - Decide I - Informed

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EP C P C I P P

Secr  C

I P C

Q UAL IT Y MANAGEMENT SYST EM GUIDANCE

Staff competency is key to the quality of laboratory operations and thus the laboratory must also ensure that the personnel they employ are: Trained Experienced and Evaluated (to competently perform the tests which the laboratory offers.) • • •

To ensure that well-trained and competent personnel are recruited the laboratory must develop procedures which aim to: Establish criteria for recruitment of staff  Develop appropriate job descriptions Ensure that relevant qualifications are included in job descriptions Develop orientation and continuing education programmes • • • •

 Additionally, new and re-assigned staff must be properly supervised and trained before they are allowed to perform tests on client samples. Competency evaluations should be performed and documented. These records now serve as proof of the laboratory’s confidence in the staff’s ability to perform testing independently. The laboratory can use several different techniques for evaluating competence. These can include but are not limited to: Testing of unknown samples Testing using reference materials, and Testing of replicate samples • • •

Up to date training records must also be kept to prove that ALL staff have undergone initial orientation, competency evaluation and participate regularly in continuing education. This can easily be kept in a separate training file developed for each staff member (ISO/IEC 17025 Clause 5.2 Personnel). Repeat the action plan format for each of the milestones (Figure 6 The Twenty Milestones ) above and share it with staff. This can comprise the majority of the Lab’s quality plan, clearly outlining what is to be done and by whom.

1.8 CONTINUOUS QUALITY IMPROVEMENT QUALITY SYSTEMS PLANNING 

The ‘Continuous Quality Improvement’ process uses established incremental quality management techniques to constantly improve processes, products and/or services provided to internal and external customers towards achieving higher levels of customer satisfaction. Continual improvement of the laboratory, its staff, and facilities and of course the QMS is vital to the success of a laboratory’s accreditation effort. A strong Quality Plan facilitates effective communication with the parent organization, laboratory staff and clients about the laboratory’s

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Q UAL IT Y MANAGEMENT SYST EM GUIDANCE

quality goals and operations. The purpose statement may be generated by using goals or objectives previously defined by the parent organization and/or the laboratory, for example, in Strategic planning. This will give guidance to decision making as the Plan is developed and implemented.

What is a Quality Improvement Plan? 

 A written description of the organization’s quality improvement program that has been approved by the management and is then periodically reviewed and updated, as necessary.

What is a Purpose Statement?

 A purpose statement will give guidance to the development and implementation of a quality plan. Quality principles previously defined by the parent organization and/or the laboratory in, for example, a strategic plan, can provide a foundation for the formulation of a purpose statement.

How will a Quality Plan Benefit the Laboratory?  • • •

It provides documentation of your commitment to quality improvement It enables your laboratory to more efficiently use the resources available It assists the staff and management to meet the requirements of accreditation bodies

How is a Quality Plan Developed? 

There are several approaches to the development of quality plans, as there are for the development of business plans. Figure 10 below illustrates how the Plan-Do-Check-Act (PDCA) quality improvement model is applicable to the laboratory’s quality planning and improvement process and Figure 11 goes even further to outline an example of a quality plan drawn up by a laboratory that is seeking to achieve accreditation.

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Q UAL IT Y MANAGEMENT SYST EM GUIDANCE

Figure 10 The PDCA Model fo r QMS Improv ement

PLAN  Act ions

 Acti on s i n

Define Procedures

Theory

Plan/Determine what will be done

Staff responsible

Means of Verification

How frequent? Who is accountable?

DO  Acti on s i n

Initiate Activities in plan

Practice

Perform processes Gather data on performance Execute training or improvement programs

CHECK Review

Monitoring and evaluation of trends

and

Who is responsible for summarizing, reviewing and reporting Report results to the Quality Committee

Evaluation

How will this activity be considered for the purposes of detecting patterns of problems and opportunities for improvement, undertaking quality interventions and corrective actions

 ACT Sustainable

Identification of indicators

 Acti on s

The plan is modified as necessary The process is implemented

 A quality plan should clearly identify the laboratory’s overall quality goals and the purpose of the quality improvement effort. The plan should also detail the desired outcomes of the laboratory’s quality initiative and the activities that must be undertaken if these outcomes are to be realized. Figure 11 outlines some of the outcomes and activities that a laboratory preparing for accreditation may want to include in their quality plan.

Page 24 of 85

Q UAL  UAL IT Y MANAGEMENT SYST  SYST EM EM GUIDANC GUIDANCE E

Figure Figu re 11 Exa Example mple of a Qua Quality lity Project Project Plan Ob j ec t i v es

Su c c es s Meas u r es

Ver i f i c at i o n

Assu mp t i o ns

Customers have increasedd confidence increase and are satisfied with reliable services

Less Customer complaints

Evaluation Record of customer complaints

Customers are willing to continue working with the organization

More requests for services/products

Client request data

Services offered meet the customers’ needs

On site visit conducted by  Accreditationn  Accreditatio  Assessors  Assess ors Non conformance report prepared with findings of root cause analysis

 Assessor  Assess or report

Lab pays Accreditation Accreditation fees fees

Non conformance report and supporting records

Root cause analysis finds and eliminates non conformances

Goal

Purpose Laboratory achieve achievess accreditation

Outcomes 1)Accreditation action 1)Accreditation plan prepared prepared and responsibilities identified  2) Quali Quality ty Manual written and approved  3) SOP SOPs s wri tten and implemented 

4) Internal Internal Audit s performed 

Staff trained in QMS, 20 Milestones, writing documents

Quality system group trained and staff sensitized

 Action plan prepared and approved

Quality Manual written according to ISO Standard requirements  Administrativee and  Administrativ Technical procedure manuals prepared and implemented  Audit program, schedule and reports prepared annually

 Approved and Issued Quality Quality Manual

Quality Manager appointed

 Approved and and Issued Procedure Procedure manuals

Consultant provides complete documentation service

Inte In tern rnaal Au Audi ditt pla plann ap appro rovved

Inte In tern rnaal Au Audi dito tors rs tr traain ined ed

Inputs  Act iv ivitities ies Outcome 1: Accreditation Acti on plan prepared

Determine status of Determine QMS  QM S  Arrange training of staff  Acquire standard and determine scope 

Ho w

Wh o

Wh en

As sum pt i on s

Do lab self  Assessment  Assessment Do training needs  Assessment  Assessm ent Purchase standard and review testing scope

Quality Manager  Executive Management Management

First QMS action plan prepared While preparing action plan While pre preparing action plan

Laboratory can get Management commitment to process

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Outcome 2: Quality Manual written and approved Ho w Perform a GAP analysis  Prepare report based on findings  Prepare RIPOF Analysis for Qualit Qualit y team 

Wh o

Wh en

Ass um pt i o ns

What do you have? What do you need?

Qual Qu alitityy Man Manag ager er

Firs Fi rstt mont monthh of act actio ionn plan With Wi thin in tw twoo wee weeks ks of GAP Analysis

Laboratory can get Management commitment to Management process

What is missing?

Qual Qu alitityy Man Manag ager er

With Wi thin in tw twoo wee weeks ks of GAP Analysis report

Ho w

Wh o

Wh en

Ass um pt i o ns

Develop policies, processes and procedures Improve existing policies, processes and procedures Prepare/obtain template for Quality Manual Develop policies required by standard and Organization Write Quality Manual

Quality working group

 At working group group sessions

Quality Manager has sufficient knowledge to guide team

Quality systems review group

 At QMS review meetings

Qual Qu alitityy Ma Mana nage gerr

Afte Af terr GAP GAP Ana naly lysi siss

Qual aliity Mana nagger

At QMS QMS Doc ocuument writing meetings

Qual Qu alitityy Ma Mana nage gerr

At Do Docu cume ment nt wr writitin ingg meeting

Prepare template for SOPs

Qual aliity Mana nagger

Aft fteer GAP GAP Ana naly lyssis

Distribute SOP Template

Qual aliity Mana nagger

At QMS QMS Doc ocuument writing meetings

Write  Administrative procedures as needed Prepare template for Test methods

Persons responsible for executing procedure Quality Ma Manager

One procedure per week at Document writing meeting

Distribute Template

Qual aliity Mana nagger

At QMS QMS Doc ocuument writing meetings

Write Test Methods as needed Prepare master list of documents

Persons responsible for procedure Quality Manager

One procedure per week at Document writing meeting Updated as procedures are

Qual Qu alitityy Man Manag ager er

Outcome 3: SOPs SOPs writ ten and imp lemented

Fill in the t he GAPS GAPS discovered in the Gap analysi s 

Write Quality Manual 

Writ e QMS Write Administrative Procedures

Writ e QMS Write QMS Test Test Procedures

Develop record Management Mana gement system  sys tem 

Pagee 26 of 85 Pag

After GA GAP An Analysis

List of policies prepared and availabl ava ilablee for use

Lis istt of of Pro Procced eduure ress pre reppare redd and av avail ailab able le for use

Reference do documents available

Q UAL  UAL IT Y MANAGEMENT SYST  SYST EM EM GUIDANC GUIDANCE E written

Outcome 4: Internal Audits performed Ho w

Wh o

Wh en

As s u mp t i o n s

Review system for compliance

Perform internal audit

Trainer/Quality Manager 

 After GAP Analysis Analysis

Internal Audit team team trained and experienced

Evaluate system routinely 

Identify opportunities for continuous quality improvement Prepare Corrective action plan

Management review team

 After internal Audit, Audit,  After Management Management review

Management team participate in meeting

 Auditee and and Quality Manager 

 After the Internal audit audit

Non conformances conformances are easy easy to solve

Correct non conformances 

 A flowchart of the QMS implementation process helps to simplify and clarify the laboratory’s planning and quality improvement process. In Figure 12 below, key activities, functions, duties and responsibilities critical to the QMS planning and implementation process are detailed.

Page Pa ge 27 27 of 85

Q UAL  UAL IT Y MANAGEMENT SYS SYST  T EM EM GUIDANCE GUIDANCE Figure 12 Diagra Diagram m of QM QMS S Process Process Activiti es

Staff functions/Respo functions/Responsibilities/Duties nsibilities/Duties Clerical/administrative Clerical/admin istrative functions Technical functions, Management functions Qualit Qua lit Man Manaa er fun functi ctions ons

Clerical/Administrative Functions Prepare lists of Reference laboratories Quality Control materials Suppliers, Equipment Staff  Tests offered

Arrange filing for Package inserts Reagent certificates Reports Other records

Activities: Purchase the standard (ISO 17025) Prepare staff orientation program, Assign computer access Prepare a Safety plan (to include evacuation plan, fire and biological hazards) Prepare an accident report form Set up housekeeping schedule and write procedures

Technical Functions: Compile list of tests done, Collect and compile technical procedures procedures Review technical procedures to ensure that they are appropriate and complete Prepare equipment records using equipment list, maintenance plans

Managerial Functions: Review report format for conformance to standard Prepare waste disposal plans, Arrange laboratory security Decide on the Quality Policy  Appoint a Laboratory Laboratory Director; Director; Appoint Appoint a Quality Manager Manager (however (however named), named), Set Management review dates

Quality Manager Functions: Prepare audit plan, and audit report forms, train internal auditors Set quality indicators e.g. turnaround times Review technical procedures to ensure they are appropriate and complete Document any missing (outstanding) procedures Set Retention time for - Records, Sample Sample storage

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Q UAL IT Y MANAGEMENT SYST EM GUIDANCE

1.9 DOCUMENTATION PLAN 

 As described above, the ISO/IEC 17025 Standard require that the laboratory develop a comprehensive Quality Management System that controls the daily operations of the laboratory supported by a considerable amount of documentation. Every clause in these standards has specific requirements in terms of the policies, procedures and records required to prove to management, staff and clients that activities have been executed as needed. There are several approaches or tools used to facilitate a laboratory’s development of the QMS in preparation for accreditation. One such tool is entitled ‘The Twenty Milestones to Accreditation”. This can be used to define and track the documentation required for compliance with relevant standards. Figure 13 summarizes the documents needed to meet the requirements of the ISO/IEC 17025 standard using the 20 Milestones tracking framework. Figure 13 Documentation plan Purpose: To facilitate the development of the Quality Management System by the Laboratory in preparation for Accreditation Milestone 1. Quality Policy

Clause # 4.1, 4.2

Legal Entity with Quality policy, Quality Goals and Quality Indicators, General Policies

Docs required Policies and procedures 4.1.5c, 4.1.5d, 4.2.3 Company registration, Quality Policy statement and Goals (SMART), Quality indicators

2. Management

Conflict of Interest Analysis and Commitments from Top Management, Medical, Technical and Quality Responsibilities/Job Descriptions

4.2, 5.1

Action (Output) required

Rec or ds pr od uc ed

Write policies, prepare procedures

Policy and Procedures

Register company,

Registration certificate,

Develop Quality Policy statement and Quality Manual Develop Quality Team, Host team meeting and incorporate writing group

Quality Policy statement, Indicator Monitoring tools List of team members and meeting minutes

4.2.5 (Program), 5.1.1 Policy

Write policy and procedure

Policy and procedure

Job Descriptions QM & Deputies

Develop Job Descriptions, Appoint Quality Manager,

Job Descriptions,

Confidentiality statements,  Application for Registration

Meeting with Ministry, Develop or review Org Chart

Organization Chart

Page 29 of 85

Signed Contracts, Signed Confidentiality Statements Meeting Minutes Organization Chart

St at us

Q UAL IT Y MANAGEMENT SYST EM GUIDANCE

3. Scope Description of Scope (Procedures/Equipment/Personnel and Analysis of all specific Requirements)

5.2.10, 5.3.11, 5.3.12, 5.3.13 5.3, 5.4, 5.5, 5.7

Prepare procedures

Procedures

Revise procedures, decide on scope (selection of tests), Check Equipment and Maintenance records,  Authorize personnel and perform competency evaluation

Updated Technical Procedures

4.3, Policy and procedures

Prepare policies and procedures

Policies and Procedures

Quality Manual

Develop Quality Manual

Quality Manual,

Develop CQI Plan

Plan for Improvements,

Technical Procedures, List of Equipment, List of authorized personnel, QC Requirements, Competency Evaluation Forms

4. Quality System

4.2, 4.3, 4.12

Quality Manual Structure, Continuous Quality Improvement

CQI Plan SOP for SOPs

5. Procedures Work Procedures /Control of Documents and Records

4.3, 4.13, 5.5

Prepare safety program, waste disposal plan

Validation records Training and Competency records Equipment and Maintenance records

SOP,

Develop technical requirements

Safety Manual

4.3.1, 4.3.2, 4.13.1, 4.3.13

Prepare policy and procedure

Policy and procedures

Retention policy

Develop Document Master log,

Updated Master Document log,

Develop retention policy,

Record management procedure, Retention policy,

Document control procedure Document master Log

6. Test Instructions

5.4,

5.4.

Instructions for Equipment and Procedures

5.5

Equipment Records Technical Procedures Validation procedure

Prepare Archive system, Prepare Backup system for data, Develop record management system

Disposal plan

Data Backup medium (CDs, etc),

Prepare policy and Procedures

Policy and Procedures

Develop log of Equipment,

Equipment Records,

Document or reference applicable test methods, Prepare Maintenance logs, Perform method validation,  Analyze QC data and trends, Prepare reagent lists, Execute training of staff 

Page 30 of 85

Technical Procedure manual, Maintenance and calibration logs, Validation procedure, Validation records, QC Data records, Reagent lists, Training records

Q UAL IT Y MANAGEMENT SYST EM GUIDANCE

7. Sampling

5.4, 5.7, 5.8

5.4. 5.7, 5.8, 5.8, 5.8 (Policies)

Prepare Policies and Procedures

Policies and Procedures

Primary sample collection,

Prepare sample collection instructions,

sample collection instructions,

Sample collection procedure,

Prepare sample collection procedure,

Sample collection procedure,

Result reports,

Perform Workflow analysis,

Result reports,

Prepare Policy and Procedure

Policy and procedure

Contract review procedure

Perform contract review, Evaluate referral labs,

Contract review procedure,

Requisition forms

Conduct meetings of lab advisors

Contract review records,

5.4, 5.8, 5.8, 5.8. (Procedures) Instructions for collecting samples and related

8. Review Contracts

4.4, 4.5, 4.7

Review Quality Manual, Requests,  Advisories, Contracts, Subcontracting labs

4.4.1, 4.5.1 Policy and Procedure

Register of Subcontracting labs

Corrective action reports

Client contracts (requisitions) Register of Subcontracting labs, Meeting Minutes

9. Quality Control

5.6

Reference Methods/Internal and External Quality Control

List of Reference materials QC Data, PT reports Corrective action forms

Perform inventory of reference materials,

List of Reference materials,

Perform QC according to requirements of test procedures,

MSDS Sheets,

Monitor QC data,

QC Data, PT Reports,

Participate in PT,

Root cause investigation,

Investigate bad PT results, determine root cause,

Corrective Action reports

Do corrective actions 10. Validation Verification and Validation of Test Procedures

5.5

5.5.1, 5.5.2

Prepare policy and procedure

Policy and procedure

Validation procedures

Perform validation analysis

Validation procedure

Verify calibrated equipment

Page 31 of 85

Validation records (X, SD, CV, TE, etc)

Q UAL IT Y MANAGEMENT SYST EM GUIDANCE

11. Work Conditions

5.2

 Accommodation, Facilities and Work Environment

5.2.4, 5.2.10 Environmental logs, Housekeeping procedures, Preventive maintenance procedures, Disaster mitigation procedure

Prepare policy and procedure

Policy and procedure

Perform environmental monitoring,

Environmental logs,

Perform preventive maintenance, Safety audit, Facility improvement plan, Ensure proper arrangements for possible disasters

Housekeeping procedures, Preventive maintenance procedures, Preventive maintenance records, Plan for facility improvement, Disaster mitigation procedure

12. Literature

4.3, 5.4, 5.5, 5.8

Check of current Standards and up to date Scientific Literature

4.3.1, 5.4.1, 5.5.1,5.5.2 Reference books (e.g. Journals, kits inserts, instruction manuals)

Ensure current and effective examination procedures are in use,

Examination procedures, Reporting format

Verify suitability of reporting format, Ensure proper document control, Search scientific literature on internet and library, Research innovations in technology

13. Traceability (Calibration) Check of Test Equipment (Calibration, Reference Materials)

5.6, 5.5

5.6,3, 5.5.1 Calibration procedures Calibration certificates List of Equipment List of Reference materials and standards Reference material procedure

Prepare policy and procedure

Policy and procedure

Prepare Calibration logs

Calibration logs

Verify calibration/reference materials

Calibration Certificates

Calibrate measuring devices (test specific) Produce secondary reference materials, Prepare calibration curves

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Certificate of  Analysis, MSDS Calibration curves Secondary reference materials procedure

Q UAL IT Y MANAGEMENT SYST EM GUIDANCE

14. Measurement Uncertainty

5.4

Training in Estimation of Measurement Uncertainty

5.4.6 Procedure for Measurement uncertainty

Facilitate measurement uncertainty training courses,

Procedure for Measurement uncertainty,

Calculate Measurement uncertainty, where applicable

Measurement uncertainty budget,

Monitor QC data and analyze,

Statistical results and calculations

Perform statistical  Analysis on data 15. Training

5.1

Job Descriptions, plan and Implementation of Training programme for the Lab Staff 

16. Monitoring

Monitoring System and Internal  Audit plan and Schedule

4.14, 5.6, 4.9, 4.12, 4.6

5.1.1, 5.1.8 (Policies)

Prepare policies

Policies

Job descriptions

Job descriptions

Training plan

Prepare Job Descriptions,

Continuing Education plan

Determine criteria for selecting staff 

Continuing Education plan

Competency evaluation forms

Perform competency evaluations

Continuing Education materials

Prepare Policy and Procedures

Policy and Procedures

Evaluate procedures and testing process,

Procedure for identifying non conformities,

4.9.1, 4.9.2, 4.9.3, 4.6.1 Policy and Procedures Procedure for identifying non conformities Procedure for evaluating suppliers Procedure for purchase and verification of supplies and services

 Appoint responsible person for dealing with non conformities in testing, Design or obtain effective Information Management system (e.g. LIS) Evaluate all suppliers  Appoint person to verify purchased items

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Training plan

Record of non conformities, Supplier evaluation Procedure, Supplier evaluation register, Procedure for purchase and verification of supplies and services

Q UAL IT Y MANAGEMENT SYST EM GUIDANCE

17. Internal Audit

4.14, 4.10, 4.11

Training of Auditors and Internal  Audit, Audit Report

4.14.2, 4.10.1, 4.11.2 Procedures

Prepare procedures

Procedures

Internal Audit procedure

Select and Train internal auditors,

Corrective action procedure

Prepare criteria for  Auditors

Internal Audit procedure, Internal  Auditor criteria,

Preventive action procedure

Prepare internal Audit schedule

Internal Audit schedule,

Conduct internal audits

Internal Audit report,

 Address all non conformances, and determine root cause

Corrective action procedure,

Investigate opportunities for Preventive action 18. Complaints

4.8

Complaint Management, Cause  Analysis, Corrective and Preventive Actions

19. Review Documents

Preventive action procedure and plan

4.8 Policy and Procedure

Prepare policy and procedure

Policy and procedure

Resolution of complaints procedure

Review complaints, Investigate root cause,

Feedback forms, Complaints forms,

Perform corrective actions

Corrective action reports,

Develop preventive action report

Preventive action report

Perform scheduled reviews of documentation as required,

Updated procedures,

Document control procedure, Document Master log Record retention policy

Management Review, Corrective  Action plan, Implementation and Control of Effectiveness

Corrective action report,

4.3, 4.13

Internal Review of Quality Documentation (Manual, Procedures, Forms, Lists, Technical and Quality Records)

20. Management Review

Training certificate,

4.15

Ensure obsolete documents are removed from general use and archived

Updated document master log Record retention policy, List of obsolete documents

Prepare procedure

Procedure

Management review procedure

Determine date for MR and invite attendees,

Management review procedure

Meeting documents (e.g. Agenda, reports, etc)

Prepare reports for Management review,

Meeting documents (e.g. Agenda, reports, etc)

Execute MR, Prepare Action plan coming out of discussions

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Management review Schedule Meeting minutes and  Action plan

Q UAL IT Y MANAGEMENT SYST EM GUIDANCE

CHAPTER 2 ELEMENTS OF THE QUALITY MANAGEMENT SYSTEM

2.1 THE QUALITY PLAN Developing a quality plan is comparable to developing a business plan. This plan will serve as the laboratory’s blueprint for its quality management program and should outline the process and details used to meet your objectives. It constitutes a concrete statement of purpose which facilitates communication among the laboratory’s management, staff and clients and will give guidance to effective decision making. Requirements for effective quality program functionin g: There is a written description of the quality program. The program is reviewed annually and modified as appropriate.  A designated senior staff member is responsible for the quality program implementation. Top management has substantial involvement and participates in quality improvement activities. There is an active quality systems committee with a defined role, structure and function. The scope of the quality improvement program is comprehensive. The quality assessment process and improvement are systematic. • • • •

• • •

These requirements dictate that the followi ng elements should be addressed in your qualit y plan:  • •

•

•

• •

•

•

•

The Quality Program’s purpose, scope, goals and objectives Completion of the quality management system’s structure including a description of roles for each staff member and function Description of the process to be used for gathering feedback and conducting satisfaction surveys Description of the methods to be used for identifying non conformities, finding the root causes and performing corrective and preventive actions Development of a listing of the staff employed, tests performed and equipment used Creation of records for each instrument and a description of how the laboratory will reasonably ensure that its professionals are qualified to provide testing services to customers Identification of a mechanism to ensure that the Quality Systems Committee’s functioning is conducted in a manner that protects the confidentiality and impartiality of the laboratory’s clients Development of a process to be used by the Quality Systems Committee to present, recommend and seek approval from management. Development of a process to be used by the Quality Committee to report to the top management and staff 

Figure 14 provides a more detailed breakdown of the components to be considered in the process of developing and implementing your quality plan and program. Page 35 of 85

Q UAL IT Y MANAGEMENT SYST EM GUIDANCE

 A critical initial step is the formation of a laboratory team that involves staff and management in the quality improvement effort. Quantifying resources and devising strategies for mobilizing what’s needed is also critical to the laboratory’s ultimate success. Identifying clear goals and objectives, conducting periodic audits and continually taking corrective action is fundamental to success.

Figure 14 Quality Plan Outline WHAT IS The POLICY

The PLAN

The PROGRAM

Document expressing management’s commitment to Quality in the laboratory

The strategy for developing your laboratory Quality Management plan and program

The details and content of your Quality Management system

 A. Develo p the Pl an

B. Develop the Program

1. Form a team (workers and management) 2. Analyze firm’s compliance with the standard 3. Review laboratory scope 4. Develop Quality objectives goals 5. Obtain senior management commitment 6. Develop a budget 7. Obtain necessary resources 8. Develop rules, practices & procedures 9. Get a professional review & evaluation 10.Quality System Committee 11. Decide on Responsibilities 12. Set timelines for the various tasks

1. Quality Policy Statement 2. Develop Training, Orientation & Communication 3. Assess method for documenting the QMS 4. Design templates and documentation 5. Develop QMS policies to reflect lab objectives 6. Schedule individual departments and positions for development of policies and procedures 7. Start to develop procedures (SOPs) with each department 8. Report to management any risks and improvement opportunities 9. Document any Quality Corrective Action Requests that might be identified (identified risk areas that require management attention and improvements)

C. Implement t he Program 1. Decide if a consultant is required for the project 2. Prepare a project plan an allocate resources 3. Assess an appropriate budget based on equipment, training, time and personnel required 4. Seek approval from management to procure required resources and attend any training 5. Instruct employees in their responsibilities 6. Provide guidance and follow-up

D. Evaluate the Program 1. Continue to audit, review and assess the QMS at the agreed time intervals 2. Continue to assess risk areas and identify improvement opportunities 3. Continue to review policies and procedures and make amendments as required 4. Continue to measure effectiveness of QMS to laboratory performance, review key elements frequently 5. Identify weakness in the program 6. Ensure deficiencies corrected promptly

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2.2 STRUCTURING YOUR QUALITY MANAGEMENT SYSTEM The first step in the structuring of your quality management system is achieving consensus among key laboratory stakeholders - management & staff - on what processes and procedures are needed to support the policies required by the standard (Appendix 2). Responsibilities for the development of these documents should then be assigned. As each of these clauses is addressed, you should assess the extent of your laboratory’s compliance with the standard and seek the resources needed to address the gaps and to fully comply. A periodic audit of progress towards the goal of compliance is helpful to ensure that resources continue to be focused on the most important gaps. Note There are clauses of the standard not requiring a writ ten policy or pr ocedure, but these must be fully complied with to ensure the efficiency and effectiveness of your syst em.

What should you incl ude in documentation? 

Efficient and effective documentation comprise the foundation of your QMS. The QMS itself must include within its control all of the activities of the laboratory that influence or have the potential to influence the validity of the test results or the satisfaction of clients. Hence some questions that you may ask are: ●

●

If the activity were to be conducted incorrectly or inadequately would it impact the result? Can this problem occur under reasonably foreseeable circumstances if it were not controlled within the QMS?

If the answer to any of the above questions is yes, the activity needs to be controlled within the QMS.  All activities within the QMS need to be documented to ensure effective control over the activity concerned. Staff must be familiar with documentation and all documents must be available when needed, must be complete, effective, easy to use, and consistently used whenever required. Note The name of the organization should at least appear on the first page of all documents developed by the laboratory.

The laboratory’s QMS documentation may include both internally and externally generated documents. For most laboratories, the QMS will include both documentation generated in the laboratory (for example the quality manual, administrative procedures, quality plans, technical procedures, calibration procedures, reports, certificates), documentation used within the laboratory but generated outside (for example contracts, requests, standards, specifications, client correspondence), and records (for example worksheets, log books, environmental control records, training records, test reports). The status of a laboratory document at any point in time must be recorded and easily accessed. Figure 15 below illustrates the possible status of a document within the laboratory’s QMS.

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Figure 15 Documentation Status

2.3 THE QUALITY POLICY STATEMENT The Quality Policy statement defines the laboratory’s overall philosophy with respect to quality and the aim or expected outcomes from the Quality Management System (Clause 4.2.2 of the ISO 17025). The Quality Policy statement is documented in the quality manual. This statement is used to establish and reinforce the Management’s commitment to the quality effort. Quality must enjoy the same high priority as the laboratory’s or parent organization's other major goals. The policy should be Issued under the authority of the Laboratory Director  Present in the quality manual Clearly stated in terms that are easily understood Posted in a conspicuous place and distributed and explained to all employees Followed by every employee, including senior management, in all work activities Reviewed annually to keep it up-to-date and in tune with current activities of the laboratory and with the latest legislation.      

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The policy statement should be readily available to appropriate personnel shall be concise and shall include the following: 1. the scope of service the laboratory intends to provide; 2. the laboratory management’s statement of the laboratory’s standard of service; 3. the laboratory management's commitment to good professional practice and to the quality of its testing and calibration in servicing its customers; 4. the objectives and purpose of the quality management system related to quality 5. a requirement that all personnel concerned with testing and calibration activities familiarize themselves with the quality documentation and implement the policies and procedures at all times in their work; 6. the laboratory’s commitment to good professional practice, the quality of its examinations, and co mpliance with th e quality management system; 7. the laboratory management’s commitment to compliance with this International Standard and to continually imp rove the effectiveness of the management system.

2.4 THE QUALITY MANUAL AN OVERVIEW 

The Quality Manual contains the laboratory’s quality policy and objectives. The Quality Manual also includes policies (Appendix 2) and general information about the laboratory including the testing services, lists of major equipment, an illustration of the organisational structure, outline of responsibilities and authority. Additionally, it should include how the elements of the QMS are controlled. (All clauses are not mandated by a policy). The quality manual should be used to inform staff members about the policies, and clients about the laboratory’s operation and structure. Confidential information need not be included. No format is mandatory. QUALITY MANUAL BASICS The following should be considered when creating your quality manual: It is the primary or foundation document of a quality management system and must provide a thorough description of the quality management system and its policies The size usually ranges from 20-50 pages although this may vary depending on the size and scope of the laboratory and the amount of information included •

•

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•

•

•

• • •

It may include processes, but does not usually include any administrative and technical procedures. Procedures are referred to in the Quality Manual where appropriate (ref: Chapter 2 Section 2.5 - Document control requirements) It will reference your laboratory’s supporting documentation: administrative and technical procedures, records, forms, charts, etc. Some of the supporting documentation could be included within the manual or as appendices The Quality Manual should indicate where all documents are located (eg. Procedure Manual) It can be kept in either electronic or paper format It must be easy for authorized personnel to update and easy for staff to access. It is typically maintained and reviewed by a Quality Manager (however named)

STRUCTURE AND CONTENT OF THE QUALITY MANUAL

The exact format, structure and contents of the quality manual are at the discretion of each laboratory. You have the freedom to design your manual in keeping with your laboratory’s size and complexity. The manual must, however, address every clause contained in the standard ISO 17025 or ISO 15189 unless the clause is not relevant to your laboratory (this is rarely the case). If your manual format does not follow the layout/design of the standard then you should provide a matrix that cross references the standard’s clauses to the manual’s layout to facilitate ease of QMS implementation and audits. In developing your quality manual content, remember that your quality management system must encompass all management activities, technical activities and processes relating to quality assurance. Organize the manual as you wish and at minimum include the following:      

Proper identification (title of document, organization name, page numbers)  A brief introduction (overview of the manual)  A description of the organization (name, address, brief history)  A quality policy statement (Clause 4.2.2 ISO 17025) General Policies (as required by ISO/IEC 17025) Policies of the Parent Organisation (e.g. policy on cell phone use)

Figure 16 below illustrates the typical contents page of a Quality Manual.

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Figure 16 Example of Table of Contents for Manual Section Number 

Section Title

ISO Standard Cross Reference

Page number 

Introduction Organisational Chart Definitions/glossary of terms Cross Reference table Quality Policy Statement, Mission, Vision General Organisational Policies Personnel Equipment Purchasing and inventory Process control, validation of processes, Internal quality control and Proficiency testing Documents and records Information management Investigation of non-conformities Evaluation (includes the use of quality indicators and internal audits) Continual (process) improvement Service and satisfaction Facilities and safety

Note Everyone in the laboratory must prov ide input into t he development of the Quality Manual, and it is essential that the entire staff is familiar with, and understands the contents of the Quality manual and its related documentation

MAINTAINING THE QUALITY MANUAL

a. The quality manual shall be maintained current under the authority of an individual given

this responsibility by laboratory management, this could be the quality manager (however named) (ISO/IEC 17025, clause 4.1.5) b. All laboratory personnel shall be instructed on the use and application of the quality manual. c. The quality manual should be reviewed, approved and updated regularly, at a minimum annually by the individual given this responsibility by top management. d. All amendments to the manual must be authorised by agreed personnel. Figure 17 that follows outlines an example of a documented amendment table

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Figure 17 Example of Quality Manual Amendment table REVISION NO.

DA TE OF CHA NGE

A UTHORISED B Y

0 1 2 3

4/10/09 25/11/09

Quality Manager Quality Manager

PA GE A ND TEXT A FFECTED

Initial Release List of Tests amended Page 4

Note This type of table reminds personnel to ensure that they are using the most up-to-date version of any document and can be placed at the front of the binder.

2.5 DOCUMENT CONTROL OVERVIEW  

Your quality manual and ALL do cumen ts in your QMS will be considered controlled documents (ref: Appendix 10–document control checklist). Changes to documents must be controlled to prevent irrelevant and unauthorised changes being introduced. The standard requires that documents shall be reviewed and approved by the original reviewer(s) or by other authorized staff thoroughly conversant with the background information on which the original documents were based. In order to ensure that documents can be issued and withdrawn efficiently and accurately, a control mechanism - such as a MASTER LIST - should be developed to record and identify documents, their revision status and the document location. Requirements for document control are as follows (ref: ISO 17025 Clause 4.3): 1. Laboratory management shall define, document and maintain procedures to control documents and records. Documents and records may be maintained and stored on any appropriate medium that maintains its integrity (Paper or electronic). 2. Authorized documents shall be available at all locations where operations essential to the effective functioning of the laboratory are performed (e.g. within easy reach of the work areas in the laboratory). 3. All documents issued to laboratory personnel as part of the quality management system shall be reviewed and approved for use by authorized personnel prior to us e. 4. A MASTER LIST, also referred to as a DOCUMENT CONTROL LOG, that identifies the current valid revisions and their distribution, must be maintained. An example of a master list is provided in Figure 18 below.

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Figure 18 Example of Master list (Document control log ) Document number 

Document name

Issue Date

 ACME – P001

Document control procedure

1/4/09

Edition no .

Prepared  Approv ed by by

Revision status

Revision date

31/3/10

Retention time

Issued to

John Smith, Senior Technologist

5. Invalid or obsolete documents shall be promptly removed from all points of use, or otherwise assured against inadvertent use. 6. A retention period for out of date documents shall be identified (this is defined by the country’s regulations or laboratory policy) 7. Retained or archived out of date documents shall be appropriately identified to prevent their inadvertent use (for example by labelling as obsolete) 8. Only currently authorized versions of appropriate documents must be available for active use at relevant locations.

ELECTRONIC DOCUMENTS 

Electronic files comprise Quality System documents, data from tests, staff records, inventory files and client information among others. These must be protected from unauthorised changes and deletions. Password protection, administrator privileges and limited access to confidential information are techniques that can be employed to ensure the protection of important electronic files. DOCUMENT IDENTIFICATION 

Unique identification numbers on documents should be easy to use, with a simple format followed throughout the QMS and communicated to everyone involved in their use. An example of a numbering system follows:  All documents relevant to the quality management system shall have a unique identification, including: a. Title (simple and relevant to the procedure) b. Edition and/or current revision date or revision number (e.g. Edn 1 Revision 2) c. Number of pages (e.g. Page 1 of 6) d. Authority for issue (not necessarily a signature, e.g. Authorised by…) e. Location of documents (including electronic documents) EXAMPLE OF A DOCUMENT IDENTIFICATION SYSTEM 

The following is an example of a numbering system used by the GGMLab: GGMLAB–X-000 P - Standard Operating Procedures (GGMLAB-P-001 series) R – Records (GGMLAB-R-001 series)

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T – Test method Documents (GGMLAB-T-001 series) E – Equipment instructions (E-001 series) L – Lists (L-001 series) F – Forms (F-001 series)

EXAMPLES OF HEADERS AND FOOTERS 

Figures 19-23 that follow present a variety of document identification examples including examples of headers and footers that meet the standard’s requirements for document identification. Any of these can be adapted for your quality manual and related documentation in your Quality Management System. Note that pagination can either be continuous or sectioned. Additionally, you should include a revision history for each individual policy and/or procedure as part of a standard header or footer. The revision history indicates the date when the document was last reviewed and what the current version is. This ensures that all persons have the same version and obsolete versions of documents are not used in the laboratory.

Figure 19 Example of Header/Footer comb ination Header :

Good Test Laboratories Quality Manual

Section 0.0 TABLE OF CONTENTS

Page 1 of 1 Revision date: Jan 31 2009

Footer :

Prepared by  Approved by

Senior Technician Lab Manager 

Issue Number  Issue Date

2 Jan 31, 2005

Figure 20 Example of a Header  Section 1.0 Quality Manual Table of Contents Revision 2

Date Issued: 21/01/09  Authorized by: Lab Manager  Approved by: Quality Manager  

Page 1 of 1

Figure 21 Example of a Footer  Prep Date: 05/11/10, Revision Date: 09/01/21  Authority for Issue: Quality Manager 

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Quality manual

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CONTROLLED AND UNCONTROLLED DOCUMENTS 

 All documents in the QMS should have some label or mark indicating whether they are controlled under the Document control system. Figures 22 and 23 below provide examples of acceptable control labelling. If the document is no longer under the control of the person responsible for Quality or the document has left the supervision of that person it is considered to be uncontrolled. For example, a document sent to a person outside of the lab for review, for information, as a resource document, etc. This is applicable whether the QMS documents are in electronic or paper format. If your quality manual and procedures are primarily electronic documents where uncontrolled printed paper copies may exist, you can consider adding footers either electronically or you may use a coloured rubber stamp on the bottom of the printed pages to identify these documents Figure 22 Example of Document control notes

NOTE: This is a CONTROLLED Document, as are all management system files on this server. Any documents appearing in paper form are not controlled and should be checked against the server file version prior to use.

Notice: The hard copy of this Document may be used for reference purposes only. The on-line copy must be considered the current document

Figure 23 Example Header/Footer with Document control note

Header : Good Test Laboratory Status: Approved

Quality Manual Section 5.1 Title: Document and Record Management Policy

Footer: Prepared by: Senior Technician

 Ap prov ed b y: Lab Manager 

Page 1 of 2 Version 2.0 Rev. Date: 2006/08/26 Effective Date: 2005/08/26

NOTE: This is a CONTROLLED document for internal use only. Any documents appearing in paper form are not controlled and should be checked against the document (titled as above) on the file server prior to use.

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2.6 RECORDS The Standard requires that the Laboratory keep detailed records of all the activities it performs as proof that the activity has been completed, the data is correct or corrective actions have been performed to improve the process. Examples of laboratory records required by the QMS are data sheets, purchasing documents, training records, raw data from testing, sampling records and equipment maintenance records.  All records must be kept in a safe location that allows them to remain legible and easily accessible and able to be disposed of in a manner that maintains confidentiality. A reasonable retention time, taking into account lab operations and storage options, should be established for each record. An example of an appropriate record management database is illustrated in Figure 24 below

Figure 24 Example of Record Management Database Record Management Database

Name of Record

Type of Record

Date created

Retention time

Date deleted

Back up

Created by

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Entered by

Storage Location

Reference no

Comments

Q UAL IT Y MANAGEMENT SYST EM GUIDANCE

CHAPTER 3 PROCEDURES 

3.1 PROCEDURE MANUAL It is suggested that the quality system procedures be compiled into a manual to instruct those involved in managing the process of transforming laboratory policies into laboratory outcomes i.e. who, what, when, where, why and how the policies and objectives expressed in the quality manual are to be addressed and achieved. Your procedure manual outlines one or more procedures arising from the relevant policies laid out in the quality manual. These define how individuals or groups of people in the same or different departments will work to meet management’s stated objectives for quality. The quality system procedures must address each requirement of the relevant clause of the standard and collectively they will define the organisation’s administrative operation, from receiving an enquiry to delivering a completed product or service. Note It should be noted that the procedures do not have to be assembled into a manual, but it is qui te likely that one master set will be in th e form of a manual, to facilitate control.

3.2 OVERVIEW OF PROCEDURE WRITING Several procedures may be required in the conduct of any of the processes conducted in the lab that arise from the laboratory’s stated policies. If you do not have a written procedure, you may start by simply writing down how you actually carry out the activity and then verify it works as you have described. This outline may be prepared as a flow chart. Flow charting is a powerful technique for generating a description of processes and is usually a good way to start (ref: Section 3.8). In documenting your administrative and technical procedures you may use the following steps: Step 1 Produce an outline of the procedure which should simply list: I. What is done? II. When it is done? III. Who does it? IV. How is it done?  All other parts of the procedure can be included at a later time. This outline may be prepared as a flow chart. Step 2 When the procedure outline has been prepared it must be reviewed by several persons who have to use it. The reviewers must check to make sure that the outline adequately describes what is being done.

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Step 3 Once the details of the procedure are listed, then the document should be reviewed following the questioning technique to evaluate the efficiency of the procedure outlined in Figure 25 below. Figure 25 The P’s of Procedure writing Purpose

Place

Progression

Person

Process/Method  

What is done?

Where is it done?

When is it done?

Who does it?

How is it done?

What shoul d be done? Why is it done?

Where should it be done? Why is it done there?

When should it be done? Why is it done then?

Who should do it?

What else might be done?

Where else might it be done?

When might it be done?

How should it be done? Why is it done that way? How else might it be done?

Why does that person do it? Who else might do it?

Step 4 When the procedure has been reviewed and is found to be adequate, the team should produce a draft procedure that is circulated for comment and, as well, should set and enforce a deadline for responses. Step 5 Comments are reviewed, suggested changes made and the procedure can then be issued for use.

3.3 ADVICE FOR WRITING PROCEDURES •

•

•

•

•

•

Procedures are short documents and should not exceed three pages if possible. If the procedure is too long it should be split into two separate procedures In each stage of a procedure each action should have a person responsible, e.g. Clerk completes the request form Procedures should be written with an eye to auditing . At every point the question should be asked. How do you prove this has been done? Procedures should be written in simple direct language, long sentences or unfamiliar words cause misunderstandings and misinterpretations The language used should be precise, there is no room for interpretation of the meaning of a word in a procedure Use verbs (active words) in the procedure description

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3.4 ADMINISTRATIVE PROCEDURE OUTLINE For Administrat ive Quality System Procedu res, the following headings are applicable. 3.4.1 Title 

 All procedures should have a title that clearly states the intent of the document. The title should be concise and descriptive. E.g. “Procedure for Purchasing Supplies and Services.” Because a procedure describes how to do something, the title should use direct language to declare what is being done to what. A procedure titled "Laboratory Equipment" is not descriptive of the procedure's content; a more appropriate title would be, "Procedure for Purchasing of Laboratory Equipment." 3.4.2 Purpose 

This section would outline the intention of the document. If a procedure were being written for procedure writing the section would read as follows: The purpose of this procedure is to define the steps to be taken in writing a procedure, to ensure that all procedures written have been adequately reviewed and are consistent. 3.4.3 Scope 

This section would outline the limits of applicability of the procedure. This section would indicate the function, department or group to which the procedure is applicable. This procedure is applicable to all staff of the stores department and is to be applied to all new equipment delivered to the laboratory. 3.4.4 References 

This section would list all the other documents referred to in the procedure or which have a bearing on the activity. These could be legislation, standards or associated procedures. 3.4.5 Definitions 

This section would list definitions of all acronyms, initials and abbreviations. It would also list definitions of all words which have specific meaning in the context of the document. 3.4.6 Responsi bil ity 

This section would list persons with specific responsibilities under the procedure, Example: “The superintendent is responsible for reviewing all test data before incorporation into the test report.” 3.4.7 Process/Methods (Act ions) 

This section would describe the details of the activity as laid out during the review steps above (Section 3.2 Procedure Writing). 3.4.8 Documents Generated (Records) 

This section would list the documents generated by the procedure.

End of Outline

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Example of an Adminis trative Procedure Prepared By:

Laboratory Technician

Date:

2009.05.01

Reviewed By:  Approved By: Title:

Senior Laboratory Technician Quality Manager Procedure for controlling Documents

Date: Date

2009.05.30 2009.06.01

Purpose To control all quality system documents (internally generated and from external sources). To identify changes made to documents including amendments by hand and electronically. To control documents maintained in computerized systems. To dispose of documents which are obsolete or irrelevant • • • •

Scope This procedure applies to the Quality Manual, all Test Methods, Forms, Standards, Specifications, Work Instructions, Registers and Standard Operating Procedures (SOP’s). The procedure ensures that: authorized editions of appropriate documents are available at all locations where  operations essential to the effective functioning of the laboratory are performed documents are periodically reviewed and where necessary revised to ensure continuing  suitability and compliance with applicable requirements invalid or obsolete documents are promptly removed from all points of issue or use to  assure against unintended use obsolete documents retained for either legal or knowledge preservation purposes are  suitably marked documents are uniquely identified  documents are approved and issued by authorized laboratory personnel  Definitions and Acron yms Quality manual – a document stating the quality policy, quality system, and quality practices of an organization Standard operating procedure (SOP) – a document that specifies or describes how an activity is to be performed. It may include methods to be used and sequence of operations. Test Methods – a document that specifies activities performed in the determination o f analyze(s) in a specific test sample (s) Responsibilities Laboratory management ensures that this document control procedure is established, implemented and maintained. The Quality Manager/Laboratory supervisor/Senior Laboratory technician oversees the day-to-day operations of document control. Laboratory technical personnel are responsible for following this procedure in its entirety. Page 50 of 85

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Laboratory technical personnel include Quality Manager, Technical Manager, Laboratory Manager Laboratory Supervisor, Senior Laboratory technician and Laboratory technician. Procedure Note  – Documents in the QMS may consist of signs, flowcharts, pictures, drawings, sketches, forms, and numbered lists. Regardless of the format, all quality system documents must be controlled through this procedure The Quality Manager develops and reviews a master list of all controlled documents (LAB-P001) and circulates for comments to all staff. Quality Manual: 1. The Quality Manual is approved by the ACME Lab Director, who signs the master copy. 2. Controlled hard copies are indicated by the “Controlled Copy” Number on the Title page of the Manual. Operating Procedures: 1. Test methods and standard operating procedures are controlled documents with limited distribution, and working copies are kept in three-ring binders. The Table of Contents includes all current procedures assigned to a given work area and the following information: the code and title of each procedure  the revision number of each procedure  the effective date of each procedure  the issue date of each procedure  review date – the date each procedure was last reviewed   total number of pages  2. Unique codes are assigned for each procedure. 3. Test methods are written with the following headings (as applicable): Scope  Description of Test Items, Sample Identification, Holding Times  Quantities to be Tested   Materials and Equipment Required   Physical Environmental Conditions Required   Procedure  Safety Measures  Method for Data Analysis and Presentation  Sensitivity, Quality Control Plan  Reference Procedures  Documents Generated  Revision History    Appendix   4. SOPs are written with the following headings (as applicable): Purpose  Scope  Definitions and Acronyms  Page 51 of 85

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      

Responsibility  Materials Required  Procedure References Documents Generated  Revision History   Appendix 

5. Procedures and Test Methods are prepared, reviewed by Laboratory technical staff authorized by Quality Manager; copies are uniquely identified, and distributed to users, with a “Controlled Copy” Number on the title page. Note – the issue date is the date the document was issued to the user for review. The effective date is the date the document is effectively in place and followed. 6. Obsolete master copies are archived for at least five (5) years. All other draft copies and obsolete versions are kept in LAB-OBS-07 –Obsol ete Document Folder. 7. The Quality Manager maintains the master copies of the current procedures. 8. The master list of procedures includes:  Code, copy number   title  revision number   review date  status (current, obsolete) Document Review: 1. Quality manual is reviewed on an annual basis by the Quality Manager/Technical Manager. Records are kept of this review and any changes made. 2. Written Administrative procedures and Test Methods are reviewed on a biennial basis. The reviewer makes a record of this review, any required changes, and forwards to the Quality Manager. Document Changes: If any changes are required for any Controlled Documents these are documented on the Change Request Form outlining the description of the change and forwarded to the Quality Manager. This form is held as a record. 1. Changes to the Quality Manual, Test Method or a procedure require the same review and approval by technical laboratory personnel who performed the original review and approval. 2. Changes are indicated by typewritten bold italic font to the revised area. The master list is updated to reflect the changes in revision status and revision release date. 3. Personnel affected by the issue of a revised procedure are informed in writing. Holders of obsolete copies return them to the Quality Manager who ensures the updated version is placed in the manual. A list of obsolete quality manual sections and procedures is maintained.

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 Amend men ts by Hand : 1. Where permitted, hand written amendments in ink are clearly marked, initialed, approved by Laboratory Supervisor/Senior Laboratory technician and dated on all copies. The relevant changes are made at the next revision of the document. Computerized Documents: 1. Electronic copies of documents are maintained under the authority of the Quality Manager. 2. Access to electronic copies is password protected and changes are made and controlled by Laboratory manager/Quality Manager/Laboratory Supervisor. 3. Documents that are revised are maintained in a folder identified as current; the obsolete version is moved to a folder identified as obsolete. 4. Relevant personnel are informed of any amendment(s) Documents Generated Document Change request Form Document Master List  Approved master copies of Quality Manual and procedures END OF EXAMPLE PROCEDURE

3.5 OVERVIEW OF TECHNICAL PROCEDURES (SOPs) Technical procedures or Standard Operating Procedures (SOPs) describe or reference all activities necessary to conducting tests and describe in detail how specific tests or calibrations are conducted. While it is not necessary to transcribe the contents of a kit insert or manufacturer’s procedure manual once the documented format is appropriate, however, these documents must form part of the controlled documentation of the laboratory and be numbered appropriately. SOPs could be presented as drawings, pictures, kit inserts, analytical methods and models. They may originate within the organization, be provided by the customer or from international scientific references.

TECHNICAL PROCEDURE/SOP OUTLINE  A technical procedure must normally be supplemented by additional information. It can be written in a very condensed form with considerable cross-referencing. For Technical Procedures, the following headings may be applicable:

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3.5.1 Title 

 All Test Methods should have a title that clearly states the intent of the document. The title should be concise and descriptive. E.g. “Determination of Calcium in drinking water” Because a procedure describes how to do something, the title should use direct language to declare what is being done to what. A procedure titled "Maintenance Chemical Analyser" is not descriptive of the procedure's content; a more appropriate title would be, "Preventive Maintenance Procedure for the Photometer." 3.5.2 Principle of test 

The scientific basis behind the reactions which occur in the test 3.5.3 Responsi bility 

Who is responsible for performing the work described? Who is responsible for reporting the work?  Are there special training or certification requirements? i.e., who will be qualified to perform the work described? 3.5.4 Reagents and Media 

The Method should include a list of the reagents or media used, which should include:  List of required reagents and/or media, Reagent name or chemical formula  Special safety requirements  Step-by-step instructions for reagent or media preparation  Degree of accuracy and any special handling instructions for measuring device  QC of reagents or media (e.g., pH testing or visual assessment)  Labelling requirements, including expiration, Storage requirements, including containers and stability Note Only provide instructions for preparing reagents when the reagents are to be prepared each time the procedure is performed

3.5.5 Equipment 

Only include a list of equipment. Instructions for calibrations and maintenance are written as separate procedures. They are only included in the technical procedure where they are performed each time the procedure is done. 3.5.5.1 Procedures for equipment calibration sho uld inclu de the followin g:  Schedule for performing the calibration – daily, weekly, monthly, semi-annually  Schedule for performing calibration verifications (Assaying of calibration materials in the same manner as patient samples to confirm that the calibration of the instrument, kit or test system has remained stable throughout the laboratory’s reportable range for patient test results)  Calibration material specifications, preparation and storage  Source of the calibration material  Step-by-step instructions for performing the calibration, including expected readings  Troubleshooting guidelines  Documentation methods and storage requirements for calibration data Page 54 of 85

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3.5.5.2 Procedures for equipment maintenance should i nclude the following:  Schedule for performing preventative maintenance – daily, weekly, monthly, semi-annually  Step-by-step instructions for performing preventative maintenance or references to equipment manuals containing instructions  

Troubleshooting guidelines Records for documenting results of maintenance

3.5.6 Supplies 

The method should include a list of the supplies (consumables) used in performing the procedure. E.g., disposable pipettes, pipette tips 3.5.7 Sample Information 

The analytic procedure should include the following information regarding the sample required:  Sample type and source   Amount of sample required, including minimum requ irements   Acceptable collection containers  Sample stability and storage requirements, Preservative/Additive  Criteria for acceptable samples and follow-up action 3.5.8 Special Safety Precautions 

This is included when ADDITIONAL safety requirements - beyond the basic handling of hazardous materials are necessary. They should include the following:  Engineering controls (E.g., Use of Fume hood)  Personal protective equipment (E.g., Respirators, gloves, face shields)  Work practice controls (E.g., Beginning a step only after certain conditions have been met or precautions have been taken) 3.5.9 Quality Control 

Instructions for QC are usually written as separate procedures. They are only included in the technical procedure where they are performed each time the procedure is done. QC procedures should include the following information:  Type of QC material to be used  Instructions for preparation and handling of control materials  Frequency with which controls must be run, number of controls to use  QC expected values and/or ranges  Explanation of control criteria (E.g., Accept or reject runs or batch criteria)  Corrective action, to be taken if controls do not meet the expected criteria  Instructions for documentation of QC data   Alternate QC measures (E.g. correlation) 3.5.10 Process/Method

Write in a step-wise fashion rather than lengthy paragraphs. Provide a COMPLETE listing of the steps required to accomplish the analysis.

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3.5.11 Interpretation of Results 

This section should include:  Comparison of the results to the expected values or to determine if the result is normal, abnormal, or indeterminate. Follow-up for indeterminate results  Recognition of results that fall outside the reportable range, and reference back to the Method Limitations section of the original procedure  Recognition and follow-up of results that exceed critical limits 3.5.12 Calculations (Quantitative procedures )

Quantitative analytic procedures should include the equations for calculations when they are applicable to the test. Include:  The full equation  Step-by-step instructions to solve the equation, An example of how to solve the equation Normal Values (Where applicable) 

Include a range of expected values for the test result, where necessary or applicable. Method Limitations 

The limitations may be due to the method itself or interfering substances. Include the following:   Analytic sensitivity and specificity  Reportable range   Appropriate dilutions or reporting measures if the reporting range is exceeded  Interfering substances such as chemicals (E.g., Preservatives). Procedure Notes (Hints, special precautions, comments) 

Insert appropriate comments which could include special hazards in performing the test. If special reporting of results is required it should be noted in this section. 3.5.13 References 

Procedures should include the references that were used as the source of the information, when applicable. References may originate from any of the following:  Manufacturer’s product literature  Text books  Published standards and guidelines  Laboratory policy manuals   Applicable regulations 3.5.14 Related Document s 

Reference (List) other related procedures, e.g. Procedure for cleaning glassware Records such as Forms used or data sheets produced

END OF PROCEDURE OUTLINE

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3.6 DOCUMENTATION CHECKLIST The following checklist may be used to determine if you have developed the documents required for the most crucial portions of the QMS. At minimum these documents will assist your system implementation and ensure effective operation of the laboratory on a daily basis.

Figure 26 Documentation Checklist for the QMS Program Do you have documentation to prove that these things have been done? 1. Policy Statement The written policy statement has been: Distributed to all employees

8. Quality Control Yes

No

Properly explained to all employees 2. Responsibilities Quality System responsibilities have been communicated to: Managers Supervisors Workers Subcontractors New managers have received a health and safety orientation 3. Document control Document control procedures are being followed

Yes

No

Yes

No

Yes

No

Yes

No

Yes

No

Yes

No

Professional training New worker orientation Continuing education First Aid training  All training sessions

Yes

No

4. Purchasing o f Supplies Yes

No

Yes

No

Items are inspected before use Supplier Evaluations are performed 5. Non conformit ies There are written procedures for identifying and controlling NCs There are written procedures for performing corrective actions

10. Reporting & Investigating Accidents Reports are kept for: Critical injuries Lost-time injuries Medical aid injuries Property damage Accident investigat ions Are Standard forms used 11. Internal Audits Standard checklists are used Planned audits are done as scheduled  Audit reports are kept Deficiencies are corrected

6. Examination/Test Procedures Yes Examination/Test procedures have been properly documented  Are available for use by relevant employees

Procedures have been established and implemented for Quality control Trends are monitored and discordant results are acted on 9. Training Training records are kept for:

No 12. Management Review Management Reviews are done The recommendations are answered and an action plan effected

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7. Accommodation and Environmental condit ions Yes Environment suitable for testing

Proper housekeeping is performed

No

13. Personnel Yes

Worker training records are kept There are staff files/ records

3.7 USE OF FLOW DIAGRAMS Flow charts are used to simplify a process by representing it in a diagrammatic fashion. They help to clarify what outcomes are expected, and what should be done to provide better customer focus and satisfaction. This is accomplished with an illustration of the sequence of steps that are performed to produce an output. The output can be a product, service, information or a combination of all three. Many complex processes or procedures can best be illustrated by the use of flow diagrams. Wherever possible, diagrams can form part of documented procedures and be used to simplify complex text. It provides a simple mechanism for greater understanding of a process and better identification of areas of variability, redundancy and potential waste and is an essential aid to developing effective procedures. You can prepare flowcharts for all processes and they can be used to identify the sequence of activities involved in a process and to identify where documented procedures are needed to describe a given task. The following is a listing of common flow chart symbols:

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Figure 27 Flowcharting Logic To construct a process flow chart

L is t th e s tep s

Seq uen ce the steps

Draw appropriate symbols

Sy stem Mo del

Ch ec k Completeness

Determine the boundaries

Use a verb to start the task description

Use post-it notes so you can move tasks Do not draw arrows until later 

Start with the basic symbols

Draw charts using system (input– process-output) approach Input – use information based upon people, machines, material, method and environment

Ensure document control is Included and complete, using title and date for easy reference

Where does a process begin?

The flowchart can either be less detailed when providing the information to understand the general process flow or be very specific and detail every finite action and decision

Process – use series of processes in steps or parallel Output – use outcomes or desired results

Where does a process end?

Finalise the flowchart

 Ask if this  Are people process is being following run the way it the process should be as charted?

Do we have a consensus?

Remove what is redundant, add what is missing

Key to symbols:  • • •

•

•

• •

Ovals show input to start the process or output at the end of the process Boxes or rectangles show task or activity performed in the process Diamonds show points in the process, where yes/no questions are asked or a decision is required  Arrows show process direction flow, usually there is only one arrow out of an activity box. If there is more than one arrow, a decision diamond is needed If there are feedback arrows, make sure the feedback loop is closed, i.e. it should take you back to an input box. Small circles are connectors from one page to another Flags contain a brief description of records generated while performing an action

Below are examples of the Flow chart symbols used in Quality Management. (See Appendix for example of a flow chart)

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fo r

Q UAL IT Y MANAGEMENT SYST EM GUIDANCE Figure 28 Flowchart symbols

 An oval is used to show the input to start the process or the output at the end of the process

 Arrows show direction or the flow taskprocess or activity performed in the of the process

There is usually only one ar row out of an activity. If there is more than one arrow, you may need a decision diamond Make sure every feedback loop is closed i.e. every path takes you back or ahead to another activity

 A diamond shows those points in the process where a yes/no question is asked or a decision is required

YES

 An oval is used to show the input to start the process or the output at the end of the process

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CHAPTER 4 FAQs in LABORATORY QUALITY 

What is Calibration? Calibration is the process of comparing a measuring instrument against a measurement standard to establish the relationship between the values indicated by the instrument and those of the standard (standard in measurement is considered to be the reference base). The purpose of calibration is to eliminate or reduce bias in your measurement system relative to the reference base. The calibration procedure compares an "unknown" or test item(s) or instrument with reference standards according to a specific algorithm. Do all measuring instruments need to be calibrated?  All measuring devices usually need to be calibrated - whether they are simple devices or state-ofthe art systems - because certain characteristics change with time. There are situations where an instrument need not be calibrated, for example where its readings are ‘for information only’ and their accuracy has little or no impact on the test, product or service being provided. How often should an instrument be calibrated? Calibration frequency can be established using manufacturer’s recommendations. In some cases, commercial calibration laboratories can suggest intervals for particular instruments. There are two main considerations when determining the calibration frequency. Firstly, the instrument’s reproducibility should be taken into account - new devices should be calibrated frequently in order to establish their reproducibility. Secondly, the required uncertainty of measurement should be assessed. If the instrument’s reproducibility is shown, by successive calibrations, to be substantially better than the uncertainty required then the interval between calibrations can be extended. At the other extreme, where the instrument’s reproducibility approaches the uncertainty needed, the calibration intervals should be much shorter. To provide confidence in the accuracy of calibration results, the measurement must show traceability. This means that all results associated with a calibration – including those relating to the calibration of the measurement standard used - must be traceable back to standards held at a national measurement institute, through an unbroken chain of comparisons and where each link has stated measurement uncertainties. In addition, it is important that appropriate equipment and procedures are used in the calibration process, in that they are used by trained and authorized personnel operating in an experimental environment. Why perform calibrations? • To improve the measurement accuracy and reliability of the instrument • To reduce the number of end-products rejected because they are outside acceptable tolerances • To provide products with reduced and more competitive tolerances, better reliability, and access to quality-conscious markets • To minimize unnecessary rework and delays, resulting in customer dissatisfaction • To eliminate health and safety, legal and regulatory issues § Page 61 of 85

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What is Traceability? Traceability is the property of the result of a measurement whereby it can be related to appropriate measurement standards, generally international or national standards, through an unbroken chain of comparisons (traceability chain) in which all uncertainties are indicated. It should be noted that the instrument itself is not traceable, but the result produced by the instrument is! Traceability applies to both physical and chemical measurements. The standard referred to is a material measure, measuring instrument, reference material or measuring system that define, realize, conserve or reproduce a unit, or one or more values of a quantity to serve as a reference. What is Traceability to in ternational standards? Representatives of seventeen nations signed the Metre Convention treaty which provided the foundation for the establishment of the International System (SI) Units. Since then, national standards laboratories have cooperated in the development of measurement standards that are traceable to the SI. The units of measurement with the highest accuracy are realized by international measurement standards. The value of the international standard is usually determined by comparison of national standards of the highest quality, or in the case of the kilogram by the mass of the International Prototype. National measurement standards, maintained in a National Metrology Institute (NMI) are compared with these international standards before they are used as a reference for calibration of standards of lower precision. Therefore it is possible to demonstrate an unbroken chain of comparisons that ends at a national standards body. What is the tr aceability chain? It is a series of comparisons between the device under test to a reference. The final comparison in the chain is made using the International System (SI) units as a reference. Each comparison is a link in the chain and the uncertainty of each comparison (link) must be known and documented. NMIs provide the ultimate measurement references for their country. The intent of all NMIs is to realize the SI units as closely as possible so that traceability to the SI can be established by comparing to an NMI that in turn compares its references to the SI. SI UNITS

Primary National Standard  NMI

Secondary Standards  NMI

Working Standards  NMI or other 

Calibration of instrument

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What are the benefits of Traceability?  Allows you to be competitive and operate in the global environment thus reducing techn ical barriers to trade It provides another way of guaranteeing a measurement’s accuracy. •

• • •

It is an essential element of quality control systems It links people, organizations, documents, techniques and measurements within a large and diverse measurement community §

What is Measurement Uncertainty? Test or calibration measurements are subjected to imperfections in each step of the process – from sampling to final measurement. Measurement uncertainty (also referred to as “uncertainty of a measurement”) is the term used to describe this imperfection, and is defined as the parameter associated with the result of a measurement, that defines the range of the values that could reasonably be attributed to the measured quantity. This indicates the interval within which the true value of the quantity being measured is expected to lie with a stated level of confidence. How is measurement uncertainty evaluated? Measurement uncertainty is evaluated by quantifying and combining a number of uncertainty components, which can be: Random Effects – e.g., fluctuations in temperature, humidity, air-pressure, variability in performance of the measurement, sampling. Systemic Effects – e.g., offset of measuring instruments, drift in its characteristics between calibrations, personal bias in reading an analogue scale or uncertainty of the value of a reference standard. The components are quantified either by evaluation of the results of several repeated measurements, or by estimation based on data from records, previous measurements, knowledge of the equipment and experience of the measurement. The evaluation from repeated measurements is done by applying a mathematical formula derived from statistical theory. The parameter determined is the standard uncertainty expressed as a standard deviation. Measurement uncertainty is usually written as an expanded uncertainty and provides an interval within which the value of the measurand is believed to lie with a higher level of confidence. It is obtained by multiplying the combined standard uncertainty by a coverage factor (k); where k is based on the level of confidence desired. For a level of confidence of 95%, k is 2. •

•

Why is measurement uncertainty i mportant? • It provides laboratories and customers with valuable information about the accuracy and reliability of test or calibration data. • It tells how well the results represent the value of the quantity being measured. • It gives confidence in comparability of results (which help to reduce barriers to trade). • It shows whether the result is within the acceptable limits or outside of it. • It is a requirement of ISO 17025:2005 (5.4.6). §

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Q UAL IT Y MANAGEMENT SYST EM GUIDANCE What is quality control (QC)? Quality control (QC) is an integral part of a laboratory’s operation. It is defined as the observation techniques and activities used to fulfill requirements for quality. The control can be a substance, sample or procedure intended to verify performance characteristics of a system. QC should not be confused with quality assurance (QA), which encompasses everything a laboratory does to assure high quality services to its customers. Why establish a QC program? Your QC program should be a monitoring system that provides immediate information about the acceptability of results, as well as a method for evaluating data over time. Most control material is accompanied by stated target values for the mean and standard deviations (S.D.). These stated values may be used if they correspond to the methodology and instrumentation employed by the laboratory. If they are not provided, then calculate the parameters after a statistically significant number of control determinations have been completed (repetitions of 20 or more). Develop control charts using the mean and S.D. to record the results of the control. Establish criteria for acceptability, e.g. by applying Westgard rules to analyze the data. Also, develop policies and procedures for remedial action for QC failures and apply them as needed to maintain accurate and reliable test results. What to look for on QC charts? 1. Excessive scatter – points are widely scattered above and below the mean. It shows poor reproducibility of results. Common cause is operator variability in pipetting or inattention to critical steps in the procedure. 2. Bias – majority of points fall either above or below the mean. The two most common causes are an error in calibration or an error in reconstituting a control material. 3. Drift or trend – QC results move away from the mean in a particular direction over an extended period of time. Causes are outdated reagents, deterioration in reagents or instrument is losing its calibration. 4. Shift – controls suddenly change from moving above and below the mean to a line that is either always above the mean or always below the mean. Common causes are: recalibration was just performed; change in reagent lot; sudden deterioration of reagent (possibly not refrigerated overnight); new analyst; major change instrument performance. What are the benefits of QC? • Demonstrates analytical capability of laboratory personnel. • Monitors the stability of test methods or systems. •  Assesses the accuracy and precision of test results and test methods. •  Alerts the analyst if there is a problem with the reagent, test method, or instrument. •  Allows the laboratory to track the overall performance of a test procedure o ver time. • Detects random and systemic errors. §

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What is Method Validation? Method validation is defined as the confirmation, through the provision of objective evidence, that the requirements for a specific intended use or application have been fulfilled. The aim is to establish the operational limits and performance characteristics of a new, modified or otherwise inadequately characterised test method. When is Method Validation done? Test methods should be validated when: a new test method is being developed an established test method is modified QC indicates that an established method is changing with time demonstrating the equivalence between two methods, e.g. a new method and a standard method. • • • •

How is Method Validation don e? The experiments used to determine method performance characteristics should be conducted with equipment that is within specification, working correctly and adequately calibrated. The analyst carrying out the experiments must be competent in the field of study and capable of making appropriate decisions from the data produced during the study. The following are common characteristics tested during method validation studies: Specificity/selectivity  – ability to accurately measure the analyte in the presence of interferences. Linearity - ability of an analytical method to produce test results which are proportional to the concentration of analyte in samples within a given concentration range.  Accuracy – closeness of the measured value to the true value for the sample. Range – the concentration interval over which acceptable accuracy, linearity and precision are obtained. Precision (Repeatability & Reproducibility)  – the amount of scatter in the results obtained from multiple analyses of a homogeneous sample. Detection Limit  – lowest concentration of the analyte that can be confidently detected by the method. Quantization Limit  – strictly the lowest concentration that can be determined with an acceptable level of repeatability, precision and trueness. Robustness  – ability of the test method to remain unaffected by small but deliberate changes, e.g. temperature. Recovery – assesses the efficiency of the method in detecting all of the analyte present. •

•

• •

•

•

•

•

•

Why is Method Validation necessary? To provide objective evidence that the results are accurate and reliable To demonstrate that a test method is “fit for purpose” Validation data can be used to design QC programs • • •

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What is Verification? Test method verification is a simplified validation process employed to check or verify a test method’s performance characteristics. It typically includes a subset of the parameters evaluated when a complete validation is performed, and asks the question “Does this new test method  perform to its specification in my laboratory?”  When is Verification done? It should be done before a new externally validated test method is employed by the laboratory to report results. How is Verification done? The laboratory should: Develop a clear, detailed verification procedure that defines the parameters to be evaluated. Define and approve the acceptance criteria (e.g., manufacturer’s package insert) to be used in analyzing the results. Compare experimental results to the previously established performance characteristics. Based on the results, accept or reject the test method. Summarize the data collected from the verification study in a final report. •

•

• • •

The following is the most common subset of characteristics used in verification studies: Characteristics Analyzed  Accuracy Precision Reportable range of test results for the test method Manufacturer’s reference intervals (medical laboratories)

•

•

• •

• •

•

•

Types of Experiments Performed Comparison of methods to estimate inaccuracy or bias Replication experiment to estimate imprecision Linearity type experiment to estimate imprecision and to d etermine reportable range Collecting reference values to verify the established reference range

Why is Verification n ecessary? To provide objective evidence that your laboratory has the ability to achieve acceptable results for a given test method. To prove that an externally validated test method is acceptable for its intended use. •

•

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CHAPTER 5 APPENDICES  Ap pen di x 1 Sum mar y of Claus es i n ISO/IEC 17025 General Requirements for Quality and Competence in Testing and Calibration Laboratories.

Following is a summary of its requirements:

MANAGEMENT REQUIREMENTS 4.1

Organi zation Laboratory management shall have responsibility for the design, implementation, maintenance and improvement of the quality management system.

4.2

Management system (QMS) The QMS shall have all its procedures documented. It shall include internal quality control and participation in interlaboratory comparisons. A quality policy statement and a documented quality manual are needed.

4.3

Do cu men t c on tr ol Define, document and maintain procedures to control all documents and information. Define retention periods and archive documents for later reference.

4.4

Review of Request, tenders and contracts Ensure that all parties understand and abide by the provisions made in contracts. Keep records of all reviews, including significant changes and maintain these records.

4.5

Subcontracting of tests and calibrations Have procedures for evaluation and selection of subcontracted laboratories and consultants. Maintain a register of all subcontractors used.

4.6

Purchasing External services and supplies Ensure external services, equipment and consumable supplies consistently meet the laboratory’s standards. Have an inventory control system and quality records of external commodities purchased.

4.7

Service to the client Clients shall be afforded consideration to verify their samples are appropriately handled and analyzed. Confidentiality shall be maintained.

4.8

Co mp lai nt s Keep records of any complaints or feedback and of investigations or corrective action taken by the laboratory.

4.9

Identification and control of non-conformities When a non-conformity is detected: a) Personnel must be designated for problem resolution; b) Corrective action must be defined and taken immediately; c) The deviation must be documented, and reviewed by staff.

4.10 Improvement Review all procedures at regular intervals to identify any potential source of non-conformance. Action plans must be developed, documented and implemented as appropriate.

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Q UAL IT Y MANAGEMENT SYST EM GUIDANCE 4.11 Corrective Action Carry out investigations to determine the root causes of problems. Document and implement any changes made to procedure. Review all procedures regularly and take action to improve the system. 4.12 Preventive Action Identify any necessary improvements and areas of non-conformities, either technical or concerning the management system. Develop action plans and procedures to reduce the likelihood of potential non-conformities. 4.13 Control of records Establish procedures for  Identification Collecting, Indexing, Access Maintenance Safe disposal of quality and technical records • • • •

4.14 Internal Audits Formally and periodically carry out internal audits to ensure that the QMS is maintained. 4.15Management review Laboratory management must periodically review the QMS to maintain and improve the system. Findings must be recorded and any corrective action needed must be taken immediately.

TECHNICAL REQUIREMENTS 5.1 5.2

Gen eral Pers on nel Define qualifications and duties for all personnel. Implement the Quality Management System (QMS) and procedures.

5.3

Accommodation and environmental conditions Ensure the facilities for examination allow for correct performance of tests and reliability of results.

5.4

Test and Calibration Methods and Method validation Use only relevant, validated, documented procedures which meet the needs of the users of the laboratory’s services. Record any deviations or changes in procedure.

5.5

Eq ui pm en t Provide the laboratory with relevant, functioning and calibrated equipment. Ensure authorized personnel operate equipment in a safe working environment.

5.6

Measurement Traceability The laboratory must have documented evidence that measurements made by the laboratory can be traced to the International System of Units (SI). Calibration certificates issued by or to laboratories shall contain the measurement results, including the measurement uncertainty or a statement of compliance with an identified metrological specification.

5.7

Sam pl ing Sampling plans should be based on sound statistical sampling techniques. The laboratory must be sure that there is a good understanding and agreement between the customer and the laboratory as

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Q UAL IT Y MANAGEMENT SYST EM GUIDANCE to how the sampling process is to be carried out. It must be properly documented and carried out according to an authorized sampling plan and its associated procedures. 5.8

Handling of Test and Calibration items  Authorized personnel must review results and determine reliabili ty before releasing results. Disposal of samples must be in accordance with local standards.

5.9

Assuring the Quality of test and calibration results Establish quality control methods to verify attainment of quality results. Document, record and retain records of results. Take action if results are suspected to be incorrect.

5.10 Reporting results Results must be reported legibly, unambiguously and in an identifiable manner. Use an audit log if the present reporting system cannot capture changes or alterations

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 Ap pen di x 2 Li st of Polic ies in ISO/IEC 17025 Policy Name (Description)

ISO 17025 Clause Number 

For ensuring the protection of confidential information

4.1.5c

For avoiding involvement in activities that would diminish c onfidence in its competence, impartiality,  jud gmen t or o perat ion al in tegr ity

4.1.5 d

Quality Policy Statement

4.2.2

For conducting r eview of requests, tenders and contracts For the selection and purchasing external services and supplies, equipment and consumable supplies that affect the quality of Tests and Calibrations

4.4.1

For the resolution of comp laints

4.6.1

4.8

To identify and control nonconfor mities when they occur To designate appropriate authorities for implementing corrective actions For identifying training needs and providi ng personnel training

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4.9.1 4.11.1 5.2.2

Section in Quality Manual

Done

Not Done

Q UAL IT Y MANAGEMENT SYST EM GUIDANCE

 Appen di x 3 Li st of Pro cedur es i n ISO/IEC 17025 Procedure Name (Description)

ISO Section in 17025 Quality/Procedure Clause Manual Number 

For ensuring protection of confidential information

4.1.5c

For avoiding involvement in any activities which would dimini sh confidence in its competence, impartiality, judgment, or operational integrity

4.1.5d

To control all documents

4.3.1

 Approval and issu e of docu ments

4.3.2.2

For hand amendments of documents pending re-issue (if allowed) To describe changes in documents maintained in the computerized systems are made and control led

4.3.3.3 4.3.3.4

For review of requests, tenders and contracts

4.4.1

For the selection and purchasing external services and suppli es that affect the quality of t ests and calibrations

4.6.1

For the resolution of complaints

4.8

To identify and control nonconfor mities when they arise

4.9.1

To designate appropriate authorities fo r impl ementing corrective actions

4.11.1

To identify, document and eliminate the root cause(s) of nonconformities

4.11.2

For initiating and monitoring preventive actions

4.12.2

For identification, col lection, indexing, access, storage, maintenance and safe disposal of records

4.13.1.1

To protect and back up records stored electronically

4.13.1.4

For internal audits which i nclude the types of audit, frequencies, methodologies and required documentation

4.14.1

For conduct ing Management reviews

4.15.1

For checking that t he environment does not adversely affect the performance of specimen collection and equipment

5.2.2

To ensure good housekeeping

5.3.5

Test and Calibrations methods

5.4.1

Procedure for validating test methods

5.4.5.2

For estimating uncertainty of measurement for calibration labs

5.4.6.1

For estimating uncertainty of measurement for testing Labs performing calibrations

5.4.6.2

For protecting th e integrity of (electronic/computer) data at all

5.4.7.2b

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Done

Not Done

Q UAL IT Y MANAGEMENT SYST EM GUIDANCE times Up to date instructions on the use and maintenance of equipment

5.5.3

For safe handling, transport, storage and use of equipment

5.5.6

For performing int ermediate checks to maintain confid ence in the calibration status of equipment

5.5.10

For ensuring correction factors are correctly updated

5.5.11

For calibration of equipment

5.6.1

For calibration of reference standards

5.6.3.1

For intermediate checks to maintain confidence in the calibration status of reference, primary, transfer or working standards and reference materials

5.6.3.3

For safe handling, transport , storage and use of reference standards For sampling performed by the lab

5.6.3.4 5.7.1

For recording relevant data and operations relating to sampling

5.7.3

For transportation, receipt, handling, prot ection, storage, retention and/or disposal of test/calibration it ems

5.8.1

For avoiding deterioration, loss or damage to the test or calibration item duri ng storage, handling and preparation.

5.8.4

Quality control procedures for monitori ng the validity of tests and calibrations undertaken

5.9.1

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 Ap pen di x 4 Li st of “ SHALLs” in ISO/IEC 17025 Requirement

Met

Not Met

N/A

Clause

The laboratory shall b e an entity that can be held legally responsible. The laboratory management system shall co ver all work carried out in p ermanent and mobile facilities

4.1.1

If personnel do perform other activities th an testing, e.g. consulting, the organization shall be defined in order to identify conflicts of i nterest

4.1.4

4.1.3

The laboratory shall have personnel and resources needed to carry out its duties according to its scope of accreditation

4.1.5.a

The laboratory shall have arrangements to avoid that their personnel are not i nfluenced of in ternal / external pressure that could in fluence the quality of their work, e.g. paid by the number tests performed The laboratory shall h ave policy and procedures to avoid involvement in anything that could diminish its confidence

4.1.5.b

The laboratory shall define its organization and management structure and the relationships in the in the organization, e.g. by using an organization chart.

4.1.5.e

The laboratory shall s pecify the responsibility, authority and interrelations of personnel that could influence the test results.

4.1.5.f 

The laboratory shall provide supervision of testing staff, including trainees, by competent personnel.

4.1.5.g

The laboratory shall have technical management with the competence and resources needed with the overall responsibility for the quality.

4.1.5.h

The laboratory shall appoint a Quality Manager.

4.1.5.i

The laboratory shall appoint deputies for key personnel.

4.1.5.j

The laboratory shall establish, implement and maintain an appropriate quality system for its activities.

4.2.1

The laboratory’s quality system and policies sh all be defined in a named Quality Manual.

4.2.2

The quality policy statement shall be signed by the management.

4.2.2.a-e

The Quality Manual shall make references to supporting document systems and outline the s tructure of the sys tem.

Page 73 of 85

4.1.5.d

4.2.3

Q UAL IT Y MANAGEMENT SYST EM GUIDANCE The roles of responsib ilities of the Technical Management and Quality Manager shall be defined.

4.2.4

The laboratory shall include / make references to external and internal documents in the quality system.

4.3.1

 Al l d oc ument s i ssued as part o f th e qu ali ty s ys tem s hal l be reviewed and approved. A master list (or equivalent) shall outline the documented quality system and be used to control the documents. The procedures adopted shall ensure that: -

Authorized documents are available where needed

-

Documents are periodically reviewed and if necessary

4.3.2.1

4.3.2.2

Replaced -

Invalid/obsolete documents are removed and marked as such

Quality system documents generated by the lab shall have id, page numbering, and information if they are valid and be authorized. Changes to documents shall be reviewed and approved by the same function that made the original.

4.3.2.3

 Al tered t ext in do cu men ts shall if po ss ible b e ident if ied in th e revised docu ment.

4.3.3.2

If the laboratory allows that changes are made by hand in documents, that procedure must be documented.

4.3.3.3

If changes to “ electronic documents” are allowed, that procedure must be documented.

4.3.3.4

The laboratory shall have procedures for the review of requests, tenders and co ntracts. Records of reviews (including subcontractors) shall be maintained. When the laboratory is goi ng to use a subcon tractor, it shall use a competent one.

4.3.3.1

4.4 4.4.2 / 4.4.3 4.5.1

The laboratory shall inform the cli ent if the laboratory uses subcontractors

4.5.2

The laboratory shall maintain a register with its approved subcontractors and their competence.

4.5.4

The laboratory shall h ave a policy and pro cedure for the selection of purchasing of services and supplies and a procedure for the approval of bought goods. The laboratory shall offer its clients service.

Page 74 of 85

4.6.1 / 4.6.2

4.7

Q UAL IT Y MANAGEMENT SYST EM GUIDANCE The laboratory shall h ave a policy and procedure for complaints and a list o f received complaints.

4.8

The laboratory shall have a policy and procedure to control non conforming work.

4.9.1

The laboratory shall m onitor the effect of any corrective action.

4.10.4

When there is a doubt that the laboratory does not follow its own procedures, the laboratory shall p erform an internal audit:

4.10.5

If there is the need / opportunity to perform a preventive action the laboratory shall do that.

4.11

The laboratory shall have a system for archiving of its documents.

4.12

Each observation etc. shall be documented in such a way making it possibl e to identify the responsible person, and if of importance, the time.

4.12.2.1

Mistakes shall not b e “ tippexed” or erased, the wrong note shall be over-lined, dated and signed together with th e correct result.

4.12.2.3

The laboratory shall have a procedure and a predetermined schedule for internal audits covering the whole quality system.

4.13

The management shall periodically, according to a schedule, perform management reviews.

4.14

The laboratory shall ensure the competence of i ts personnel. That competence shall be documented.

5.2.1

The laboratory shall have a policy about training/competence and a procedure to detect the need of training.

5.2.2

The laboratory shall have up-dated doc umented job d escriptions.

5.2.4

The laboratory shall have documented authorizations for personnel to perform specific tasks, e.g. signing of test reports.

5.2.5

The laboratory must have facilities and environment that does not affect the test result.

5.3.1

The laboratory shall, if n ecessary monitor, control and record environmental conditions.

5.3.2

The laboratory shall use appropriate test methods and laboratory specifi c SOPs wh ere needed.

5.4.1

The laboratory shall i nform the cli ent of the appropriate method to meet the clients’ needs; the lab shall choose international, regional or national methods or methods p ublished in reputable organizations / technical journals or methods proposed by the manufacturer of the equipment used. Non standard methods sh all be validated before use.

5.4.2

Page 75 of 85

5.4.4 / 5.4.5.2

Q UAL IT Y MANAGEMENT SYST EM GUIDANCE When calibrating, the uncertainty shall be estimated.

5.4.6.1

Testing laboratories shall have procedures to estimate its uncertainty.

5.4.6.2

Calculations and data transfers shall be checked periodically.

5.4.7.1

The laboratory shall validate own developed software and have procedures to protect data stored electronically, e.g. log i n / user name and backups. The laboratory shall have the equipment needed to perform the tests. Used equipment shall have the quality needed and shall be appropriate calibrated.

5.4.7.2

The equipment shall be operated by c ompetent persons; instructions shall be available where needed.

5.5.1 5.5.2 5.5.3

Each item of equipment shall be identified and properly documented. Equipment suspected to function in correct shall be prevented for unintended use.

5.5.4 / 5.5.5

When intermediate checks (verifications) are needed to guarantee the function of a piece of equipment those checks shall be performed according to a defined plan and procedure.

5.5.10

The laboratory shall have a program for calibration of its equipment.

5.6.1

5.5.7

When necessary the testing laboratory shall have traceability to SI units for the physical factors in qu estion.

5.6.2.2

The laboratory shall have a program and procedures for the calibration of its reference standards.

5.6.3.1

Reference material shall be traceable to SI units or to certified reference material if possible.

5.6.3.2

The laboratory shall have procedures to ensure the calibration status of its standards and reference material.

5.6.3.3

The laboratory shall have procedures for the handling of i ts standards and reference materials.

5.6.3.4

If the laboratory carries out sampling, it sh all have a plan and procedure for that.

5.7

The laboratory shall have procedures for receipt, transport, pretreatment labeling / identification etc. of test items.

5.8.1 / 5.8.2

If any abnormal is detected upon receipt of a test item that shall be recorded and noted in the test report.

5.8.3 / 5.10.3.1.a / 5.10.3.2.e

Page 76 of 85

Q UAL IT Y MANAGEMENT SYST EM GUIDANCE The laboratory shall h ave plans and procedures for monitori ng the validity of its results. Systems shall be used in o rder to detect trends, e.g. the use of statistical evaluations.

5.9

The result shall be presented in a calibration certificate or test report fulfilling the requirements in ISO 17025.

5.10

If opinions and interpretations are includ ed in the report, the basis of that must be explained and clearly separated from the result.

5.10.5

If subcontractors have been used that must be c lear from the report. In the case of electronic transmission o f results that must be agreed (in writin g) with the client and the requirements in ISO 17025 mus t be m et.

5.10.6

 Addi ti on s o r cor rec tion s to a tes t repo rt can on ly be m ade b y a new document with an explanation.

5.10.9

Page 77 of 85

5.10.7

Q UAL IT Y MANAGEMENT SYST EM GUIDANCE

 Ap pen di x 5 Doc um ent Con tro l Ch eck li st Instructions - If the laboratory has implemented the action, process or procedure referred to, the auditor will tick YES and state in the Proof/Comments column what was seen to verify or prove implementation. If not, then tick NO and include any relevant and useful comments Yes No Proof/Comments 1. Is there an up to date SOP for document control? 2. Is the document current and within review date? 3. Is there evidence that the document has been prepared, checked and approved by a suitably qualified member of staff? 4. Does the document have the necessary information such as version number, unique identification, title, review dates, etc.? 5. Is there evidence of cross referencing to other documents? 6. Is there evidence that documents are accessible and secure? 7. Is there evidence of appropriate document distribution? 8. Is there evidence that this is working? 9. Is there evidence of a process for document change? 10. Is there evidence of a backup procedure for the document control system? 11. Is there evidence that previous versions of documents have been archived? 12. Are previous versions of documents available for retrieval? 13. Is there evidence that staff adhere to the document control procedure? 14. Is there evidence that out of date documents are being withdrawn from circulation? 15. Are out of date documents reviewed? 16. Are they in date, appropriately formatted etc? 17. Is there evidence of regular document review? 18. When was the last document review? 19. Is staff trained in document control? 20. Do they have documented evidence of the training? 21. Is their adequate back-up of documents? 22. Is staff informed when documents are updated and available?

Page 78 of 85

Q UAL IT Y MANAGEMENT SYST EM GUIDANCE

Appendix 6 Example of a Flowchart

START

Responsibilities

Documents Generated

Quality Manager 

Identify persons to train as auditors

Quality Manager 

Identify facilitator and establish

Trainer

Develop training materials

Training Manual

Human Resources

Schedule and organize training

Training Schedule

Conduct training

Attendance Register  Evaluation Forms

Trainer 

Quality Manager 

List of Trainee Internal Auditors

Training Proposal

Is the training effective?

 No

Conduct investigation & document findings

Competency Evaluation Investigation Report

YES

Quality Manager 

Quality Manager 

Update training records

Personnel Records

Plan and execute Audits

Audit plan and schedule

END

Page 79 of 85

Q UAL IT Y MANAGEMENT SYST EM GUIDANCE

 Ap pen di x 7 Chec kl ist fo r revi ewi ng Qual it y Managem ent Sys tem Implem ent ati on This checklist will be used to review the Quality Management Implementation process being conducted by the Lab against ISO/IEC 17025. Items from this checklist are discussed in detail in the standards. If the item is present simply tick the checkbox, otherwise leave it blank if element is not available. Note that all items below must be included in a QMS. If an item is not relevant, an explanation must be provided. Also note that the process may either be described or referenced in the Quality Manual; however, all references should be readily accessible within the organization and provided to the Staff. Lab Name: Lab Address: Country : Tel: Quality Manager:

Fax:

Email:

Yes ORGANIZATION 1.

Is Legal status of Laboratory identified and available (e.g. Company registration certificate, etc)?

2.

Are arrangements for confidentiality and impartiality outlined?

3.

Is there a description of the process for resolving disputes?

4.

Is there a statement of the organization's Quality policy? 4a. Q policy statement includes general objectives/goals? 4b. Q policy statement includes requirements from standard?

5.

Is organizational chart available? 5a. Organizational chart identifies all important Managerial/Technical positions of the organization? 5b. Organizational Chart identifies position of QA manager and lines of reporting?

6.

Does it include authorities and independence of the QA manager and staff?

7.

Describes procedures to ensure QA staff has access to appropriate levels of management?

Page 80 of 85

Comments/Page(s)

Q UAL IT Y MANAGEMENT SYST EM GUIDANCE Yes 8.

Discusses how management assures understanding and implementation in all programs?

9.

Identifies how internal coordination of QA and QC activities is performed?

QUALITY SYSTEM COMPONENTS 11. Describes principal quality system components (e.g., quality manual, administrative procedures, test procedures, records management system, annual reviews and planning, project-specific quality documentation? (Please identify the components in Comments section.) 12. Description of components includes how they are implemented and responsibilities of management and staff?? 13. Lists responsibilities for implementing each component (e.g., Quality Systems Audits, Training Plans, Management review? 14. Identifies review and approval procedures? QUALIFICATIONS AND TRAINING 15. Is there a policy regarding Quality training for management and staff? 16. Does it describe the process for identifying, maintaining, ensuring, and documenting that personnel have necessary quality-related qualifications? 16a Have records of competency analysis been prepared? 17. Is there a process for identifying the need for quality-related retraining based on changing requirements and the roles, responsibilities, and authorities for these processes? PROCUREMENT OF ITEMS AND SERVICES 18. Is there a process for reviewing and approving all purchase agreements? 18a. The process ensures documents are complete and accurate and agreement clearly describes the item or service needed? 18b. The process ensures agreement describes the associated technical and quality requirements? 18c. The process ensures agreement describes the quality system elements for which the supplier is responsible? 18d. The process ensures that the supplier’s conformance to the customer’s requirements will be verified? 19. Describes process for reviewing and approving applicable requisitions to ensure that they satisfy all technical and quality r equirements? 19a. Review process ensures the review of evidence of the supplier’s capability to satisfy quality requirements?

Page 81 of 85

Comments/Page(s)

Q UAL IT Y MANAGEMENT SYST EM GUIDANCE Yes 19b.Review process ensures procured items and services are acceptable? 20. Describes process for review and approval of suppliers’ quality-related documentation (e.g., QA Project Plans and QMPs)? 21.

Describes roles, responsibilities, and authorities for the above processes process to ensure policies are satisfied?

DOCUMENTS AND RECORDS 24.

Describes process for identifying quality-related documents and records (including electronic) requiring control?

25.

Describes procedure for preparing, reviewing, approving, issuing, using and revising documents and records?

26. Describes process for maintaining documents and records including confidentiality, transmittal, distribution, retention, access, preservation, traceability, retrieval, removal of obsolete documentation, and disposal? 26a. Have all test methods been documented? 27.

Does it describe the roles, responsibilities, and authorities for the above processes? COMPUTER HARDWARE AND SOFTWARE 28.

Describes process for developing, installing, testing, using, maintaining, controlling, and documenting computer hardware and software?

29.

Describes process for assessing and documenting the impact of changes to user requirements and/or the hardware and software on performance?

30. Describes process for evaluating purchased hardware and software? 31. Describes process for ensuring that data and information produced from or collected by computers is backed up and secured? 32. Describes the roles, responsibilities, and authorities for the above processes? PLANNING 33.

Includes a description of the systematic planning process for operations and identification and involvement of all customers and suppliers?

34.

Does process include specification of needed QA and QC activities to assess the quality performance criteria?

35.

Does process include specification of performance criteria for measuring quality (e.g. Control chart)?

36. Describes the roles, responsibilities, and authorities for the above processes?

Page 82 of 85

Comments/Page(s)

Q UAL IT Y MANAGEMENT SYST EM GUIDANCE Yes IMPLEMENTATION OF WORK PROCESSES 37. Describes process for ensuring that work is performed according to planning and technical documents? 38. Describes the roles, responsibilities and authorities for the above process?  AUDIT 39. Describes the process for assessing the adequacy of the quality system at least annually? 40. Describes the process for planning, implementing and documenting audits and reporting results to management? 40a. Process includes selecting an audit tool, the expected frequency, and the roles and responsibilities of assessors? 40b.Process includes determining the level of competence, experience and training needed for audit personnel? 40c. Process includes ensuring that personnel have no real or perceived conflict of interest, and have no direct involvement or responsibility for the work being assessed? 40d.Process includes ensuring that personnel conducting audits have sufficient authority, access to programs and managers, access to documents and records? 41. Describes process for management’s review of, and response to findings? 42. Describes process for identifying how and when corrective actions are to be taken in response to the findings of the audit? 42a. Process includes ensuring corrective actions are made promptly and actions documented? 42b.Process includes confirming the implementation and effectiveness of any corrective action? 43. Are past QS management audit findings resolved? (Put date of Final Report in Column 3.) 44. Describes the roles, responsibilities, and authorities for the above processes? QUALITY IMPROVEMENT 44. Describes process for ensuring that conditions adverse to quality are prevented, identified promptly, corrected promptly and that actions are taken toward prevention, documented and actions tracked to closure? 45. Describes process for encouraging staff to establish communications between customers and suppliers, identify process improvement opportunities, and identify and propose solutions for problems? 46. Describes the roles, responsibilities and authorities for the above processes?

Page 83 of 85

Comments/Page(s)

Q UAL IT Y MANAGEMENT SYST EM GUIDANCE Yes

OTHER REVIEW CRITERIA 47. Have all administrative procedures as required by standard been documented and implemented? 48. Has scope of testing been defined and documented? 49. Have staff been trained in use of the QMS documentation? 50. Has a Quality team been designated?

Page 84 of 85

Comments/Page(s)

Q UAL IT Y MANAGEMENT SYST EM GUIDANCE

REFERENCE DOCUMENTS  Preparing For Accreditation: Guidance on Implementation of Quality Management Systems (QMS) for Medical Laboratories. A QMS “How To” Guide. Edition 1 December 2006 Strengthening Of Medical Laboratory Services In The Caribbean. A CARIFORUM Project Funded by the European Union (CAREC EU Project) Estimation of uncertainty of measurement in Medical Laboratories, 12 th September 2006. European Diagnostic Manufacturers Association Position paper. www.edma-ivd.be M3003 The Expression of Uncertainty and Confidence in Measurement, Edition 2 August 2006 United Kingdom  Accreditation Service www.ukas.com Uncertainty of Measurement in Clinical www.ifcc.org/ejifcc/vol13no4/130401006

Microbiology.

Fuentes-Arderiu

X,

eJIFCC

vol

13

no.

International Laboratory Accredi tation Cooperation (ILAC) Documents  www.ilac.org

ILAC G2 Traceability of Measurement ILAC G9 Guidelines for the Selection and Use of Certified Reference Materials ILAC G13 Guidelines for the requirements for the Competence of Providers of Proficiency Testing Schemes

Clinical laboratory testing and in vitr o diagnostic test systems 

ISO 15189:2003 ISO 15190:2003 ISO/TR 22869:2005

Medical laboratories – Particular requirements for quality and competence Medical laboratories –Requirements for safety Medical laboratories – Guidance on laboratory implementation of ISO 15189:2003

Quality Management Standards 

ISO/IEC 17025:2005

General requirements for the competence of testing and calibration laboratories

ISO/IEC 17043

Conformity Assessment – General Requirements for Proficiency testing

ISO/IEC Guide 2:2004

Standardisation and related activities – General Vocabulary

ISO/IEC 17000

Conformity Assessment - General Vocabulary

ISO 19011:2002

Guidelines for quality and/or environmental management system auditing

ISO/TR 10013:2001

Guidelines for Quality Management System documentation

ISO 10002: 2004

Quality Management – Customer Satisfaction – Guidelines for complaints handling in organisations

ISO 10002: 2004

Quality Management – Customer Satisfaction – Guidelines for complaints handling in organizations

ISO 9000

Quality Management Systems – Fundamentals and vocabulary

ISO 9001

Quality Management Systems – Requirements

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4.