Accreditation of Laboratories

A
General Approach
By
N V SARMA
Retired Chief Chemist,CAL Nagpur

1
What is Accreditation?

What is its Necessity?

What are its Advantages?

2
 1. (What is it?)
Laboratory Accreditation :
Formal Recognition of Technical Competence – by
an Authoritative body (NABL)
• for specific Tests / measurements based on third
party assessment and following International Standard
• facilitating mutual acceptance of test results and
measured data
• obtained by a transparent system of control over the
accredited laboratories
• assurance given by the accreditation body that the
accredited laboratory fulfils the accreditation criteria at
all times.

3
 2. (Why is it necessary?)
Current Global Scenario:
Globalistion of Indian economy
The liberalisation policies initiated by the Govt in
reducing trade barriers makes it imperative that the
accredited Laboratories be at International level of
competence
Essential pre-requisite of Trade:
Any product or service accepted formally in one
country must also be free to circulate to other
economies without having to undergo extensive
retesting.

4
 3.(Advantages of Accreditation)
• Benchmark for performance: Increased
confidence in Testing / Calibration data
and personnel performing work
• International Recognition of the Labs &
Recognition of testing competence
• Marketing advantage: Potential increase in
business due to enhanced customer
confidence and satisfaction.
• Greater access for their products, in both
domestic and international markets, when
tested by accredited laboratories
5
• Savings in terms of time and money due to
reduction or elimination of the need for re-
testing of products.
• Better control of laboratory operations due
to sound Quality Assurance System and
technical competence.
• Customers can search and identify the
laboratories accredited by NABL for their
specific requirements from the Directory of
Accredited Laboratories or NABL website.
Accreditation thus benefits Business,
Govt & society at large
6
Accreditation bodies & Standard Organisations

The International Organisation for Standardisation – ISO

• European Union –EU

• International Electrotechnical Commission - IEC

• International Accreditation Forum – IAF

• Pacific Accreditation Cooperation – PAC

• Southern African Regional Accreditation Cooperation - SARAC

7
• International Laboratory Accreditation co-operation – ILAC

The Regional bodies ( all working within the ILAC umbrella)

include
• European Accreditation co-operation-EAC

• Asia Pacific Laboratory Accreditation co-operation – APLAC

• Inter American Accreditation co-operation- IAAC

Over 40 Lab accreditation bodies have signed a multi-lateral

recognition agreement
8
 Which are the other organizations in India
providing accreditation services...?

• NABL is the sole accreditation body in

India that provides third party assessment
and has been authorized by Government
of India.

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. What types of laboratories can seek accreditation...?

 Labs that are legally identifiable & appropriately registered.

Labs that are a part of a big organization or an independent

entity.

Labs undertaking testing or calibration in specified fields.

Private or government labs.

Small operations to large multi-field labs.

Site facilities, temporary field operations and mobile labs.

Basis Of Giving Accreditation

Capability to perform test(s) / calibration(s)

Provide accurate and reliable results.

As little as one to as many tests / calibrations

Tests performed in accordance with NABL criteria.

11
 National Accreditation Board
for Testing & Calibration Laboratories-NABL
• An autonomous body - Department of Science &
Technology (DST), Ministry of Science and
Technology, Government of India
• Registered under the Societies Registration Act
1860 .
• Authorised by the Government of India as the sole
accreditation body for Testing and Calibration
laboratories for Govt & Industries in general.
NABL maintains linkages with the International
bodies & is full member of both ILAC & APLAC
http ://www.ilac.org/arrangement.htm
http://www.aplac.org/members/signatoriesmra.htm
12
How the objectives are achieved?
• NABL provides laboratory accreditation
services in a non-discriminatory manner to
laboratories in accordance with NABL criteria,
• based on internationally accepted Standards
and Guidelines in India and other countries
that do not have accreditation bodies
Laboratories assessed-General Requirements for
the competence of Testing and Calibration
laboratories - ISO/IEC 17025:2005 - predecessor
being European Standard-EN 45001
(originally known as ISO/IEC Guide 25-issued
by ISO in 1999)

13
 ISO/IEC 17025:2005 :
The std was published in 2001 and the allignment
work completed on 12 May 2005.The most
significant changes introduced –
Emphasis on the responsibilities of senior
management with continual improvement to
produce valid results
• Communication with the customer
• Customer satisfaction
• No essential changes in the Technical
Requirements

Necessary to conform with ISO 9001-2000-

QUALITY MANAGEMENT STSTEM

14
 ISO 9000 Vs
• Quality System Management only
• Compliance to international
management system standards
• Involves auditing of organization’s
quality management system
• services + Quality system
Gives confidence of the
laboratory’s quality system
• Tells nothing about technical
competence or ability to provide
reliable and accurate test data
NABL 17025
• Provides formal recognition of
technical competence besides QSM
of the labs
• Ready means for customers to find
reliable testing and calibration
• Higher level activity than ISO 9000
• Technical evaluation by technical
experts to assess the lab as per
internationally accepted criteria in a
document called ISO/IEC 17025.
• Also covers the quality
management elements of ISO 9000
• More appropriate than quality ISO-
9000 certification.
 Accreditation -
given on the basis of its capability to
perform test(s) / calibration(s) and provide
accurate and reliable results
Scope of Accreditation
• From as little as one to as many tests /
calibrations provided it is performing these
in accordance with NABL criteria
Laboratory also has an option to widen the
scope of accreditation in terms of specific
tests and calibrations

16
Testing Calibration Medical
Laboratories Laboratories Laboratories
Biological Electrotechnical Clinical Biochemistry
Chemical Mechanical Clinical Pathology
Electrical Fluid Flow Haematology and
Electronics Thermal & Immunohaematology
Fluid-Flow Optical Microbiology and
Radiological Serology
Mechanical
Non-Destructive Histopathology
Photometry Cytopathology
Genetics
Radiological
Thermal Nuclear Medicine (in-vitro
tests only)
Forensic
17
 The contents of ISO /IEC 17025-comprises of 5
elements:
• Scope
• Normative References
• Terms and Definitions
• Management Requirements
• Technical Requirements
A laboratory wishing to be accredited by NABL must
have a Quality Manual ( Policies, Procedures,
Records) on its Quality System satisfying the
requirements as described in various clauses of
ISO/IEC 17025
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 QUALITY POLICY AND
QUALITY OBJECTIVES
Central Agmark Laboratory, Nagpur strives
for excellence in testing of agricultural
commodities by providing reliable and
timely analytical services.
• Continuously striving for achieving
accuracy for testing of the commodities for
various Quality Parameters as notified
under Agricultural Produce (Grading &
Marking) Act, 1937 as amended from time
to time.
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• Adopting Good Laboratory Practices
(GLPs) and following National/
International test methods/ validated
methods to meet customer requirements.

• Enhancing knowledge and skill of the

laboratory personnel through training
programmes.

• Ensuring achievement of accurate and

timely issue of reports.
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Documentation system as required by NABL
Typical structure of management system document hierarchy

Q-Policy
statement
Q-manual
(Level A)

Procedure (SOPS)
(Level B)

Work Instructions, Forms and

Formats and Records(Level C)
21
Document, Document, Document.
   ISO/IEC Guide 25, Section 5.2 requires that a laboratory
have a quality manual, and that it "shall state the laboratory’s
policies and operational procedures established in order to
meet the requirements." The manual and other quality-related
documentation must include:

A quality policy statement

The laboratory’s organizational structure

Procedures for document control

Job description of key staff

Procedures that document how the lab achieves traceability

Document, Document, Document. (Contd.)
Descriptions of the types of tests a laboratory can perform,
references to the test procedures, and procedures for
handling

A procedure to ensure that it can properly perform new

tests

Procedures to ensure calibration of test equipment and

verification of standards
 Document, Document, Document. (Contd.)

Procedures for dealing with complaints and protecting

customer confidentiality

Procedures for audit and review.

. Imparttraining on the key elements of documentation, such

as document format, authorization of document, issue and
withdrawal procedures, document
review and change, etc.

Each document should have ID No., name of controlling

authority, period of retention, etc.

24
Management Requirements: (Clause 4.1- 4.15.2)
• 4.1 Organisation & Organization Structure
• Main activities of the Laboratory
• Responsibilities and Activities of key Personnel-
 Laboratory I/C ,
 Quality Manager (QM),
 Technical Manager (TM),
 Chemists
 Administration assistant
• 4.2 Management System
(Policies,Systems,Q Manual,QSP,Instructions,Etc.)
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• 4.3 Document Control
(Document Approval,Issue,Changes)
• 4.4Review of requests ,Tenders & contracts
• 4.5 Subcontracting of tests
• 4.6 Purchasing services and supplies
• 4.7 Service to the customer
• 4.8 Complaints
• 4.9 Control of non-conforming testing
• 4.10 Improvement
• 4.11 Corrective action
• 4.12 Preventive action
• 4.13Control of Records

26
• 4.14 Internal Audit
• 4.15 Management Review meeting-
(Suitabiliy,Reports of Supervisor, Internal
Audits, Corrective & Preventive Action,
Assessment by External Bodies, results of
ILC/PT,Changes in volume of work,
Customer Feedback, Complaints,
Recommendations for
Improvement,QC,resources,Training etc.)

27
Technical Requirements: (Clause 5.1- 5.10.9)
5.1 General:
• Human factors and Handling of test items
• Accommodation and environment
• Selection of methods
• Test methods and method Validation
• Equipment calibration
• Measurement traceability
• Handling of test items
28
5.2 Personnel
 Number required for workload
 Qualifications and experience
 Responsibilities and authorities
 Job descriptions
 Performance criteria and performance
appraisal
 Training needs identification
 Training records
 Continuing education
29
5.2 Personnel
 Number required for workload
 Qualifications and experience
 Responsibilities and authorities
 Job descriptions
 Performance criteria and performance
appraisal
 Training needs identification
 Training records
 Continuing education
30
5.3 Accommodation & Environmental Conditions
(Facilities for testing, Whether environmental conditions affect
results, monitoring of environmental factors,ie sterility of room,
dust, electromagnetic disturbances,humidity,Temoerature,Sound
levels etc),Separation between neighboring areas, avoidance of
incompatible activities,cross contamination etc.)

5.4 Test & Calibration Methods & Method

Validation
Appropriate methods of Testing,handling,transport,Storage,
Calibration,Insructions,Standards,Manuals,Reference Data,
Should be readily available, Only documented deviation
permissible, validated Methods,MU estimation, Data Control,

31
 5.5 Equipment

5.6 Measurement Traceability

• Calibration status
• Testing
• Reference Standards & Reference Materials
• Intermediate Checks
• Transport & Storage
• Records of all equipments and software
• Details of damage, repairs

32
5.7 Sampling

5.8 Handling of test items Assuring of quality of

Test Results
(Transportation,Receipt,handling,Protection,Stora
ge,Retention,Disposal)

5.9 Assuring Quality of Test /CalibrationResults

(Use of CRMs,Participation in ILC/PT
programmes,Replicate Tests, Retesting of
calibration of retained items)
33
5.10 Reporting the Results
(Report Accuratey,Clearly,Objectively,in accordance to the
Scope.Use standard format,Incorporate all the
Customer’s needs
Standard Format includes-
Title
Name & address of Customer Lab.
Name & Address of Customer
Unique Identificaion Number
Condition of the tested item
Date of receipt
Test Results with Unit of Measurement
Name,Function,Signatureof authorized Person
Statement that the result pertains to the tested sample only.
Deviations if any ,
Calibration Certificates if demanded
Opinions & Interpretations,Electronic transmission details.)
34
 Preparations Required By A Laboratory Before
Applying For Accreditation

Nominate a responsible person to coordinate all activities related to

seeking accreditation.

Nominate a Quality Manager who is familiar with laboratory's

existing Quality System..

Nominate a Technical manager well conversant with the technical

aspects of analysis

Procure all relevant NABL documents from NABL Secretariat and

get fully acquainted with each of these. (as given in the next slide.)

Ascertain the status of existing Quality System and Technical

Competence with regards to requirements for NABL Accreditation.

Check if the system is well documented and effective or does it

need modification.
 Pre-Requisites for Laboratories seeking NABL
Accreditation
 Laboratory shall be legally registered so that it can be held responsible for the
testing and / 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 wishes to seek accreditation.

 Laboratory must comply with all the requirements as laid down in the Standard
ISO/IEC 17025, relevant Specific Criteria and other NABL documents.

 Ensure that all test equipment in the laboratory are timely & properly calibrated only
by NABL certified agencies and have traceability to National / International
standards.
 Pre-Requisites for Laboratories seeking NABL

Accreditation (Contd.)
 Complete one Internal Audit covering all clauses of ISO/IEC 17025

 Conduct a Management Review Meeting as per ISO/IEC 17025:2005.

 Participate in at least one Proficiency Testing/ILC Programme conducted by

NABL or other reputed national or international organizations in accordance
with the international standard ISO/IEC. Guide 43.
 Maintain records of a) Analysis b) Calibration (of Glassware, Equipment) c)
AMC d) Environmental Factors e) Stock Solutions f) CRMs g) Chemicals,
Apparatus, Instruments, Equipment, Breakage Registers etc.
 Get calibration of instrument/equipment done only by NABL certified
agencies only.
PRE-REQUISITES FOR LABORATORIES SEEKING
NABL ACCREDITATION (Contd.)

Prepare Quality Manual and verify its contents, as per " Guide for
Preparing Quality Manual" (NABL 160). Prepare Standard Operating
Procedures for operation of Instruments, In-House Calibration,
Maintenance of Records etc.

Remember Quality Manual is a policy document, which has to be

supplemented by a set of other documents like Procedural Manuals,
Work Instructions etc.

Ensure that procedures described in the Quality Manual and other

documents are being implemented.

Train personnel in Laboratory Quality Management System,

Internal Audit and MU conducted by NABL

Discuss relevant requirements for NABL accreditation amongst

concerned staff of the laboratory. This will enable them to understand
their weaknesses and strengths.
 Stages of Accreditation

• Filling of NABL Application Form

• Pre-Assessment visit by NABL Authorities

• Closure of Non-conformances

• Final Assessment by NABL

• Validity of Accreditation

39
 Process of Accreditation
Stage I
Fill up the application form for NABL
accreditation, giving all desired information as per
NABL 131/151
Enlist the test(s) along with range and
measurement uncertainty as per scope.
 Laboratory can apply either for all or part of its
testing facilities.
 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. 40
Laboratories are required to submit
• 3 sets of NABL 131/151
• duly filled in application forms for each
field of testing / calibration
• 2 sets of Quality Manual and
• Internal Audit Report
• Application Fees.
Note- Special care is to be taken to fill the
SCOPE of accreditation

41
 After scrutiny of application by NABL–
• A unique Customer Registration
Number will be allocated to laboratory
for further processing of application
• Lead Assessor nominated for giving
Adequacy Report on the Quality
Manual / Application submitted
• The laboratory shall submit Corrective
Action Report.

42
 Stage II

Pre-Assessment audit by NABL –(after

satisfactory Corrective action Report)
• Carried out 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.
Laboratory must carry Internal-Audit before
Pre-assessment
43
• 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 organised by NABL.
44
 Stage III
• NABL Secretariat organizes the Final
Assessment at the laboratory site(s) for its
compliance to NABL Criteria and for that
purpose appoints an Assessment team.

• The Assessment Team shall comprise of a

Lead Assessor and a Technical Assessor(s)
in the relevant fields depending upon the
scope to be assessed.

45
• 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.

• The Lead Assessor will provide a copy of

consolidated report of the assessment to
the laboratory and send the original copy
to NABL Secretariat.
46
• 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.

 Laboratory shall have to take corrective

action on any concerns raised by the
Accreditation Committee.

47
 Stage IV
• 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.

48
 Laboratory shall take corrective action on any
concerns raised by the Accreditation Committee
 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 assessed.
49
 Stage V
• Accreditation Committee shall make the
appropriate recommendations regarding
accreditation of a laboratory to NABL
Secretariat.
• Accreditation to a laboratory shall be valid
for a period of 2 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.
50
 Summary
• Documentation - Mainly Quality Manual
and procedural Manuals (SOPs)
• Procurement of Reference standards and
materials
• Calibration of Equipment & Glassware
• Inter-laboratory comparison/ Proficiency
testing
• Measurement uncertainty/ Z score
• Submission of application to NABL
51
A unique Customer Registration Number

Lead Assessor nominated for giving Adequacy
Report on Quality manual &application

Corrective Action Report by Lab

Pre-Assessment audit by NABL

Corrective Action Report submitted to NABL
Secretariat.


52
Final Assessment - by an Assessment team(Lead
assessor & Technical Team)

Non-Conformance(s) (Raised and closed)

correction by Laboratory within 2 months

Accreditation Committee examines the findings of
the Assessment

Accreditation Committee determines whether the
recommendations in the assessment report is
consistent with NABL

53
 Accreditation Committee
recommendations regarding accreditation
of a laboratory to NABL

Accreditation to a laboratory shall be valid
for a period of 2 years and NABL

Periodical Surveillance after one year

Renewal after 6 months
54
• Directory of NABL Accredited Laboratories
- published at regular intervals , which
contains laboratories' contact details and
information on their Scope of Accreditation
• Documents necessary for Accreditation
(free/ paid)

www.nabl-india.org

55
Is Accreditation A One-time Phenomenon...?

NABL accreditation is not a one-time phenomenon.

Valid only for a period of 2 years

 NABL conducts periodical surveillance of the laboratory on

annual basis.

 Laboratory has to apply for renewal of accreditation to NABL

at
least 6 months before the expiry of the validity of
accreditation. 
 What is Mutual Recognition Arrangement (MRA) with
international bodies and what are the benefits of such
arrangements for the laboratories accredited by NABL...?
Many countries around the world have a formally recognized
organization responsible for the accreditation of their
laboratories.(In India it is NABL.) Most of these accreditation
bodies are presently following ISO/IEC 17025 as the basis for
accrediting their country's testing and calibration laboratories.

Adoption of international standards has helped countries

employ a uniform approach to determine laboratory
competence. It has also encouraged laboratories to adopt
internationally accepted testing and measurement practices
where possible.
 
Uniform approach allows accreditation bodies to establish
arrangements between themselves through APLAC and EA peer
evaluation by an expert team appointed by APLAC / EA MRA/MLA
councils based on mutual evaluation and acceptance of each other's
laboratory accreditation systems.

Such international arrangements, called Mutual Recognition

Arrangement, are crucial in enabling test data to be accepted
between countries. In effect, each partner in such an agreement
recognizes the other partner's accredited laboratories as if they
themselves had undertaken the accreditation of the other partner's
laboratories.

The international mutual recognition arrangements between

accreditation bodies arrived on the basis of peer-evaluation have
enabled accredited laboratories to achieve international recognition,
and allowed test data accompanying exported goods to be readily
accepted in overseas markets. This effectively reduces costs for both
the exporters and the importers, as it reduces or eliminates the need
for products to be re-tested in another country. ILAC MRA is effective
from 31.01.01
Countries without viable accreditation systems can seek to
have their laboratories accredited by established accreditation
systems, so that their test data and associated goods can be
accepted in foreign markets. These countries can also
endeavour to develop their own accreditation system based
on the structure and experience of established systems in
other countries.

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.
No Name of Document Document Price
Number Rs.
1 General information brochure NABL - 100 Free
2 Terms and conditions for Maintaining NABL - 131 Free
Accreditation
3 NABL Guidelines to Accredited NABL - 133 Free
Laboratories for use of NABL Logo
4 Guidelines for Estimation and Expression NABL - 141 250/-
of Uncertainty of Measurement
5 Policy on Calibration and Traceability of NABL - 142 Free
Measurements
6 Application Form for Testing Laboratories NABL - 151 Free
7 Guide for Preparing a Quality Manual NABL - 160 250/-
8 Guide for Internal Audit and Management NABL - 161 200/-
Review for laboratories
9 Policies and Procedures for inter-laboratory NABL - 163 Free
comparisons and / or Proficiency Testing
10 Master list of NABL documents NABL - 200 Free

11 Pre-assessment Guidelines and Forms NABL - 209 Free

12 Interpretation of the Accreditation Criteria and NABL – 211 100/-

Guidelines for Assessment
13 Guideline document on Validation of Test NABL – 212 100/-
Methods
14 Policy and Procedures for assessment, NABL – 214 Free
Surveillance & Re-assessment of laboratories

15 Policies & Procedures for dealing with Adverse NABL - 216 Free
Decisions
 NABL Newsletters
NABL publishes Newsletter on quarterly basis. NABL regularly
sends the newsletter to all the empanelled assessors and
accredited as well as the applicant laboratories.
 
Proficiency Testing programmes organized by NABL or APLAC

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-ordinator 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
(www.aplac.org)
 Training courses offered by NABL

NABL conducts following training courses regularly:

NABL Assessor Training

5-day residential course designed for experts with technical
knowledge and current experience of working in a laboratory to
train them as NABL Technical Assessors for conducting on site
assessment of laboratories that perform testing and calibration.
Laboratory Quality System, Management & Internal Audit
Training
4-day course is designed for senior laboratory personnel
involved in the management and establishment of laboratory ‘s
Quality System, and establish / manage an Internal Audit
programme for their laboratories as required by NABL Criteria
& International Standard ISO/IEC 17025.
 
 Use Of NABL Symbol
Use NABL symbol on letterhead, test / calibration reports and any other
relevant documents.
Use for identifying correctly and unambiguously the test / calibration services
accredited by NABL.
Ensure that design and its manifestations are not distorted,
Can be reproduced in any single color (preferably black) and any size.
use of symbol should not misrepresent the scope of accredited testing /
calibration services.
 When accreditation sought and granted does not cover all the activities of the
laboratory's services care should be exercised to 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 use a letterhead without NABL symbol or
specially identify those tests/ measurements which are not covered by
accreditation..
THANX FOR LISTENING