Content of Equipment Record on NABL-ISO/IEC 17025:2017


The technical requirements have been sub-divided into two sections. The first section includes the general requirements applicable to most of the disciplines and the second section includes discipline wise requirements.

Personnel

As per the latest Notification issued by Ministry of Health & Family Welfare (MoHFW) dated 18th May, 2018 notifying Clinical Establishment (Central Government) Amendment Rules, 2018, all laboratories are required to comply with it as applicable.

Note 1: If the above notification is not applicable, laboratory may give valid justification by producing evidence of alternate applicable rules and regulations.

In all cases, it is the responsibility of laboratory to abide by the National/ Regional/ State/ Local regulatory requirements/ Acts/ Rules/ Legal orders/ Court Decisions/ Orders issued by Government/ Statutory Bodies as applicable and effective from time to time.

Laboratory Director/Head of Laboratory/Technical Head (Howsoever named) shall have the overall responsibility of operations of the laboratory. For review, evaluation and release of results, he may delegate selected duties/ responsibilities to qualified personnel.

Note 2: NABL is a voluntary accreditation body and has no statutory powers. Checking of compliance to the regulatory requirements falls under the purview of respective/applicable regulator.

Verification of all automated / semi-automated systems is also required and includes precision, accuracy, carryover and wherever applicable, linearity.

The laboratory shall check each lot of control and reagent against an earlier tested in-use control / reagent lot. The laboratory can follow guidelines mentioned in Annexure. Records of comparative data shall be maintained.

The equipment shall be calibrated from NPL, India or a calibration laboratory accredited by NABL or any MRA partners, accredited for the specified scope.

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