Facility and Requirement for NABL –ISO/IEC 17025:2017

 


                The sole purpose of the NABL-ISO 17025 is to provide third-party assessment to ensure          excellent quality and technical competence of testing and calibration laboratories, which enables the 
government and the industry to streamline and maintain the standardized quality environment.

ISO/IEC 17025:2017 describes two options for fulfilling the management system requirements, Option A & Option B. Besides meeting the requirements of Clause 4 to clause7 of ISO/IEC 17025:2017, the laboratory shall also implement a management system according to Option A or B.

Option A

Laboratory shall address the requirements of as a bare minimum.

Option B

If a laboratory has established and maintains management system in accordance with the requirements of ISO 9001:2015, these may be referred against the requirements of clause of ISO/IEC 17025:2017 in the laboratory’s quality management system. Compliance to these requirements shall be verified during on-site assessment by NABL.

Management System Documentation (Option A)

Laboratory management shall establish, document, and maintain policies and objectives for the fulfillment of the purposes of ISO/IEC 17025: 2017 and shall ensure that the policies and objectives are documented, acknowledged and implemented at all levels of the organization. Laboratory shall have a management system document / Manual (howsoever named) for the purpose of compliance to ISO/IEC 17025: 2017.

Laboratory shall control the documents that fulfills the requirements of this Clause.

 Laboratory should be able to explain in detail how it addresses risk in carrying out its activities, albeit, standard ISO/IEC 17025:2017 does not define any standard method or risk management process, but it may be more difficult to demonstrate compliance without risk management approach.

Internal audit Laboratory shall conduct internal audit at least once in a year covering all elements of ISO/IEC 17025: 2017. This may be done all at once or scheduled throughout the year depending on the scope and size of the laboratory. Internal auditor shall be well conversant with Laboratory’s operations / activities and the requirements of ISO/IEC 17025:2017.

Facilities

 Calibration Facility

Testing / Calibration performed by staff of a laboratory or entity at the customer premises or location outside of a permanent laboratory.

 Mobile Facility

Fully equipped, self-contained, transportable testing or calibration facility capable of performing tests / calibrations under controlled environmental conditions.

The organization and management structure of the laboratory can be in various forms i.e. individual laboratory at single location, laboratory being part of larger organization, laboratory with multiple locations, laboratory in Public Private Partnership (PPP) mode etc. For Public Private Partnership (PPP), accountability of test reports / calibration certificate issued, shall lie with the laboratory as per the contractual agreement, albeit, such agreement shall be devised on long term basis (Minimum 02 years).

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