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QUALITY MANUAL PGI-ML-QM As per IS / ISO / IEC 17025: 2017 PGI - Metallurgical Laboratory (A sister concern of Punjab General Industries Private Limited) Plot No. 149-150, Sector 24, Faridabad 121005 Haryana Mobile : 98108 45111, 99711 56448,Telephone: +91 129 4199922, 4063227, E-mail :
[email protected] , Website : www.pgiindia.com
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PGI –Metallurgical Laboratory (A Sister Concern Of Punjab General Industries Private Limited )
Plot-149-150, Sector 24 ,Faridabad
Quality Manual As Per ISO/IEC 17025 : 2017 Section Number 1.0 1.1. 1.2. 1.3 1.4 2.0 3.0 3.1 4.0 4.1. 4.2. 5.0 6.0 6.1. 6.2. 6.3. 6.4. 6.5. 6.6. 7.0 7.1. 7.2. 7.3. 7.4. 7.5. 7.6. 7.7. 7.8. 7.9. 7.10. 7.11. 8 8.1. 8.2. 8.3. 8.4. 8.5. 8.6. 8.7. 8.8. 8.9
Section Name and Description Quality Manual Cover Table of Contents (with revision status and history ) Release Authorization General Introduction Index,Issue,Revision and Distribution Scope and Purpose Company Profile Quality Policy and Quality Objectives References Terms and Definitions Abbreviations General requirements Impartiality Confidentiality Structural requirements (5.1 to 5.7) Resource requirements General Personnel Laboratory facilities and environmental conditions Equipment Metrological traceability Externally provided products and services Process requirements Review of requests, tenders and contracts Selection, verification and validation of methods Sampling Handling of test or calibration items Technical records Evaluation of measurement uncertainty Assuring the quality of results Reporting of results Complaints Management of nonconforming work Control of data-information management Management requirements Options Management system documentation Control of management system documents Control of records Actions to address risks and opportunities Improvement Corrective action Internal audits Management reviews End
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PGI-ML-QM Issue no-02 Issue Date-1.6.19 Rev-01/ 19.11.2019
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PGI –Metallurgical Laboratory (A Sister Concern Of Punjab General Industries Private Limited )
Plot-149-150, Sector 24 ,Faridabad
Quality Manual As Per ISO/IEC 17025 : 2017
PGI-ML-QM Issue no-02 Issue Date-1.6.19 Rev-01/ 19.11.2019
Revision History: Clause no 1.2 5.5 a 1.3 5
Section Name and Description Scope and Purpose Organization Structure At the end of this manual Scope Structural requirements
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Revision No. 01 01 02 02
Date & Changes 25.11.2019 ; Scope added for external and internal customers. Interrelationship between PGI and PGI-Ml established Scope made as per PGI-metallurgical Laboratory Made as per PGI-Metallurgical laboratory
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PGI –Metallurgical Laboratory (A Sister Concern Of Punjab General Industries Private Limited )
Plot-149-150, Sector 24 ,Faridabad
PGI-ML-QM Issue no-02
Quality Manual
Issue Date-1.6.19 Rev-01/ 19.11.2019
As Per ISO/IEC 17025 : 2017 Release Authorization QUALITY MANUAL PGI-ML-QM ( Issue No. : 02 , Issue Date : 19th-Nov-2019 ) As per IS/ISO/ IEC 17025: 2017
This Quality Manual is released under the authority of Mr. Ankit Jindal Director of M/s. PGI Metallurgical Laboratory
For implementation of Quality Management System As per ISO 17025: 2017 at PGI – Metallurgical Laboratory, Plot No. –149-150, Sector – 24, Faridabad – 121005, Haryana This Quality Manual is the property of PGI-ML ( A sister concern of Punjab General Industries Private Limited)and shall not be reproduced without the written permission from their director.
Mr. Ankit Jindal Director
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PGI –Metallurgical Laboratory (A Sister Concern Of Punjab General Industries Private Limited )
Plot-149-150, Sector 24 ,Faridabad
Quality Manual As Per ISO/IEC 17025 : 2017 1.0
General Introduction
1.1
Index ,issue revision and distribution
PGI-ML-QM Issue no-02 Issue Date-1.6.19 Rev-01/ 19.11.2019
Index;Quality Manual PGI-ML-QM is structured as per the requirements of IS/ISO/IEC 17025: 2017. Numbering and name of Sections of this quality manual corresponds directly to IS/ISO/IEC 17025:2017. Section numbers, section name, revision number status with date is indicated for each section. Pages are numbered serially at the bottom right hand side. Issue:All pages of “Master Copy” of the manual bear signatures of Director of Punjab General Industries Pvt.Ltd. who is the issuing authority for this manual. Revisions:Quality Manual is reviewed once 2 years from the date of last amendment / or if there is any revision in the standard IS/ISO/IEC/17025:2017, whichever is earlier, by the Quality Manager. Updates, changes, amendments to this manual will be made by re-issuing the relevant section of this manual and updating the revision number in the Table of Contents which is incremented by 1, initial revision no. is 0 (Zero). Date and description of changes in brief are recorded in the quality manual revision history sheet. Each revision is introduced formally by the Quality Manager by issue of revised chapters for each of the copy as per the distribution list. Complete Quality manual is revised in case of major and many changes occur, or when needed,need assessed by Quality manger or when the edition of IS/ISO/IEC is revised. Obsoletes sections or Quality Manuals are marked Obsolete and retained with the Quality Manager. Distribution: Quality Manual has 3 copies,marked as Copy No.1, 2 ,3. CopyNo. 1 and Copy No. 2 and theirscanned soft copies are available with the QM and TM respectively. Copy No. 3 and its scanned copy is available for use of all relevant Personnel and auditors on demand from the Quality Manger, who ensures latest version is available to the all users.
1.2
Scope and purpose
This quality manual documentsquality management system at PGI Metallurgical Laboratory to meet all the requirements of IS/ISO/IEC 17025:2017, which specifies the general requirements for the competence of Testing and Calibration Laboratories. It demonstrates competence, impartiality and consistent operationsfor confirming and recognition by our customers, regulatory authorities, accreditation bodies and other assessing organizations. PGI-Metallurgical Laboratory is an Independent body and all activities of PGI-Metallurgical Laboratory is available to both External (Open to others) and internal activities ( Punjab General Industries Private Limited )
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PGI –Metallurgical Laboratory (A Sister Concern Of Punjab General Industries Private Limited )
Plot-149-150, Sector 24 ,Faridabad
Quality Manual As Per ISO/IEC 17025 : 2017 1.3
PGI-ML-QM Issue no-02 Issue Date-1.6.19 Rev-01/ 19.11.2019
Company profile
“PGI-Metallurgical laboratory” is a sister concern of “Punjab General Industries Pvt. Ltd” has its office and works in Faridabad (Haryana) and Regd. Office in New Delhi. Founded in the year 1970, the company started its journey in with the setting of its first Rolling Mill in Faridabad (Haryana).
PGI – Metallurgical Laboratory houses state of art Quality Control Testing Equipments: 42 Channel Spectrometer – Angstrom, 20 Channel Spectrometer – Jarrell Ash, Fully Equipped Chemical Wet Lab. Ultrasonic Flaw Detector. Universal Tensile Testing Machine.Rockwell Hardness Tester, Brinell Hardness Tester. Muffle Furnace.Shore Hardness Tester, Acid etching tanks for Macro Examination, Metallurgical Microscope with Image Analyzer, Hacksaw machine and lathes for Macro Streak flaw detection test. Impact Testing Machine MPI Testing Facility, Dye Penetrate Test. The company has been constantly upgrading its technology base and diversifying its manufacturing range in tune with global market requirements by making considerable investments every year to upgrade production, quality control technology, human resource, information technology etc.
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PGI –Metallurgical Laboratory (A Sister Concern Of Punjab General Industries Private Limited )
Plot-149-150, Sector 24 ,Faridabad
Issue no-02
Quality Manual
Issue Date-1.6.19 Rev-01/ 19.11.2019
As Per ISO/IEC 17025 : 2017 1.4
PGI-ML-QM
Quality Policy and Quality Objectives PGI – Metallurgical Laboratory
Quality Policy The Management is committed to: Provide reliable and impartial test results , Work ethically and ensure confidentiality, Prompt and courteous service to customers, Follow Quality Management System as per IS/ISO/IEC 17025:2017 Quality Objectives Maximize Customers& Minimize complaints Continuous up-gradation of test facilities Train laboratory personnel to impliment the policies and procedures Continually improve Quality Management system by complying with IS/ISO/IEC 17025: 2017 standard.
Mr. Ankit Jindal Director Date: 19.11.2019
PGI Metallurgical Laboratory Plot No. – 149-150, Sector – 24, Faridabad – 121 005, Haryana - India
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PGI –Metallurgical Laboratory (A Sister Concern Of Punjab General Industries Private Limited )
Plot-149-150, Sector 24 ,Faridabad
Quality Manual
Issue no-02 Issue Date-1.6.19 Rev-01/ 19.11.2019
As Per ISO/IEC 17025 : 2017 2.0
PGI-ML-QM
References
National and International standards, NABL India documents, other relevant documents are referred where required to meet the compliance of the IS/ISO/IEC 17025. Reference to quality procedures, work instructions, records, charts ,machine manuals etc. is mentioned at appropriate places in this manual where required. 3.0
Terms and definitions
Terms and definitions given in ISO/IEC Guide 99 and ISO/IEC 17000 , and available at online browsing platform https://www.iso.org/obp and at http:www.electropedia.org/ apply. 3.1
Abbreviations
Given below is the list of abbreviations, synonyms and definitions used in this quality manual PGI ML PO TP TR FC CAL CRM RM NABL
Punjab General Industries Metallurgical Laboratory Purchase Order Testing procedure Test Report Flow Chart Calibration Certified reference material Reference Material National Accreditation board for Testing and Calibration laboratories International Organization for standardization Indian Standards International Electro-technical Committee Laboratory Proficiency Testing Uncertainty
ISO IS IEC LAB PT UNC
AMC CA PA IA NC NCR QM TM QMS LMS
Annual Maintenance contract Corrective Action Preventive Action Internal Audit Non Conformity Non Conformity report Quality Manager Technical Manager Quality Management System Lab Management System
MRM QP WI QA ILC UOM
Management review meeting Quality Procedure Work Instruction Quality Assurance Inter lab Comparison Uncertainty of Measurement
4.0
General Requirements
4.1
Impartiality
4.1.1The laboratory activities are undertaken impartially and structured and managed so as to safeguard impartiality. 4.1.2The laboratory management is committed to impartiality as stated in Quality Policy and quality objectives in the general introduction section of this quality manual. Personnel are made aware of this Quality policy and quality objectives through training and the policies are also displayed at prominent locations in the laboratory. 4.1.3 PGI-ML laboratory does not allow commercial, financial, or other pressures internal or external on laboratory personnel or laboratory activities which can lead to a compromise in impartiality. None of the activities in the laboratory are directly linked to financial or commercial or other incentives to create pressures.
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Plot-149-150, Sector 24 ,Faridabad
Quality Manual As Per ISO/IEC 17025 : 2017
PGI-ML-QM Issue no-02 Issue Date-1.6.19 Rev-01/ 19.11.2019
The integrity of test results is the responsibility of all personnel. Management ensures that employees are never instructed or forced to alter or falsify data. All personnel of the laboratory commit to the PGI-ML “Code of ethics for Personnel” F-4.1-04 and sign an undertaking on confidentiality and impartiality prior to joining.Employees shall not: Falsify records, prepare fraudulent reports, or make false claims Seek or use privileged or confidential company information, or data from any customer, for any purpose beyond the scope of employment Conduct non-laboratory business on laboratory time, or use company facilities or equipment to conduct outside interests in business, unless prior approval has been obtained Solicit business on their own behalf (rather than the laboratory) from a customer Be employed by, or affiliated with, organizations whose products or services compete with laboratory products or services Have employment that negatively affects or interferes with their performance of laboratory duties Allow association, family, or friends to influence business decisions to their benefit - decisions must be made on a strictly business basis, always in the best interest of the laboratory Make any decision that provides gains or benefits to the employee and/or others Have personal financial dealings with an individual or company that does business with the laboratory which might influence decisions made on the laboratory’s behalf. 4.1.4PGI-ML identifies risks to its impartiality on an on-going basis, yearly. The quality manager identifies, in the course of laboratory’s work, the risks to the impartiality. This includes those risks that arise from its activities, or from its relationships, or from the relationships from its personnel. It should be noted that such relations may not necessarily represent a risk for the laboratory’s impartiality. 4.1.5If a risk to impartiality is identified, the laboratory takes proposed measures for risks elimination or minimizing it and keeping under control Identification of risks and proposed measures taken and assessment of success of undertaken measures are recorded in document “Risks to Impartiality – Assessment and Measures” F-4.1-03.This document contains: - Risk description (can be ownership/ governance/ management/ personnel/ shared resources/ finances/ contracts/ marketing/ sales commission etc.), assessment of risk existence/occurrence, proposed measures for risks elimination or keeping under control, assessment of success of undertaken measures. The quality manager along with staff members analyze possible risks and define proposals of necessary measures for their prevention every year,which are presented at the management review meeting and all aspectsof impartiality are considered, where assessment is made of the undertaken measures,and their success for the previous year and decisions taken for upkeep and improvement are adopted. 4.2
Confidentiality
4.2.1Laboratory ensures the protection of its customer’s confidential information and proprietary rights, including the protecting the electronic storage and transmission of results. The laboratory is responsible through legally enforceable commitments, for the management of all information obtained or created during the performance of laboratory activities. Only authorized persons in the PGI-ML have access to it. Electronic transmission by email is to authorized persons of the customers only, and hard copies of reports are sent or handed over to their authorized persons or couriered to their respective shipping address as statedby them. Test report and samples (after completion of test) collection/delivery records are maintained in register “Test Report delivery” F-8.4-02 No informationrelated to testing activities by PGI-ML is placed in the public domain. If in any case the need to place it public domain arises then PGI-ML informs the customer in advance, of the information it intends to place in the public domain. Except for information that the customer makes publicly available, or when agreed between the laboratory and the customer, all other information is considered proprietary information and is regarded as confidential. 4.2.2When the laboratory is required by law or authorized by contractual arrangements to release confidential information, the customer concerned is notified of the information provided (unless prohibited by law). 4.2.3Information about the customer obtained from sources other than the customer is confidential between the customer and laboratory. The provider of this information is confidential to the laboratory and is not shared with the customer, unless agreed by the source.
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Plot-149-150, Sector 24 ,Faridabad
Quality Manual As Per ISO/IEC 17025 : 2017
PGI-ML-QM Issue no-02 Issue Date-1.6.19 Rev-01/ 19.11.2019
4.2.4Personnel, including any committee members, contractors, personnel of external bodies, or individuals acting on the laboratory's behalf, keep confidential all information obtained or created during the performance of laboratory activities, except as required by law. They are bound by a PGI-ML Code of Ethics, which is signed by them before the commencement of their work in the PGI-ML.
5.0 Structural requirements 5.1 PGI - Metallurgical laboratory is a sister concern of of Punjab General Industries Pvt. Ltd , having registered office in New Delhi and works at address Punjab General Industries Pvt. Ltd. Plot No. 149-150, Sector – 24, Faridabad Haryana and operating all activities from these address.It is a private limited company which is registered with Company Registarar - Government of India New Delhi, under Company Act 1956 bearing certificate of incoporation no 55-98259 of 1998-1999.GST registration with Government of Haryana with GSTIN: 06AABCP4823A1ZZ. Any legal issues of PGI-Metallurgical laboratory will be at the sole discretion of Punjab General Industies Private Limited.PGI-Metallurgical Laboratory does not bear any concern related to legal issues raised by customers and the same will be taken care by Punjab Geneal Industries Private Limited. 5.2 Directors of PGI-Metallurgical Laboratory . has overall responsibility including the responsibility for all its activities except 5.3 Allactivities at PGI-Metallurgical Laboratory conforms to IS/ISO/IEC 17025 : 2017 and to this Quality Manual PGI-ML-QM.Where certain activities like sampling , calibration, laboratory developed test methods etc which are not applicable to PGI-ML are indicated clearly as not applicable against those relevant clauses in this quality manual. 5.4 All activities in PGI-ML are at permanent testing facilities only (No on-site or mobile facility) and meet the requirements of IS/ISO/IEC 17025 : 2017, regulatory authorities and accredition bodies like NABL, and customer’srequirements and of any other organization providing recognition to PGI-ML. 5.5 a)Organization structureis provided as “Organization Chart” PGI-ML-FC-01for organization and as PGI-ML-FC-02 for PGI Metallurgical Laboratory. Note : PGI-ML-FC-01 & PGI-ML-FC-02 are attcahed at the end of this Manual. b) Responsibility, authority and interrelationship of all personnel, designation wise in PGI-ML, who manage perform or verify work affecting the results of PGI-ML activities are as provided in Quality procedure “Recruitment and training” PGI-ML-QP – 02 c) PGI-ML has documented procedures,(supported by formats,work instructions, flow charts working manuals, test procedures, test methods) where necessary and where required by IS/ISO/IEC 17025:2017 which ensure the consistent application of all its laboratory activities and the validity of the test results’aster list of documents is maintained as Annexure-1 “Master List of documents” to the Quality procedure “Control of documents and records” PGI-ML-QP-01. 5.6 Top Management of PGI-ML and all personnel in laboratory have authority and resources to carry out their duties. Quality Manager is responsible, and has authority and resources and Reporting to the Director PGI-ML a) for implementation, maintenance and improvement of the management system. b) Identification of deviations from the management system or from the procedures for performing laboratory activities. c) Initiation of actions to prevent or minimize such deviations; Quality Manager and Technical Manager are responsible, and have authority and resources for d) reporting to laboratory management on the performance of the management system and any need for improvement. QM and TM can take feedback and inputs from the other personnel of PGI-ML for improvement. e) Quality Manger and Technical Manager along with all lab personnel are responsible and have authorities and resources as stated in job descriptions in clause 5.5 b) to ensure the effectiveness of laboratory activities. However sole and overall responsibility is of Partner and Quality Manager of PGI-ML. 5.7PGI-ML ensures effective communication through monthly meetings and yearly Management review meetings a) That appropriate communication processes are established within the laboratory for implementation of the management system, and customers’ requirements are met. b) And that the integrity of the management system is maintained when changes to the management system are implemented. When changes to the system, which are likely to affect the integrity, which are absence of personnel for long periods, additional workload, equipment out of order etc. These are reviewed and adequate steps taken to ensure system integrity is maintained. Top Management ensures that the Management System implemented and effective and continual improvement is made. Top Management also communicates to the personnel the importance of meeting customer as well as statutory and regulatory requirements.
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Quality Manual As Per ISO/IEC 17025 : 2017 6.0
PGI-ML-QM Issue no-02 Issue Date-1.6.19 Rev-01/ 19.11.2019
Resource requirements
6.1 General PGI-ML has personnel, facilities,equipments,systems and support services necessary to manage and perform its laboratory activities.Qualified experienced and skilled personnel are employed at PGI-ML to carry out laboratory activities. Training needs are assessed and trainings provided.Chemical sections houses Spectrometers and analyzers and other equipments and instruments for chemical analysis. Mechanical section has universal tensile testing machines, impact testing machine,hardness testers, microscopes and many other equipments and instruments to carry out mechanical tests. Support services for calibration and maintenance are from external sources.The requirement of power, water, air,and specific environmental conditions have been assessed and providedat PGI-ML.A detailed “List of equipments” F-6.4-11covering all equipments, machines and instruments stating their calibration and maintenance status is readily maintained. 6.2
Personnel
6.2.1 All personnel of the laboratory, either internal or external, act impartially and are competent and work in accordance with the management system. 6.2.2Management has determined and documented the competence requirements for each function in terms of education, qualification, technical knowledge, training experience and skills of the laboratory personnel. Training needs are identified and planned yearly or when needed. Management compares the job description to the skills and knowledge of the already working personnel and new incumbent to determine the training needs. Training needs may arise as a result of new technologies, contracts, markets, or change in standards, or for improvement programs. The necessary training is provided to the personnel. And it is ensured that they must demonstrate competency when under observation by management. The verification of the effectiveness of the action taken is reviewed. 6.2.3 The Management of the laboratory ensures personnel are competent through the evaluation carried out including the knowledge they possess to identify and evaluate the significance of deviations, which they may encounter while performing the laboratory activities. 6.2.4 The responsibilities and duties are documented and these are communicated to all personnel in the laboratory. The Job description is provided to the employees and their signatures obtained as evidence 6.2.5 The Laboratory has “Recruitment and training”procedure PGI-ML-QP – 02and records for the following a) “Competency requirement of Personnel” F-6.2-05 aredetermined and maintained by QM. b) Recruitment is on the basis of qualification /experience/skill/training for each position and is defined.The selection of the candidate is done by personal interview by QM and TM . The record of the results of the interview of the candidates called for personal interview is maintained by administration. c) The training process is addressed in “Recruitment and training” procedure PGI-ML-QP – 02 andrecords maintained for training need assesment,plans, trainings provided,certificates issued , training evaluation and effectiveness. d) Adequate supervision is provided when and where required by authorized personnel. e) The authorization of personnel for testing and other functions are clearly defined in job descriptions. f) QM and TM monitors the competence of the personnel through the annual performance review and identifies any training needed. 6.2.6 The authorizations for the following have been done a) Verification and initiation of new method/ new specification is done by QM and TM,Development and modifications of test methods are not required as no deviation form the standard method is allowed. b) Those authorized to sign reports have been qualified based on their ability to analyze the results and provide statements of conformity wherever called for. c) The review and authorization of the test results is done by QM or TM. 6.3
Facilities and environmental conditions
6.3.1 PGI-ML ensures that the facilities and environmental conditions are suitable for the performance of tests and it does not adversely impact the test results .Energy sources, lighting, heating, and ventilation facilitate proper performance of tests in the
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PGI –Metallurgical Laboratory (A Sister Concern Of Punjab General Industries Private Limited )
Plot-149-150, Sector 24 ,Faridabad
Quality Manual As Per ISO/IEC 17025 : 2017
PGI-ML-QM Issue no-02 Issue Date-1.6.19 Rev-01/ 19.11.2019
laboratory. It is further ensured that dust, electromagnetic interference, humidity, line voltage, temperature, sound and vibration levels temperature changes that adversely affect the measurement) are appropriate as specified in method or for machine /equipments used for measurement. Good housekeeping practices are promoted to have a clean, uncluttered laboratory.Safety conditions are met as required or risk assessed. 6.3.2 The test methods and machine manuals describe the conditions to be met for facility and environment, and these conditons are met. 6.3.3 At PGI-ML in the Chemical and Mechanical sections adequate number of air conditioners are provided to meet temperature requirements, records for temperature and humidity “Room Temperature and Relative Humidity” F-6.3-10on daily basis are 0 0 maintained and work is immediately stopped if temperature is out of the specified range.of 10 C to 35 C in Mechanical section and 0 0 18 C to 28 C in the Chemical section. Monitoring devices are maintained to give accurate results and calibrated as per plan. 6.3.4 Measures to control the facilities is implemented and is reviewed and suitable updated. Measures to control include the following a) Access into the Mechanical and Chemical sectionsis restricted to the testing personnel only. Unauthorized personnel are not allowed into the test area without permission. b) Prevention of dust is ensured through closed door working, air conditioning and restricted access. c) Chemical testing area is effectively separated from the mechanical section and both are further separated from reception and accounts and other areas of the laboratory. 6.3.5 When tests are done at site not owned by it, PGI-ML ensures the facilities and environmental conditions are met as at laboratory and records of monitoring are maintained. 6.4
Equipment
6.4.1 PGI-ML houses and has access to equipments , measuring instruments , softwares ,reference materials consumables for testing and measurement for the correct performance of the tests. Equipment is used in an environment appropriate to its proper performance. All equipment and instruments and reference standards are listed and identifiable with uniqued identification nos. in laboratory premesis with calibration status. List of primary and secondary samples ( CRM,RM,control and working samples and standards) for Chemical and Mechanical laboratories is maintained as “List of Reference Material” F-6.4-12with traceability certificates and reports and results. 6.4.2 When equipment is used outside the laboratory’s permanent control, it ensures that the requirements for equipment of this Quality Manual are met. Record of equipment going outside the control of laboratory is maintained “Equipment In-Out” F-6.4-14 6.4.3PGI-ML has a documented procedure “Handling of Equipments” PGI-ML-QP-04for safe handling, transport, storage, use and maintenance of measuring equipment to ensure proper functioning and prevent deterioration. 6.4.4 The procedures for checking newly received equipment are as determined by manufacturers’ specification and/or those determined by the laboratory during procurement. When received, equipment is checked to establish that it meets the laboratory’s specification requirements, complies with the relevant standard specifications, and is checked and calibrated before use. 6.4.5 Equipment and software used for testing are capable of achieving the accuracy required and comply with specifications relevant to the tests and/or calibrations concerned. 6.4.6 The equipment that require calibration are identified. When the measurement accuracy affects the test results or when calibration is required for establishing metrological traceability of the results, such equipment are identified for calibration,and calibrated atleast once a year in routine use, or when after maintenance or overhaul which can effect the existing calibration results. A detailed “List of Equipments” F-6.4-11 covering all equipments, machines and instruments stating their calibration and maintenance status is readily maintained. 6.4.7 Calibration programs are established for key quantities or values of the instruments where these properties have a significant affect on the results / metrological traceability needs to be established as stated above.. The calibration program is adjusted based on its usage and results of calibration. In normal routine Calibration is done once a year, atleast. 6.4.8All Equipmentsand measuring devices requiring calibration is labeled to indicate the calibration status and/or operational status and the date when re-calibration is due. Those, which are due for calibration, are labeled Out of Calibration / Out of Service .
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Plot-149-150, Sector 24 ,Faridabad
Quality Manual As Per ISO/IEC 17025 : 2017
PGI-ML-QM Issue no-02 Issue Date-1.6.19 Rev-01/ 19.11.2019
6.4.9 Equipment that has either been subjected to overloading or mishandling, or gives suspect results, or has been shown to be defective or outside specified limits, is taken out of service, clearly marked as Out of Service / Not in Use , and appropriately stored until it has been repaired and shown by calibration or test to perform correctly. Routine testing work is completely discontinued on equipment that even shows minor non-conformities. Actions are initiated even on minor non-conformities, as they are often indicative of major breakdowns in expensive equipment. These breakdowns are avoided wherever possible.Out of service equipment is clearly marked as outlined above The laboratory examines the effect of the defect or departure from specified limits on previous test and/or calibrations and institutes the “Control of Nonconforming Work” procedure. PGI-ML-QP-08. 6.4.10Wherever intermediate checks are needed to maintain confidence, in the performance of the equipment, such checks are carried out as per procedurelistedi“Ensuring Validity of Test Results” PGI-ML-QP-07.The equipment requiring intermediate checks have been identified and listed and intermetiate checks done and recorded. 6.4.11 When calibrations and reference materials identify reference values or correction factors, such values are updated and implemented. 6.4.12 Equipment are protected from any unintended adjustments. 6.4.13 Records are maintained of each equipment“Equipment History Sheet” F-6.4-13significant to the tests performed. The records include the following: identity of the equipment including software versions. manufacturer’s name, type identification, and serial number and/or other unique identification checks that equipment complies with the specification current location, where appropriate the manufacturer’s instructions, if available, or reference to their location dates, results and copies of reports and certificates of all calibrations, adjustments, acceptance criteria, and due date of next calibration maintenance carried out to date and the maintenance plan (includes calibration) damage, malfunction, modification or repair to the equipment Date received, date placed in service and dates of transfer to the sites/store condition when received (e.g., new, used, refurbished) dates and results of calibration and/or verification and date of next calibration and/or verification performance history, where appropriate The above information related to service and maintenance and history is kept in individual equipment files, or in , along the “Equipment History Sheet” F-6.4-13 Operation manuals and instructions for proper maintenance of equipment are available to the staff and located in the laboratory. Equipment is used or operated only when in a safe and reliable condition, by authorized personnel who have been trained and are qualified. User instructions / Work Instructionsare available for equipments where required. Primary standards are calibrated by the National Institute of Standards and Technology or by an ISO 17025 accredited laboratory and calibration reports are maintained in the laboratory files.Secondary standards are calibrated by comparison to primary standards.Calibration reports are maintained in the laboratory files.Working standards are calibrated by comparison to secondary standards using calibration procedures. Calibration reports are maintained in the laboratory files. List of Primary and Secondary samples “List of Reference Material” F-6.4-12 (CRM,RM,control and working samples/standards) for Chemical and Mechanical laboratories is maintained with traceability certificates and reports and results. 6.5
Metrological traceability
6.5.1 PGI-ML has established and maintains metrological traceability of its measurement results by means of a documented unbroken chain of calibrations, each contributing to the measurement uncertainty, linking them to an appropriate reference. 6.5.2 The laboratory ensures that measurement results are traceable to the SI units through a) calibrations of all equipment carried out in or by a laboratory accredited to ISO 17025. b) Certified values of certified reference materials, when used will be from a competent producer or accredited to ISO 17034 .
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Quality Manual As Per ISO/IEC 17025 : 2017
PGI-ML-QM Issue no-02 Issue Date-1.6.19 Rev-01/ 19.11.2019
c) Direct realization of SI units ensured by comparison directly or indirectly with National or international standards. 6.5.3 When metrological traceability to the SI units is not technically possible, the laboratory will demonstrate traceability to an appropriate reference by a) Certified values of certified reference material from a competent producer b) Results of reference measurement procedures, specified methods or consensus standards are clearly described and accepted as providing measurement results fit for their intended use by suitable comparison. 6.6
Externally provided products and services
6.6.1PGI-ML throughprocedure “Externally provided products and services” PGI-ML-QP-06 ensures that only suitable externally provided products and services that affect the laboratory activities are used. The products/services include equipment, accessories and their spares, calibration and equipment maintenance services or auditing services. All the products/services supplied by external source for incorporation into the laboratory activities or to support the laboratory operation,and Services obtained from external source, provided to the customer either in part or in full directly to the customer are all included and ensured to be suitable. 6.6.2 The procedure “Externally provided products and services” PGI-ML-QP-06 includes and records retained for all the following a) defining , reviewing and approving the laboratory requirements for externally provided products/services. b) criteria for evaluation , selection and monitoring of performance and re evaluation of external providers c) Verification of the supplies and services against the requirement of the laboratory before it is put to use d) taking actions arising out of the evaluation, monitoring and reevaluation of the external providers 6.6.3 The Laboratory communicates its requirement through a purchase orders, over telephone for repeat and regular ordersor by e mail and which clearly specifies the following as applicable a) products and services to be provided along with the specification details b) acceptance criteria c) competence requirement if required d) activities to be performed at the external providers site if so desired by the customer.
7.0
Process requirements
7.1
Review of requests tenders and contracts
7.1.1 It is the policy of the laboratory to ensure that customer requirements are understood and met. Procedure “Review of requests tenders and contracts” PGI-ML-QP-03 exists which ensure that a) Requirements , including the methods are defined, documented and understood b) PGI-ML has the capability and resources to meet the requirements c) If to meet the requirement, external providers are used requirements of 6.6 are met with and customer is communicated about the same and his approval is sought. d) the appropriate test method is selected and capable of meeting customer requirements 7.1.2 The laboratory does not accept any method which is not appropriate or not suitable and informs the customer if request for a non standard method is made. 7.1.3When requested by the customer PGI-ML provides statement of conformity / non conformity to a specification or a standard, by comparing results observed to those specified . It provides the results along with the specified requirements. 7.1.4 Any differences between the request and the contract is resolved before the commencement of work. A “Job order request”F7.1-20 is to be filled by the customer, or he provides a challan/purchase order/work order/request letter/e-mail request any one , clearly specifying the sample details and tests required to be conducted.Sample is not accepted for testing if PGI-ML is not capable of doing the tests as per the list of tests in its scope. No deviation in test method is accepted.,unless documented in “Deviation Form”F-7.1-21 with reasoning and approved by both QM of PGI-ML and by the customer.A list of tests along with prices“Price List”and “Scope of Testing”in Chemical and Mechanicalfield is availableat the reception cum sample booking counter and provided to the customer by post,e-mail, in person.These lists list tests which PGI-Metallurgical Lab is capable of conducting. 7.1.5 Any deviation from the contract is informed to the customer and approval obtained and recorded in “Deviation Form” F-7.121
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As Per ISO/IEC 17025 : 2017
7.1.6 If a contract is amended after the work is commenced a review is conducted and amendment is issued to all concerned personnel. 7.1.7 PGI-MLonly after approval from QM/TM provides access to the customers to the relevant areas of work to monitor the laboratory performance or winess test results for his samples. Records of these visits are maintained “Customer Visits” F-7.1-22All clarifications are provided to the customer when needed by post, e-mail, phone orby personal meetings.Records of visits by customer,and if required minutes of such meetings are maintained. 7.1.8 Records of requests, reviews and changes are retained such as Job order requests, Challans, Purchase/Work orders, request letters,deviation forms.Minutes of meetings and other discussions are also retained.
7.2
Selection verification and validation of methods
7.2.1.1At PGI-MLmethods and procedures used for all tests are appropriate, and cover handling, transport, storage, and preparation of items to be tested an estimation of the measurement of uncertainty as well as statistical techniques for analysis of test and/or calibration data where appropriate 7.2.1.2 All methods, procedures and supporting documents work instructions and instruction manuals are kept up to date and are readily available to the testing personnel. 7.2.1.3 Instructions on the use and operation of all relevant equipment and on the handling and preparation of items for testing are available. All Latest and valid versions of instructions, standards, manuals and reference data relevant to the work of the laboratory are maintained current and up to date and readily available to personnel.
7.2.1.4PGI-ML uses only National and International standards (IS/ISO/IEC/ASTM/ASM) and guidelines from reputable technical organization that contain sufficient and concise information on how to perform the tests. A list of all tests along with the Standard Test methods is maintained for Chemical and Mechanical tests in scope of testing. The standard test methodsare not necessarily supplemented or re-written as an internal procedure when they are written in a way that can be used as published by laboratory staff. 7.2.1.5 The laboratory verifies that it can perform methods before introducing them and records are maintained ensuring the required performance has been achieved. 7.2.1.6 PGI-ML is not involved in development of methods as it uses only standard methods 7.2.1.7 Deviations are not generally permitted, however if deviation from standard methods are made, they are documented in“Deviation Form”F-7.1-21, technically justified, authorized and approved and accepted by the customer. 7.2.2 Validation of the methods This is not applicable to PGI-ML. 7.3
Sampling
PGI-ML does not perform sampling and hence this is not applicable . 7.4 Handling of test and calibration items 7.4.1 Procedures “Handling of Test Items” PGI-ML-QP-5 exist for the transportation, receipt, handling, protection, storage, retention and/or disposal of test items, including all provisions necessary to protect the integrity of the test item, and the interests of the laboratory and the customer. Precautions are taken to avoid loss or damage to the item when it is in the custody of the laboratory. Handling instructions of the customer are followed and support for handling is also obtained from the customer. 7.4.2PGI-MTL has a system of identification of the test items received for testing. This identification is done by a reference number assigned at the time of booking a test item (sample) for test, which is unambiguous marked by a permanent marker or sticker and it is ensured that this marking is retained when the test item (sample) is under the responsibility of the PGI-ML.
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7.4.3 Upon receipt all items are verified for suitability for testing and if it is unsuitable or does not match description provided, it is brought to the notice of the customer before proceeding with the test. All such instances are recorded. If deviations are accepted, a disclaimer is included indicating the results which may be affected. 7.4.4Test samples which need to be stored or condition under specific conditions are maintained as specified. Records of which are maintained as “Sample Conditioning record” F-7.4-23 7.5
Technical records
7.5.1 The records for each test contain sufficient information to facilitate, if possible, identification of factors affecting the test uncertainty and to enable the test to be repeated under conditions as close as possible to the original. The records include the identity of personnel responsible for performing of each test, date of test and checking of results. Observations, data, and calculations are clearly and permanently recorded and identifiable to the specific job at the time they are made. Data acquisition system by computer for computerized machines exists for capturing all test observations. Hand written records are made immediately after the observation is made for tests in mechanical section and records maintained in the“Observation Register Mechanical”which has no formal format,machine or test specific records are laso maintained separately when required along with “Observation Register Mechanical”. Inthe Chemical section of the laboratory the records for analysis conducted are stored in computer and in the operating software of the spectromer itself. 7.5.2 Any changes made to the technical record can be tracked to previous observations both original and amended, which includes data alterations, aspect altered and the signature of the personal making the alteration. 7.6
Evaluation of measurement uncertainty
7.6.1PGI-ML identifies contirbutions to measurement uncertainty for chemical and mechanical tests in its scope. When evaluating all significant contributors are taken into account and appropriate methods used for analysis. 7.6.2Not applicable to PGI-ML as it is only a testing laboratory and not doing any calibration activity. 7.6.3 Measurement uncertainties are estimated as provided in the test methods for all test methods in scope of PGI-ML, and records maintainedas soft copy in computer in a file named “Evaluation of Measurement Uncertainty”. It is done once a year atleast or when required. 7.7
Ensuring validity of test results
7.7.1 Quality control procedures“Ensuring Validity of Test Results”PGI-ML-QP-07 is followed to monitor the validity of test results. These procedures are for each test method utilized in the laboratory. The resulting data are recorded so that trends are detectable. This monitoring is planned and reviewed and includes, but not limited to, the following: a) use of reference material/quality control material is practiced for equipment which has reference materials . b) use of alternative instrument during test/ on completion of test cross verify the results using an alternate instrument c) functional checks of measuring instruments- This is done for equipment where the calibration has been done for the output quantity which is being reported. But other parameters which are not calibrated are subjected to functional checks. d) use of check or working standards, control charts where applicable. e) intermediate check on measuring equipments f) replicate testing where possible as per plan for the tests under scope g) retesting of retained items where possible as per plan for tests under scope h) correlation of results for different characteristics where possible i) Review of reported results by the QM/TM j) intralaboratory comparison. k) testing of blind sample where possible. 7.7.2 PGI-ML monitors its performance by comparison with results of other laboratories. This monitoring is done by one or both the methods given below a) Participation in proficiency testing as per the plan for all tests in scope. b) Participation in interlaboratory comparisons other than PT
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Results/reportsof ILC and PT obtained are all reviewed for performance and records maintained. 7.7.3 Data from all monitoring activities is collected and analyzed and used for improvement. If the results are outside the limits of variation, immediate action is initiated as per the procedure“Control Of Noncomforming Work” PGI-ML-QP-08 7.8
Reporting of results
7.8.1 General 7.8.1.1 The results are reviewed and authorized by the TM or QM. 7.8.1.2The results of each test or series of tests are reported accurately, clearly, unambiguously and objectively, and in accordance with any specific instructions in the test or calibration methods. The results are reported, normally in a test report and include all the information requested by the customer and necessary for the interpretation of the test results and all information required by the method used. All issued reports are retained as technical records. 7.8.1.3 When agreed with the customer, the report may be simplified , however all information as required in 7.8.2 to 7.8.7 will be retained. 7.8.2 Common Requirements for Test Reports 7.8.2.1 The test reportsissued by PGI-ML include the following information a) Title-test report b) name and address of laboratory, and location where tests were carried out if different from the address of the laboratory c) location of the performance of the test d) unique identification of the test report (such as a serial number), and on each page an identification in order to ensure that the page is recognized as a part of the test report and a clear identification of the end of the test report. e) name and contact information of the customer f) identification of the method used g) Description, condition, and unambiguous identification of the item(s) tested h) date of receipt of the test item i) date(s) of performance of the test j) Date of issue of report k) Sampling is not applicable to PGI-ML l) a statement to the effect that the results relate only to the items tested m) test results with, where appropriate, units of measurement n) Additions to, deviations or exclusions from the method o) the name(s), function(s) and signature(s) or equivalent of person(s) authorizing the test report p) Clear identification or remark when an external service provider is used for testing A format of the test report “Test Certificate” F-7.8-26 covering the above common and standard requirements is approved for reporting results. 7.8.2.2 PGI-ML is responsible for the information provided in the report, except for those provided by the customer, which are clearly identified. A disclaimer is added in the report if any information provided by the customer could affect the validity of the results.A statement stating sampling not done by PGI-ML and results pertain only to the received sample from the customer is mentioned on each report. 7.8.3 Specific Requirements for test reports 7.8.3.1 In addition to the requirements as above, test reports include the following a) information on specific test conditions b) statement of conformity/non conformity is provided when requested by customerned along with the associated measurement uncertainty c) measurement uncertainty where requested by customer is determined and reported d) Opinions and interpretations are not provided e) Any other additional information as required by the customer or authorities 7.8.3.2PGI-MLdoes not undertake sampling and therefore this is not applicable. 7.8.4 Specific requirements for calibration certificates,This is not applicable to PGI-METALLURGICAL LABL. 7.8.5PGI-MLdoes not undertake sampling so reporting sampling is not applicable.
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7.8.6 Reporting statements of conformity 7.8.6.1PGI-ML when provide statement of conformity, the results are always within the specified range with respect to the specifications, and this same decision rule is in agreement with the customer. 7.8.6.2 Statement of conformity clearly identifies to results applicable , specification standard name and/or number,decision rule if required. 7.8.7 Reporting Opinions and Interpretation: Not applicable as PGI-ML does not provide opinions/interpretation for results. 7.8.8 Amendments to reports 7.8.8.1 When an issued report needs to be changed, amended or re-issued, the changes are clearly identified with reason for the change 7.8.8.2Material amendments to a test report after issue are made only in the form of a further document, or data transfer, which includes the statement “Amendment to Test Report No. XXX “ or similar wording. Such amendments meet all the requirements of this standard. 7.8.8.3 When a complete new report needs to be issued, it is uniquely identified and contains a reference to the original that it replaces. . 7.9
Complaints
7.9 Complaints 7.9.1 The laboratory has a documented procedure “Handling Customer Complaints” PGI-ML-QP-09which details the process of receiving, evaluating and making decisions on complaints 7.9.2 The procedure for complaints is made available to anyone on request. Upon receipt of a complaint, the laboratory confirms that it relates to thelaboratory activities that it is responsible for , and , if so, deal with it. QM is responsible for all decisions at all levels of the handling process of complaints 7.9.3 The procedure “Handling Customer Complaints” PGI-ML-QP-09 includes the following: a) Process for receiving, validating, investigating the complaint and deciding on the actions to be taken b) Record the complaints,track them including actions undertaken to resolve them c) Ensuring that appropriate actions are taken by the management 7.9.4 On receipt of the complaint, information is gathered and analysed to validate the complaint 7.9.5 The receipt of the complaint is acknowledged and progress report and outcomes are provided to the complainant. 7.9.6 The outcome to be communicated is prepared, reviewed and approved by the TM/QM who have not been involved in the specific testing activity. 7.9.7 The formal notice of the end of complaint is provided at the end of the complaint handling, to the complainant. 7.10
Nonconforming work
7.10.1It is the policy of the laboratory that no non-conforming work, however trivial, should be processed to the next stage. The procedure “Control of Nonconforming Work” PGI-ML-QP-08 is used to control any aspect of testing, or the results of this work, when they do not conform to the test methods or the agreed requirements of the customer. The procedure ensures that a) Responsibilities and authorities for the management of non-conforming work are designated and actions (including halting of work and withholding of test report as necessary) are defined and taken into consideration when non-conforming work is identified b) Actions including halting or repeating of work and withholding of results as necessary depending on the risk to the laboratory c) an evaluation of the significance of the non-conforming work is made and its impact on previous results d) remedial actions are taken immediately, together with any decision about the acceptability of the non-conforming work e) where necessary, the customer is notified and the work is recalled f) the responsibility for authorizing the resumption of work is defined 7.10.2 PGI-ML retains records of the nonconforming work along with any actions taken as specified above in 7.10.1 7.10.3 Where evaluation indicates that non-conforming work could recur or that there is doubt about the compliance of the laboratory’s operations with its own policies and procedures, thecorrective action is implemented.
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As Per ISO/IEC 17025 : 2017 7.11
PGI-ML-QM
Control of data and information management
7.11.1 All laboratory personnel have access to all data and information as needed to perform laboratory activities. 7.11.2 The laboratory information management used for the collection, processing, recording , reporting, storage or retrieval of data is validated for functionality , including the functioning of interfaces within.Whenever there are changes,including software configuration or modifications to commercial off the shelf software are authorized, documented and validated before implementation. 7.11.3 The Laboratory information management system is a) protected from unauthorized use b) safeguarded against tampering and loss by limited access c) is operated in a suitable environment complying with the specification of the vendor,. Storage of hard copies in a secure almirah in a room protected from loss. d) Integrity of the data is protected by ensuring that access to use of external devices is denied e) any system failures are recorded and immediate corrective actions are taken. 7.11.4 The Laboratory information management system is managed internally and personnel involved in this work abide by the confidentiality requirements of the “Code of ethics for Personnel” F-4.1-04. 7.11.5 The laboratory ensures that instructions, manuals and reference data relevant to the laboratory information management system are made available to all personnel. 7.11.6 Calculations and data transfer checks are done in a systematic manner and the person performing this task is identified in the report. 8.0
Management system requirements
8.1
Options
8.1.1 The laboratory has established, documented, implemented and maintains a system which supports the consistent achievement of the requirements of ISO 17025. The laboratory has established and implemented a system in accordance with Option A . 8.1.2 The requirements are addressed in 8.2 to 8.9 8.1.3 Option B : This is not applicable as Option A is chosen. 8.2
Measurement system documentation
8.2.1PGI-ML has established its policy and objectives and is documented at the general introduction section of this manual. This Quality policy is signed by the laboratory managementDirector Mr.Sunil Jindaland is implemented at all levels. Copies of the policy are pasted in strategic locations in the laboratory. 8.2.2 The policy addresses the impartiality, competence and consistent operation of the laboratory 8.2.3 The laboratory management is committed to development and maintenance of the system and ensures timely review and action when called for. 8.2.4 All documentation, processes, systems and records related to the fulfillment of ISO 17025:2017 are either included or referred in the manual or the next level procedures. The System developed is in four tiers consisting of the manual, Procedures, Work Isntructions and formats. 8.2.5 All personnel of the laboratory have access to the relevant parts of the documents. 8.3
Control of management system documents
8.3.1 The Procedure “Control of Documents and Records”PGI-ML-QP-01 is used to control all Management System documents (internally generated and from external sources). These include documents of external origin, such as regulations, standards, other normative documents, test and/or calibration methods, as well as drawings, specifications, instructions, and manuals. Document means any information or instructions including policy statements, procedures, specifications, calibration tables, charts, textbooks,
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posters, notices, memoranda, software, drawings, and plans. These may be in various media, whether hard copy or electronic and they may be digital, analog, photographic or written. The documents to be controlled include: Quality Manual Standard Operating Procedures / Work instructions Formats of records Standards Drawings Charts 8.3.2 The Laboratory ensures through the procedure a) All documents issued to personnel in the laboratory as part of the Management System are reviewed and approved for use by authorized personnel prior to issue (i.e., reviewed by personnel knowledgeable in the documented activity and then approved by management). b) Documents are periodically reviewed and updated as necessary c) The changes and current revision status of documents are identified as described in the procedure. d) The document distribution is controlled and relevant versions are available at points of use through the master list, which also identifies the copy holders e) All documents are uniquely identified f) Obsolete documents are removed from point of use and if retained for either legal or knowledge preservation purposes are suitably marked (i.e., stamped "OBSOLETE" ) 8.4
Control of records
8.4.1 The laboratory has established and retains legible records to demonstrate fulfillment of the requirements of ISO 17025:2017. 8.4.2 The procedure“Control of Documents and Records” PGI-ML-QP-01is used to identify, collect, index, access, file, store, maintain, protect, backup, and dispose quality and technical records. All records are safely stored and held secure in locked areas, or in computers having authorized pass word protected access and in confidence to the customer. Records are maintained in the designated archival area for years or months as per decided retention time for each. The master list of records is organized with the following information: Format No. Record Name Filing Method (loose/filed/electronic/others) Retention period for records is maintained as Annexure 4 “Retention Period of records” to procedure “Control of Documents and Records” PGI-ML-QP-01 8.5
Actions to address risks & responsibilities
8.5.1 The laboratory has considered the risks and opportunities associated with the laboratory activities in order to a) give assurance that the system achieves its intended results b) Enhance opportunities to achieve the purpose and objectives of the laboratory c) Prevent or reduce undesirable impacts and potential failures in laboratory activities d) Achieve improvement 8.5.2 The risk analysis is done by the laboratory and has plans in place to a) take actions to address those risks b) Integrate and implement these actions into the management system and evaluate effectiveness of these actions. 8.5.3 Actions taken to address risk and opportunities are proportional to the potential impact on the validity of results. “Risk Analysis –Actions taken” F-8.5-29 is maintained by the Technical Manager. This is reviewed annually during MRM.
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Improvement
8.6.1 PGI-ML identifies and selects opportunities for improvement through its policies and objectives, analysis of customer feedback, trends in quality control results etc. 8.6.2PGI-ML Obtains feedback positive or negative from the customer on a yearly basis through a form “Customer feedback” F-8.630 This feedback is analyzed and used to improve the Management System, testing activities, and customer service by PGI-ML. Analysis and improvement records maintained in MRM records. 8.7
Corrective action
8.7.1 When a nonconformity occurs the laboratory a) reacts to the non conformity and takes action to control and correct it and also address the consequences b) Procedure “Control Of Noncomforming Work” PGI-ML-QP-08 is utilized to evaluate the need for action to eliminate the cuases of the nonconformity , in order that it does not recur or occur elsewhere by - reviewing and analyzing the nonconformity -Determining the causes of the nonconformity -Determining if similar nonconformities exist or could occur c) procedure addresses the implementation of any action needed d) Implemented actions are verified for effectiveness e) the risk register is updated based on the above f) make changes to the management system , if necessary. 8.7.2 Corrective actions determined are appropriate to the effects of the non-conformities identified. 8.7.3 The laboratory retains records of the following a) Nature of the nonconformity, causes and any subsequent action taken. b) The results of the corrective actions for the same . 8.8
Internal audit
8.8.1PGI-ML conducts internal audits annually to ensure that the management system a) Conforms to the laboratory’s own requirements for its management system and laboratory activities as well as the requirements of ISO 17025 b) Is effectively implemented 8.8.2 The Laboratory has developed a procedure “Internal Audit”PGI-ML-QP-10 which includes the following a) The quality Manager prepares an annual internal audit plan covering all laboratory activities and support services, identifying the responsibility for audit and reporting. The frequency of such audits is Increased based on importance of the activity, previous audit results and changes affecting the laboratory activities. Person performing internal audits are so chosen that they are independent of the activity audited and are qualified and trained to conduct audit. b) The audit criteria and scope is defined for each audit c) The audit report and the findings are submitted to the management of PGI-ML d) The corrective actions are identified and quality manager ensures that these are implemented without delay e) Records are retained of the audit programme, audit report, the findings and corrective actions taken. 8.9
Management review
8.9.1 Management of the laboratory schedules and conducts a review of the laboratory’s Management System and testing activities to ensure their continuing suitability, adequacy and effectiveness, including the stated policies and objectives and to introduce any necessary changes or improvements.. This review is conducted atleast once a year , chaired by the Director and Quality Manager. The input to the management is includes the following a) Changes in internal and external issues relevant to the laboratory b) Fulfillment of objectives
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As Per ISO/IEC 17025 : 2017 c) Suitability of policies and procedures d) Status of actions from previous review e) Outcome of recent internal audits f)Corrective actions g) Assessment by external bodies such as NABL h) Changes in the volume and type of work i) Customer & personnel feedback j) Complaints k) Effectiveness of any implemented improvement action l) Adequacy of resources m) Results of risk identification n) Outcomes of the assurance of validity of results like PT/Internal QC o) Other factors such as monitoring activities and training needs 8.9.3 The output from the review is recorded as minutes identifying decisions and actions relating to a) effectiveness of the management system and all its processes b) improvement of the laboratory activities relating to the fulfillment of the requirements of ISO 17025 c) Provision of required resources d) any need for change Records of Management review meetings as maintained “Management Review” F-8.9-35.
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Punjab General Industries Director
Accounts and HR
PGI- Metallurgical Laboratory
Steel Melting Shop
Accountant
Director
Manager
Organization Chart –PGI-ML-FC-01 (As per Cl 5.5a)-Relatioship between PGI and PGI-ML
Director PGI-Metallurgical Laboratory
Quality Manager PGI-Metallurgical Laboratory
Technical Manager PGI-Metallurgical Laboratory
Metallography Test (Engineer)
Chemical Testing (Chemist)
Mechanical Testing (Engineer)
Customer Cell (Executive)
Organization Chart –PGI-ML-FC-02 (As per Cl 5.5a)- PGI-Metallurgical Laboratory
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