General, Structural & Resource requirements

IS / ISO/ IEC 17025:2017

Part – 1 : Basic knowledge
National Accreditation Board for Testing and Calibration Laboratories (NABL)
National Accreditation Board for Testing and Calibration Laboratories (NABL)

1. An autonomous body

2. Registered under Societies Act in1992

3. Under the aegis of Department of Science & Technology, Government of India.

Terminology
1. MRA : Mutual Recognition Arrangement Certificate
2. ILAC : International Laboratory Accreditation Cooperation IAF : International Accreditation Forum
3. APLAC : Asia Pacific Laboratory Accreditation Cooperation SADCA : The Southern African Development
Community Cooperation in Accreditation
4. IAAC : The Inter American Accreditation Cooperation
5. EA : The European cooperation for Accreditation
6. NATA : National Association of Testing Authorities, Australia IANZ : International Accreditation New Zealand
7. HOKLAS : Hong Kong Accreditation Service
8. NABL : National accreditation board for testing and calibration laboratories
Linkage
1. NABL ,as an accreditation body, operates its own system as per ISO/IEC 17011 .
2. NABL is signatory to APLAC / ILAC Mutual Recognition Arrangements (MRA) since 2000 .
Scope of NABL accreditation

1. NABL Grants accreditation in almost all areas of science, engineering and medical testing.

2. The international standards followed are :

1. ISO 15189:2007 (for Medical Testing) .

2. ISO/IEC 17025:2017 (for Testing, calibration).

3. ISO 17043:2010 (for PT providers).

 Basic concept : Certification vs Accreditation

Certification Accreditation

1. Certification is a comprehensive 1. Accreditation is the formal declaration by a

evaluation of a process, system, product, neutral third party that the certification

event, or skill typically measured against program is administered in a way that meets the

some existing norm or standard. relevant norms or standards of certification

program
2. Certification does not make any
statement about the technical 2. Uses criteria specifically developed to determine

competence of the laboratory. technical competence of the laboratory.

Example ISO 9001:2015 Certification 3. This is an independent evaluation of laboratory’s

technical competence

Accreditation-Example ISO 17025

Benefits

1. Customers can search laboratories

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

the NABL website or Directory of accredited laboratories.

3. Increased confidence in reports

4. The labs are required to participate in proficiency testing which is again demonstration of competence. So,

there is increased confidence in the reports released by the laboratory.

5. The customers get services by credential staff.

6. Savings in terms of time and money as it reduces or

7. eliminates the need of re-testing.
Benefits

8. Use of NABL symbol

9. The accredited laboratories can issue test reports bearing the accreditation body’s symbol or endorsement,

as an indication of accreditation.

10. International Recognition

11. Lab accreditation is highly regarded both nationally and

12. internationally as an indicator of technical competence

13. Satisfaction of the staff

14. The staff in an accredited laboratory is satisfied as it provides for continuous learning ,good working

environment, leadership.
Part – 2 : Process of getting accreditation
General, Structural & Resource requirements

IS / ISO/ IEC 17025:2017

Pre-requisites for laboratory
1. Laboratory or the organization of which it is part shall be legally registered so that it can be held responsible for
the testing and / or calibration activities it carries out.
2. 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.
3. Laboratory must comply with all the requirements as laid down in the Standard ISO/IEC 17025:2017, relevant
Specific Criteria and other NABL documents.
4. Ensure all test equipment in the laboratory are properly calibrated and have traceability to
National/International standards.
5. Laboratory must have completed one Internal Audit covering all clauses of ISO/IEC 17025:2017 and a
Management Review.
6. Laboratory must have satisfactorily participated in at least one Proficiency Testing Program conducted by NABL
or other reputed national or international organizations in accordance with the international standard ISO/IEC
Guide 43.
 Accreditation Procedure
Application for Accreditation by Laboratory

Acknowledgement & Scrutiny by NABL Secretariat

Feedback
Adequacy of Quality Manual by Lead Assessor
to
Pre-Assessment of Laboratory by Lead Assessor Laboratory

Final Assessment of Laboratory by Assessment Team

Scrutiny of Assessment Report by NABL Secretariat

and
Recommendations for Accreditation by Accreditation Committee

Approval for Accreditation by Chairman, NABL Necessary

Corrective
Issue of Accreditation Certificate by NABL Secretariat
Action
174
Application for Accreditation
Laboratory shall apply to NABL in the prescribed Application Form (NABL 151 for Testing Laboratories
and NABL 152 for Calibration Laboratories) along with laboratory’s Quality Manual in accordance with
ISO/IEC 17025 and applicable application fees.

Acknowledgement and Scrutiny of Application

1. NABL Secretariat on receipt of laboratory’s application after scrutiny for its completeness in all
respects will issue an acknowledgement and a unique customer registration number to the
laboratory.
2. NABL Secretariat may seek additional information / clarification(s) from the laboratory, if necessary.
.
Adequacy of Quality Manual
• NABL will appoint a Lead Assessor to study in detail the information provided by the laboratory in its
application and verify the compliance of laboratory’s QSD (previously called as Quality Manual) in
accordance with ISO/IEC 17025:2017 and relevant NABL Specific Criteria.
• Lead Assessor Selection is based on:
1. Technical Expertise
2. Availability
3. Preferable from Near by Place
Adequacy of Quality Manual
• Documents Provided to Lead Assessor:
1. Applications
2. Quality Manual
• Lead Assessor submits the Adequacy Report to NABL indicating the inadequacies, if any. Laboratory is
then required to take necessary corrective action(s) within specified time and submit a report to
NABL.
Pre-Assessment
Pre assessment of Laboratory is conducted to
1. Check the preparedness of the laboratory to undergo Final Assessment.
2. Have better understanding of documentation and operations of the laboratory.
3. Familiarize with the facilities, sites/ location, circumstances and to have better knowledge of
operations.
4. Make the methodology to be adopted for the assessment
5. Ascertain number of assessor / man-days required for Final Assessment and to review the Scope
of Accreditation.
Pre-Assessment
• Lead Assessor shall submit the pre assessment Report to NABL/laboratory.
• Laboratory is then required to take necessary corrective action(s) on the inadequacies as observed
during Pre-assessment, if any, within specified time and submit a corrective action report to NABL.
Final assessment
• In case no inadequacies are pointed out in the pre assesment report or after
• Final -Assessment is conducted by the Lead Assessor and Technical Assessors to cover the entire
scope of accreditation.
Scrutiny of report by NABL Secretariat
After satisfactory corrective action by the laboratory and closure of non-conformance(s) raised by the
assessment team, NABL Secretariat scrutinizes the assessment report and place the report before
Accreditation Committee for examination.

NABL Accreditation Committee

1. NABL Accreditation Committee examines the assessment report, corrective actions taken and
additional information as sought from the laboratory.

2. Accreditation Committee shall then give appropriate recommendations for grant of accreditation or
otherwise to the Chairman - NABL.
Approval of Accreditation from Chairman -NABL
Approval is sought from Chairman NABL for grant of Accreditation or otherwise based on Accreditation
Committee’s Recommendation.
Issue of Accreditation Certificate
1. On approval from Chairman-NABL for grant of Accreditation, NABL will issue an Accreditation
Certificate to a laboratory having unique number for each field of testing or calibration and having
specified validity period along with detailed Scope of Accreditation.

2. Accreditation Certificate to a laboratory is initially issued for a period of 2 years.

Surveillance audit
1. NABL conducts Annual surveillance of an Accredited Laboratory in its first accreditation cycle, to
ensure that the laboratory continues to comply with the requirements of the standard ISO/IEC
17025 and NABL.

2. Surveillance is conducted by an assessment team which submits its detailed report to NABL.
Laboratory shall take necessary corrective action(s) on the non-conformances observed, if any,
during Surveillance within specified time and submit a corrective action report to NABL.
Re-assessment
1. Accredited laboratories shall apply for renewal of accreditation in the prescribed application form,
at least 6 months prior to the expiry of validity of its accreditation so that the process of re-
assessment is completed before the certificate expires.

2. The process for Re-assessment is similar to that of the initial assessment.

3. When the laboratory is recommended for renewal of accreditation, NABL will re-issue the
Accreditation Certificate to the laboratory.
Part – 2 Relation between ISO 9001 and and ISO/IEC 17025 :2017
Accreditation vs Certification
ISO/IEC 17000:2020 ‘Conformity assessment — Vocabulary and general principles’ states

• Accreditation is the “third party attestation, related to a conformity assessment body, which is a formal
recognition of their competence to perform specific activities of conformity assessment.”
• Certification is the “third-party assurance that: product (services), process, personnel, organization or
management system conforms to specific requirements.”

Attestation vs Assurance
What is ISO and IEC
ISO/IEC 17000:2020 ‘Conformity assessment — Vocabulary and general principles’ states

• ISO (the International Organization for Standardization) and IEC (the International Electrotechnical Commission)
form the specialized system for worldwide standardization. The ISO Committee on conformity assessment is called
as CASCO.
• National bodies that are members of ISO or IEC participate in the development of International Standards through
technical committees established by the respective organization to deal with particular fields of technical activity.
• ISO and IEC technical committees collaborate in fields of mutual interest.
• Other international organizations, governmental and non-governmental, in liaison with ISO and IEC, also take part
in the work.
Different specifications
1. ISO 3534 (all parts), Statistics — Vocabulary and symbols
2. ISO 9000:2015, Quality management systems — Fundamentals and vocabulary
3. ISO 15189, Medical laboratories — Requirements for quality and competence
4. ISO/IEC 17011, Conformity assessment — Requirements for accreditation bodies accrediting conformity
assessment bodies
5. ISO/IEC 17020, Conformity assessment — Requirements for the operation of various types of bodies performing
inspection
6. ISO/IEC 17021-1, Conformity assessment — Requirements for bodies providing audit and certification of
management systems — Part 1: Requirements
7. ISO/IEC TS 17021-4, Conformity assessment — Requirements for bodies providing audit and certification of
management systems — Part 4: Competence requirements for auditing and certification of event sustainability
management systems
Different specifications
8. ISO/IEC TS 17023, Conformity assessment — Guidelines for determining the duration of management system
certification audits
9. ISO/IEC 17024, Conformity assessment — General requirements for bodies operating certification of persons
10. ISO/IEC 17025, General requirements for the competence of testing and calibration laboratories
11. ISO/IEC TS 17027, Conformity assessment — Vocabulary related to competence of persons used for certification
of persons
12. ISO/IEC TR 17028, Conformity assessment — Guidelines and examples of a certification scheme for services
13. ISO/IEC 17029, Conformity assessment — General principles and requirements for validation and verification
bodies
14. ISO/IEC 17030, Conformity assessment — General requirements for third-party marks of conformity
Different specifications
15. ISO 17034, General requirements for competence of reference material producers
16. ISO/IEC 17040, Conformity assessment — General requirements for peer assessment of conformity assessment bodies and
accreditation bodies
17. ISO/IEC 17043, Conformity assessment — General requirements for proficiency testing
18. ISO/IEC 17050-1, Conformity assessment — Supplier's declaration of conformity — Part 1: General requirements
19. ISO/IEC 17065, Conformity assessment — Requirements for bodies certifying products, processes and services
20. ISO 19011, Guidelines for auditing management systems
21. ISO 19600, Compliance management systems — Guidelines
22. ISO/IEC Guide 2, Standardization and related activities — General vocabulary
23. ISO Guide 30, Reference materials — Selected terms and definitions
24. ISO/IEC Guide 99, International vocabulary of metrology — Basic and general concepts and associated terms (VIM)
25. Glossary, Agreement on Technical Barriers to Trade: https://www.wto.org/english/thewto_e/glossary_e/glossary_e.htm
Certification
There are three (3) main types certifications

1. Product certification, ISO/IEC 17065:2012 (products, processes and services certified).

2. Management system certification, ISO/IEC 17021-1:2015 (ISO 9001 certified company).

3. Personnel certification, ISO/IEC 17024:2012 (Welder/Food safety certified).

Product / Process /Service Certification
Product certification, ISO/IEC 17065:2012 (products, processes and services certified).

1. The overall aim of certifying products, processes or services is to give confidence to all interested parties that a

product, process or service fulfills specified requirements.

2. The value of certification is the degree of confidence and trust that is established by an impartial and competent

demonstration of fulfillment of specified requirements by a third-party.

Product / Process /Service Certification
4 basic drivers for product, process and service certification:

1. Provide consumers (users) of products with sufficient information to allow them to make informed decisions on

products and services;

2. Assist the suppliers of certified products to achieve market acceptance. If the product has a recognizable mark on

it consumers may be more willing to make the purchase;

3. Product certification plays a role in regulated products (subject to technical regulations);

4. Assists manufactures in selecting the components for their own products;

5. Retailers have confidence in the products they are selling.

 1. Initial product testing with assessment of the quality management system.
Product certification 2. Testing of samples from factory and/or the open market;
3. Initial testing and surveillance testing;
4. type testing : testing of a sample product.

1. Will depend on the level of risk to the consumer as well as other factors;
2. For a very low risk product you may have a once-off type test;
Selection criterion
3. For a high risk product you may have a scheme which has type testing, requires an ISO 9001
management system in place with regular product testing from the factory and also
products taken from the outlets for testing.

ISO/IEC 17065
Can be used in combination with a number of related product standards and guides to
Conformity assessment - Requirements
demonstrate that a product complies with specified criteria.
for bodies certifying products, processes
and services
Product / Process /Service Certification
The requirements of ISO/IEC 17065 allow Product certification bodies to demonstrate that they are competent,
impartial and reliable; There are hundreds of marks of conformity for products in the market place; This is the most
visible form of certification.
Big question : What is management system
Set of interrelated or interacting elements of an organization to establish policies and
objectives and processes to achieve those objectives.#

#
ISO/IEC Directives, ISO Supplement, Annex SL, Appendix 2, cl. 3.04 (2014)
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