NABL & Accreditation Process
S.SUBRAMANIAN
1
Ministry Of
Commerce & Industry
Fields of Accreditation by NABL
•
Testing Laboratories
(ISO/IEC 17025)
 Biological
 Chemical
 Electrical
 Electronics
 Fluid-Flow
 Mechanical
 Non-Destructive
Testing
 Optical and
Photometry
 Radiological
 Thermal
Calibration Laboratories
(ISO/IEC 17025)
Medical Laboratories
(ISO 15189)
 Electro-Technical
 Mechanical
 Radiological
 Thermal
 Optical
 Fluid-Flow
 Clinical Biochemistry
 Clinical Pathology
 Haematology and
Immunohaematology
 Microbiology & Serology
 Histopathology
 Cytopathology
 Genetics
 Nuclear Medicine (Invitro Test Only)
Proficiency Testing Provider
(ISO/ IEC 17043)
Reference Material
Producers
(ISO 17034)
2
Ministry Of
Commerce & Industry
The International Picture
•
The international accreditation network is expanding.
There are 101 accreditation bodies from 103 different
economies, that are signatories to the ILAC MRA . In
addition, there are 46 accreditation bodies that are
Associate members, Affiliate members and stakeholders
of ILAC .
There
are
currently
over
80,000
laboratories
and
approximately
11,000
inspection
bodies that are accredited by the ILAC MRA signatories.
3
Ministry Of
Commerce & Industry
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.
 First evaluated by APLAC in 2000 (for testing and calibration laboratories);
 Second evaluation by APLAC in 2004 (for testing & calibration laboratories);
 Third evaluation by APLAC in 2008 (for testing, calibration and medical
laboratories);
 Fourth Evaluation by APLAC in 2012 (for testing, calibration and medical
laboratories), MRA valid for four years;
 Fifth Evaluation by APLAC in 2016 (for testing, calibration, medical
laboratories, PTP and RMP), MRA valid for four years
 Sixth Evaluation (recent) by APAC in 2021(for testing, calibration, medical
laboratories, PTP and RMP), MRA valid for four years
4
Ministry Of
Commerce & Industry
Global Acceptance of Reports
•
Test reports issued by an NABL accredited laboratory is
considered equivalent to those issued by ILAC/APAC MRA
partners.
Global MRA has network of ~80,000 Accredited labs.
5
Ministry Of
Commerce & Industry
•
6
Ministry Of
Commerce & Industry
•
Pre-requisites for Laboratory
 Lab or organization of which it is part shall be legally registered
so that it can be held responsible for testing or calibration
activities it carries out.
 Laboratory should have adequate facilities and technically
competent qualified staff to carry out the testing and / or
calibration for which it wish to seek accreditation.
 Laboratory must comply with all requirements as laid down in
Standard ISO/IEC 17025, relevant NABL documents. 163, 133,
142
7
Ministry Of
Commerce & Industry
• Pre-requisites for Laboratory
 Ensure all equipment in lab are properly calibrated & have
traceability to National/International standards.
 Laboratory must have completed one Internal Audit covering all
clauses of ISO /IEC 17025 and a Management Review.
 Laboratory must have satisfactorily participated in at least one
Proficiency Testing / Inter Laboratory Comparison in accordance
with the international standard ISO/IEC 17043.
8
Ministry Of
Commerce & Industry
Application for Accreditation by Laboratory (On-line)
Acknowledgement & Scrutiny by NABL Secretariat
Adequacy of Quality Manual by Lead Assessor
Feedback
to
Laboratory
Pre-Assessment of Laboratory by Lead Assessor (Optional)
Final Assessment of Laboratory by Assessment Team
and
Scrutiny of Assessment Report by NABL Secretariat
Necessary
Recommendations for Accreditation by Accreditation Committee
Corrective
Action
Approval for Accreditation by CEO, NABL
Issue of Accreditation Certificate by NABL Secretariat
by
Laboratory
Ministry Of
Commerce & Industry
LIST OF IMPORTANT NABL DOCUMENTS
•
 NABL 100 – General Information Brochure
 NABL 120 – Guidance on classification of Product groups in testing
 NABL 142 –
results
Policy on metrological traceability of measurement
 NABL 163 – Policy for participation in Proficiency Testing Activities
 NABL 131 – Terms & conditions for obtaining & maintaining NABL
accreditation
 NABL 133– Policy for use of NABL symbol/ and/or claim of
accreditation
 NABL 151– Application form for testing laboratories
10
Ministry Of
Commerce & Industry