Annual Report 1999-2000

Autonomous Institutions

National Accreditation Board for Testing & Calibration Laboratories

Aims & Objectives

Some of the Aims & Objectives of NABL are:

• To promote, coordinate, guide, implement and maintain a accreditation system for laboratories suitable for the country in accordance with the relevant national and international standards and guides.
  
• To ensure that all measurements either during calibration or testing by accredited laboratories are traceable to appropriate national / international standards maintained at National Physical Laboratory (NPL) and at Bhabha Atomic Research Centre (BARC) through an unbroken chain of comparisons.
  
• To encourage Proficiency Tests / Inter-laboratory comparisons in order to ensure accuracy, reliability and reproducibility of test results.
  
• To ensure that the accredited laboratories adhere to all the conditions of accreditation, by periodic surveillance.
  
• To organize Awareness Programmes on all aspects of laboratory accreditation for the laboratories by various means including seminars, workshops and laboratory-industry-accreditation body meets etc.
  
• To acquire travelling standards and artifacts for conducting studies on measurements by the accredited laboratories and thereby to help improve reliability and reproducibility of results.
  
• To establish and maintain strong linkages with international and regional for a such as International Laboratory Accreditation Conference (hitherto referred to as ILAC), European Accreditation Cooperation for Laboratories (hitherto referred to as EAL), Asia Pacific Laboratory Accreditation Cooperation (hitherto referred to as APLAC) etc. and to take active participation in Plenary Sessions, Committee Meetings etc. in order to keep pace with the latest developments and for promoting Bi-lateral .
  
• To undertake all the activities which shall promote undertaking Bi-lateral / Multilateral Recognition Agreements between NABL and laboratory accreditation bodies in other countries so that test results of NABL accredited laboratories become acceptable in all countries.
  

Scope of Accreditaion

Accreditation is a formal recognition of the technical competence of a laboratory based on third party assessment and following international guidelines. The assessment is carried out by trained Assessors taken from institutions all over India, with established credentials in testing and calibration activities. Currently, NABL Accreditation is limited to the following fields:

• Testing Laboratories

Category A: General

Biological, Chemical, Electrical, Electronics, Fluid-Flow,Mechanical,Non-Destructive Testing, Optical and Photometry, Radiologica

Category B: Clinical

Blood Bank and Transfusion Services, Clinical biochemistry, Clinical pathology, Cytogenetics, Cytopathology, Haematology, Histopathology, Immunology, Microbiology and Serology, Nuclear Medicine

Category C : Forensic

Chemistry, Toxicology, Biology, Serology, Explosives, Physics, Ballistics, Questioned Documents, DNA Finger printing, Forensic Psychology, Fingerprints, Narcotics

• Calibration Laboratories

Category A:

Electro-Technical Measurements, Mechanical Measurements, Radiological Measurements, Thermal and Optical Measurements, Fluid-Flow Measurements

Re-alignment and Revision of Accreditation Criteria

During 1991-92, the accreditation programme earlier known as National Coordination of Testing and Calibration Facilities (NCTCF) scheme was renamed as National Accreditation Board for Testing and Calibration Laboratories (NABL). The accreditation Criteria was then aligned to latest prevailing international criteria i.e. ISO/IEC Guide - 25 (1990). Since then a series of NABL documents have been published.

Establishing Linkage with ILAC & APLAC

India is a signatory to WTO. WTO recognizes that non-acceptance of test results and product certificates across the frontiers of the countries is a Technical Barrier to Trade. Laboratory accreditation is considered as the first essential steps to facilitate mutual acceptance of test results and product certificates. Besides, the laboratory Accreditation Bodies are also required to enter into Multilateral Recognition Agreement with other Accreditation Bodies based on peer review. Asia Pacific Laboratory Accreditation Cooperation (APLAC) and International Laboratory Accreditation Cooperation (ILAC) provide the platform for entering into such Multilateral Recognition Agreement. NABL became a full member of APLAC in 1996 and has been regularly taking part in APLAC programmes. NABL is also hosting APLAC 99 in India. Besides, NABL has recently full membership status of International Laboratory Accreditation Cooperation (ILAC). NABL professionals have been taking part in the deliberations of Technical Committees of both ILAC and APLAC on various issues connected with laboratory accreditation. APLAC offers attachment training for 3 months to professionals from the member countries. NABL has already taken advantage from this. NABL has also taken advantage of APLAC Proficiency Testing training programme by sending two professionals, One on testing and another on calibration held by APLAC at Chinese, Taipei.

Status of Activities

Quality Manual and Operational Procedure Manual of NABL.

In conformity with ISO/IEC Guide-58 and APLAC MR001, NABL has formulated its Quality Manual and Operational Procedure Manual.

Internal Audit of NABL Quality System

An experienced and reputed Quality Consultant was engaged by NABL to conduct Internal Audit of NABL Quality System including the documentation and the accreditation process. This study was also extended to NABL wing located at NPL. Based on this internal audit, NABL Quality Manual and NABL Operational Procedure Manual were revised and certain additional documentations were also made.

Proficiency Testing Programme

In accordance with ISO/IEC Guide 58, NABL is required to conduct inter-laboratory proficiency testing. Besides, as per provisions for ISO/IEC Guide 25 (1990) the accredited laboratories are required to take part in Inter-laboratory proficiency testing. NABL has initiated this activity recently and has selected nodal laboratories to conduct inter-laboratory proficiency testing following NABL Guidelines based on ISO/IEC Guide 43. Till date NABL has completed 16 inter-laboratory proficiency Testing programme while 9 other nearing completion. This enables the laboratory to know confidentially from NABL its performance in terms of Z score, which is an indication of departure of the result from the assigned value. Therefore, laboratory gets a chance to improve its performance in subsequent studies.

APLAC had entrusted NABL to conduct inter-laboratory proficiency testing on tensile testing of steel on its behalf. This has now been completed with the participation of nearly 150 laboratories from India as well as foreign countries majority of which are from member countries of Asia Pacific Laboratory Accreditation Cooperation (APLAC).

Assessors Training & Training of Laboratory Personnel on Quality System Management

In order to facilitate accreditation of Testing and Calibration of Laboratories, NABL has established a full fledged training service to formally train Assessors and Laboratory Personnel. The Assessors Training course is focused to train technical experts from various disciplines in the auditing of Laboratory Quality Systems. These Assessors work for NABL on assignment basis to do on site assessment of laboratories seeking accreditation. The Assessor Training is based on a intensive five day module on residential basis having a formal examination which aspiring participants have to qualify for empanelment as NABL assessors. Two such courses were organised at Mumbai during the year 1999-2000.

Training courses on Laboratory Quality System Management and Internal Audit are also offered for participants from various Testing & Calibration Laboratories to enable them to have in depth understanding of accreditation requirement, implementing the quality system and introduce the system of internal quality audits. These courses are regularly organised at Jaipur, Mumbai, Bhubaneswar and Mysore thereby covering all the four regions of the country. In addition to this, these courses are also offered to big organisations on exclusive basis for their in-house participants. 16 such courses were organised during the year 1999-2000.

Starting from end 1994, 77 training courses have been organised so far comprising of 19 courses for Laboratory Assessors and 58 courses for Laboratory Personnel on Quality System Management and Internal Audit.

Status of NABL Accreditation, Surveillance and Re-assessment

Records of Accreditation - { as on 24/01/2000 }

TESTING LABORATORIES
DISCIPLINE	1994	1995	1996	1997	1998	1999	2000	TOTAL
Biological	01	03	05	02	01	04	01	17
Chemical	04	05	11	10	16	17	02	65
Clinical	-	-	-	-	-	07	-	07
Electrical	-	03	-	09	04	01	03	20
Electronics	02	-	02	-	03	03	-	10
Fluid Flow	-	01	01	-	01	-	-	03
Mechanical	02	09	06	08	07	10	05	47
NDT	-	01	01	03	03	02	03	13
Radiology	-	-	01	01	-	-	-	02
Photometry	-	-	-	-	-	02	-	02
TOTAL	09	22	27	33	35	46	14	186

Records of Accreditation - { as on 24/01/2000 }

DISCIPLINE	1994	1995	1996	1997	1998	1999	2000	TOTAL
Electro-Technical	03	05	09	01	12	03	-	33
Fluid-Flow	-	-	02	-	-	-	-	02
Mechanical	-	07	07	03	08	08	08	41
Radiological	-	-	-	01	-	-	-	01
Thermal & Optical	01	02	04	-	02	01	-	10
TOTAL	04	14	22	05	22	12	08	87

NABL - News

NABL brings a quarterly ‘NABL – News’ so far 14 issues have come out and are being sent to accredited laboratories, Assessors, expert of the committees and all those who have received NABL training of any kind. It is a policy of NABL to mail this book to each member NABL family. This document is a free document with any subscription.

Pre-Evaluation of NABL by APLAC Evaluators

A 2-member team of APLAC MRA Evaluators, consisting of Ms Roxanne Robinson, Vice-President, A2LA, and Mr C P Ramani, Vice-President, ICBO, conducted pre-evaluation of NABL during 12-14 July, 1999. As part of this pre-evaluation, the experts discussed the quality system of NABL and its conformance to ISO/IEC Guide-58 and APLAC MR001, the organisational structure of NABL, the NABL documents on accreditation, surveillance intervals, reassessment of laboratories, inter-laboratory proficiency testing, etc. Besides, the team also examined some of the files belonging to individual accredited laboratories. The team visited National Physical Laboratory on 12 July morning and also observed assessment of surveillance of a calibration laboratory accredited by NABL. On 14 July, the team presented their findings to NABL in the presence of Chairman, NABL. Conclusion of their report is summarized below:

"The team commends the Department of Science and Technology for their extraordinary vision in creating NABL. A strong laboratory accreditation program operating under internationally recognized standards is essentially to facilitate international trade as technical barriers to trade start replacing quotas and tariffs. A successful consummation of NABL’s application to join the APLAC MRA will provide greater opportunities for acceptance of data generated by India’s accredited testing and calibration laboratories. Much has been done by the NABL organization towards meeting the requirements of the APLAC MRA, and the team commends them for their efforts.

This evaluation resulted in a number of major concerns (staffing, surveillance intervals and accommodations at NPL) that need attention prior to the full APLAC evaluation. Tentatively the team and NABL management agreed that the full evaluation could take place in six to eight months. NABL will provide a progress report before the end of this year so plans for the final evaluation can commence. The team feels that a four-person evaluation team will be required for the full evaluation, thus adding two evaluators to concentrate on the calibration and electrical / electronic fields. The full evaluation should require one week’s time.

The team wishes to thank the NABL staff for their cooperation and hospitality. Their openness and transparency made the evaluators’ task most pleasant."

Launching of Accreditation of Forensic Laboratories

NABL Specific guideline document on accreditation of Forensic Laboratories was developed in JUNE ’98 by a Technical Committee appointed by Chairman, NABL. Accreditation of Forensic Laboratories under NABL was launched during a special meeting held at India Habitat Centre, New Delhi, on 02 May, 1999. Mr N Vittal, Chief Vigilance Commissioner, gave a special lecture on White Collar Crime. Mr B B Nanda, Director General, BPR&D, released the NABL Specific Guideline Criteria. The meeting was inaugurated by Prof V S Ramamurthy, Chairman, NABL.

Bi-Lateral Cooperation Programme between NABL and National Institute of Standards, Cairo, Egypt

Director, NABL, visited National Institute of Standards, Cairo, during 9-15 June, 1999 as a part of a bi-lateral programme between India and Egypt. A programme of cooperation on Metrology and Accreditation has been worked out between NIS and NABL.

Assessors’ Conclave

NABL has planned to hold Assessors’ Conclave on regional basis for both testing and calibration laboratories in order to enable a dialogue between NABL executives and the assessors, so that a higher degree of uniformity in the assessment of laboratories could be brought about. This also provides an opportunity for assessors to share their experiences amongst each other. The first Assessors’ Conclave was held during 5-6 June, 1999 at CFTRI, Mysore.

Joint Activity with Quality Council of India, Confederation of Indian Industry and similar organisations

• Quality Council of India (QCI), Confederation of Indian Industries (CII) and NABL joined hands to organise one-day Appreciation Programme on Uncertainty of Measurements at Hotel Samrat, New Delhi, on 17 April, 1999. 150 participants mainly from industries attended the programme.
  
• One-Day NABL Appreciation Programme on Uncertainty of Measurements was held at Bombay on 19 March, 1999 jointly between NABL and Society of Engineers India, Bombay Chapter. 70 participants from industries attended this programme.
  

Progress of Accreditation of Clinical Laboratories

• A meeting was held between NABL and Medically Aware & Responsible Citizens of Hyderabad (MARCH) at Hyderabad on 18 July, 1999. The Specific Guideline Criteria on Accreditation of Clinical Laboratories was released by Ms Sujata Rao, Joint Secretary, Ministry of Health & Family Welfare. The first accreditation certificate for clinical laboratories was presented by Prof V S Ramamurthy, Chairman, NABL, to Speciality Ranbaxy Laboratory, Mumbai. Dr S K Sood, Consultant Haematologist, Sir Gangaram Hospital, New Delhi, made a presentation on Specific Guideline Criteria on Accreditation of Clinical Laboratories. About 150 participants including members from MARCH and others from various clinical laboratories as well as professional societies participated in this meeting.
  
• An NABL Awareness Programme on Accreditation of Clinical Laboratories was held on 03 July, 1999 at T N Medical College and BYL Nair Ch. Hospital, Bombay. 120 participants attended the programme. Professional societies such as Indian Association of Pathologists and Microbiologists, Association of Clinical Biochemists of India, Indian Society for Haematology and Blood Transfusion, were represented in this programme.
  
• One day Appreciation Programme on Accreditation of Clinical Laboratories was also held at St. John’s Medical College, Bangalore on the 8th of August, 1999. 150 participants attended this programme.
  

In all these Awareness/Appreciation programmes, a panel discussion was held at the end were the members of the professional bodies and laboratories took active part. This programmes have created significant amount of consciousness regarding the need for laboratory accreditation and their implementation procedures.

Progress on setting up GLP Compliance Monitoring Authority

A Committee of Secretaries had earlier met and decided that a GLP Compliance Monitoring Authority can be set up within the premises of NABL. As a follow-up, Dr K M Cherian, M/s Hindustan Lever Ltd., Bombay, was nominated by a Committee of Experts, to attend GLP Inspectors Training Programme at Italy during 12-16 April, 1999 organised by OECD. A workshop on Preparing Laboratories for GLP Compliance is expected to be held in the first quarter of the year 2000, in which experts from OECD countries are expected to address to the laboratories engaged in testing of toxic chemicals.