Understanding NABL accreditation / ISO 17025 and its requirements

Understanding NABL accreditation / ISO 17025 and its requirements

NABL stands for National Accreditation Board for Testing and Calibration Laboratories.
NABL accreditation is a formal recognition of the technical competence of a testing, calibration or medical laboratory. It has been established with the objective to provide Government, Industry Associations and Industry in general with a scheme for third-party assessment of the quality and technical competence of testing and calibration laboratories. NABL provides laboratory accreditation services to laboratories that are performing tests / calibrations in accordance with ISO/IEC 17025:2005 and ISO 15189:2007 for medical laboratories. These services are offered in a non-discriminatory manner and are accessible to all testing and calibration laboratories in India and abroad, regardless of their ownership, legal status, size and degree of independence.

Mandatory documents for ISO 17025.

All laboratories seeking or maintaining accreditation must comply with all policy and requirements documents listed below.

All laboratories should have an official copy of ISO/IEC 17025.
A copy of the General Requirements for Accreditation.
Conditions for Accreditation.
Proficiency Testing Requirements and Annex.
Traceability Policy.
Advertising Policy.
If laboratory performs testing and/or calibration at sites other than the permanent laboratory premises additional policies may be applicable such as, Uncertainty for Testing Laboratories and field-specific annexes to the measurement uncertainty policy and Field Calibration Measurement Uncertainty Policy
How to get ISO 17025 accreditation?

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.

The laboratories seeking accreditation are assessed in accordance with ISO/IEC 17025:2005 for testing and calibration laboratories and ISO 15189:2007 for medical laboratories. A laboratory wishing to be accredited must have a Quality Manual satisfying the requirements as described in various clauses of ISO/IEC 17025 or ISO 15189 standards.

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 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.

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