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ISO/IEC 17025:2017 Lead Implementor / Lead Auditor Version 1.1
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ISO/IEC 17025:2017 Lead Implementor / Lead Auditor
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About The Knowledge Academy •
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Administration •
Trainer
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Fire Procedures
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Facilities
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Days/Times
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Breaks
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Special Needs
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Delegate ID check
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Phones and Mobile devices
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Outlines •
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Module 1: Introduction to ISO 17025 Module 2: Requirements of ISO 17025 Module 3: ISO 19011 relationship to ISO 17025
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Module 4: Scope
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Module 5: Normative references
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Outlines •
Module 6: Terms and definitions
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Module 7: General requirements
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requirements •
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Module 8: Structural requirements •
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Module 9: Resource requirements
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Module 10: Process requirements
Module 11: Management system
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Module 12: Management system documentation Module 13: Control management system documents Module 14: Control of records
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Outlines •
Module 15: Address risks and opportunities
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Module 16: Improvement
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Module 17: Corrective actions
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Module 18: Management reviews
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Module 20: Fundamental audit concepts and principles Module 21: Auditing requirements and assessment: ISO 17011:2017, ISO 19011:2018 Module 22 Recognition and oversight of ILAC, IAAC, APAC etc.
Module 19: Terminology – – ISO 9000, VIM etc.
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Outlines •
Module 23: Test Reports, AB
symbols, equipment stickers, certificates
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PT/ILC, Traceability •
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Module 24: Clauses 4, 5, and 6 review •
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Module 25: Clauses 7 and 8 review Module 26: Guidelines for auditing: ISO 19011
Module 27: GUM (Uncertainty),
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Module 28 Opening and closing meeting activities Module 29: ISO 19011 relationship to ISO 17025 Module 30: Auditing technical methods
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Outlines •
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Module 31: Reporting audit results Module 32: Audit checklists and audit reports Module 33: Review of standards and internal auditing issues Module 34: Introduction to Lab Management System (LMS)
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Module 35: Planning LMS implementation Module 36: Implementing LMS Module 37: Laboratory Management System Monitoring, Measurement, and Continuous Improvement
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Outlines •
Module 38: Planning ISO 17025 Audit
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Module 39: Conducting the ISO 17025 Audit Module 40: Concluding and ensuring follow‐up of ISO 17025 Audit
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Module 1: Introduction to ISO 17025
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ISO 17025 •
ISO 17025 is the international standard which sets out the general needs for the
competent, impartial, as well as regular operation of laboratories •
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It defines the works that should be involved in laboratory operations to develop confidence in its capability to produce valid as well as consistently strong testing, sampling outcomes, as well as calibration ISO/IEC 17025:2017 is the current updated standard. This standard was issued with participation among the International Organisation for Standardisation (ISO) and International Electro technical Commission (IEC)
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ISO 17025 (Continued) •
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According to ISO 9001 or ISO 14001, certification is the recognition which is an effective management system is in place, and ISO/IEC 17025 involves recognition of the technical capacity of laboratories Accreditation is a legal declaration by an Accreditation Body, after confirmation and evaluation, a laboratory is useful in meeting the needs of ISO 17025 to perform experiments according to its accredited scope The accreditation and standard are utilised by independently owned and operated laboratories, and those who are part of bigger companies, irrespective of the industry as well as size, which is included in measurement or sampling works
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Module 2: Requirements of ISO 17025
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Requirements of ISO 17025 •
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The ISO 17025 laboratory testing, as well as compliance standard, involves a series of various needs, can divided into eight categories These categories involve Scope, Normative references, terms and definitions, general requirements, structural requirements, resource requirements, process requirements, management system requirements These categories laid out a variety of rules as well as standards for testing as well as calibration laboratories, involving testing and calibration standards, staff capacity, standards of equipment, quality management, etc.
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Module 3: ISO 19011 Relationship to ISO 17025
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ISO 19011 •
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ISO 19011:2018 (Guidelines for auditing management systems), was published in July 2018 in response to demand for guidance on combined management system audits It provides comprehensive guidelines for auditing quality and/or environmental management systems The goal is to encourage organisations to save money, energy, effort and expense by eliminating uncertainty about the goals of the environmental or quality audit programme
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Ensure the audit reports are in the best format and include all relevant information
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Securing alignment of goals within an audit system for individual audits
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ISO 19011 (Continued) •
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Assessing the competence of audit team members against appropriate standards and minimising duplication of effort in the conduct of hybrid environmental / quality audits Significant updates to the new High‐Level Architecture of ISO 19011:2018 are as follows: A risk‐based approach
Extension of audit program management
Detailed instructions on how to perform an audit
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ISO 19011 (Continued)
Extension on auditors' competency criteria
Removal of "Auditor's Guidance and Examples of Discipline‐ Specific Knowledge and Skills" Annex A in ISO 19011:2011
Expansion on "Planning and performing audit guidelines for auditors“
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Four essential decisions / support tools for efficient preparation, implementing and reviewing quality and environmental audits are now available within a single standard
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ISO 17025 (Continued) •
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ISO 17025 is the main international standard for general test and calibration laboratory competency specifications In major countries, ISO/IEC 17025 is the standard that most laboratories need to be certified to be deemed technically competent There are many commonalities with the ISO 9001 standard, but ISO/IEC 17025 is more stringent in competency criteria and refers specifically to those entities that generate testing and calibration results and are focused on more scientific standards that give laboratories many benefits
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ISO 17025 (Continued) •
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The universal ISO 17025 standard applies to all or any laboratory irrespective of the size or complexity of research and calibration practices Generally, laboratories use ISO / IEC 17025 to incorporate a Quality Management System (QMS) to improve their ability to comply with relevant tests. It is also the basis for an accreditation body Since the standard is about skills, accreditation is simply the formal recognition of a presentation of that ability The common quality manual content follows the ISO / IEC 17025 standard outline
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ISO 17025 Major Changes in ISO/IEC 17025:2017 Include •
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It reduced the prescriptive guidelines of the standard and resulted in additional guidelines based on performance An additional chapter on risk‐based thought Greater flexibility in systems, policies, recorded knowledge, and organisational obligations Technology updates. For example, the standard now recognised and incorporates the use of computers, electronic records, and production of electronic records and reports
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Module 4: Scope
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Scope •
Scope of accreditation is the complete and official statement of works for which the laboratory is accredited
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In substance, this is a series of experiments which your laboratory is accredited to perform Several laboratories forget regarding the value of determining their scope when receiving accredited or re‐accredited
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Scope (Continued) •
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Companies always instantly put their scope together rather than consideration carefully and present it to the accreditation body without completely considering which they have to be accredited to perform In substance, the scope of accreditation follows two objectives: To determine the particular areas the activities of the laboratory which are to be included the accreditation To give the user of an accredited laboratory with a clear view of the particular calibrations included by the accreditation
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Module 5: Normative References
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Normative References •
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The Normative references clause lists that documents for information which are mentioned in the text in a way that their content constitutes of the document The references which are applied is discovered in the place where they are mentioned in the document, and not in the Normative references clause This series of references references are provided for the comfort of the user, who may consult the place where they are mentioned in the document in order to understand as well as evaluate to how they apply
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Module 6: Terms and Definitions
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Terms and Definitions •
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Some explanations of the terms have been presented in the updated version of ISO 17025 that are inter as well as intra laboratory comparison, proficiency testing, impartiality, verification, decision rule, complaint as well as validation In the definition of the laboratory, there are definitions of some other terms known as equipment calibration, sampling works, as well as sample testing
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Terms and Definitions (Continued) •
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An administration structure needs to be established, and the structure needs to be experienced, equipment required to be joined joined as well as looked after correctly with the help of strategies for maintenance, methods of testing needs to be accepted, and the examine nature should be insured The utilisation of our accr accreditation editation to standard may confirm the ability of an organisation providing inspecting administrations that are a new idea in an up‐to‐date version of ISO 17025
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Module 7: General Requirements
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General Requirements •
ISO/IEC 17025 signifies the general requirements for the impartiality, competence and consistent operation of laboratories
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ISO/IEC is relevant to every company doing laboratory works, regardless of the number of employees Regulatory authorities, laboratory customers, companies as well as schemes utilising peer‐ assessment, accreditation bodies and others utilise ISO/IEC 17025 in recognising or confirming the competence of laboratories
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Impartiality •
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Impartiality is an essential fragment in ISO/IEC 17025. This fragment directs the risks linked with creating biased outcomes There is no permission to the lab to let conflict of interest affect its outcomes under any circumstance, and the lab should be dedicated to risk‐based when addressing impartiality In substance, there should not be any conflict of interest about the following:
Commercial interest
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Financial interest
Relationship interest
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Impartiality (Continued) •
As well as the laboratory should recognise risks to impartiality from:
Activities
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Relationships
Personal relationships
The lab needs to recognise any risk to impartiality on a continuous basis. If impartiality or risk is detected, the lab requires to take remedial action as well as demonstrate how it has reduced or eliminated the risk
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Confidentiality •
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ISO/IEC 17025 addresses the needs including confidentially The lab is liable for the management of all knowledge collected or created during laboratory works as well as is held liable by legal actuation The standard needs that the lab should notify information to its clients in advance what it plans to share with the society Moreover, it directs steps it will take if confidential information is issued among the public
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Confidentiality (Continued) •
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Confidentially need also includes laboratory employees Usually, the laboratory and its employees are liable for the information created or collected during the performance of the laboratory works, as well as all information is regarded as possessive information and shall be considered as confidential, with exception to what is needed by law
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Module 8: Structural Requirements
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Structural Requirements •
The laboratory should determine as well as document the following regarding the laboratory operations: The organizational structure
The management with responsibility
The responsibility of the laboratory personnel
The activities of the laboratory
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Structural Requirements (Continued) •
The laboratory must have authorised employees to assure that regular contact takes place concerning: Improvement and implementation and of the management system The effectiveness of the management system The value of meeting customer and regulatory requirements
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The laboratory is must to document its processes to produce consistency of its works as well as to assure that the outcomes are correct
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Structural Requirements (Continued) •
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Usually, the procedures of laboratory are documented with a quality manual, activities instructions as well as standard operating processes The new standard has identified the need in which the lab should claim conformity with ISO 17025 standard for this series of laboratory works It means the lab is intended to be accredited and should involve in its scope of accreditation for just just to calibration, testing or sampling works which are using its resources
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Module 9: Resource Requirements
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Resource Requirements •
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Calibration and testing utilise the resource needs of ISO/IEC 17025 to improve their management system for quality, technical operations as well as administrative Moreover, ISO 17025 accreditation is crucial in enhancing the reputation of the laboratory Part of the procedure of accreditation is recognising the resource needs of standard
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General •
Resource requirements include employees,
facilities, services equipment, systems as well as support •
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The 17025 standard needs all internal as well as external employees of the laboratory to be capable and have an impartial attitude This involves employees who are included in calibration, testing, sampling works, and employees who are involved indirectly, like technical employees
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Personnel •
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To become an ISO/IEC 17025 accredited lab, all personnel of the laboratory, all internal as well as external personnel should be capable and work inside the structure of the management system of the laboratory For each and every job job purpose of the laboratory, an accurate documentation is needed It involves detail capacity as well as job job descriptions, supervision, training, as well as authorisation of personnel of the laboratory Laboratory management will communicate the responsibilities as well as authorities to laboratory personnel by regular meetings or reviews of personnel performance
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Personnel (Continued) •
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Management should to communicate to personnel for their responsibilities, duties and work for what they are allowed to perform Besides, the lab should have processes as well as maintain records for the following: o
Determining the competence requirements
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Choosing personnel
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Training personnel
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Personnel (Continued)
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Supervision of personnel
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Authorisation of personnel
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Competence of personnel
The personnel must perform these tasks for which they are allowed: o
Development, modification, verification, and validation of methods 45
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Personnel (Continued) o
Analysis of results
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Reports, reviews and authorisation of results
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Facilities and Environmental Conditions •
About the facilities and environmental situations of ISO 17025, the laboratory must be relevant to perform all works and not impact the validity of the outcomes. As a laboratory, the situations should be:
Documented Controlled Monitored Recorded
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Facilities and Environmental Conditions (Continued} •
Environmental situations that could affect your lab involve: Dust Humidity Electrical supply Temperature Vibration
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Facilities and Environmental Conditions (Continued} •
Laboratory work areas should be: o
Defined
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Controlled
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Isolated from areas with inconsistent activities of laboratory to stop interference or contamination of the activities
If any actions are performed outside, the laboratory should assure that all of the environmental conditions are met which is determined in this standard 49
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Equipment •
The laboratory will have a way to the accurate equipment needed for the performance of activities of the laboratory
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A recorded calibration program will require to set that involves the following: o
Records for every equipment that may impact activities of the laboratory, involving the handling, storage, transport, usage as well as maintenance of equipment
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Equipment (Continued} o
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Recognition of status of calibration, involving out of service as well as non‐calibrated equipment Tamper counteraction program in order to protect unauthorised adjustments that would invalidate the calibration status of the equipment
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Metrological Traceability •
ISO 17025 laboratories have to manage and set traceability of their measurements outcomes utilising a recorded continuous chain of calibrations, every contributing to measurement uncertainty as well as connecting them to an accurate reference
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Laboratories should give objective proof The measurements outcomes should be traceable to the International System of Units (SI) in one of these steps: o
A capable laboratory gave calibration
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Metrological Traceability (Continued) o
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Certified values of certified reference materials given through a capable producer with stated metrological traceability to the SI The demonstrable realisation of the SI assured by comparison, directly as well as indirectly, with standards which are national as well as international
If the measurement may not be traceable to the SI, the laboratory should direct metrological traceability to an accurate reference
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Externally Provided Products and Services •
ISO/IEC 17025 laboratories should assure that only satisfactory externally products which are provided as well as services that can affect the activities of the laboratory products and services are: which are utilised when o
o
o
expected for inclusion inside the activities of the laboratory are given directly to the clients through the laboratory, as earned from the external provider are utilised to support the laboratory's operation
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Externally Provided Products and Services (Continued) •
As determined in ISO/IEC 17025, the laboratory should have a procedure as well as retain records for the following: o
o
o
Reviewing, defining, as well as approving needs for externally given products as well as services Defining the basis for selection, evaluation, monitoring of performance as well as re‐evaluation of the providers which are external Assuring that the services as well as products which provided externally, meet the needs of the lab
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Externally Provided Products and Services (Continued) o
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Activities originating from monitoring, evaluations or performance of providers which is external
The laboratory should communicate needs to external providers involving: o
Acceptance criteria
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Capacity, involving any needed eligibility of employees
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Works that the lab or its customer plans to perform at the premises of the external provider
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Module 10: Process Requirements
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Process Requirements •
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Process requirements are related to the Technical Requirements of ISO 17025 standard Determining the Decision Rule for customer need for conformity report is most important in this clause A laboratory must have a determined method for the receipt, transportation, taking care of, maintenance, stockpiling, as well as calibration and testing items The lab should have a different entry for each and every new thing to be tested or calibrated in the lab facility under standard prescribed situations Divergence from indicated lab conditions are needed to be recorded at every situation
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Review ‐ Requests, Tenders, and Contracts •
ISO 17025, requirements says that your laboratory should have a process for the review of requests, tenders, as well as contracts, this process needs to assure the following: o
o
o
The requirements are determined, recorded as well as understanding The lab has the ability as well as resources to match the requirements The lab needs to match the requirements of products as well as services which are provided externally if the external providers are utilised
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Review ‐ Requests, Tenders, and Contracts (Continued) o
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The relevant techniques or processes are chosen as well as able to meet the needs of the customers
The laboratory should have excellent communication with the client The lab also should assure that the requirements of customers met, but also notify the client if the techniques of the lab are improper or expired, or if the request of the lab may not be made because it would compromise the lab’s honesty
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Selection, Verification, and Validation of Methods Selection and verification of methods •
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The laboratory is needed to utilise accurate techniques as well as processes for works, and while necessary, for evaluation of the measurement uncertainty and mathematical methods for data analysis Techniques, processes as well as supporting documentation required to be updated as well as available to all employees Besides, ISO 17025 mandates that the lab remain updated with the accurate way and while the clients did not specify a method, the lab selects the best as well as an updated version
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Selection, Verification, and Validation of Methods (Continued) •
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The lab needs to tell the customer what way they are utilising While selecting a way, the lab must confirm that the method they are using has been issued either nationally as well as internationally, regionally, or through other reputable technical company. Scientific journal, journal, as well as texts, are also valid issues The lab needs to verify that it may perform the ways which they choose
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Selection, Verification, and Validation of Methods Validation of Methods •
ISO/IEC 17025 needs laboratories to validate methods which they utilize
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It involves non‐standard ways, laboratory‐improved methods as well as standard ways
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The methods validation should be as long as important to match the requirements of the provided application The impact of the changes should be understood when the changes are performed to a validated method
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Selection, Verification, and Validation of Methods (Continued) •
The laboratory maintains the records of validation which are the following: The validation of the procedure used Specification of the requirements Determination of the performance characteristics of the method Results obtained A statement on the validity of the method
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Sampling •
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ISO/IEC needs every laboratory to have a sampling plan as well as method when carrying out a sampling of materials, substances or products for subsequence calibration or testing The laboratory needs to determine if the sampling methods state the factors to be controlled to assure the validity of subsequent testing, as well as assure that the sampling plan or method is available at the site where sampling is undertaken Sampling is required to utilise accurate methods of statistical
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Sampling (Continued) •
Sampling methods must describe: o
The selection of samples or sites
o
The sampling plan
o
The preparation and treatment of samples
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Sampling (Continued) •
While the laboratory is sampling, they needs to maintain accurate records of samples. These records should involve, when necessary: o
References to the sampling method
o
Date and time of sampling
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Data to identify and describe the sample
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Sampling (Continued) o
Personnel performing the sample
o
Environmental or transportation conditions
o
Diagrams or other equivalent means to identify the sampling location
o
Deviations, additions or exclusions from the sampling method and sampling plan
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Handling Test or Calibration Items •
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The laboratory needs to a process handling, protection, disposalfor ortransportation, return of test orreceipt, calibration itemsstorage, retention, as have well as
It involves all provisions important to protect the honesty of the test or calibration item as well as to protect the honesty of the calibration or test item, and the interest of the customer as well as lab The lab needs to take precautions to avoid contamination, deterioration, damage or loss to the item during handling, storing, transporting as well as preparing for calibration or test
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Handling Test or Calibration Items •
The laboratory also needs the following: Establish handling instructions Have a method for the apparent identification of calibration or test items Maintain identification when the lab is liable for the item Assure that the items did not get confused Accommodate a sub‐division of an item or groups of items and the transfer of items Record any deviations
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Technical Records •
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A lab must assure that technical records for every activity of the lab include results, a report, as well as information to facilitate, if feasible, components identification influencing the measurement outcomes and its connected measurement uncertainty, as well as allow to repetition of the activities of the lab below situations as soon as possible to the original u have to involve the date as well as identify Yo You the employees who are responsible for the activities of the lab while you are maintaining records
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Technical Records (Continued) •
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Records can involve the data, observations as well as evaluations, and have to be recorded at the time when they are made If there are any changes made, these revisions should be followed to old versions or to the real observations Maintain all the records, containing the original and revisions, involving altered aspects, date of the alteration as well as employees responsible for any changes
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Evaluation of Measurement Uncertainty •
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As an ISO/IEC 17025 accredited laboratory, it is necessary to understand, from where measurement uncertainty is coming The laboratory should identify the contributions to the uncertainties While you are calculating for uncertainty, you should think about all significant contributions, even arising from sampling
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The lab requires to evaluate its equipment for uncertainty if you are doing calibrations
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While performing testing, you must evaluate measurement uncertainty
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Ensure Results Validity •
The laboratory will have a process for controlling the validity of results
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As an ISO/IEC 17025 accredited lab, assuring the validity of outcomes to be the priority
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Be capable of identifying trends utilising statistical methods is one of the primary goals of validity The laboratory needs to develop a process for controlling the validity of their outcomes, to match the needs The main aim is to understand if the procedure or system can be ineffective so you may take defensive steps
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Reporting of Results •
This clause may be divided into these sub clauses: General
Common Requirements for Reports Specific Requirements for Test Reports Specific Requirements for Calibration Certificates Reporting Sampling‐ Specific Requirements Reporting Statements of Conformity Reporting Opinions and Interpretations Amendments to Reports
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Complaints •
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Managing complaints of the customers is essential, and you should have a recorded procedure to evaluate, receive as well as make decisions to handle ISO 17025 complaints if your lab wants to be accredited The procedure requires to be easily available to any party which is interested If the issued complaint is suit suitable able to the works performed by the laboratory, the laboratory should confirm that it is liable for the complaint, and the lab must be liable for every decision made around to handling this complaint
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Nonconforming Work •
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This clause indicates that labs need to have a process that should be executed while results or activities did not conform to their processes or the agreed requirements which are made by the customer The laboratory needs to maintain records of nonconforming work, as well as if the lab believes nonconformities can retake place, the lab should to take steps which are remedial For non‐conformance, the process required to involve the following: o
Who is authorised as well as liable for the management of nonconforming activity
o
Establish steps based on the risk level
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Nonconforming Work (Continued) o
An assessment of the significance of the nonconforming activity involving an influenced analysis
o
The decision to be taken for the nonconformity
o
Assurance that the customer is notified
o
Who is responsible for authorising the resumption of work
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Control of Data and Information Management •
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Control of data, as well as information, is an essential factor for laboratories to do works Labs must confirm that they have the essential reach to input data as well as information required to perform its all activities The labs must assure that the information management system which is utilised for processing, collection, reporting, recording, storing as well as retrieving data is validated for functionality It involves the accurate function of interfaces inside the laboratory information management system
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Module 11: Management System Requirements
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Management System Requirements Options •
The laboratories need to implement a management system under Option A or B
General •
According to the ISO 17025, the laboratory needs to establish, document, retain as well as implement management which is able of supporting and demonstrating the commitment to the needs
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Management System Requirements Option A •
Option A has the various clauses which required to be followed. Overall at the bare least, the management system should address the following given below: o
Management System Documentation
o
Control of Management System Documents
o
Control of Records
o
Actions to address risks and opportunities
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Management System Requirements (Continued) o
Improvement
o
Corrective Actions
o
Internal Audits
o
Management Reviews
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Management System Requirements (Continued)
Option B •
Option B says that your laboratory complies if: o
o
The laboratory has established as well as managed a management system under the needs of ISO 9001 You are able of supporting as well as demonstrating the compatible fulfilment of the needs from clauses of ISO 17025
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Management System Requirements (Continued) o
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You have satisfied management system documentation as well as management review requirements of ISO 17025
If your laboratory is accredited to ISO 9001:2015, you may select Option B. It permits for more elasticity as you implement 17025:2017
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Module 12: Management System Documentation
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Management System Documentation •
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While laboratories are moving for accreditation, particular ISO/IEC 17025 documentation requirements should be satisfied These documents are utilised to develop as well as design testing and calibration laboratories There are many categories of requirements for better understanding as well as defining quality systems in the laboratory according to the ISO/IEC 17025 standard
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Management System Documentation •
These document categories were defined as following:
Policies Documents Procedures Records Processes Review
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Module 13: Control Management System Documents
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Control Management System Documents •
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The ISO 17025 document management requirements relevant to both paper as well as electronic files and call in laboratories in order to set processes for the control and security of those documents ISO 17025 does not highlight the types of documents which needs to be controlled in a lab setting ISO laboratory control standard also specifies an apparent procedure for document access, accessibility, review, revision, approval, storage as well as deletion
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Control Management System Documents (Continued) •
The primary document control requirements in the ISO 17025 standard given below: Review Revision Organization Accessibility Document deletion or storage
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Module 14: Control of Records
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Control of Records •
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The laboratory will set as well as retain processes for identification, indexing, collection, filing, access, storage as well as maintenance as well as disposal of quality and technical records Quality records will involve reports from internal audits as well as management reviews and records of corrective and preventive actions All records will be clear as we well ll as be stored and maintained in such a method which they are easily retrievable in facilities which gives a relevant environment to stop damage or deterioration as well as to stop loss The laboratory will have processes to back‐up as well as protect stored electronically and to stop unauthorised access to or amendment of these records
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Module 15: Address Risks and Opportunities
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Address Risks and Opportunities •
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•
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The concept in this requirement is regarding action on risks and opportunity arises from ISO 9001:2015, that has a strong customer focus ISO 17025 and ISO 15189 are standards written by the people of the laboratory who are experienced in what may go wrong They are intended to assure that testing‐related risks are maintained, containing business risks such as damage which is reputational You are addressing all the areas of risk as well as the opportunity for testing service, by complying these international standards and by having accreditation
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Module 16: Improvement
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Improvement •
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The laboratory will constantly enhance the effectiveness of its management system by the use of the quality policy, quality objectives, data analysis, corrective as well as preventive actions and management reviews For improvement, we have to do the following: Corrective Actions Root Cause Analysis Preventive Actions Management Review Non Conformance
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Improvement (Continued) Internal Audits Peer Review QC Data Review Lower Detection Limits New Equipment/Instruments More Employees Complaints and Customer Surveys
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Module 17: Corrective Actions
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Corrective Actions •
These are the following steps to take corrective actions: General Cause analysis Selection and implementation of corrective actions Monitoring of corrective actions Additional audits
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Module 18: Internal Audit and Management Reviews
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Internal Audit •
the Internal audit assures that quality accreditation system fulfils ISO /IEC 17025 requirements, suitable particular criteria document and regulatory bodies •
•
The audit also assures whether the requirements of the laboratory quality manual and associated documents are applied at all work levels or not The non‐conformities discovered during the internal audit provide valuable information for the improvements of the technical competence and laboratory’s quality system, which is to be utilised as an input to management reviews
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Management Reviews •
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•
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Management reviews are critical procedures in multiple quality‐management systems, involving laboratory‐management systems, under ISO/IEC 17025 and ISO 15189 These reviews are exceptional opportunities to understand as well as manage the inputs as well as outputs of a quality management system Usually, laboratory meet some problems that exploit the process of the management review entirely as they do not understand the importance of this process or they do not have the experience to run this process in the way of giving expected results This activity presents a management review checklist that assists laboratories in carrying out a useful management review running by the all essential aspects of the quality management system
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Module 19: Terminology – – ISO 9000, VIM etc.
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ISO 9000 Terminology in English What is ISO 9000? •
ISO 9000 is a set of standards, developed and published by International Organisation for Standardisation, which describes, establishes and maintains an efficient quality assurance framework for the manufacturing and service industries
Some of the common ISO definitions are as follows: 1. •
Accred Accredita itatio tion n
The act of giving an organisation formal approval to operate an audit and registration program
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ISO 9000 Terminology in English 2.
Audi Audito torr
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ISO auditors carry out evaluations and monitoring
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They are considered as the "front line" during an audit
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An internal auditor is generally an employee who is trained in auditing and he also performs annual or bi‐annual audits depending upon the needs of an organisation External audits are conducted by a firm that is not in any way affiliated with the audited organisation
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ISO 9000 Terminology in English 3. •
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This is the formal act of waiving, surrendering or yielding a privilege or a right It is usually made in writing by a customer when it has been determined that a in a practical or cost efficient manner a contractual requirement cannot be met, and the desired outcomes will not be affected materially by dropping the requirements
4. •
•
Conc Concess essio ion n
Corr Correc ecti tive ve action request (CAR)
A CAR is one of the most commonly used terms for corrective action in ISO The essence of a CAR is to identify a problem that has already occurred and needs root cause analysis and resolution in order to avoid recurrence
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ISO 9000 Terminology in English 5. •
Disc Discre repa panc ncy y
It can be defined as a failure of meeting the requirement that are specified, supported by evidence and is also known as “deficiency or “nonconformance”
6.
Docu Docume ment nt Management System
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This is the software that is used to track and store electronic documents
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It is capable of keeping track of the several versions modified by several users
7. •
Fault ult Tree Analysis(FTA)
FTA FTA is the process of finding out possible design weaknesses by using a logic diagram that defines basic faults and events which can cause system failures and/or safety hazards
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ISO 9000 Terminology in English 8.
Ob Obser serva vatio tion n
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An “observation” is a statement of fact that is made in an report of audit team
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It indicates an audit finding that does not rise to the level of a nonconformity
9. •
Polic olicy y
It is a definite course or method of action to guide present and future decisions. ISO makes it mandatory to develop and use a Quality Policy as a basis for your quality objectives
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ISO 9000 Terminology in English
10. Preventiv Preventive e Action •
It is an action which is taken to reduce the causes of a potential nonconformity
11. Procedure Procedure •
It is a particular method of achieving something, and an established way of doing things.
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A series of steps followed in a specific regular order
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It assures a consistent and repetitive approach to actions
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ISO 9000 Terminology in English 12. Quality Quality Audit •
It is an examination of an organisation’s quality management system to ensure conformance to a specific quality standard, like ISO 9001
13. Quality Quality Manual •
It is a document in which your quality standards are defined and where your Quality Policy is stated
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ISO 9000 Terminology in English 14. Quality Quality Management System •
It is a collection of business processes concentrating on obtaining your Quality Policy and quality objectives
15. Registrar Registrarss •
These are organisations that issue ISO certification
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Module 20: Fundamental Audit Concepts and Principles
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Fundamental Audit Concepts and Principles •
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The essential principle of internal audit can be described by a participant who involves in the program actively These make the audit a reliable and an effective tool in support of management policies and controls
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Module 21: Auditing Requirements and Assessment: ISO 17011:2017, ISO 19011:2018
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Auditing : ISO 17011:2017 Internal Audits •
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The accreditation body shall develop internal audit procedures to check compliance with the requirements of this International Standard and the implementation and maintenance of the management system Internal audits are performed generally at least once a year Internal audit frequency may be decreased if the accreditation body can demonstrate that its management system has been successfully applied in compliance with this International Standard and has proven stability
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Auditing : ISO 17011:2017 (Continued) •
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The audit programme needs to be planned by taking into consideration the significance of the processes and areas to be audited and the results of previous audits The accreditation body must ensure that: o
o
Internal audits are managed by qualified staff who is knowledgeable with auditing, accreditation and the requirements of this International Standard Internal audits are managed by personnel who are different from those who are performing the activity to be audited
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Auditing : ISO 17011:2017 (Continued) o
Personnel responsible for the audited area are informed regarding the outcome of the audit
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Actions are taken in a timely and suitable manner
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Any development opportunities are identified
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Auditing : ISO 19011:2018 Introduction •
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Several new management system standards have been published since the first version of this International Standard was published in 2002 As a result, there is now a requirement to consider a broader scope of management system auditing, as well as providing more generic guidance In 2006, the ISO Conformity Assessment Committee (CASCO) developed ISO/IEC 17021, that sets out needs for third‐party management system certification and that was based on the guidelines contained in the first version of this International Standard
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Auditing : ISO 19011:2018 (Continued) •
•
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The second version of ISO / IEC 17021, published in 2011, has been extended to transform the guidance offered in this International Standard into needs for certification audits of management systems The second edition of this International Standard provides guidance for all users, including small and medium‐sized organisations It focuses on what is commonly referred to as "internal audits" (first‐party) and "customer audits on their suppliers" (second party)
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Module 22: Recognition and Oversight of ILAC, IAAC, APAC etc.
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Description of ILAC What is ILAC? •
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The full form of ILAC is International Laboratory Accreditation Cooperation It was established in 1977 to facilitate communication between the world's laboratory accreditation bodies In 1996, the Memorandum of Understanding (MOU) was formalised as a cooperation with 44 bodies
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Description of ILAC (Continued) •
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A Mutual Recognition Agreement (MRA) was signed on 2 November 2000 among those participants who successfully completed a peer evaluation In October 2012, the MRA was extended to include the accreditation of the inspection body and 85 signatories (full members) to the Arrangement representing 70 economies On 20 January 2003, ILAC was founded in the Netherlands
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ILAC’s Global Role Principle International Forum for: •
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Recognition through its Mutual Recognition Arrangement (MRA) of competent testing and calibration laboratories and inspection bodies worldwide Development and appropriate harmonisation of accreditation practice for laboratory and inspection bodies
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As a trade facilitation tool promotion of laboratory and inspection accreditation
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Assisting with the laboratory development and inspection accreditation systems
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Abbreviations The Full Forms are as Follows EA (France)
European Cooperation for Accreditation
APAC (Australia) Asia Pacific Accreditation Cooperation Incorporated IAAC (Mexico)
Inter American Accreditation Cooperation
SADCA (South Africa)
Southern African Development Community Cooperation in Accreditation
AFRAC (South Africa)
African Accreditation Cooperation
ARAC (Morocco) Arab Accreditation Cooperation
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Abbreviations ILAC Resolutions •
•
GA 8.11 The General Assembly acknowledges that evaluating the technical competence of bodies producing reference materials with specified values is the accreditation of a conformity assessment activity GA 9.28 ISO Guide 34 accreditation. Be included in the current ILAC arrangement when ILAC develops and agrees with appropriate procedures for this activity
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ILAC Documents RM(Records Management) Regional & ILAC Documents •
•
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Guidance and requirements on the Accreditation of a Reference Material Producer APLAC TC 012: Guidelines for the Acceptability of Chemical Reference Materials and Commercial Chemicals for Equipment Calibration Used in Chemical Testing IAAC MD 028/13: Compulsory And Non‐Compulsory Application for the Assessment and Accreditation of Reference Material Producers
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ILAC Documents (Continued) •
ILAC G9: Guidelines for the Selection and Use of Reference Materials (ILAC G‐9 is now replaced by ISO Guide 33‐2015)
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ILAC G12: Guidelines for the Requirements for the Competence of RMPs
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ILAC P10: Policy on Traceability of Measurements
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ILAC P10 Traceability Policy It is provided by CRMs(Certified Reference Material): •
RMs may not be traceable
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CRMs by definition are traceable
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Values assigned to CRMs by NMIs in the BIPM KCDB or developed under the scope of accreditation by an accredited RMP are considered traceable CRM values in JCTLM DB are considered traceable and the majority of other RMs & CRMs produced by other RMPs can be regarded as critical consumables that the laboratory must demonstrate are appropriate
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Module 23: Test Reports, AB Symbols, Equipment Stickers, Certificates
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AB symbols •
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Particular guidance on requirements for placing their accreditation symbols on the calibration certificate for a specific instrument is provided by Accreditation Bodies (AB) From country to country, these can vary a little, while the requirements that are critical do not vary. These are: o
o
In the lab scope‐of ‐accreditation, all results of measurements need to be included, and if not, it is important to denote them clearly in the report as non‐accredited measurements It is must to include the measurement uncertainty per the ISO GUM3 in the measurement report with all measurement
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Certificates Introduction •
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We need to maintain standardised calibration certificates as an ISO/IEC 17025 accredited calibration laboratory This standardisation provides our customers with the ultimate level of trust in our services, as they can ensure that all their data are not only accurately represented, but are fully traceable
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Certificates Certificate Naming Convention •
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One of the significant needs of our ISO 17025 accreditation is creating a certificate naming convention ISO/IEC 17025:2017 Section 7.8.2.1.d requires: o
o
o
“Unique identification of the test report or calibration certificate“ Yo You u may have observed a unique convention used to name the documents in the daily operations of Fox Valley Metrology Because of a large number of documents created by Fox Valley Metrology on a daily basis, it is important that we create a unique name for each document that removes duplication, but is simple to understand and use
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Certificates (Continued) •
The documents which utilise convention of naming include: Calibration Certificates Quotations On‐Site Job Numbers Internal Reference Number Purchase Orders
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Module 24: Clauses 4, 5, and 6 Review
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Clause 4:General Requirements Clause 4 is broken down in the following two parts: •
4.1 impartiality o
o
o
In ISO 17025, impartiality is a major clause The risk associated with creating biased results are addressed in this clause, and when addressing impartiality, the lab needs to be committed to risk‐based thinking In summary, regarding the following, there must not be any conflict of interest: commercial interest
financial interest
relationship interest
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Clause 4:General Requirements (Continued) o
The laboratory must identify risks to impartiality from the following aspects : Acti Activi viti ties es
•
Rela Relati tion onsh ship ipss
Personal relationships
4.2 Confidentiality o
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All requirements involving confidentiality are discussed in clause 4.2 of ISO 17025:2017 Managing all the information is the responsibility of the lab, that is created or obtained during laboratory activities and held is responsible by legal enforcement
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Clause 4:General Requirements (Continued) o
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The standard requires that the lab ought to inform in advance to its customer about the information that is intended by it to share with the public Moreover, it addresses the action it will take if in public the confidential information is released
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Clause 5: Structural Requirements •
The following are the laboratory operations that the laboratory needs to define and document in order to get ISO 17025:2017 accredited: The organisational structure
•
The activities of the laboratory
The responsibility of the laboratory personnel
The management with responsibility
The laboratory needs to have personnel authorised to make sure that regular communication occurs regarding:
Implementation and improvement of the management system
The effectiveness of the management system
The importance of meeting customer as well as regulatory requirements
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Clause 6: Resource Requirements Clause 6 is broken down in the following six sub‐clauses: •
6.1 General
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6.2 Personnel
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6.3 Facilities and Environmental Conditions
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6.4 Equipment
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6.5 Metrological Traceability
•
6.6 Externally Provided Products and Services
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Module 25: Clauses 7 and 8 Review
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Clause 7: Process Requirements Process requirements are classified into 11 Sub‐clauses •
7.1 Review of Requests, Tenders and Contracts
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7.2 Selection, Verification and Validation of Methods
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7.3 Sampling
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7.4 Handling of Test and Calibration Items
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7.5 Technical Records
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7.6 Evaluation of Measurement Uncertainty
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Clause 7: Process Requirements •
7.7 Ensuring the Validity of Results
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7.8 Reporting of Results
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7.9 Complaints
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7.10 Nonconforming Work
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7.11 Control of Data and Information Management
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Clause 8: Option •
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Clause 8 Option‐ ISO 17025 requires the laboratory to establish, document, implement and maintain a management system capable of supporting and demonstrating commitment to the requirements Laboratories must implement a management system in accordance with Option A or B in addition to the requirements of Clauses 4‐7
Option A •
Option A has many clauses that need to be followed. Overall, at the bare minimum, the management system needs to address the following: Management System Documentation Control of Management System Documents
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Clause 8: Option (Continued) Control of Records Actions to address risks and opportunities Improvement Corrective Actions Internal Audits Management Reviews
Option B •
Option B takes care that your laboratory meets the requirements of ISO 9001:2015 if the laboratory has developed and maintained a management system
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Clause 8: Option (Continued) •
•
•
Yo You u are able to support and demonstrate consistent compliance with the requirements of clause 4‐7 of ISO 17025:2017 And have complied with the requirements for documentation and management review of the management system (clauses 8.2 and 8.9 of ISO17025:2017) If your laboratory is ISO 9001:2015 certified, choice B can be chosen. It provides more flexibility when implementing 17025:2017
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Module 26: Guidelines for Auditing: ISO 19011
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ISO 19011 Auditing Guidelines What is ISO 19011? •
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•
•
ISO 19011 is defined as the standard that sets audit management systems guidelines This norm provides guidelines on the management of an audit program, auditing standards, and assessment of individuals responsible for the management of audit programs The audit program consists of the arrangements made to complete all the audits necessary for a specific purpose ISO 19011:2018 provides valuable guidance on how to consistently improve an audit program, just just the way other organisational divisions are expected to improve
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ISO 19011 Auditing Guidelines (Continued) •
•
•
•
One component of such change is to ensure that the goals of the audit program are compatible with the policies and priorities of the management system Organisations should consider the needs of customers and other interested parties in pushing for reforms in auditing In general, the definition of risk is a field of increasing importance in management systems for auditing and business Risk has been incorporated as of the 2011 version throughout the ISO 19011:2018 audit program management component
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ISO 19011 Auditing Guidelines Standard Facts of ISO 19011 •
When the US adopts a standard version, it is referred to as an American National Standard (ANS) and is similar to an international standard
•
The edition of ANSI may or may not change the standard's international i.e. ISO version
•
ASQ/ANSI/ISO 19011:2018 is available in both print and digital (PDF) formats
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ISO 19011 Auditing Guidelines Who ISO 19011:2018 Should Be Used ? •
•
•
•
If your company performs internal or external management system audits or if you operate an audit program, then ISO 19011 and the ANSI version will be applied ISO 19011 can be used by anyone interested in audits or audit programs In particular, ISO 19011 is designed for people responsible for managing an audit system and assessing individuals involved in audit systems and audits Anyone who has been commissioned to develop an audit system would probably find the importance of ISO 19011:2018
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ISO 19011 Auditing Guidelines What Does ISO 19011:2018 Accomplish? •
ISO 19011 provides guidance on all audit phases of a management system such as:
Defining Program Objectives
Completing the Audits Needed
Reviewing the Results and Process
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Module 27: GUM (Uncertainty), PT/ILC, Traceability
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GUM (Uncertainty) •
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The GUM stands for the Guide to the Expression of Uncertainty in Measurement (GUM) Calibration and testing laboratories are the most common methods of estimating uncertainty for ISO/IEC 17025
Most Common Mistakes while Calculating Uncertainty Not Calculating Uncertainty or Missing Uncertainty Budgets Not Following the GUM Method to Calculate Uncertainty Measurement Traceability Not Including ‘Type A’ Uncertainty Data
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GUM (Uncertainty) (Continued) Not Considering all Influences to Measurement Uncertainty Combining Incompatible Units of Measure Not Updating Your Uncertainty Budgets Using Manufacture’s Uncertainty Specifications Not Reporting Uncertainty to Two Significant Figures Reporting Uncertainty Smaller Than Your CMC Uncertainty
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PT/ILC •
•
•
•
In the Test and Measurement Industry, PT (Proficiency Testing) and ILC (Inter‐Laboratory Comparisons) are the terms that are used synonymously. They both are similar but different slightly According to ISO guide 43, PT is an exercise that is formal and is managed by a coordinating body that involves a reference or standard laboratory In the formal report, the results are issued that provides the Z and En score clearly According to ISO 17025, ILC is the organisation, performance, and evaluation of tests or measurement on the same item by two or more than two inspection or laboratories that are as per predetermined conditions
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PT/ILC (Continued) •
•
•
Further, it is described in ISO Guide 43 an inter‐laboratory comparison as an exercise which is done by agreement between two or more laboratories taking part, where the results are given in the formal report So, in an ILC, the difference is a proficiency test that an independent third party organises and manages. Also, the participation of a reference laboratory is included in a PT and to determine participant performance utilise their results The use of a coordinating body or a reference laboratory is not required by an ILC. Thus, in participant laboratories, the only comparison of performance among the group group of participating members is made
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Traceability •
•
•
•
For meeting the requirements of ISO 17025 accreditation, measurement traceability is a crucial factor for laboratory Measurement traceability is essential as assurance and confidence provided by it enables you to make sure that results of your measurement agrees with the international or national standard in the statement of uncertainty in measurement In calibration or test report, a laboratory may claim anything they desire without traceability The risk of falling victim to fraudulent activities and information, can be minimised with the traceability and the independent analysis of an inspection body
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Module 28: Opening and Closing Meeting Activities
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Opening Meeting What Happens in an Opening Meeting? •
•
•
•
An audit opening meeting's primary purpose is to confirm the audit plan and previous arrangements It is also an opportunity to introduce members of the audit team and explain your audit approach The first meeting will be led by the Lead Auditor and will be held with the organisation's management and audit areas. The meeting should be held in a friendly manner, and the auditee should be confident
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Opening Meeting (Continued) •
•
•
•
If you are assigned guides or accompanied by observers, you can use the opening meeting to explain their roles carefully to avoid possible interruptions during the audit For the auditee, Remember to allocate time in the opening meeting to ask the questions The opening meeting can also provide insights into the level of commitment and support from the management The details covered in the opening meeting should be consistent with the auditee's familiarity with the audit process
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Opening Meeting (Continued) •
•
The opening meeting may consist of communication which an audit is being conducted and explaining the audit's nature for internal audits in a small company The opening meeting may be very formal and even capture attendance records for other audit circumstances, especially third‐party audits
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Closing Meeting What Happens in a Closing Meeting? •
•
•
The closing or exit meeting is the last opportunity for internal audit to show its professionalism and presentation skills. It is also an opportunity to establish a positive relationship with the customer At the conclusion of the fieldwork, auditors usually hold the exit meeting and treat it as a "nonevent." So, there should be no surprises during the exit meeting and all problems should be addressed before the meeting starts Auditors may need to schedule a series of pre‐exit meetings to ensure that the final meeting runs smoothly
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Closing Meeting (Continued) •
•
The "real" exit meeting is often attended by senior managers who did not participate directly in the audit It can then be confined to a presentation and discussion of the audit process and results, rather than serving as a working meeting
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Module 29: ISO 19011 Relationship to ISO 17025
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ISO 19011 •
•
•
•
ISO 19011:2018 (Guidelines for auditing management systems), was published in July 2018 in response to demand for guidance on combined management system audits It provides comprehensive guidelines for auditing quality and/or environmental management systems The goal is to encourage organisations to save money, energy, effort and expense by eliminating uncertainty about the goals of the environmental or quality audit programme It ensures that the audit reports are in the best format and include all relevant information
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ISO 19011 (Continued) •
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It secures alignment of goals within an audit system for individual audits It assess the competence of audit team members against appropriate standards and minimising duplication of effort in the conduct of hybrid environmental / quality audits
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ISO 17025 •
•
•
•
ISO 17025 is the international standard for general test and calibration laboratory competency specifications In major countries, ISO/IEC 17025 is the standard that most laboratories need to be certified in in order to become technically competent There are many commonalities with the ISO 9001 standard, but ISO/IEC 17025 is more stringent in competency criteria and refers specifically to those entities that generate testing and calibration results and are focused on more scientific standards that give laboratories many benefits The universal ISO 17025 standard applies to all or any laboratory irrespective of the size
or complexity of research and calibration practices
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ISO 17025 (Continued)
•
•
It is used by laboratories to improve their quality, body, and technical management system Generally, laboratories use ISO / IEC 17025 to incorporate a Quality Management System (QMS) to improve their ability to comply with relevant tests
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Module 30: Auditing Technical Methods
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Auditing Technical Methods •
•
For an auditor, the evidence is required to form an opinion with regard to financial statements The reliability of the audit report will reduce if the proper evidence is not collected by the auditor
•
The methods by which the evidences are collected is called audit techniques
•
The following are the few essential audit techniques: Vouching Confirmation Reconciliation
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Auditing Technical Methods (Continued) Testing Physical Examination Analysis Scanning Inquiry Verification of Posting Flow Chart
Observations
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Module 31: Reporting Audit Results
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Reporting Audit Results Internal Audit report •
•
•
A document is an internal audit report which contains formal results of an audit. Internal Auditor utilises it for showing what is examined, highlighting negative, positive, and conclusions Thus the management of the company can get to know what needs improvement and what is going well It is crucial for the report to be prepared carefully. The text must be clear, impartial, and objective for making sure that the results of an audit are useful and the organisation can
utilise them as a guide in order to set the direction of action
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Module 32: Audit Checklists
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Audit Checklist ISO 17025: 17025:2017 2017 Audit Audit Checklist for Laboratory Accreditation System Requirements •
•
•
Accreditation ISO/IEC 17025 is used worldwide in laboratories for calibration and research The audit checklist ISO 17025:2017 is a document needed to validate the laboratory accreditation program when certifying ISO/IEC 17025:2017 in the laboratory testing and calibration In order to simply achieve ISO 17025:2017 certification, every company must comply
with the ISO 17025 examination carried out by the ISO certification body. ISO 17025 checklist for rapid ISO/IEC 17025 accreditation, is globally verified as ISO documents © 2020 The Knowledge Academy Ltd
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Audit Checklist Content of ISO/IEC 17025:2017 Audit Checklists •
ISO 17025:2017 audit checklist deals with audit questions based on the specifications of ISO/IEC 17025:2017 for each testing and calibration laboratory department as set out below o
o
ISO 17025 checklists are considered to be a very good tool for auditors to send an audit questionnaire while ISO 17025 tests the efficacy of the laboratory management system implemented Based on the ISO 17025:2017 standard, more than 200 internal audit questions are planned
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Module 33: Review of Standards and Internal Auditing Issues
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Review of Standards •
•
The standards, the Institute of Internal Auditors (IIA) declared, are the primary mechanism to guarantee the internal auditors of an organisation consistently and accurately provide essential services in a cost‐effective and timely method The standard also: o
Provide a framework to perform a broad range of value‐added internal audit
o
Describe the fundamental principle that represents the internal auditing practice
o
For the evaluation of internal audit performance, establish the basis
o
Foster improved process and operations of an organisation
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Review of Standards (Continued) •
•
•
The Institute of Internal Auditors (IIA) declared that the standards are the primary mechanism to make sure that the internal auditors of an organisation consistently and accurately provide essential services in a cost‐effective and timely method For internal auditors throughout the world, the standards are recognised as the benchmark and are available in more than three dozen translations that are officially authorised The standards need an organisation to have an external quality assessment that is
independent for once every five years, that contains a conformance review with the standards
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Internal Auditing Issues •
•
•
Internal auditing is a complex task which includes: o
The identification of risks that can prevent an organisation from achieving its goals
o
Helping to ensure the leaders of an organisation know about these risks
o
Proactively recommending improvements to diminish the risk to a satisfactory level
False assurance is the biggest issue, when in an audit, something is missed by auditors, and they conclude that the processes are well‐controlled, but they are not The standards help to guarantee that the duties are performed effectively by the internal auditor
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Internal Auditing Issues (Continued) •
•
Important risks can be overlooked easily if internal auditing is not performed as per to the standards Therefore, business opportunities can be missed, and the stated objectives would not be met by the organisation
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Module 34: Introduction to Lab Management System (LMS)
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Standard and Regulatory Framework •
•
IS ISO O 1702 17025 5 is an in inte tern rna ati tion onal al standar standard d to tes testt and standar standardise dise laboratories Thes These e sets sets of requ requir irem emen ents ts are are used by laboratories to show that they work as a quality management syst system em and the they y ar are e techn technica ically lly expert to do the work
Scope
Normative References
Terms and Definitions
Management Requirements
Technical Requirements •
The The stan standa dard rd is writ writte ten n in fi five ve clauses:
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Standard and Regulatory Framework 1. •
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Scop Scope e
The scope refer to a clear statement of everything that lab works for which it wants to be accredited Specific methods for conducting its tests is set out by a testing lab A calibration lab will record the specific measurements and related uncertainty it might have in its calibration work Describing the scope denotes that the lab can classify skilled staff appropriately and give clients a confidence for its tests and measurements
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Standard and Regulatory Framework 2. •
No Norm rmat ativ ive e References
The Normative references clause mention information, those documents that are quoted in the text in a form that some or all of their content, set up requirements of the document
•
This clause shall be numbered as Clause 2 and shall not be subdivided
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Referenced documents which are listed are not numbered
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Standard and Regulatory Framework 3.
Ter erms ms and Definitions Impartiality Complaint Inter‐laboratory Comparison Proficiency Testing Laboratory Decision Rule Verification Validation
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Standard and Regulatory Framework •
The following requirements are included in the 2017 version of the ISO/IEC 17025 standard:
1. •
•
Ge Gene nerral Requirements
This clause highlights two main components: confidentiality and impartiality. This clause makes sure that the laboratory is committed to impartiality and that the risks associated with impartiality are identified on a constant basis Meantime, confidentiality assur assures es that before releasing the information into a public domain, clients are informed
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Confidentiality also involves not releasing the information received from a source other than the client, and the information's source to the client unless it has been authorised by the source
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Standard and Regulatory Framework (Continued) •
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Additionally, this clause emphasises the release of confidential information when needed by law or authorised by contractual arrangements The laboratory must commit to assure information confidentiality throughout all treatments, processes and interactions
2. •
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St Stru ruct ctur ural al Requirements
This clause emphasises the laboratory's legal status and structure, the identification of the management and personnel, and the personnel's availability accountable for executing and maintaining the integrity of the management system It also emphasises the documentation of procedures to the extent required to assure consistency in applying laboratory activities and the validity of the outcomes
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Standard and Regulatory Framework 3. •
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Resou Resourc rce e Requirements
This clause sets the requirement for laboratories to assure the availability of facilities, personnel, systems, equipment and support services necessary for the smooth operations/performance and management of all its activities Equipment's calibration should be done when measurement uncertainty or measurement accuracy influences the validity of reported outcomes, and this will further help to establish the metrological traceability of the reported outcomes The laboratory shall also assure that it communicates to its clients on all externally given
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products and services, i.e. purchasing services, subcontracting activities and supplies with needs and controls in place
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Standard and Regulatory Framework 4. •
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Pr Pro ocess cess Requirements
This clause describes the procedures and other methods for the review of tenders, requests, and contracts The clause includes the client's requests, the decision rule and the distinctions among requests and tenders that must be applicable to clients prior to any other laboratory activity takes place It also includes the selection, validation and verification of methods. It assures that the laboratory will utilise relevant procedures and methods for its activities Moreover, the laboratory will assure that it is utilising the most current methods which include the latest technological developments
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Standard and Regulatory Framework 5. •
For establishing a management system, this clause now provides two different options (Option A and Option B)
a. •
Mana Manage geme ment nt System Requirements:
Op Opti tion on A
The least requirements for the execution of a management system, as per option A, are as follows: o
Clause 8.2 Management system documentation
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o
Clause 8.3 Control of management system documents
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Standard and Regulatory Framework (Continued) o
Clause 8.4 Control of records
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Clause 8.5 Actions to address risks and opportunities
o
Clause 8.6 Improvement
o
Clause 8.7 Corrective actions
o
Clause 8.8 Internal audits
o
Clause 8.9 Management review
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Standard and Regulatory Framework b. •
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Opti Option on B
Option B provides a provision of establishing and maintaining a management system according to the requirements of ISO 9001 This option points out that a laboratory which has already established and maintained a management system in compliance with the requirements of ISO 9001, with satisfactory proof of compliance to clauses 4 to 7 of the ISO/IEC 17025 standard can be considered to fulfil, at least the intention of the management system requirements set out in clauses 8.2 to 8.9 of the ISO/IEC 17025 standard
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Standard and Regulatory Framework (Continued) •
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This option makes it simpler and practicable for laboratories to manage the implementation of ISO 9001 and ISO/IEC 17025 at the same time In summary, if a laboratory has already implemented ISO 9001, Option B may enable for higher flexibility in implementing ISO/IEC 17025:2017
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Laboratory Management System ISO/IEC 17025: 2017 Sub‐clause Matrix at a glance 4. General
5. Structural
6. Resource
Requirements
Requirements
requirements
4.1
5.1 Legal entity
6.1 General
7. Process Requirements
8. Management System Requirements
7.1 Review of requests, tenders
8.1 Options (A or B)
& contract
Impartiality
5.2 Identify management 6.2 Personnel
4.2
5.3 Define activities
6.3 Facilities &
validation of methods
8.2 Management system documentation
Confidentiality
5.4 Requirements to
Environmental
7.3 Sampling
8.3 Control of management system
meet
conditions
7.4 Handling of test &
documents
5.5. Organisation
6.4 Equipment
calibration items
8.4 Control of records
7.5 Technical records
8.5 Actions to address risk and
trological Metrological structure, Responsibility, 6.5 Me
7.2 Selection, verification &
Option‐A:
authority, inter‐
Traceability
7.6 Evaluation of measurement
opportunities
relationship,
6.6 Externally
uncertainty
8.6 Improvement
Documented procedures
provided products
7.7 Assuring validity of results
8.7 Corrective action
5.6 Controlling authority
& services
7.8 Reporting of results
8.8 Internal Audit
7.9 Complaints
8.9 Management review
5.7 Communication &
Integrity of management
rk 7.10 Non‐conforming wo work
system
7.11 Control of data – – information management
Option‐B: ISO 9001: 2015 & Clause 4 to 7 of ISO 17025: 2017.
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Laboratory Management System Continued) Merits of ISO/IEC 17025 Laboratory Management System •
Increase your status
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Increase competitive advantage
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Increase laboratory effectiveness
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Make new business connections
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Improve accessibility to more contracts for testing and calibration
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Laboratory Management System (Continued) •
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Offer efficiency in improving processes of work Attain customer trustworthiness Offer more reliable and proficient lab testing and results
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Laboratories and Accreditation Principles •
The following are the principles of ISO 17025 Laboratories and Accreditation: Capacity Exercise of Responsibility Scientific Method Objectivity of Results Impartiality of Conduct Traceability of Measurement Repeatability of Test Transparency of Process
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Testing and Calibration Concepts •
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Any testing /calibration laboratory that desires to display their capacity to provide reliable and defined laboratory testing/calibration results requires ISO 17025 18 associated organisations like International Laboratory Accreditation Cooperation (ILAC) and other laboratories established the recognised standard of ISO IEC 17025 It is a standard value for those laboratories whether possessed by the government or private sector industry performing:
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Laboratory Testing
Laboratory Sampling
Equipment Calibration
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Identifying the Objective and Scope •
11 vital steps that can help your thoughts as you prepare for implementation of ISO 17025 Obtain Support of Management
Conduct Internal Audits
Determine Context of Organisation
Define Scope, Management, Commitment and Responsibilitie s
Address Risk and Opportunities
Define Processes an Procedures
Operate LMS
Engage with the Accreditation Body
Perform Training and Awareness Program
Implement Procedures, Processes and Control
Management Reviews
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Understanding Organisation Everything regarding organisation, is mentioned in clause 4.1 An organisation must be : •
Legally identifiable
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Meet the needs of the clients
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Regulatory Authorities
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Scope •
Facilities of permanent nature and mobile both
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Understanding Organisation (Continued) •
Sites away from permanent or temporary facility
Defined Authority and Responsibility •
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Part of large organisation Nominated mangers for technical and quality function Nominated deputies
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Understanding Organisation (Continued) •
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Free from commercial and financial pressure Confidential information of clients and proprietary rights Competence, judgement, judgement, impartiality
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Inter personnel relationship
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Analysing Existing System •
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Companies are now conscious about the merits of executing quality management systems and obtaining accreditation But the processes of maintenance and implementation processes comprise major investment Organisations recognise that customer satisfaction is vital to their business Also, government bodies seek the services of an accredited laboratory understanding decision is based on reliable and accurate data The existence of quality assurance, by appropriate use of processes and guarantees clients that errors, management methods in test results, are minimised
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Module 35: Planning LMS Implementation
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Leadership and LMS Project Approval Leadership in ISO/IEC 17025:2017 5.2 The laboratory shall identify management that has overall responsibility for the laboratory.. laboratory 5.3 The laboratory shall define and document the SCOPE of accreditation. Externally provided laboratory activities (sub‐contracting of entire test or calibration activity) on an ongoing basis is not allowed. 5.4 5.4 Requirements Requirements of the standard and that of customers and accreditation agency to be covered in activities. 5.5 5.5 Organization Organization structure, responsibility & authority to be assigned following the norms of accreditation agency. 5.6 Competent 5.6 Competent person shall be made responsible for overseeing the effectiveness of quality management system of laboratory. Such post is usually designated as Quality Manager. 5.7 Effective 5.7 Effective communication system to be established within laboratory needed for QMS and meeting customers’ requirements. Integrity of management system to be ensured. © 2020 The Knowledge Academy Ltd
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Laboratory Policies (Continued) •
•
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Policies involve the quality policy statement that required to be documented in the Quality Manual Senior management must record a quality policy statement, that must express the commitment of the laboratory’s quality The quality manual outlines the quality system and documents of the laboratory’s objectives and the entire concept regarding conforming the ISO/IEC 17025
•
•
It should also explain how the excess of the quality system documentation will be ordered It must be done by working groups denoting distinct departments
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Document Management Process •
Records to prove conformity with ISO/IEC 17025 and as requisite by customers shall be maintained for a particular period of time o
o
o
Examples are: Test results, original laboratory observations ,supporting documents like Training certificates, chromatograms, and equipment calibration protocols Templates, Checklists, forms etc., help to execute quality work consistently and very well These includes worksheets and checklists for handling nonconforming test results vendor assessment, and also for the internal audits
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Document Management Process (Continued) •
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Maintenance and development of documentation must be controlled by the procedure of document control and management that forms a part of the management system Documents cover both internal, like
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SOPs, training plans, quality manuals, and external reports, like instrument operating manuals, test methods, regulations, standards
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Document Management Process (Continued) •
The document control procedure must ensure : o
o
o
o
Official documents are produced or obtained, reviewed, and approved before use Documents are uniquely identified with the document and date of the change, revision number, and issuing authority QA controls a quality list with all controlled documents The list involves document and revision number, locations, title, date of issue, date of the last review
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Document Management Process (Continued) o
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Internal documents cover page numbers and total in the number of each page Users of the documents should be adequately trained before they are released
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Prevailing authorised versions of documents are easily obtainable at the workspace of the user
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Module 36: Implementing LMS
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Design of Controls •
Management needs are mainly allied to organisation, analysis of contracts, apprise documents control, and analysing optimisation regarding quality management system
Control of Documents and Records •
This section integrates the design to control the system of amendment of documents and confirm access to up‐to‐date documents, averting use of outdated versions
•
It also includes a system to record control
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Design of Controls (Continued) Control of Accommodations and Environmental Conditions •
•
Covers sufficiency of accommodations, comprising its organisation, to the activities undertaken at the laboratory On the basis of this simple policy, laboratories and documents control centre can, together improve procedures to make sure the correct access, inform and use of documents
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Drafting of Specific Policies and Procedures •
•
No format has been set in ISO 17025 on writing a quality manual Though, laboratories must develop a quality manual as it describes their Quality Management System along with procedures to implement it
The Fundamentals of Writing a Quality Manual •
It should define the system as it is functioned
•
It must be a working document
•
It should not be a portrayal of an ideal world
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Drafting of Specific Policies and Procedures (Continued) Points to Avoid •
•
•
Writing a difficult documentation structure, is challenging to maintain Redundancy of information in various documents as it is hard to ensure that it is hard to maintain versions and consistent all together in different documents along with maintenance Even if you will to go beyond the standard, do not commit to anything beyond the standard
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Drafting of Specific Policies and Procedures (Continued) Uncertainty of Measurement •
As per ISO/IEC 17025, this segment explains procedure and policies of your laboratory in shaping method for performance validation and measuring the uncertainty of measurement
•
It shall contain: o
A depiction of procedures to be used at the earlier justification justification of methods
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Drafting of Specific Policies and Procedures
(Continued) Procedure During Data Suspicion •
•
•
It must certify that the laboratory follows a procedure if there is a suspicion of faulty data It generally involves your quality manager to conduct an enquiry, an audit which may also call for corrective action Your laboratory’s policy must notify clients as early as possible regarding suspicion of data
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Drafting of Specific Policies and Procedures (Continued) Handling of samples and administration of work •
While writing a quality manual with ISO/IEC 17025 standards, your laboratory should offer a complete depiction of the following: o
Measures for getting, and recording samples
o
Sample orders and labelling
o
Distribution of work
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Drafting of Specific Policies and Procedures
(Continued) o
Quality inspection of results
o
Reports preparation
o
Hand out reports
o
Recording of outcomes
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Drafting of Specific Policies and Procedures (Continued) Disposal of Samples and Other Waste •
Your laboratory must classify: o
The policy on the time duration when samples are kept
o
The policy on discarding
o
The assurance to the accountable discarding of toxic materials
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Drafting of Specific Policies and Procedures (Continued) Appointment of Staff, Training and Review •
It must define the following: o
The process for choosing staff for training, and conducting training
o
The machinery for measuring competency
o
The mechanism for delivering authorisations to conduct tests, calibrations,and other procedures
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Drafting of Specific Policies and Procedures (Continued) •
The method for an annual review of staff skills and the ways of results recording
Procedures for Audit and Evaluation of the Quality System •
This part must refer to the procedures for the audit and review of the quality system to write a detailed quality manual
•
Though, your laboratory should contain the records records that are to be kept and the policy on the regularity of audits and reviews
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Communication Planning •
Information must be shared among internal and external departments
•
It also have to be shared among the vendors, regulators and clients of laboratories
•
When the information flow is upgraded, the laboratory is developed
•
•
The information must be bi‐directional and it’s responsibility lies to the laboratory management It shall not only involve the sending information, policies, memos etc. but it should also have the mechanism to receive the feedback from the clients as well
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Communication Planning (Continued) •
The communication planning must first analyse the purpose for communication
•
The appropriate utilisation of laboratory services include Orders
Specimen Collection Occurrence of Test Orders Report Formats and Additional report comments etc.
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Communication Planning (Continued) •
The most noteworthy changes make a big emphasis on the accountabilities of senior management, and unambiguous requirements for regular improvements of the management system itself, chiefly, communication with the customer
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Training and Awareness Planning •
•
•
The efficiency of the training should be assessed If the training is associated to a particular test method, the trainee can show adequate qualification by successfully managing proficiency test sample or a quality control Vendor also require installation, acquaintance, and training services
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•
•
A training program must be developed and applied for each employee on the basis of mandatory skills and existing qualifications Till a well‐planned training for ISO 17025 is not prepared, the execution will not be operative and the laboratory cannot get the desired benefits from the laboratory QMS
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Resource Management •
The resource management requirements are mentioned in clause 6
6.1 General 6.2 Personnel •
Considering competence of supervision and technical staff
•
Personnel should be stable or contract
•
•
Procedures and policies to understand training needs are needed Job description is to be given in at least minimum contents
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Resource Management (Continued) •
Particular personnel assigned for specific tests such as authorised personnel
6.3 Facilities and Environmental Conditions •
Facility and environmental conditions must be satisfactory to confirm correct calibrations/performance of tests
•
If conditions sacrifices results, Tests / calibrations is to be clogged
•
Unsuitable activities are to be separated
•
Right to use the facilities is to be controlled
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(Continued)
Resource Management
6.4 Equipment •
•
•
Equipment must be obtainable, capable to achieve requisite accuracy, defined by an established calibration program, functioned by authorised personnel and exclusively identifiable Records are to be maintained and consist location, maintenance schedule, model number etc., and check that it meets terms Indication of calibration status
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Resource Management (Continued) •
Equipment which are out of service are to be recognised clearly
•
If equipment needs to be validated before use if they goes outside the lab
•
Safeguard against unplanned adjustments, such as use passwords to control computers
6.5 Metrological Traceability •
•
Confirm a satisfactory program for the calibration of equipment Make sure calibration is traceable to SI units, consensus standards or, or, Certified Reference Materials (CRM) or inter‐lab validated agreed methods
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(Continued)
Resource Management
6.6 Externally Provided Products and Services •
•
•
•
Authorising of tests and calibrations obliges the lab to direct and pursue approval from the customer, rather in writing (partial or specific) Lab is liable for subcontractor's work except they are specified by the customer of controlling authority Keep a register of all subcontractors comprising records
Procedures are required for the choosing service/supplies
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Resource Management (Continued) •
•
Formal approval or techniques to make sure that materials and services should meet the terms with stipulations Retain records on the history and QA consents of suppliers if any
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Customer Management •
•
•
•
This procedure’s aim to define all the activities allied to the customer service process for receiving and recording customer requests, contracts and tenders The activities which are recognised under this procedure are a compulsory requirement that is to be documented This applies to both external and internal laboratory customers The clause of 7.1.7 ‐ the laboratory shall cooperate with clients to clarify the request and to enable the client to monitor the performance of the laboratory
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Operations Management •
•
•
This International Standard is used by laboratories in making their management system developed for administrative, quality, and technical operations Laboratory customers, accreditation bodies, and regulatory authorities can also use it in identifying and confirming the competency of laboratories The word 'management system' in this International Standard refer to the quality,
technical systems and administration that direct the operations of a laboratory •
The agreement with governing and safety requirements on the operation of laboratories is not included in the International Standard
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Operations Management
•
There are 5 fundamental (auditable) clauses in ISO/IEC 17025:2017
1.
Gene Generral Requirements (clause 4)
2.
Str Struct uctur ural al Requirements (clause 5)
3.
Reso Resour urce ce Requirement (clause 6)
4.
Proc Proces esss Requirement (clause 7)
5.
Mana Manage geme ment nt System Requirements (clause 8)
•
•
•
•
Management requirements (clause 8) deals with the effectiveness and operation of the quality management system in the laboratory, that is very similar to the ISO 9001. Calibr Calibrations, ations, tests, and other laboratory operations should follow the earlier defined terms such as client‐defined specifications, laboratory specifications. These are addressed in Process Requirements (clause 7). It explains to confirm that nonconforming test and calibration results are properly followed up, and that rectifications are instigated.
Clause 4, 5 and 6 are related mainly to setting of ethics, working structure, scope and resources which are needed for effective and efficient operation of laboratory activities.
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Module 37: Monitoring, Measurement, and Continuous Improvement
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Monitoring, Analysis, and Evaluation •
•
•
•
The word “ Monitoring” is used in all processes of the ISO 9001: 2015 standard and it always come along with calibration or measurement Monitoring is the method of analysing, evaluating, and inferring results from data which is a measured parameter in a prescribed time to prove conformity Each monitoring activities require measuremen measurementt results to have effective data to analyse and evaluate Calibrated measuring instruments are used while monitoring activities, to achieve confidence with our monitoring results
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Monitoring, Analysis, and Evaluation (Continued) Reasons to Monitor 1.
Qu Qual alit ity y maintenance
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2.
De Dev velo elop or to make better processes
3.
To know defects, if any
4.
Main Mainta taini ining ng safety
5.
Make sure to maintain the efficiency of operation and control of these processes
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Monitoring, Analysis, and Evaluation
(Continued) 6.
Valida alidate te the conformity of services and products as per requirements
7.
Maint Maintena enance nce of monitoring and measurement resources through adjustments, deterioration, damage or that would undermine the calibration status and following results of measurements
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Monitoring, Analysis, and Evaluation (Continued) Techniques Applied to Analyse and Evaluate Monitoring and Evaluation of Results Control charts
Tables
Graphs
Mean and standard deviation (Basic Statistical Data Analysis)
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Monitoring, Analysis, and Evaluation
(Continued) •
Use of Monitoring and Measurement as per the Requirements of ISO 17025:2017 1. Monitoring of competence of personnel 2. Monitoring of environmental conditions 3. Monitoring performance of external providers 4.Monitoring of controlled conditions for handling of items 5. Monitoring of validity of results
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Treating Problems and Nonconformities Non‐conformance •
It is noncompliance of a condition
•
It is a problem‐solving method which aims to identify the root cause(s) of a problem
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•
•
The goal is to inhibit the repetition of the non‐conformance It is quite tedious to perform and thus requires discussion with people involved knowing the best about the pr process ocess
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Treating Problems and Nonconformities
(Continued) •
•
•
It occurs after the immediate rectification of a non‐conformance It is required when a non‐conformance is important It is needed for non‐conformances recognised by audits and for deteriorating proficiency of test reports
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Treating Problems and Nonconformities (Continued) Process for Treating Problems •
Using different methods for problem solving to identify the fundamental causes of problems or incidents, the problems can be treated effectively
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•
Who should work on problem? o
•
It is best if it is done by those who are in touch of a work on a daily basis
Define problem
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Treating Problems and Nonconformities
(Continued) •
At times “Why” isn’t the first question o
What, when, where, how can form the first question
•
Be simple, draw an outline
•
Anlayse and prevent
•
It leads to remedial action, which is proposed to prevent repetition of nonconformance
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Treating Problems and Nonconformities (Continued) •
•
It leads to remedial action, which is proposed to prevent repetition of nonconformance Preventive Action is the action taken to
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eradicate the cause of a probable nonconformance or other detrimental possible situation
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Treating Problems and Nonconformities •
When the root cause is recognised, you must apply a fix corrective action to check it does not happen again o
o
o
Find possible corrective actions Choose and execute the action that is much suitable to eradicate the problem and avert repetition Corrective actions are suitable to the scale and risk of the problem
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Continual Improvement •
•
Continual Improvement is the regular activity to enhance the capacity to fulfil requirements Thus, a continual improvement is the approach that is repeated having pauses between recurrences
•
•
It is a phased system, whereby developments are made And also, there is brake to measure and study the success, when improvements are made
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(Continued) •
Continual Improvement
The key to continual improvement is to consume the tools which are needed by the standard, such as: Management Reviews
Internal Quality Audits
Corrective and Preventive Actions
Regular Review of Controlled Documents
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Continual Improvement (Continued) •
It helps the company to endure growth while preserving competence and compliance
•
In the sphere of continual improvement, these should be positive
•
Even after the standards are achieved, while looking from the potential of learning and improving, the audit can also find protective actions that makes the system better, cooperative, and more efficient
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Accreditation Preparation
•
The following are the steps for Accreditation Preparation
Know About the Standard
Conduct a Gap Analysis
Plan your Project
Provide Training
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Accreditation Preparation (Continued)
Document your Quality Management System
Implement QMS and Hold Business
Audit Your QMS
Accreditation Audit
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Implementers Evaluation
•
Implementing a quality management system that is built on the requirements stated in ISO/IEC 17025 standard is challenging, because of two main reasons:
1.
The intense technical difficulty in degree of some tests used for materials characterisation
2.
Most science laboratories offer materials characterisation tests and also conduct development and research activities
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Implementers Evaluation (Continued) •
Quality Manual, Quality Plan, Job descriptions, Standard Operating Procedures (SOPs), work instructions, and records are some documents that are required to make or reviewed
•
•
•
The formation of these documents will help all laboratory personnel and so, improvement in the quality system will influence the work load While implementing the QMS, training should also be considered The laboratory will need to employee further personnel to maintain the QMS and guiding consultant will be the advantage in the implementation process
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(Continued)
Implementers Evaluation
Results of the Evaluation via Accreditation Body •
Evaluation for implementation begins with
Impartiality
Confidentiality
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Module 38: Planning ISO 17025 Audit
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Planning ISO 17025 Audit
•
•
•
The quality manager is responsible for planning the audit, but the plan for the future must be considered and approved at the quality system review meeting
An annual plan must be prepared, and the suggested timing of audit must be pointed on the plan and, when the audit plan is finished, the real date and auditor name must be added The quality manager should be given the complete authority to assure that the plan is adhere to
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Planning ISO 17025 Audit •
•
The reviews and audits must be treated as a vital issue and should not put off for any reason It is shown by the experience that once the programme is falling behind, it is not easy to catch up
•
Especially audits are a crucial issue in an ISO 17025 quality system since the complete philosophy is that the design of laboratory and execution of the quality management system and then takes the audits to assure that it is working well
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Planning ISO 17025 Audit
•
•
•
When the audits are not present, problems will be detected only when they lead to failure of quality
Approach to quality control aimed at error detection; compliant quality management system of an ISO 17025 concentrates on the prevention of error by quality insurance, and with the help of audit working of the system system is ensured by the laboratory When the laboratory does not consider its audits seriously, makes assessors more uncomfortable
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Planning ISO 17025 Audit Frequency of Audit and Review •
•
In general practice, an audit programme must be conducted on a rolling basis such that in any one year, every perspective of the quality system will be included at least once At least two vertical audits must be there in any one year
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Auditor in vertical audit did not examine one aspect of the system but tracks a particular sample or samples within the laboratory, from receipt to results reporting, and verify the documented procedures have been followed and all the maintained records
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Planning ISO 17025 Audit
There is nothing in ISO 17025 that prevents an annual, one‐off, audit of the entire system, but it is not considered as good practice except in very small companies where external auditors need to be used It is described by the rolling system, where the audit is seen as a continuous part of management, is usually preferred Annual management reviews are usually executed by accreditation bodies, and it is doubtful that this will change
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Planning ISO 17025 Audit (Continued) •
It is recommended that the frequency of internal audit will be more in the first year of operation of a new quality management system, i.e. a review after every six‐month in a rolling audit programme of six‐month.
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The audit programme must be phased within the execution of the different elements of the quality system and not delayed till it is all in place. This gives a quality check on the elements of the quality system as they are set.
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Settling period of two to three months must be permitted for every part of the system and then that part should be audited In establishing the quality system a responsive and effective audit system is a powerful tool Necessarily people will not remember to do the things needed by the quality system from time to time, but when they understand that any negligence will be quickly noticed and corrections would be asked for, then they will rapidly get good habits and will make less mistakes.
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Preparing the ISO 17025 Audit Introduction •
Preparing for an audit is a very vital step for the laboratory. The external audit makes a 3rd party accreditation body is the last step before the laboratory gets accreditation to ISO 17025
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These are the following objectives that auditors have: o
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Checks that documentation meets all the needs of the standard Assure your employees that they must know their roles in QMS and are well‐known with the needs of ISO 17025 that concern to their role in the organisation The processes and procedures are followed correctly
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Preparing the ISO 17025 Audit
The results will award your certification or need corrective actions that your organisation should meet before becoming accredited On the day of the accreditation audit, show your QMS and how have your addressed the needs Being audited is costly and consume more time, so you need to make sure that you are prepared well
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Preparing the ISO 17025 Audit •
These are the following steps that can assist you laboratory:
Give the laboratory ample time to prepare
Prepare the employees
Documented Information
Processes and Procedures
Prepare the facility
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Preparing the ISO 17025 Audit
Give the Laboratory ample time to Prepare
Effort and time is needed to prepare your lab for an audit When you have decided that getting accreditation is important for the laboratory, you must set goals and provide a proper amount of time to meet the need of the standard
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Preparing the ISO 17025 Audit 2. •
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Pr Prep epar are e the Employees
Your employees will show that your lab is executing with the needs of ISO 17025 Yo You u will need to ensure that all the employees must know what the scope of the audit is and when the audit will take place
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Every employee must have a clear thought of the competence objectives od lab, and how their job job role contributing to them Every employee must have proper training on the tasks that they will do
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Preparing the ISO 17025 Audit
Docu Docume ment nted ed Information
Another vital aspect of preparing for your audit is Documented information During the audit preparation, you are required to be assured that the records and documents have been updated Along with this, all the documents must be reviewed, approved, communicated and must be followed by everyone included in the activity or process Yo You u also must assure that old documents are not used by anyone
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Preparing the ISO 17025 Audit 4. •
Pr Proc ocess esses es and Procedures
Procedures and Processes need to be followed carefully
Your laboratory need to make sure that every process is meeting the planned arrangement that you have targeted to achieve, then they are being followed and performed in the right and same way by each employee
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Pr Prep epar are e the Facility
Your lab must be cleaned and organised well when you prepare the audit. It is simple to drop non‐conformance if your facility is chaos You need to make sure that you are well aware of each area of the facility so that you are not required to find any hidden concerns during the audit When your organisation is getting ready for the audit, check bulletin boards, drawers, counters for uncontrolled documents, examining instruments, uncalibrated measuring and non recognised parts or supplies
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Conducting an Opening Meeting
The main objective of an opening meeting of an audit is to affirm the audit plan and previous arrangements This is an opportunity to introduce the team
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members of the audit and describing the audit approach •
This opening meeting is headed by the Lead Auditor and held with the organisational management and the areas areas that need to be audited
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Conducting an Opening Meeting •
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The meeting must be conducted in a friendly way and put the auditee at rest. From the beginning of the audit you want to make a trust and cooperation If you will be specified guides, or be followed by observers, the opening meeting may be used to explain their roles fully to avoid probable disturbances when the audit is going on Keep in mind to allot time in the opening meeting for the auditee so that they can ask a question
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Conducting an Opening Meeting
The opening meeting may also provide insights into the management's commitment level and support If you will be specified guides, or be followed by observers, the opening meeting may be used to
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explain their roles fully to avoid probable disturbances when the audit is going on •
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Keep in mind to allot time in the opening meeting for the auditee so that they can ask a question The opening meeting may also provide insights into the management's commitment level and support
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Conducting an Opening Meeting •
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The detail included in an opening meeting must be compatible with the auditee's familiarity with the audit process In a small organisation, for audit, the opening meeting consists of communicating that an audit is being conducted and describing the audit's nature For other audit situations, especially third‐party audits, the opening meeting migh mightt be formal and even take attendance records
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Conducting an Opening Meeting
These are the following topics of agenda that must be considered, as suitable:
Introduction of meeting participants
Roles of auditor; auditee; guide; observer
Attendance list (names, titles, contact information)
Audit objective (purpose or reason for the audit)
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Conducting an Opening Meeting (Continued)
Audit scope (coverage of areas; processes; clauses)
Audit criteria (applicable requirements)
Documentation status (changes since plan developed)
Agenda plan (agenda; assignments; meetings; times)
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(Continued)
Audit methods (procedure; sampling; forms)
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Risk management (reduce risk from presence of audit team)
Communications (auditee to be kept well‐informed)
Language (to be used during the audit)
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Conducting an Opening Meeting (Continued)
Confirmation of resources and facilities
Confidentiality (results only to the auditee)
Safety, security, and emergency considerations
Reporting method (including severity grading, if any)
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Conducting an Opening Meeting
(Continued)
Closing meeting (date, time, and location)
Acknowledgments (who accepts nonconformities)
Complaints or appeals (system for feedback)
Concerns or questions (ready to begin audit?)
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Module 39: Conducting the ISO 17025 Audit
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Gener enera al
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Initiating Audit
The obligation for conducting the audit must remain with the audit team leader which is until the audit is completed
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Est Establ ablish ishing ing contact with auditee
The audit team leader must assure that contact is made with the auditee majorly to: o
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Confirm communication channels with the representatives and authority of the auditee and to conduct the audit Give suitable information on the audit scope, objectives, criteria, methods and audit team composition, involving any technical experts
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Initiating Audit (Continued) o
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Request access to appropriate information for planning purposes; make arrangements for the audit involving the schedule Define applicable statutory and regulatory needs and other requirements – – confirm the agreement with the auditee about the extent of the disclosure and the treatment of confidential information
Defi Defini ning ng possibility of audit
The possibility of the audit must be defined to give reasonable confidence that the audit objectives can be attained Where the audit is not possible, an alternative should be proposed to the audit customer, in agreement with the auditee
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Preparing Audit Activities
Pe Perf rfor ormi ming ng a review of the documented information
The appropriate management system documented information of the auditee should be reviewed in order to: – –
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Collect information to understand the operations of the auditee and to prepare the applicable audit work documents and audit activities, e.G. On processes, functions Establish an overview of the documented information's extent to determine feasible conformity to the audit criteria and detect possible areas of concern, like deficiencies, conflicts or omissions, an alternative must be proposed to the audit client, in agreement with the auditee
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Preparing Audit Activities 2. •
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Audi Auditt Planning
A risk‐based approach to planning The team leader of an audit must adopt a risk‐based approach to planning the audit on the basis of information in the audit programme and the documented information given by the auditee The detail amount given in the audit plan must reflect the complexity and scope of the audit, and the risk of not attaining the audit objectives Risks to the auditee can result from the audit team member's preference negatively influencing the arrangements of an auditee for health and safety, environment and quality, and its services, products, personnel or infrastructure (e.g. contamination in cleanroom facilities)
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Preparing Audit Activities
For combined audits, special attention must be provided to the communications between operational processes and any competing objectives and priorities of the
various management systems •
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The audit planning's scale and content can vary from case to case Audit planning should be adequately flexible to allow changes which can become essential as the audit activities pr progress ogress Audit planning must address or reference the essential information of audit such as objectives, methods, scope, criteria, schedule, audit team etc.
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Preparing Audit Activities (Continued) •
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Audit plans must be presented to the auditee Any issues with the audit plans must be resolved among the audit team leader, the auditee and, if required, the individual(s) handling the audit programme
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As Assig signi ning ng work to the audit team
In consultation with the audit team, the audit team leader should assign to every team member responsibility for particular auditing processes, functions, activities or locations and, as relevant, authority for decision ‐making
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Preparing Audit Activities
Take into account the objectivity and impartiality and competence of auditors and the efficient utilisation of resources, as well as various roles and responsibilities of auditors,
auditors‐in‐training and technical experts •
The audit team leader must hold audit team meetings as appropriate
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Pr Prep epar arin ing g documented information for audit
The audit team members must gather and review the information suitable to their audit assignments and prepare documented information for the audit, utilising any relevant media o
digital or physical checklists
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Preparing Audit Activities (Continued)
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audit visual information, audit sampling details
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audio visual information
Documented information prepared for, and resulting from, the audit must be preserved at least until the completion of audit, or as particularised in the audit programme Documented information made throughout the audit process including proprietary or confidential information must be suitably safeguarded by the audit team members
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Conducting Audit Activities
Condu Conduct ctin ing g the opening meeting
The primary purpose of the opening meeting is to: – –
Confirm the agreement of all participants to the audit plan (e.g. Auditee, audit team) o Introduce the audit team and their roles o Assure that all planned audit activities can be done o
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An opening meeting must be held with the audit auditee's ee's management and, where suitable, those responsible for the processes o functions to be audited
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During the meeting, a chance should be given to ask questions
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The team leader of an audit should chair the meetin
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Conducting Audit Activities 2. •
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Commun Communica icatin ting g during audit
The audit team must confer periodically to exchange information, evaluate audit progress and reassign work among the audit team members, as required Evidence gathered during the audit that recommends an instant and significant risk should be reported without delay to the auditee and, as suitable, to the audit client Where the available audit evidence shows that the audit objectives are unachievable, the audit team leader must report the reasons to the audit client and the auditee to define appropriate action
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Conducting Audit Activities
Audi Auditt information availability and access
How, where, and when to access audit information is important to the audit
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It is independent of where the Information is created, used and/or stored The audit methods need to be defined according to these issues. The audit can use a combination of methods Additionally, audit circumstances may mean that the methods required to change throughout the audit
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Conducting Audit Activities 5. •
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Revi Review ewin ing g documented information while conducting audit
The relevant documented information of an auditee should be reviewed to: Define the conformity of the system, as far as documented, with audit criteria Collect information to assist the audit activities The audit team leader should inform both the individual(s) managing the audit programme programme and the auditee if sufficient documented information cannot be given within the time frame given in the audit plan A decision should be made as to whether the audit should be continued or suspended
until information concerns are resolved, and it depends upon the audit as well as objectives scopedocumented
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Conducting Audit Activities
Coll Collec ecti ting ng and verifying information
During the audit, information appropriate to the audit objectives, criteria and scope, involving information associating with interfaces among functions, processes, and
activities must be collected by means of proper sampling and should be verified, as far as practicable •
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The only information which can be subject to some extent of verification must be accepted as audit evidence Where the degree of verification is low, the auditor should utilise their professional judgement to define the degree of reliance that can be placed on it as evidence Methods of collecting information involve: interviews; observations; review of documents, involving records
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Conducting Audit Activities (Continued) Source of Information Gathering using suitable Sampling Audit Evidence Evaluating against Audit Criteria Audit Findings
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Conducting Audit Activities
Reviewing
Audit Conclusions
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Conducting Audit Activities 7. •
Dete Determ rmin inin ing g audit conclusions
Preparation for a closing meeting meeting:: The audit team must confer before the closing meeting in order to o
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Review the audit findings and any other suitable information gathered during the audit, against the audit objectives; Agree on the audit conclusions, consider the uncertainty inherent in the audit process;
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Prepare recommendations, if particularised by the audit plan;
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Discuss the audit follow‐up, as applicable
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Conducting Audit Activities
Co Cond nduc uctt audit conclusions
Audit conclusions should address issues such as:
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The degree of conformity with the audit criteria and strongness of the management system, involving the management system's effectiveness in meeting the expected outcomes, the risk's identification and effectiveness of actions taken by the auditee to address the risks The efficient implementation, main maintenance tenance and improvement of the management system Attainment of audit objectives, coverage of audit scope and fulfilment of audit criteria
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Conducting Audit Activities (Continued) Similar findings made in various areas that were audited or from a previous or joint joint audit to recognise trends
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Cond Conduc ucti ting ng Closing Meeting
A closing meeting should be held to present the audit findings and conclusions The closing meeting should be chaired by the audit team leader and attended by the management of the auditee and involve, as applicable: o
Those accountable for the functions or processes which have been audited
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Conducting Audit Activities
Other members of the audit team
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Other relevant interested parties as defined by the audit client and/or auditee
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Meeting can be formal or less formal
Any diverging opinions about the audit findings or conclusions among the audit team and the auditee should be considered and, if possible, resolved. If not resolved, these should be recorded
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Conducting Audit Activities 10. Preparing Preparing audit report •
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The audit team leader must report the conclusions of audit in accordance with the audit programme The audit report should give a complete, correct, short and clear record of the audit, and should involve or refer to Audit scope, audit objectives, and the functions or processes audited o Identification of the audit team, audit client, and auditee’s participants in the audit o Locations and dates where the audit activities were conducted o Audit criteria, audit findings and associated evidence, audit conclusions o
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A statement on the extent to which the audit criteria have been fulfilled unresolved diverging opinions among the audit team and the auditee Any
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Conducting Audit Activities
11. Distributin Distributing g audit report •
Within an agreed period of time, the audit report should be issued
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The audit report should be dated, reviewed and accepted, as suitable, in line with the audit programme The audit report should then be distributed to the appropriate interested parties described in the audit programme or audit plan Consider suitable measures to assure confidentiality
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Conducting Audit Activities 12. Completing Completing audit •
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When all planned audit activities have been carried out, or as otherwise agreed with the audit client then the audit is completed Documented information concerning the audit should be retained or disposed If disclosure of the contents of an audit document is needed, the audit client and auditee should be informed as soon as possible Lessons learned from the audit can identify risks and possibilities for the audit programme and the auditee
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Conducting Audit Activities 13. Conducting Conducting audit follow‐up •
The result of the audit can be depending on the audit purposes, show the necessity for
corrections, or corrective actions, or possibilities for improvement •
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Such actions are normally determined and undertaken by the auditee within an agreed timeframe The completion and effectiveness of these actions should be verified. This verification may be part of a subsequent audit Results should be reported to the individual managing the audit progra programme mme and the audit client for management review
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Module 40: Concluding and ensuring follow‐up of ISO 17025 Audit
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Audit Documentation •
The quality manual is an important piece of quality documentation, that explains its policies, the structure of Quality system documentation and agreement to ISO/IEC 17025:2017 & appropriate accreditation particular criteria
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Generally, quality manual is made and verified by laboratory management, normally under the entire co‐ordination of the quality manager However it must be officially authorised to issue a point in a management hierarchy as high as possible; the typical points are chairman, chief executive and director‐general This assures that the manual has the strongest authority and it also shows that to the accreditation body, there is a commitment on the side of the senior management to the quality system
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Audit Documentation (Continued) Policies and Quality Manual
Processes
Standard Operating Procedures (SOPs) and Work Instructions Records
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Audit Documentation Policies and Quality Manual •
Policies that involve the statement of the quality policy must be documented in the
Quality Manual •
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The quality policy statement must be written by the Senior management, that must outline the commitment of laboratory to quality The quality manual must explain the documents the goal of laboratory and quality system and entire idea for how to comply to ISO/IEC 17025 It must also explain how the remains of the quality system documentation are prepared. It must be enhanced by working groups that represent various departments
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Audit Documentation Processes •
Standard procedures or Processes explain how different needs of ISO/IEC 17025 can be attained o
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For example, it explains how the needs ‘All personnel included in testing and calibration must be capable for the given task’ can be executed
Another instance is the approach of the laboratory to verify and calibrate various types of equipment For a good understanding, process flowcharts must be involved in the description process
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Audit Documentation Standard Operating Procedures (SOPs) and Work Instructions
Generally these are defined as Standard Operating Procedures (SOPs) or Work Instructions •
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Whereas processes and quality manuals explains approaches and tasks, procedures and work instructions provide instructions step‐by‐step on doing tasks. The examples of SOPs are calibration of equipment and procedures for verifying Every laboratory SOPs must use the same format, so as to make reading and writing easier. A good method is to have an SOP for how to author, review, approve, distribute, and update the SOPs Senior members of expected user groups must write SOPs. This assist to assure that SOPs have the correct level of information and are used and followed.
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Audit Documentation Records •
Records to show adherence with ISO/IEC 17025 and as needed by customers must be retained for a particular time o
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The examples are original laboratory observations, supporting documents, test results like training certificates, chromatograms, and equipment calibration protocols
Checklists, templates, forms, and examples assist in executing the quality work consistently and efficiently o
Examples of these involve worksheets and checklists to handle nonconforming test results, vendor assessment. These things assist particular document tasks consistently and efficiently
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Audit Documentation •
The documents that are given below must‐haves as claimed by ISO 17025:2017
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Remember that if you omit any of the clauses from the scope of your implementation, then the documents for those clauses shall not be needed for your lab Document and Record Control Procedure (Clauses 8.2.1, 8.3 & 8.4)
Quality Policy (Clauses 8.2.1 & 8.2.2)
Competence, Training and Awareness Procedure (Clause 6.2.5)
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Audit Documentation (Continued) Externally Provided Products and Services Procedure (Clause 6.6.2)
Facilities and Environment Procedure (Clause 6.3)
Equipment and Calibration Procedure (Clauses 6.4.3 & 6.5)
Customer Service Procedure (Clauses 7.1.1 & 8.6)
Test and Calibration Method Procedure (Clauses 7.2.1 & 7.2.2)
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Audit Documentation (Continued)
Quality Assurance Procedure (Clauses 7.7.1 – – 7.7.3)
Sampling Procedure (Clauses 7.3, 7.5 & 7.8.5, applicable only to laboratories that do sampling)
Handling of Laboratory Test or Calibration Items Procedure (Clause 7.4)
Complaint, Nonconformity and Corrective Action Procedure (Clauses 7.9 – 7.10 & 8.7)
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Audit Documentation (Continued) Testing Report Procedure (Clauses 7.8.2 & 7.8.3, applicable to test laboratories that write reports of the test)
Calibration Report and Certificate Requirements Procedure (Clauses 7.8.2 and 7.8.4, applicable to calibration laboratories that write calibration certificates)
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Quality Review •
Quality manager is responsible for the audits’ organisation and reviews, though he/she will usually include other staff in the actual carrying out audits
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It is the responsibility of the quality manager to check that any corrective actions agreed sufficient, is carried out and is efficient The audit's frequency and review of systems is not compulsory in ISO 17025, but a note in the standard requires that every aspect of the system will be audited at least yearly and reviews will be conducted at least once in a year
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Closing Meeting •
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The main objective of a closing audit meeting is to give the audit findings and results, assuring a clear understanding of the results, and giving consent on the timeframe of corrective action The closing meeting is managed by lead auditor The participants must involve management of the auditee and mangers of that area that were audited
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Closing Meeting •
The following agenda topics should be considered, as appropriate:
Introductions
Attendance
Thanks
Disclaimer
Criteria
Conformity areas
Scope
Summary of Nonconformities
Conclusions
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Closing Meeting •
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When the closing meeting is being conducted, listen with interest and speak with authority. Maintain your body language, good manners, and keep control of the meeting Keep a record of any concern that is being raised during the meeting When new audit proofs are given, remove nonconformities that were mentioned in error. Still, one must keep valid nonconformities in the report, even when they are fixed before the meeting If it is appropriate, the lead auditor must give a guide to the auditee when any condition come during the audit that may reduce the confidence that may be placed in the audit conclusions
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Closing Meeting •
If it is defined in the management system, or by agreement with the client of the audit, the participators must give his consent on the time frame for an action plan to address
any of the nonconformities of the audit •
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The detail level in the closing meeting must be compatible with the auditee's familiarity with the process of audit For some audits, the meeting may be formal with minutes being kept. In some cases, the closing meeting can be less casual and communication of the audit findings and audit conclusions is done
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Closing Meeting •
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If it is possible, then any auditee and audit team differences of views on the audit findings or conclusions must bee considered and solved The concern of auditee must be recorded, and the process of the appeals explained to them If the direction for the enhancement are presented, you must highlight that the recommendations are not binding Complete the meeting having clear result and explain the next steps, tasks, and due dates
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Evaluation of Corrective Action plans •
Corrective action are needed each time when a quality problem is recognised
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The audit is a definite mechanism to find out whether corrective action is important, but there are some other potential sources of information, and each of them must be used Definite sources are information passed on from the staff of laboratory of the quality issues, complaints from clients, detection of non‐conforming work, and direct detection of quality failures resulting from the monitoring of quality control The ability of Interlaboratory testing and feedback from outsider assessors and auditors will also fall in the category of useful sources external to the organisation
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Evaluation of Corrective Action plans •
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It helps separate the record system for reporting quality problems from the system to plan and record corrective action because of the source variety providing for corrective action This permits the same corrective action management and recording system to serve for all the sources of information on quality problems o
For instance, the audit is reported on a form given to that purpose, and for the corrective action requests, this is cross‐referenced
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Surveillance audit can be recognised three months before the due date by the AB, and the client should be communicated of the proposed date and due date of the Surveillance audit o
If the client is not able to confirm the date of the Surveillance audits latest within the seven days of the due date, then the suspension letter is issued to the client
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ISO 17025 Surveillance Audits (Continued) •
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When the Suspension letter is issued, then the cancellation letter is issued to the client on the upcoming date of the due date These are on‐site audit, but they are not certainly the entire system audit They are planned along with the other Surveillance activities so that confidence is maintained by the certification body that the certified management system remains to meets the needs between recertification audits
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It is the responsibility of the assigned team leader to manage and conduct the assessment with the other members of the team At least, the Team Leader should be of Auditor status o
The team leader also assure that any of the Technical Expert are not permitted to independently function and are constantly
accompanied by Lead Auditor/Auditor
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Assure on‐site audit evaluating the certified fulfilment of the management system of the client of particularised needs regarding the standard in which the certification is granted Assure that the management system is continuously suitable to the product/service/process given by the client with the ability to improve and manage the performance
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Assess Continual Improvement in management system of the client In addition to this the statements of the client regarding its operations Enquiries from the certification body to the certified client on aspect of certifications Requests to the client to give records and
documents
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Other means of observing and certified performance of client Management reviews and internal audits Action’s review taken on non‐conformities recognised during the previous audit Actions taken on complaints of the customer
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Efficiency of the management system in order to attain the purposes Advancement of planned activities aimed at continuous enhancement
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Ongoing operational control
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Review the use of AB & CB marks
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The client file must be reviewed by the team leader, specially the last audit report to create a note of any concerns to be followed up, that includes the corrective action plan and non‐ conformities The audit plan must be sent to the clients in advance so that they can request any changes regarding timing etc. it is seen inconvenient because of administrative reasons
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ISO 17025 Surveillance Audits •
The audit must be conducted according to the surveillance audit plan provided in the
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last audit report when there are any changes due to any explained reasons, and the same must be recorded in the auditor's notes, and in the report, surveillance audit plan must be updated •
•
When opening and closing meeting are going on, the record sheet of attendance is being circulated and record the names and designation of the client representative present. Either one person can record the name & designation for all the present one or each person can do so individually The corrective action that is taken on the nonconformities recognised in the last audit must be checked for its efficacy. If the corrective action is not taken adequately, then the sharpness of the minor NC need to be reissued escalated to Major and client should be guided respectively
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ISO 17025 Surveillance Audits •
If there is a change in address/ scope of site needed to again issue the certificate, then the ‘certification Detail’ in the audit should be completed, and the database of the client should be updated o
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Any important change such as a change in manpower, a process requiring the change in consequent audit duration should be recorded, and post review of the contract is done by AB. Other changes such as a change in person/ contact number etc. should be recorded in the report to update the database of the client
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Congratulations
Congratulations on completing this course! Keep in touch
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