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| Why
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 globalisation of Indian economy and the liberalisation
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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| Benefits
of Accreditation |
Formal
recognition of competence of a laboratory by an Accreditation
body in accordance with international criteria has many
advantages: |
- Potential increase in business due to enhanced customer
confidence and satisfaction.
- 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 and feedback
to laboratories as to whether they have sound Quality
Assurance System and are technically competent.
- Increase of confidence in Testing / Calibration
data and personnel performing work.
-
Customers can search and identify
the laboratories accredited by NABL for their specific
requirements from the Directory of Accredited Laboratories.
- 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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| Scope
of Accreditation |
| 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
- Haematology 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 e.g. textiles, plastics, building
materials, metallurgical products, shall have to apply
in relevant field(s) separately depending upon to which
field(s) the test(s) belongs. |
The
accreditation granted to a laboratory shall remain valid
for a period of 2 years subject to satisfactory periodical
(annual) surveillance. Laboratory also has an option
to widen the scope of accreditation in terms of specific
tests and calibrations. NABL has established policies
and procedures for granting, suspending and withdrawal
of accreditation of accreditation in accordance with
ISO/IEC 17011:2004 |
Directory
of NABL Accredited Laboratories is published at regular
interval, which contains laboratories' contact details
and information on their Scope of Accreditation. |
| Assessment
Criteria |
The
laboratories seeking accreditation are assessed in accordance
with ISO/IEC 17025 for testing and calibration laboratories and
ISO 15189:2003 for medical laboratories.A laboratory
wishing to be accredited by NABL must have a Quality
Manual on its Quality System satisfying the requirements
as described in various clauses of ISO/IEC 17025 or ISO 15189 standard.
Quality System documentation and its implementation
by the laboratories shall be verified by the Assessors
for its compliance in accordance with ISO/IEC 17025 or ISO 15189
standard. The laboratory management shall demonstrate
to the NABL Assessment Team that all requirements as
laid down in the ISO/IEC 17025/ISO 15189 standard, Specific Criteria
and other Guidelines / Requirements of NABL are being
followed. All applications for accreditation shall have
to be in accordance with ISO/IEC 17025 or ISO 15189 Standard. |
Modifications
to the Accreditation Criteria |
If
NABL modifies the accreditation criteria, it shall inform
the laboratory of this in writing giving a transition
period of at least 6 months to the laboratory to align
in accordance with the modified criteria. |
| Appeal |
All
decisions regarding accreditation to laboratories shall
be open to appeal to NABL by laboratories and their
users. Decision by NABL after investigation of appeal
shall be final. |
|
Stage
I |
- 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 & 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 three sets
of duly filled in application forms for each field
of testing / calibration along with two 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.
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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. |
Stage
II |
- 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 organised by NABL.
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| Stage III |
- NABL Secretariat shall organise 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.
- 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.
|
Stage
IV |
- After satisfactory corrective action by the laboratory,
the Accreditation Committee examines the findings
of the Assessment Team and recommend 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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| Stage V |
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