Accreditation of Laboratories A General Approach By N

Accreditation of Laboratories A General Approach By N V SARMA Retired Chief Chemist, CAL Nagpur 1

What is Accreditation? What is its Necessity? What are its Advantages? 2

1. (What is it? ) Laboratory Accreditation : Formal • • Recognition of Technical Competence – by an Authoritative body (NABL) for specific Tests / measurements based on third party assessment and following International Standard facilitating mutual acceptance of test results and measured data obtained by a transparent system of control over the accredited laboratories assurance given by the accreditation body that the accredited laboratory fulfils the accreditation criteria at all times. 3

2. (Why is it necessary? ) Current Global Scenario: Globalistion of Indian economy The liberalisation policies initiated by the Govt in reducing trade barriers makes it imperative that the accredited Laboratories be at International level of competence Essential pre-requisite of Trade: Any product or service accepted formally in one country must also be free to circulate to other economies without having to undergo extensive retesting. 4

• • 3. (Advantages of Accreditation) Benchmark for performance: Increased confidence in Testing / Calibration data and personnel performing work International Recognition of the Labs & Recognition of testing competence Marketing advantage: Potential increase in business due to enhanced customer confidence and satisfaction. Greater access for their products, in both domestic and international markets, when tested by accredited laboratories 5

• Savings in terms of time and money due to reduction or elimination of the need for retesting of products. • Better control of laboratory operations due to sound Quality Assurance System and technical competence. • Customers can search and identify the laboratories accredited by NABL for their specific requirements from the Directory of Accredited Laboratories or NABL website. Accreditation thus benefits Business, Govt & society at large 6

Accreditation bodies & Standard Organisations The International Organisation for Standardisation – ISO • European Union –EU • International Electrotechnical Commission - IEC • International Accreditation Forum – IAF • Pacific Accreditation Cooperation – PAC • Southern African Regional Accreditation Cooperation - SARAC 7

• International Laboratory Accreditation co-operation – ILAC The Regional bodies ( all working within the ILAC umbrella) include • European Accreditation co-operation-EAC • Asia Pacific Laboratory Accreditation co-operation – APLAC • Inter American Accreditation co-operation- IAAC Over 40 Lab accreditation bodies have signed a multi-lateral recognition agreement 8

Which are the other organizations in India providing accreditation services. . . ? • NABL is the sole accreditation body in India that provides third party assessment and has been authorized by Government of India. 9

. What types of laboratories can seek accreditation. . . ? Ø Labs that are legally identifiable & appropriately registered. ØLabs that are a part of a big organization or an independent entity. ØLabs undertaking testing or calibration in specified fields. ØPrivate or government labs. ØSmall operations to large multi-field labs. ØSite facilities, temporary field operations and mobile labs.

Basis Of Giving Accreditation ØCapability to perform test(s) / calibration(s) ØProvide accurate and reliable results. ØAs little as one to as many tests / calibrations ØTests performed in accordance with NABL criteria. 11

National Accreditation Board for Testing & Calibration Laboratories-NABL • An autonomous body - Department of Science & Technology (DST), Ministry of Science and Technology, Government of India • Registered under the Societies Registration Act 1860. • Authorised by the Government of India as the sole accreditation body for Testing and Calibration laboratories for Govt & Industries in general. NABL maintains linkages with the International bodies & is full member of both ILAC & APLAC http : //www. ilac. org/arrangement. htm http: //www. aplac. org/members/signatoriesmra. htm 12

How the objectives are achieved? • NABL provides laboratory accreditation services in a non-discriminatory manner to laboratories in accordance with NABL criteria, • based on internationally accepted Standards and Guidelines in India and other countries that do not have accreditation bodies Laboratories assessed-General Requirements for the competence of Testing and Calibration laboratories - ISO/IEC 17025: 2005 - predecessor being European Standard-EN 45001 (originally known as ISO/IEC Guide 25 issued by ISO in 1999) 13

ISO/IEC 17025: 2005 : The std was published in 2001 and the allignment work completed on 12 May 2005. The most significant changes introduced – Emphasis on the responsibilities of senior management with continual improvement to produce valid results • Communication with the customer • Customer satisfaction • No essential changes in the Technical Requirements Necessary to conform with ISO 9001 -2000 QUALITY MANAGEMENT STSTEM 14

ISO 9000 Vs NABL 17025 • • • Quality System Management only Compliance to international management system standards Involves auditing of organization’s quality management system Gives confidence of the laboratory’s quality system Tells nothing about technical competence or ability to provide reliable and accurate test data • • • Provides formal recognition of technical competence besides QSM of the labs Ready means for customers to find reliable testing and calibration services + Quality system Higher level activity than ISO 9000 Technical evaluation by technical experts to assess the lab as per internationally accepted criteria in a document called ISO/IEC 17025. Also covers the quality management elements of ISO 9000 More appropriate than quality ISO 9000 certification.

Accreditation - given on the basis of its capability to perform test(s) / calibration(s) and provide accurate and reliable results Scope of Accreditation • From as little as one to as many tests / calibrations provided it is performing these in accordance with NABL criteria Laboratory also has an option to widen the scope of accreditation in terms of specific tests and calibrations 16

Testing Laboratories Calibration Laboratories Medical Laboratories Biological Chemical Electronics Fluid-Flow Mechanical Non-Destructive Photometry Radiological Thermal Forensic Electrotechnical Mechanical Fluid Flow Thermal & Optical Radiological Clinical Biochemistry Clinical Pathology Haematology and Immunohaematology Microbiology and Serology Histopathology Cytopathology Genetics Nuclear Medicine (in-vitro tests only) 17

• • • The contents of ISO /IEC 17025 -comprises of 5 elements: Scope Normative References Terms and Definitions Management Requirements Technical Requirements A laboratory wishing to be accredited by NABL must have a Quality Manual ( Policies, Procedures, Records) on its Quality System satisfying the requirements as described in various clauses of ISO/IEC 17025 18

QUALITY POLICY AND QUALITY OBJECTIVES Central Agmark Laboratory, Nagpur strives for excellence in testing of agricultural commodities by providing reliable and timely analytical services. • Continuously striving for achieving accuracy for testing of the commodities for various Quality Parameters as notified under Agricultural Produce (Grading & Marking) Act, 1937 as amended from time to time. 19

• Adopting Good Laboratory Practices (GLPs) and following National/ International test methods/ validated methods to meet customer requirements. • Enhancing knowledge and skill of the laboratory personnel through training programmes. • Ensuring achievement of accurate and timely issue of reports. 20

Documentation system as required by NABL Typical structure of management system document hierarchy Q-Policy statement Q-manual (Level A) Procedure (SOPS) (Level B) Work Instructions, Forms and Formats and Records(Level C) 21

Document, Document. ISO/IEC Guide 25, Section 5. 2 requires that a laboratory have a quality manual, and that it "shall state the laboratory’s policies and operational procedures established in order to meet the requirements. " The manual and other quality-related documentation must include: A quality policy statement The laboratory’s organizational structure Procedures for document control Job description of key staff Procedures that document how the lab achieves traceability

Document, Document. (Contd. ) ØDescriptions of the types of tests a laboratory can perform, references to the test procedures, and procedures for handling ØA procedure to ensure that it can properly perform new tests ØProcedures to ensure calibration of test equipment and verification of standards

Document, Document. (Contd. ) ØProcedures for dealing with complaints and protecting customer confidentiality ØProcedures for audit and review. Ø. Impart training on the key elements of documentation, such as document format, authorization of document, issue and withdrawal procedures, document review and change, etc. ØEach document should have ID No. , name of controlling authority, period of retention, etc. 24

Management Requirements: (Clause 4. 1 - 4. 15. 2) • 4. 1 Organisation & Organization Structure • Main activities of the Laboratory • Responsibilities and Activities of key PersonnelØ Laboratory I/C , Ø Quality Manager (QM), Ø Technical Manager (TM), Ø Chemists Ø Administration assistant • 4. 2 Management System (Policies, Systems, Q Manual, QSP, Instructions, Etc. ) 25

• 4. 3 Document Control (Document Approval, Issue, Changes) • 4. 4 Review of requests , Tenders & contracts • 4. 5 Subcontracting of tests • 4. 6 Purchasing services and supplies • 4. 7 Service to the customer • 4. 8 Complaints • 4. 9 Control of non-conforming testing • 4. 10 Improvement • 4. 11 Corrective action • 4. 12 Preventive action • 4. 13 Control of Records 26

• 4. 14 Internal Audit • 4. 15 Management Review meeting- (Suitabiliy, Reports of Supervisor, Internal Audits, Corrective & Preventive Action, Assessment by External Bodies, results of ILC/PT, Changes in volume of work, Customer Feedback, Complaints, Recommendations for Improvement, QC, resources, Training etc. ) 27

Technical Requirements: (Clause 5. 1 - 5. 10. 9) 5. 1 General: • • Human factors and Handling of test items Accommodation and environment Selection of methods Test methods and method Validation Equipment calibration Measurement traceability Handling of test items 28

5. 2 Personnel Ø Number required for workload Ø Qualifications and experience Ø Responsibilities and authorities Ø Job descriptions Ø Performance criteria and performance appraisal Ø Training needs identification Ø Training records Ø Continuing education 29

5. 2 Personnel Ø Number required for workload Ø Qualifications and experience Ø Responsibilities and authorities Ø Job descriptions Ø Performance criteria and performance appraisal Ø Training needs identification Ø Training records Ø Continuing education 30

5. 3 Accommodation & Environmental Conditions (Facilities for testing, Whether environmental conditions affect results, monitoring of environmental factors, ie sterility of room, dust, electromagnetic disturbances, humidity, Temoerature, Sound levels etc), Separation between neighboring areas, avoidance of incompatible activities, cross contamination etc. ) 5. 4 Test & Calibration Methods & Method Validation Appropriate methods of Testing, handling, transport, Storage, Calibration, Insructions, Standards, Manuals, Reference Data, Should be readily available, Only documented deviation permissible, validated Methods, MU estimation, Data Control, 31

5. 5 Equipment 5. 6 Measurement Traceability • Calibration status • Testing • Reference Standards & Reference Materials • Intermediate Checks • Transport & Storage • Records of all equipments and software • Details of damage, repairs 32

5. 7 Sampling 5. 8 Handling of test items Assuring of quality of Test Results (Transportation, Receipt, handling, Protection, Stora ge, Retention, Disposal) 5. 9 Assuring Quality of Test /Calibration. Results (Use of CRMs, Participation in ILC/PT programmes, Replicate Tests, Retesting of calibration of retained items) 33

5. 10 Reporting the Results (Report Accuratey, Clearly, Objectively, in accordance to the Scope. Use standard format, Incorporate all the Customer’s needs Standard Format includes. Title Name & address of Customer Lab. Name & Address of Customer Unique Identificaion Number Condition of the tested item Date of receipt Test Results with Unit of Measurement Name, Function, Signatureof authorized Person Statement that the result pertains to the tested sample only. Deviations if any , Calibration Certificates if demanded 34 Opinions & Interpretations, Electronic transmission details. )

Preparations Required By A Laboratory Before Applying For Accreditation ØNominate a responsible person to coordinate all activities related to seeking accreditation. ØNominate a Quality Manager who is familiar with laboratory's existing Quality System. . ØNominate a Technical manager well conversant with the technical aspects of analysis ØProcure all relevant NABL documents from NABL Secretariat and get fully acquainted with each of these. (as given in the next slide. ) ØAscertain the status of existing Quality System and Technical Competence with regards to requirements for NABL Accreditation. ØCheck if the system is well documented and effective or does it need modification.

Pre-Requisites for Laboratories seeking NABL Accreditation Ø Laboratory shall be legally registered so that it can be held responsible for the testing and / or calibration activities it carries out. Ø Laboratory should have adequate facilities and technically competent qualified staff to carry out the testing and / or calibration for which it wishes to seek accreditation. Ø Laboratory must comply with all the requirements as laid down in the Standard ISO/IEC 17025, relevant Specific Criteria and other NABL documents. Ø Ensure that all test equipment in the laboratory are timely & properly calibrated only by NABL certified agencies and have traceability to National / International standards.

Pre-Requisites for Laboratories seeking NABL Accreditation (Contd. ) Ø Complete one Internal Audit covering all clauses of ISO/IEC 17025 Ø Conduct a Management Review Meeting as per ISO/IEC 17025: 2005. Ø Participate in at least one Proficiency Testing/ILC Programme conducted by NABL or other reputed national or international organizations in accordance with the international standard ISO/IEC. Guide 43. Ø Maintain records of a) Analysis b) Calibration (of Glassware, Equipment) c) AMC d) Environmental Factors e) Stock Solutions f) CRMs g) Chemicals, Apparatus, Instruments, Equipment, Breakage Registers etc. Ø Get calibration of instrument/equipment done only by NABL certified agencies only.

PRE-REQUISITES FOR LABORATORIES SEEKING NABL ACCREDITATION (Contd. ) ØPrepare Quality Manual and verify its contents, as per " Guide for Preparing Quality Manual" (NABL 160). Prepare Standard Operating Procedures for operation of Instruments, In-House Calibration, Maintenance of Records etc. ØRemember Quality Manual is a policy document, which has to be supplemented by a set of other documents like Procedural Manuals, Work Instructions etc. ØEnsure that procedures described in the Quality Manual and other documents are being implemented. ØTrain personnel in Laboratory Quality Management System, Internal Audit and MU conducted by NABL ØDiscuss relevant requirements for NABL accreditation amongst concerned staff of the laboratory. This will enable them to understand their weaknesses and strengths.

Stages of Accreditation • Filling of NABL Application Form • Pre-Assessment visit by NABL Authorities • Closure of Non-conformances • Final Assessment by NABL • Validity of Accreditation 39

Process of Accreditation Stage I ØFill up the application form for NABL accreditation, giving all desired information as per NABL 131/151 ØEnlist the test(s) along with range and measurement uncertainty as per scope. Ø Laboratory can apply either for all or part of its testing facilities. Ø Take special care in filling the scope of accreditation for which the laboratory wishes to apply. ØIn case, the laboratory finds any clause (in part or full) not applicable to the laboratory, it shall furnish the reasons. 40

Laboratories are required to submit • 3 sets of NABL 131/151 • duly filled in application forms for each field of testing / calibration • 2 sets of Quality Manual and • Internal Audit Report • Application Fees. Note- Special care is to be taken to fill the SCOPE of accreditation 41

After scrutiny of application by NABL– • A unique Customer Registration Number will be allocated to laboratory for further processing of application • Lead Assessor nominated for giving Adequacy Report on the Quality Manual / Application submitted • The laboratory shall submit Corrective Action Report. 42

Stage II Pre-Assessment audit by NABL –(after satisfactory Corrective action Report) • Carried out by Lead Assessor at the laboratory sites. • The pre-assessment helps the laboratory to be better prepared for the Final Assessment. • It also helps the Lead Assessor to assess the preparedness of the laboratory to undergo Final Assessment. Laboratory must carry Internal-Audit before Pre-assessment 43

• A copy of Pre-Assessment Report will be provided to Laboratory for taking necessary corrective action on the concerns raised during audit, if any. • The laboratory shall submit Corrective Action Report to NABL Secretariat. • After laboratory confirms the completion of corrective actions, Final Assessment of the laboratory shall be organised by NABL. 44

Stage III • NABL Secretariat organizes the Final Assessment at the laboratory site(s) for its compliance to NABL Criteria and for that purpose appoints an Assessment team. • The Assessment Team shall comprise of a Lead Assessor and a Technical Assessor(s) in the relevant fields depending upon the scope to be assessed. 45

• Assessors shall raise the Non. Conformance(s), if any, and provide it to the laboratory in prescribed format so that it gets the opportunity to close as many Non-Conformance(s) as they can before closing meeting of the Assessment. • The Lead Assessor will provide a copy of consolidated report of the assessment to the laboratory and send the original copy to NABL Secretariat. 46

• Laboratory shall take necessary corrective action on the remaining Non. Conformance(s) / other concerns and shall submit a report to NABL within a maximum period of 2 months. Laboratory shall have to take corrective action on any concerns raised by the Accreditation Committee. 47

Stage IV • After satisfactory corrective action by the laboratory, the Accreditation Committee examines the findings of the Assessment Team and recommends additional corrective action, if any, by the laboratory. • Accreditation Committee determines whether the recommendations in the assessment report is consistent with NABL requirements as well as commensurate with the claims made by the laboratory in its application. 48

Laboratory shall take corrective action on any concerns raised by the Accreditation Committee Laboratories are free to appeal against the findings of assessment or decision on accreditation by writing to the Director, NABL. Whenever possible NABL will depute its own technical personnel to be present at the time of assessment as Coordinator and NABL Observer. Sometimes, NABL may at its own cost depute a newly trained Technical Assessor as "Observer" subject to convenience of the laboratory to be assessed. 49

Stage V • Accreditation Committee shall make the appropriate recommendations regarding accreditation of a laboratory to NABL Secretariat. • Accreditation to a laboratory shall be valid for a period of 2 years and NABL shall conduct periodical Surveillance of the laboratory at intervals of one year. • Laboratory shall apply for Renewal of accreditation to it at least 6 months before the expiry of the validity of accreditation. 50

• • • Summary Documentation - Mainly Quality Manual and procedural Manuals (SOPs) Procurement of Reference standards and materials Calibration of Equipment & Glassware Inter-laboratory comparison/ Proficiency testing Measurement uncertainty/ Z score Submission of application to NABL 51

A unique Customer Registration Number Lead Assessor nominated for giving Adequacy Report on Quality manual &application Corrective Action Report by Lab Pre-Assessment audit by NABL Corrective Action Report submitted to NABL Secretariat. 52

Final Assessment - by an Assessment team(Lead assessor & Technical Team) Non-Conformance(s) (Raised and closed) correction by Laboratory within 2 months Accreditation Committee examines the findings of the Assessment Accreditation Committee determines whether the recommendations in the assessment report is consistent with NABL 53

Accreditation Committee recommendations regarding accreditation of a laboratory to NABL Accreditation to a laboratory shall be valid for a period of 2 years and NABL Periodical Surveillance after one year Renewal after 6 months 54

• Directory of NABL Accredited Laboratories - published at regular intervals , which contains laboratories' contact details and information on their Scope of Accreditation • Documents necessary for Accreditation (free/ paid) www. nabl-india. org 55

Is Accreditation A One-time Phenomenon. . . ? ØNABL accreditation is not a one-time phenomenon. ØValid only for a period of 2 years Ø NABL conducts periodical surveillance of the laboratory on annual basis. Ø Laboratory has to apply for renewal of accreditation to NABL at least 6 months before the expiry of the validity of accreditation.

What is Mutual Recognition Arrangement (MRA) with international bodies and what are the benefits of such arrangements for the laboratories accredited by NABL. . . ? Many countries around the world have a formally recognized organization responsible for the accreditation of their laboratories. (In India it is NABL. ) Most of these accreditation bodies are presently following ISO/IEC 17025 as the basis for accrediting their country's testing and calibration laboratories. Adoption of international standards has helped countries employ a uniform approach to determine laboratory competence. It has also encouraged laboratories to adopt internationally accepted testing and measurement practices where possible.

Uniform approach allows accreditation bodies to establish arrangements between themselves through APLAC and EA peer evaluation by an expert team appointed by APLAC / EA MRA/MLA councils based on mutual evaluation and acceptance of each other's laboratory accreditation systems. Such international arrangements, called Mutual Recognition Arrangement, are crucial in enabling test data to be accepted between countries. In effect, each partner in such an agreement recognizes the other partner's accredited laboratories as if they themselves had undertaken the accreditation of the other partner's laboratories. The international mutual recognition arrangements between accreditation bodies arrived on the basis of peer-evaluation have enabled accredited laboratories to achieve international recognition, and allowed test data accompanying exported goods to be readily accepted in overseas markets. This effectively reduces costs for both the exporters and the importers, as it reduces or eliminates the need for products to be re-tested in another country. ILAC MRA is effective from 31. 01

Countries without viable accreditation systems can seek to have their laboratories accredited by established accreditation systems, so that their test data and associated goods can be accepted in foreign markets. These countries can also endeavour to develop their own accreditation system based on the structure and experience of established systems in other countries. NABL is a signatory to ILAC as well as APLAC Mutual Recognition Arrangements (MRA), which is based on mutual evaluation and acceptance of other MRA Partner laboratory accreditation systems. Such international arrangements facilitate acceptance of test / calibration results between countries to which MRA partners represent.

No Name of Document Number Price Rs. 1 General information brochure NABL - 100 Free 2 Terms and conditions for Maintaining Accreditation NABL - 131 Free 3 NABL Guidelines to Accredited Laboratories for use of NABL Logo NABL - 133 Free 4 Guidelines for Estimation and Expression of Uncertainty of Measurement NABL - 141 250/- 5 Policy on Calibration and Traceability of Measurements NABL - 142 Free 6 Application Form for Testing Laboratories NABL - 151 Free 7 Guide for Preparing a Quality Manual NABL - 160 250/-

8 Guide for Internal Audit and Management Review NABL - 161 for laboratories Policies and Procedures for inter-laboratory NABL - 163 comparisons and / or Proficiency Testing 200/- 10 Master list of NABL documents NABL - 200 Free 11 Pre-assessment Guidelines and Forms NABL - 209 Free 12 Interpretation of the Accreditation Criteria and Guidelines for Assessment NABL – 211 100/- 13 Guideline document on Validation of Test Methods NABL – 212 100/- 14 Policy and Procedures for assessment, Surveillance & Re-assessment of laboratories NABL – 214 Free 15 Policies & Procedures for dealing with Adverse Decisions NABL - 216 Free 9 Free

NABL Newsletters NABL publishes Newsletter on quarterly basis. NABL regularly sends the newsletter to all the empanelled assessors and accredited as well as the applicant laboratories. Proficiency Testing programmes organized by NABL or APLAC All NABL accredited testing and calibration laboratories are required to participate in Proficiency Testing Programmes conducted by NABL or the nodal organizations appointed by NABL. Accredited and applicant laboratories are required to approach NABL Co-ordinator for Proficiency Testing programs or the nodal laboratories appointed by NABL whenever a PT programme for a specific testing / calibration is organized by NABL. For calibration laboratories, NPL, Delhi is the main nodal laboratory. Laboratories are also expected to participate (as far as available and practicable) in international Inter- Laboratory Comparison / Proficiency Programmes conducted by APLAC, EA or equivalent organizations. NABL keeps the accredited laboratories informed about all such international programmes through NABL newsletter / APLAC newsletter (www. aplac. org)

Training courses offered by NABL conducts following training courses regularly: NABL Assessor Training 5 -day residential course designed for experts with technical knowledge and current experience of working in a laboratory to train them as NABL Technical Assessors for conducting on site assessment of laboratories that perform testing and calibration. Laboratory Quality System, Management & Internal Audit Training 4 -day course is designed for senior laboratory personnel involved in the management and establishment of laboratory ‘s Quality System, and establish / manage an Internal Audit programme for their laboratories as required by NABL Criteria & International Standard ISO/IEC 17025.

Use Of NABL Symbol ØUse NABL symbol on letterhead, test / calibration reports and any other relevant documents. ØUse for identifying correctly and unambiguously the test / calibration services accredited by NABL. ØEnsure that design and its manifestations are not distorted, ØCan be reproduced in any single color (preferably black) and any size. Øuse of symbol should not misrepresent the scope of accredited testing / calibration services. Ø When accreditation sought and granted does not cover all the activities of the laboratory's services care should be exercised to use of symbol only to those accredited activities. ØThe letterheads and publicity materials, brochures, test / calibration reports of the accredited laboratory bearing the NABL symbol shall cover only the test results under accredited category. ØFor non-accredited category use a letterhead without NABL symbol or specially identify those tests/ measurements which are not covered by accreditation. .

THANX FOR LISTENING