Laboratory Accreditation - Procedural Guidelines
Laboratory Accreditation - Procedural Guidelines
Laboratory Accreditation - Procedural Guidelines
Accreditation is the formal recognition, authorization accreditation. The laboratory should carry out the
and registration of a laboratory that has demonstrated following important tasks towards getting ready for
its capability, competence and credibility to carry out accreditation:
the tasks it is claiming to be able to do. It provides
feedback to laboratories as to whether they are 1. Contact NABL Secretariat with a request for
performing their work in accordance with international procuring relevant NABL documents (NABL
criteria for technical competence. Contact address and the list of NABL documents
given in Annexure-3 and 1, respectively).
The concept of laboratory accreditation was developed 2. Get fully acquainted with all relevant documents
to provide third-party certification that a laboratory is and understand the assessment Procedure and
competent to perform the specific test or type of tests. methodology of making an application.
Laboratory accreditation is a means to improve
customer confidence in the test reports issued by the 3. Train a person on Quality Management System
laboratory so that the clinicians and through them the and Internal Audit (4-day residential training
patients shall accept the reports with confidence. courses conducted by NABL. Contact NABL
Secretariat for details).
The National Accreditation Board for Testing and 4. Prepare QUALITY MANUAL as per ISO 15189
Calibration Laboratories (NABL) is an autonomous standards.
body under the aegis of the Dept. of Science &
Technology, Govt. of India, and is registered under the 5. Prepare Standard Operating Procedure for each
Societies Act. NABL, which was initially established investigation carried out in the laboratory.
with the objective to provide accreditation to testing & 6. Ensure effective environmental conditions
calibration laboratories, later on extended its services (temperature, humidity, storage placement, etc.).
to the clinical laboratories in our country. 7. Ensure calibration of instruments / equipment.
Govt. of India has authorized NABL as the sole Only NABL ACCREDITED CALIBRATION
accreditation body for testing and calibration LABORATORIES are authorized to provide
laboratories. The objective of NABL is to provide third calibration. NABL website gives the names of
party assessment of quality and technical competence. NABL accredited calibration laboratories in the
Four years ago NABL established links with various fields of Accreditation.
international bodies - Asia Pacific Laboratory 8. Impart training on the key elements of
Accreditation Cooperation and International documentation, such as document format,
Laboratory Accreditation Cooperation. This has authorization of document, issue and withdrawal
imparted international recognition to NABL accredited procedures, document review and change, etc.
laboratories. The international standard currently Each document should have ID No., name of
followed by NABL is ISO 15189, specific for medical controlling authority, period of retention, etc.
laboratories.
9. Ascertain the status of the existing quality system
Getting Ready for Accreditation and technical competence with regard to NABL
standards and address the question “Is the
It is very important for a laboratory to make a definite system documented and effective OR does it
plan for obtaining accreditation and nominate a need modification?”.
responsible person as QUALITY MANAGER (who
should be familiar with the laboratory’s existing quality 10. Remember Quality Manual is a policy document,
system) to co-ordinate all activities related to seeking which has to be supplemented by a set of other
next level documents. Therefore ensure that these
documents are well prepared.
Author for Correspondence :
11. Ensure proper implementation of all aspects that
Dr. A.S. Kanagasabapathy have been documented in the Quality Manual and
Kamineni Hospitals Ltd., other documents.
L.B. Nagar,
Hyderabad - 500 068, India
ANNEXURE-1
NABL PUBLICATIONS (Essential for clinical laboratories) (as on July 1st, 2005)
ANNEXURE-2