Laboratory accrediation

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National accreditation Board for Testing and calibration laboratory (NABL) is involved

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1 LABORATORY ACCREDITATION SYSTEM IN INDIA Rajendra Dafal M. Pharm rdafal@gmail.com

Overview:

Overview Why Laboratory Accreditation ? Benefits of laboratory Accreditation Organization of NABL Promotion & Implementation of Accreditation system for laboratories Scope of Accreditation Co-operations with Related Bodies New Areas of Accreditation NABL customer profile Present status 2 Rajendra Dafal. Bombay College of Pharmacy, Kalina, Mumbai-98

Why Laboratory Accreditation ?:

Why Laboratory Accreditation ? The concept of Laboratory Accreditation was developed to provide a means for third-party certification of the competence of laboratories to perform specific type(s) of testing and calibration. Laboratory Accreditation provides formal recognition of competent laboratories, thus providing a ready means for customers to find reliable testing and calibration services in order to meet their demands. Laboratory Accreditation enhances customer confidence in accepting testing / calibration reports issued by accredited laboratories Reducing trade barriers and providing greater thrust to exports makes it imperative for Accredited Laboratories to be at international level of competence. 3 Rajendra Dafal. Bombay College of Pharmacy, Kalina, Mumbai-98

Benefits of Accreditation:

4 Benefits of Accreditation Better control of laboratory operations Improves staff confidence and enhances business Enhanced customer confidence and satisfaction Reliability of data for R&D Insurance companies can rely on test results Ensures better support in the event of legal cases Provides traceability in measurements to national standards Provides global equivalence Saving of time & money due to re-testing

About NABL:

About NABL National Accreditation Board for Testing & Calibration Laboratories ( NABL) is an autonomous body under the Department of Science & Technology, Government of India, and is registered under the Societies Act. NABL has been established with the objective to provide Government and Industry with a scheme for third-party assessment of testing, calibration and medical laboratories Program started in 1981 First Accreditation granted in 1992 Autonomous Body registered under societies Act in 1998 5 Rajendra Dafal. Bombay College of Pharmacy, Kalina, Mumbai-98

Implement Accreditation System for Laboratories :

Implement Accreditation System for Laboratories 6 NABL grants accreditation to testing & calibration laboratories as per ISO/IEC 17025 and medical laboratories as per ISO 15189. NABL operates its own system as per ISO/IEC 17011. Rajendra Dafal. Bombay College of Pharmacy, Kalina, Mumbai-98

Organization Structure of NABL:

Organization Structure of NABL 7

International Recognition of NABL:

International Recognition of NABL NABL is signatory to Asia Pacific Laboratory Accreditation Co-operation (APLAC) Mutual Recognition Arrangements (MRA) and International Laboratory Accreditation Co-operation (ILAC) MRA since 2000. 8 Rajendra Dafal. Bombay College of Pharmacy, Kalina, Mumbai-98

Promote Accreditation System for Laboratories :

Promote Accreditation System for Laboratories 9 NABL promotes accreditation to Government & Regulators Central Government Health Scheme, Bureau of Energy Efficiency, Food Safety and Standards Authority of India, State Electricity Boards, Agricultural and Processed Food Products Export Development Authority, Telecom Engineering Centre, Central Pollution Control Boards, Export Inspection Agency, Tea Board, Coffee Board, Spices Board. Rajendra Dafal. Bombay College of Pharmacy, Kalina, Mumbai-98

Promote Accreditation System for Laboratories :

Promote Accreditation System for Laboratories 10 NABL adopts the requirements of Government & Regulators in the Criteria documents to suit their requirements. NABL is responsive to the needs of the customers for initiating accreditation in new areas, e.g. GMO Testing, Mobile Phone Testing, Forensic Electronics, Crime Scene Investigations. Rajendra Dafal. Bombay College of Pharmacy, Kalina, Mumbai-98

Scope of NABL Accreditation :

Scope of NABL Accreditation Testing Laboratories Biological Chemical Electrical Electronics Fluid-Flow Mechanical Non-Destructive Testing Optical and Photometry Radiological Thermal Forensic 11 Rajendra Dafal. Bombay College of Pharmacy, Kalina, Mumbai-98

Scope of NABL Accreditation:

Scope of NABL Accreditation Calibration Laboratories Electro-Technical Mechanical Radiological Thermal & Optical Fluid-Flow 12 Rajendra Dafal. Bombay College of Pharmacy, Kalina, Mumbai-98

Scope of NABL Accreditation :

Scope of NABL Accreditation Medical Laboratories Clinical biochemistry Clinical Pathology Cytogenetics Cytopathology Haematology Histopathology Immunology Microbiological & Serology Nuclear Medicine 13 Rajendra Dafal. Bombay College of Pharmacy, Kalina, Mumbai-98

Evaluating the Competence:

Evaluating the Competence On site assessment of the laboratory by the experts for its technical competence and its adherence to management system practices By analyzing the test data of a particular test/measurement generated by the laboratory during participation in a proficiency testing program 14 Rajendra Dafal. Bombay College of Pharmacy, Kalina, Mumbai-98

Training Programs for Assessors and Laboratories:

Training Programs for Assessors and Laboratories NABL organizes Assessors’ training courses as per ISO/IEC 17025 and ISO 15189. NABL also organizes technical training & quality system courses for laboratories. NABL imparts in-house training as per ISO/IEC 17011. NABL has organized Assessors’ training courses for Sri Lanka, Nepal, Bangladesh, Mauritius & Mongolia. 15 Rajendra Dafal. Bombay College of Pharmacy, Kalina, Mumbai-98

Standards and Conformance Infrastructure:

Standards and Conformance Infrastructure 16 Rajendra Dafal. Bombay College of Pharmacy, Kalina, Mumbai-98

Co-operation with Related Bodies:

17 Co-operation with Related Bodies Documentary Standards Body (Bureau of Indian Standards) Accreditation (NABL) Government and Regulatory Bodies Quality Council of India National Scientific Organisations (IIP, CBRI, IICT, CFTRI, CECRI, IHBT) NMI (National Physical Laboratory) Rajendra Dafal. Bombay College of Pharmacy, Kalina, Mumbai-98

Support from National Physical Laboratory:

Support from National Physical Laboratory International National Traceability to Accredited Laboratories. Proficiency Testing Inter-Laboratory Camparison Programs Technical Assessors for NABL Assessments Experts for decision making in Accreditation Committee Training to Assessors, Laboratories and NABL Staff in Calibration Programs Provides expertise for preparation of specific criteria and technical documents 18 Rajendra Dafal. Bombay College of Pharmacy, Kalina, Mumbai-98

PowerPoint Presentation:

Co-operation from National Scientific Laboratories Development of Certified Reference Materials ( CRMs ) on the basis of market demand as proposed by NABL Traceability for Chemical Reference Material (as NMI) in collaborative arrangement with NPL.

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Arrangement with Bureau of Indian Standards (BIS) Develop standards for products and tests Propagates accreditation through Laboratory Recognition Scheme Training of Assessors, Laboratories and NABL Staff Provides Technical Assessors for assessment of NABL laboratories Representatives from BIS are members in various decision making and Technical Committees

PowerPoint Presentation:

Arrangement with Bureau of Indian Standards (BIS) NABL represents BIS in ISO CASCO (WG 28) for revision of ISO Guide 43 NABL represents in various BIS committees Laboratories of BIS have been accredited by NABL as per ISO/IEC 17025. Assists BIS in creating awareness regarding Quality

PowerPoint Presentation:

Arrangement with Quality Council of India (QCI) Promotes Laboratory Accreditation through: Quality Conclaves Workshops Seminars etc.

New Areas of Accreditation:

New Areas of Accreditation Accreditation of PT Providers Accreditation of Reference Material Producers Accreditation in Software Testing Accreditation in Medical devices Accreditation in Wild Life for Forensic 23 Rajendra Dafal. Bombay College of Pharmacy, Kalina, Mumbai-98

Customer Profile:

Customer Profile Sl. No. Name Testing Calibration Total 1 Department of Atomic Energy 01 -- 01 2 Ministry of Agriculture 01 -- 01 3 Ministry of Chemicals & Fertilizers 11 01 12 4 Ministry of Commerce & Industry 05 -- 05 5 Ministry of Communications & Information Technology 09 12 21 6 Ministry of Consumer Affairs & Public Distribution 09 03 12 7 Ministry of Defence 46 05 51 8 Ministry of Environment & Forests 02 -- 02 9 Ministry of Heavy Industries & Public Enterprises 08 07 15 24 Govt. Agencies Cont’d.. Rajendra Dafal. Bombay College of Pharmacy, Kalina, Mumbai-98

Customer Profile:

Customer Profile Sl. No. Name Testing Calibration Total 10 Ministry of Home Affairs 08 -- 08 11 Ministry of Petroleum & Natural Gas 28 -- 28 12 Ministry of Power 07 04 11 13 Ministry of Small Scale Industries 03 03 06 14 Ministry of Textiles 17 -- 17 15 Council of Scientific and Industrial Research ( CSIR ) 08 02 10 TOTAL 163 37 200 25 Govt. Agencies Rajendra Dafal. Bombay College of Pharmacy, Kalina, Mumbai-98

Customer Profile:

Customer Profile Sl. No. Name 1 Torrent Pharmaceutical Ltd., Gujarat 2 Maruti Udyog Ltd. (Polymer Laboratory), Gurgaon 3 TATA Power/TISCO/TATA Refractories / TATA Steel 4 Reliance Industries Ltd., Hazira , Jamnagar & Coimbatore 5 HCL ltd., Chennai 6 GE India Technology Centre, Bangalore 7 TUV Sud South Asia Pvt. Ltd., New Delhi, Mumbai, Tirupur 8 Hindustan Coca-Cola Beverages Pvt. Ltd., Medak & Palakkad 9 ITC R&D Centre, Bangalore 10 MICO Application Centre (MICO Bosch Group), Bangalore 11 MRF – R&D Corporate Technical, Chennai 26 Non Govt. Agencies Cont’d.. Rajendra Dafal. Bombay College of Pharmacy, Kalina, Mumbai-98

Customer Profile:

Customer Profile Sl. No. Name 12 SGS India Pvt. Ltd., Gurgaon, Chennai, Thane 13 UltraTech Cement Limited, Anantapur Dist. 14 Birla Cement Works, Chittorgarh 15 Larsen and Toubro Limited, Mumbai 16 Raymond Limited – Denim Division, Yavatmal 17 Godfrey Philips India Limited, Mumbai 18 Sundaram Auto Components Ltd, Hosur 19 Whirlpool of India Limited, Pune 20 Blue Star Limited, Chennai, New Delhi & Kolkata 21 Mahindra & Mahindra Ltd. (Metrology Lab), Kandivili 22 Wipro Technologies, Bangalore 27 Non Govt. Agencies Rajendra Dafal. Bombay College of Pharmacy, Kalina, Mumbai-98

Customer Profile:

Customer Profile Cross Border Laboratory Accreditation by NABL SGS Bangladesh Ltd, Dhaka, Bangladesh, (Mechanical & Chemical Fields) Bureau Veritas Consumer Products Services (Bangladesh) Ltd., Dhaka, Bangladesh (Mechanical & Chemical Fields) Textile Training & Services Centre – Textile Testing Laboratory, Sri Lanka, (Mechanical & Chemical Fields) Bureau Veritas Consumer Products Services (Lanka) Ltd., Sri Lanka, (Mechanical & Chemical Fields) SGS Lanka Pvt. Ltd, Colombo, Sri Lanka, (Mechanical, Biological & Chemical Fields) ITS Labtest, Bangladesh (Mechanical & Chemical Fields) 28 Rajendra Dafal. Bombay College of Pharmacy, Kalina, Mumbai-98

Growth of Accredited Laboratories:

Growth of Accredited Laboratories 29 Rajendra Dafal. Bombay College of Pharmacy, Kalina, Mumbai-98

Status of NABL Accreditation (as on 31st May 2009):

Status of NABL Accreditation (as on 31 st May 2009) Testing Laboratories Laboratories accredited : 641 (in 1055 fields) Calibration Laboratories Laboratories accredited : 275 (in 431 fields) Medical Laboratories Laboratories accredited : 156 (in 692 sub-fields) Total Laboratories Accredited : 1072 (in 2178 fields/sub-fields) 30 Rajendra Dafal. Bombay College of Pharmacy, Kalina, Mumbai-98

Reference:

Reference http://www.nabl-india.org/nabl/html/about-lab-acc.asp http://www.who.int/genomics/policy/india/en/index1.html http://en.wikipedia.org/wiki/ISO/IEC_17025 http://www.indiamart.com/priyaconsultancy/services-offered.html 31 Rajendra Dafal. Bombay College of Pharmacy, Kalina, Mumbai-98

Thank you…:

Thank you…

PowerPoint Presentation:

33 Present Conformity Structure International Laboratory Accreditation Cooperation (ILAC) International Accreditation Forum (IAF) Asia Pacific Laboratory Accreditation Cooperation (APLAC) Testing Laboratories International Mutual Recognition Pacific Accreditation Cooperation (PAC) National Accreditation Board for Testing and Calibration Laboratories (NABL) Quality Council of India (QCI) NABCB NABET NABH ISO/IEC 17011 ISO/IEC 17025 ISO 15189 ISO/IEC 17021 Certification Bodies Training & Eductaion Inspection Bodies Calibration Laboratories Medical Laboratories ISO/IEC 17020 Hospital & Healthcare providers ISO/IEC 17011 NBQP ISO/IEC 17024 Quality Promotion Rajendra Dafal. Bombay College of Pharmacy, Kalina, Mumbai-98