Nabl guidlines part 1
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This document provides an overview of ISO/IEC 17025:2005, which establishes the general requirements for the competence of testing and calibration laboratories. It discusses the key elements of the standard, including management requirements like organization, document control, customer complaints, and corrective/preventive actions. It also covers technical requirements regarding personnel, equipment, sampling methods, measurement traceability, and reporting of results. The benefits of ISO 17025 accreditation are highlighted such as improved quality, customer confidence, marketing advantages, and greater recognition of technical competence.
Nabl guidlines part 1
- 1. Training on ISO/IEC 17025:2005 In Calibration and Testing Laboratories Team HimalayaTeam Himalaya Sukanya. P
- 2. Team HimalayaTeam Himalaya 2 What’s quality?
- 3. Team HimalayaTeam Himalaya 3 Overview; ISO/IEC 17025 – 2005 What is Quality? • Degree to which a set of inherent characteristics fulfils requirements “Quality is "fitness for purpose".
- 4. Team HimalayaTeam Himalaya 4 How quality can be assured?
- 5. Team HimalayaTeam Himalaya 5 Key Focus of Regulators
- 6. Team HimalayaTeam Himalaya 6 Overview; ISO/IEC 17025 – 2005 WHAT IS ISO ? • ISO -Greek word “isos” means “equal”, pronunciation “eye- soh” • ISO is a worldwide federation of national standards from more than 140 countries, called “International Organization for Standardization”. • ISO is a non-governmental organization established in1947 with head quarters in Geneva, Switzerland. • IEC-International Electro technical Committee 17025-is the number
- 8. Team HimalayaTeam Himalaya 8 THE INTERNATIONAL PICTURE NABL ,as an accreditation body, operates its own system as per ISO/IEC 17011 . NABL is signatory to APLAC / ILAC Mutual Recognition Arrangements (MRA) since 2000 after its first evaluation by APLAC . Second & Third evaluation by APLAC in 2004 & 2008 respectively. Fourth evaluation Completed in Sep. 2012,next is due in 2016.
- 9. Team HimalayaTeam Himalaya 9 Overview; ISO/IEC 17025 – 2005. Benefits of ISO 17025 Accreditation • A systematic approach to control all its processes and well defined procedures and supporting documentation. • Laboratories implementing Management System as per ISO/IEG 17025 standard helps them in improving their ability to consistently produce valid results. • Achieve international recognition of its technical competence gain the confidence of customers and interested parties, as well as open doors to new market both locally and international. • Greater quality awareness amongst employees and reduced defects, scraps, rework failures and service. • Have a better corporate image in the eyes of regulators, customers, employees as well as the society at large. • Savings in terms of time and money due to reduction or elimination of the need for re-testing of products
- 10. Team HimalayaTeam Himalaya 10 Overview; ISO/IEC 17025 – 2005. Benefits of ISO 17025 Accreditation •Better control of laboratory operations and feedback to laboratories as to whether they have sound Quality Assurance System and are technically competent. •Control laboratory methods variation. •Increase of confidence in Testing / Calibration data and personnel performing work. •Validity and appropriateness of test methods. •Traceability of measurements and calibrations to national standards. •Suitability, calibration and maintenance of test equipment & Testing environment. •Sampling, handling and transportation of test items Quality assurance of test and calibration data. Potential increase in business due to enhanced customer confidence and satisfaction.
- 11. Team HimalayaTeam Himalaya 11 Overview; ISO/IEC 17025 – 2005 Application of ISO 17025:2005 A Bench Mark for Performance • Benchmark for maintaining the competence • Areas for improvement Marketing advantage • Accreditation is an effective marketing tool for testing, calibration and measurement laboratories. • Laboratory accreditation is highly regarded both nationally and internationally as a reliable indicator of technical competence. • Many accreditation bodies also publish a directory of their accredited laboratories, which includes the laboratories' contact details plus information on their testing capabilities. This is another means of promoting a laboratory's accredited services to potential customers.
- 12. Team HimalayaTeam Himalaya 12 Overview; ISO/IEC 17025 – 2005. Application of ISO 17025:2005
- 13. Team HimalayaTeam Himalaya 13 Who should go for 17025 Accreditation? ISO/IEC17025:2005 is applicable to all laboratories regardless of the number of personnel or the extent of the scope o testing and/or calibration activities. When a laboratory does not undertake one or more of the activities covered by ISO/IEC17025:2005 ,such as sampling and the design/development of new methods , the requirements of those clauses do not apply. In com plete need to include som e points
- 14. Team HimalayaTeam Himalaya 14 NATIONAL ACCREDITATION BOARD FOR TESTING AND CALIBRATION LABORATORIES (NABL) IN INDIA • It is an autonomous body • Registered under Societies Act in1992 • Under the aegis of Department of Science & Technology, Government of India. www.nabl-india.org NABL –FUNCTIONING ROLE IN INDIA • Grants accreditation in almost all areas of science, engineering and medical testing. • The international standards followed are : ISO 15189:2007 (for Medical Testing) , ISO/IEC 17025:2005 (for Testing, calibration) & ISO 17043:2010 (for PT providers)
- 15. Team HimalayaTeam Himalaya 15 Structure of ISO/IEC 17025 1 Scope 2 Normative references 3 Terms and definitions 4 Management requirements 5 Technical requirements
- 16. Team HimalayaTeam Himalaya 16 Scope of ISO/IEC 17025 Covers General Requirements of Laboratory performing Testing and calibrations using - • Standard methods, • Non standard methods • Laboratory-developed methods Applicable to all organizations performing tests and/or calibrations, These include, for example, First-party, second party and third-party, and where testing and/or calibrations forms part of inspections and product verifications. This Standard is for use by labs in developing their management system for Quality, administrative and technical operations. Lab customers, regulatory authorities and accreditation bodies may also use it in confirming or recognizing the competence of laboratories. This Standard is not intended to be used as the basis for certification of laboratories.
- 17. Team HimalayaTeam Himalaya 17 Requirements of ISO/IEC 17025 : 2005 4. MANAGEMENT REQUIREMENTS 4.1 Organization 4.2 Management system 4.3 Document control 4.4 Request, tender and contract review 4.5 Sub-contracting of tests and calibrations 4.6 Purchasing services and supplies 4.7 Service to the customer 4.8 Complaints 4.9 Control of nonconforming testing and/or calibration work 4.10 Improvement 4.11 Corrective action 4.12 Preventive action 4.13 Records 4.14 Internal audits 4.15 Management reviews
- 18. Team HimalayaTeam Himalaya 18 Requirements of ISO/IEC 17025 : 2005 Contd.., 5. TECHNICAL REQUIREMENTS 5.1 General 5.2 Personnel 5.3 Accommodation and environmental conditions 5.4 Test and calibration methods and method validation 5.5 Equipment 5.6 Measurement traceability 5.7 Sampling 5.8 Handling and transportation of test and calibration items 5.9 Assuring the quality of test and calibration results 5.10 Reporting the results.
- 19. Team HimalayaTeam Himalaya 19 4. MANAGEMENT REQUIREMENTS QUALITY MANAGEMENT PRINCIPLES ManagementPrinciples
- 20. Team HimalayaTeam Himalaya 20 4.1 ORGANIZATION 4. MANAGEMENT REQUIREMENTS
- 21. Team HimalayaTeam Himalaya 21 4.1 ORGANIZATION 4.1.5 The laboratory shall have
- 22. Team HimalayaTeam Himalaya 22 4.2.1 Establish, maintain and implement Quality System appropriate to the scope of activities 4.2.2 Management System Policies and Objectives shall be defined in Quality Manual. Quality Policy shall be issued under the authority of chief executive and shall Contain
- 23. Team HimalayaTeam Himalaya 23 4.3 DOCUMENT CONTROL
- 24. Team HimalayaTeam Himalaya 24 4.3.3 DOCUMENT CHANGES
- 25. Team HimalayaTeam Himalaya 25 4.4 REVIEW OF REQUESTS, TENDERS AND CONTRACTS 4.4.2 Maintenance of records of review 4.4.3 Review also to cover sub-contracted work 4.4.4 Customer to be informed any deviation 4.4.5 Amendments to a contract shall also to be reviewed and communicated
- 26. Team HimalayaTeam Himalaya 26 4.5 SUBCONTRACTING OF TESTS AND CALIBRATIONS 4.5.1 If laboratory sub-contracts the work, this shall be done on suitable subcontractors: satisfying the requirements of this standard 4.5.2 Information to Customer on such arrangement 4.5.3 Laboratory shall be responsible for subcontractor’s work 4.5.4 Maintenance of register of subcontractors ca 4.6 SUBCONTRACTING OF TESTS AND CALIBRATIONS 4.6.1 Procedure for selection and purchasing of services and supplies that affect quality of tests/ calibration 4.6.2 Use of purchased materials only after inspection / verification 4.6.3 Review and approval of purchase documents before release 4.6.4 Evaluation of suppliers and maintenance of records ( for critical materials)
- 27. Team HimalayaTeam Himalaya 27 4.7 SERVICE TO Customer Laboratory shall afford Customer cooperation to clarify Customer’s request and monitor performance of laboratory in relation to work performed and protect confidentiality of other Customers 4.8 COMPLAINTS Procedure for resolution of complaints from Customers and other parties Maintenance of Records of Complaints 4.9 CONTROL OF NONCONFORMING TESTING/ CALIBRATION 4.9.1 Procedure for dealing with nonconforming testing/ calibration. The procedure shall ensure a) Authority for management of nonconforming work to be defined b) Evaluation of nonconforming work c) Notification to Customer, if needed d) Defined responsibility for resumption of work 4.9.2 In case of possibility of recurrence , initiation of suitable corrective action
- 28. Team HimalayaTeam Himalaya 28 4.10 COMPLAINTS The laboratory shall continually improve the effectiveness of its management system through the use of the quality policy, quality objectives, audit results, analysis of data, corrective and preventive actions and management review. 4.11 CORRECTIVE ACTION
- 29. Team HimalayaTeam Himalaya 29 4.12 PREVENTIVE ACTION
- 30. Team HimalayaTeam Himalaya 30 4.13 CONTROL OF RECORDS 4.13.1 GENERAL 4.13.1.1 Procedure for Quality and Technical Records (identification, collection, indexing, access filing, storage, maintenance and disposal) 4.13.1.2 Records shall be legible 4.13.1.3 Security of records 4.13.1.4 Procedure for protection and back-up 4.13.2 TECHNICAL REPORTS 4.13.2.1 Records of original observations, derived data and personnel responsible for checking 4.13.2.2 Observations, data and conclusions shall be made when they are made 4.13.2.3 When mistakes occur the changes are entered after crossing the original observation; not by erasing
- 31. Team HimalayaTeam Himalaya 31 4.14 INTERNAL AUDITS
- 32. Team HimalayaTeam Himalaya 32 4.15 MANAGEMENT REVIEWS 4.15.1 Predetermined procedure and schedule for Management review. The review shall cover •Suitability of policies and procedures •Reports from Management and supervisors • Outcome of Internal Audits •Corrective and Preventive actions •Assessment by external agencies •Inter-laboratory comparisons/ proficiency testing •Changes in volume and type of work •Customer feedback / complaints 4.15.2 Records of Management Review and follow up for actions