NABL Certification

PRESENTATION ON:

National Accreditation Board for Testing and

Calibration Laboratories (NABL) -Certification

PRESENTED BY:

ANKIT AGRAWAL M.PHARM, PHARMACEUTICAL MANAGEMENT AND REGULATORY AFFAIRS BATCH-2010-2011

E-MAIL: [email protected]

LACHOO MEMORIAL COLLEGE OF SCIENCE AND TECHNOLOGY

DIRECTOR: PROF. (DR.) B.P. NAGORI

NABL CERTIFICATION

ANKIT AGRAWAL, M.PHARM (PHARM MGT. & REGULATORY AFFAIRS)

E-MAIL: [email protected] Page 2

CHAPTER PLAN:

1. Introduction and Objective of NABL

2. Laboratory Accreditation

2.1 Concept of Laboratory Accreditation

2.2 Requirement of Laboratory Accreditation

2.3 Benefits of Accreditation

2.4 Types of Laboratory can seek Accreditation

2.5 Fields of Testing and Calibration Covered by NABL

3. Preparations Required by Laboratory for Accreditation

4. Process of Accreditation

4.1 Stage I (Filling of Application)

4.2 Stage II (Pre-Assessment audit)

4.3 Stage III (Final Assessment)

4.4 Stage IV (Corrective Reassessment)

4.5 Stage V (Granting of Accreditation)

5. NABL Certification Differ from ISO 9000 Certification

6. Proficiency Testing Programmes Organized by NABL

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7. Criteria for using NABL Symbol

8. International Recognition of NABL

8.1 Asia Pacific Laboratory Accreditation Cooperation (APLAC)

8.2 ISO/IEC 17025

8.3 International Laboratory Accreditation Cooperation (ILAC)

9. References

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1. Introduction and Objective of NABL:

National Accreditation Board for Testing and Calibration Laboratories (NABL) is an autonomous body under the aegis of

Department of Science & Technology, Government of India, and is registered under the Societies Act.

NABL has been established with the objective to provide Government, Industry and Society in general with a scheme for third-

party assessment of the quality and technical competence of testing and calibration laboratories.

Government of India has authorized NABL as the sole accreditation body for Testing and Calibration laboratories.

In order to achieve this objective, NABL provides laboratory accreditation services to laboratories that are performing tests /

calibrations in accordance with NABL criteria based on internationally accepted standard for laboratory accreditation ISO/IEC

17025.

These services are offered in a non-discriminatory manner and are accessible to all testing and calibration laboratories in India

and abroad, regardless of their ownership, legal status, size and degree of independence.

NABL has established its Accreditation System in accordance with ISO/IEC 17011:2004, which is followed internationally. NABL

also compiles to the requirement of APLAC MR001 for the fulfillment of APLAC MRA and ILAC Arrangements.

Location of NABL Office:

NABL Secretariat is functioning from its office situated at 3rd Floor, NISCAIR, 14, Satsang Vihar Marg, New Mehrauli Road –

New Delhi 110067.

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NABL Secretariat administers and co-ordinates all activities of NABL including accreditation related activities for Testing and

Calibration laboratories.

Registered Office of NABL is located in Department of Science & Technology, Technology Bhavan, and New Mehrauli Road,

New Delhi – 110016.

Office Timing: The working days of NABL are from Monday to Friday. The office timings are from 9-00 a.m. to 5-30 p.m.

2. Laboratory Accreditation:

2.1 Concept of 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.

The globalization of Indian economy and the liberalization policies initiated by the Government in reducing trade barriers and

providing greater thrust to exports makes it imperative for Accredited Laboratories to be at international level of competence.

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2.2 Requirement of Laboratory Accreditation:

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.

Society also needs to know the technically competent laboratory in fields such as Medical, Forensic, and Food Testing etc.

The globalization of Indian economy and the liberalization policies initiated by the Government in reducing trade barriers and

providing greater thrust to exports makes it imperative for Accredited Laboratories to be at international level of competence.

2.3 Benefits of Accreditation:

1. Potential increase in business due to enhanced customer confidence and satisfaction.

2. Savings in terms of time and money due to reduction or elimination of the need for re-testing of products.

3. Better control of laboratory operations and feedback to laboratories as to whether they have sound Quality Assurance

System and are technically competent.

4. Increase of confidence in Testing / Calibration data and personnel performing work.

5. Customers can search and identify the laboratories accredited by NABL for their specific requirements from the directory

of Accredited Laboratories.

6. Users of accredited laboratories will enjoy greater access for their products, in both domestic and international markets,

when tested by accredited laboratories.

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2.4 Types of Laboratory can seek Accreditation:

The laboratories should be legally identifiable & appropriately registered. They can be a part of a big organization or an

independent entity.

NABL can provide accreditation to:

Laboratories undertaking any sort of testing or calibration in the specified fields.

Private or government laboratories.

Small operations to large multi-field laboratories.

Site facilities, temporary field operations and mobile laboratories.

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2.5 Fields of Testing and Calibration Covered by NABL:

NABL Accreditation is currently given in the following fields:

TESTING LABORATORIES CALIBRATION LABORATORIES MEDICAL LABORATORIES

Biological

Chemical

Electrical

Electronics

Fluid-Flow

Mechanical

Non-Destructive

Photometry

Radiological

Thermal

Electro-Technical

Mechanical

Fluid Flow

Thermal & Optical

Radiological

Clinical Biochemistry

Clinical Pathology

Hematology and Immunohaematology

Microbiology and

Serology

Histopathology

Cytopathology

Genetics

Nuclear Medicine (in-vitro tests only)

Accreditation to a laboratory is given on the basis of its capability to perform test(s) / calibration(s) and provide accurate and

reliable results. A laboratory may apply for accreditation from as little as one to as many tests / calibrations provided it is

performing these in accordance with NABL criteria.

Classification of the Testing Laboratories has been done on the basis of basic fields of testing. The laboratories doing inter-

disciplinary testing of products, for eg. Textiles, Plastics, Building materials, Metallurgical products, etc. shall have to apply in

relevant field(s) separately depending upon to which field(s) the test(s) belongs.

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3. Preparations Required by Laboratory for Accreditation:

1. Laboratory management should first decide about getting accreditation for its laboratory from NABL.

2. It is important for a laboratory to make a definite plan of action for obtaining accreditation and nominate a

responsible person to coordinate all activities related to seeking accreditation. The person nominated should be

familiar with laboratory's existing Quality System. S/he should be formally designated as the Quality Manager.

3. Procure all relevant NABL documents from NABL Secretariat and get fully acquainted with each of these.

4. Laboratory needs to ascertain the status of its existing Quality System and Technical Competence with regards to

requirements for NABL Accreditation. Is the system documented and effective or does it need modification. Does it

need to build the Quality System of the laboratory from scratch?

5. It must be remembered that Quality Manual is a policy document, which has to be supplemented by a set of other

documents like Procedural Manuals, Work Instructions etc. to align the Quality System in accordance with NABL

Criteria. The laboratory must ensure that the procedures described in the Quality Manual and other documents are

being implemented. For preparing Quality Manual or verifying its contents, the laboratory may take help of “Guide

for Preparing Quality Manual" (NABL 160). The laboratory may also get its personnel trained in NABL's training

programme on Laboratory Quality System, Management and Internal Audit.

6. Relevant requirements for NABL accreditation should be discussed amongst concerned staff of the laboratory. This

will enable them to understand their weaknesses and strengths.

7. Quality Manager must conduct an Internal Audit and take corrective actions before applying for accreditation.

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4. Process of Accreditation:

4.1 Stage I (Filling of Application):

Prepare your laboratory's application for NABL accreditation, giving all desired information and enlisting the test(s) /

calibration(s) along with range and measurement uncertainty for which the laboratory has the competence to

perform. Laboratory can apply either for all or part of their testing / calibration facilities. Formats NABL 151, NABL

152 & NABL 153 are to be used by Testing, Calibration and Medical Laboratories respectively for applying to NABL for

accreditation.

Laboratory has to take special care in filling the scope of accreditation for which the laboratory wishes to apply. In

case, the laboratory finds any clause (in part or full) not applicable to the laboratory, it shall furnish the reasons.

Laboratories are required to submit five sets of duly filled in application forms for each field of testing / calibration

along with five sets of Quality Manual and Application Fees.

NABL Secretariat on receipt of application will issue acknowledgement to the laboratory. After scrutiny of application

for it being complete in all respects, a unique Customer Registration Number will be allocated to laboratory for

further processing of application.

NABL Secretariat shall then nominate a Lead Assessor for giving Adequacy Report on the Quality Manual / Application

submitted by the laboratory. A copy of Adequacy Report by Lead Assessor will be provided to Laboratory for taking

necessary corrective action, if any. The laboratory shall submit Corrective Action Report.

After satisfactory corrective action by the laboratory, a Pre-Assessment audit of the laboratory will be organised by NABL.

Laboratories must ensure their preparedness by carrying out its internal audit before Pre-Assessment.

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4.2 Stage II (Pre-Assessment audit):

NABL Secretariat shall organise the Pre-Assessment audit, which shall normally be carried 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 apart from Technical Assessor(s)

and Total Assessment Man-days required vis-à-vis the scope of accreditation as per application submitted by the

laboratory.

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 organized

by NABL.

4.3 Stage III (Final Assessment):

NABL Secretariat shall organize the Final Assessment at the laboratory site(s) for its compliance to NABL Criteria and

for that purpose appoint an assessment team.

The Assessment Team shall comprise of a Lead Assessor and other Technical Assessor(s) in the relevant fields

depending upon the scope to be assessed.

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.

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The Lead Assessor will provide a copy of consolidated report of the assessment to the laboratory and send the

original copy to NABL Secretariat.

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.

4.4 Stage IV (Corrective Reassessment):

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.

Laboratory shall have to take corrective action on any concerns raised by the Accreditation Committee.

Accreditation Committee shall make the appropriate recommendations regarding accreditation of a laboratory to

NABL Secretariat.

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 accessed.

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4.5 Stage V (Granting of Accreditation):

Accreditation to a laboratory shall be valid for a period of 3 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.

5. NABL Certification Differ from ISO 9000 Certification:

ISO 9000 Certification is on Quality System Management only whereas the NABL Accreditation provides formal recognition of

technical competence of the laboratories, thus providing a ready means for customers to find reliable testing and calibration

services in order to meet their demands as well as the Quality system. Accreditation is a higher level activity than system

certification.

Laboratories can be checked and certified for their compliance to international management system standards such as ISO

9000. This involves the auditing of an organization’s quality management system. Although this will give you confidence of the

laboratory’s quality system, it tells you nothing about its technical competence or its ability to provide reliable and accurate test

data that will be accepted by your customers and trading partners.

Proper technical evaluation requires the use of technical experts who can assess the laboratory against internationally accepted

criteria. These criteria are embraced globally in a document called ISO/IEC 17025. Accreditation bodies may also apply

additional technical requirements for evaluating a laboratory, as per requirements of different technical fields.

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Laboratory accreditation against the standard ISO/IEC 17025 does, however also covers the quality management elements of

ISO 9000. So laboratory accreditation, which is based on ISO/IEC 17025 is a measure of both technical competence and quality

management and is the most appropriate process rather than quality ISO-9000 certification.

6. Proficiency Testing Programmes Organized by NABL:

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-coordinator 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.

It is essential for all its accredited laboratories to participate in International / Regional Proficiency Testing Programmes

including APLAC in a manner so that all major areas of scope of accreditation are covered in a cycle of 4 years. This of course

applies to those special areas where Inter-Laboratory Proficiency Testing Programmes are not available.

All applicant laboratories are required to successfully participate in at least one Inter - Laboratory Proficiency Testing in

accordance with ISO/IEC Guide-43. For this purpose all alternative techniques covered in ISO/IEC Guide-43 will be acceptable.

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For calibration laboratories, measurement audits will be considered to be a complimentary effort to Inter-Laboratory Proficiency

Testing. Technical assessors for calibration laboratories will be provided with artifacts with their characterization by National

Physical Laboratory, New Delhi or any other NMI's who are signatory to BIPM like PTB, NIST etc.

7. Criteria for using NABL Symbol:

All NABL accredited laboratories are expected to use NABL symbol on their letterhead, test / calibration reports and

any other relevant documents. NABL symbol shall be used for the purpose of identifying correctly and unambiguously

the test / calibration services accredited by NABL.

While using the symbol it shall be ensured by the laboratory that design and its manifestations are not distorted, it

can be reproduced in any single color (preferably black) and any size.

It shall be responsibility of the accredited laboratory that the use of symbol does not misrepresent the scope of

accredited testing / calibration services. In case where the accreditation sought and granted do not cover all the

activities of the laboratory's services care should be exercised to restrict the use of symbol only to those accredited

activities. The 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. For non-accredited category the

laboratory shall use a letterhead without NABL symbol or specially identify those tests/ measurements which are not

covered by accreditation.

Accredited laboratories shall not authorize the use of symbol for tests / calibration services sub-contracted to other

laboratories, which are not accredited by NABL.

In case of complaints in this regard from users and other laboratories, NABL shall get the same examined by a

committee and take appropriate action.

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8. International Recognition of NABL:

NABL maintains its linkages with the international bodies like International Laboratory Accreditation Co-operation (ILAC)

and Asia Pacific Laboratory Accreditation Co-operation (APLAC). NABL is a full member of both ILAC and APLAC.

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.

In order to achieve the objective of the acceptance of test / calibration data across the national borders, NABL operates and is

committed to update its laboratory accreditation system as per international norms. A current NABL criterion for Laboratory

Accreditation is ISO/IEC 17025 standard for testing and calibration laboratories and ISO 15189:2003 for medical laboratories.

8.1 Asia Pacific Laboratory Accreditation Cooperation (APLAC):

It is the group of accreditation bodies in the Asia Pacific region responsible for accrediting calibration, testing and inspection

facilities.

This reduces the need for re-testing of products and therefore saves time and money. APLAC has active programmed for the

development of technical guidance documents, inter-laboratory comparisons (proficiency testing), and for training of laboratory

assessors.

APLAC is recognized by Asia Pacific Economic Cooperation (APEC) member economies as a Specialist Regional Body (SRB).

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8.2 ISO/IEC 17025:

ISO/IEC 17025 is the basis for competency of testing and calibration laboratories.

Accreditation to ISO/IEC 17025 requires that:

The laboratory has a quality system meeting requirements of ISO 9001.

The lab facility has adequate equipment to perform its testing or calibration tasks.

The lab facility has adequate laboratory personnel with the competence to perform the calibration and testing.

In addition most accreditation schemes in the U.S. require proficiency testing amongst the laboratories.

Therefore, ISO/IEC 17025 is recognition of laboratory competence, while ISO 9001 alone is simply recognition of conformance

to a quality system.

8.3 International Laboratory Accreditation Cooperation (ILAC):

ILAC first started as a conference in 1977 with the aim of developing international cooperation for facilitating trade by

promotion of the acceptance of accredited test and calibration results.

In 1996, ILAC became a formal cooperation with a character to establish a network of mutual recognition agreements among

accreditation bodies that would fulfill this aim.

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9. References:

http://www.nabl-india.org.

http://www.fda.org.

http://www.ilac.org/arrangement.htm.

http://www.aplac.org/members/signatories_mra.htm.

THANK YOU

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NABL Certification