Scope and Applicability of ISO/IEC 17025

Consider the following users and laboratory activities when applying the standard:

1. Users of the standard

• Testing and calibration laboratories.
• Laboratory customers.
• Regulators and accreditation bodies, including the VILAS programme, using the standard to assess or recognize laboratory competence.

2. Types of laboratories

• First-party laboratories serving internal testing or calibration needs.
• Second-party laboratories associated with customers or commissioning organizations.
• Third-party laboratories, including regulatory laboratories, independent research laboratories and testing or calibration service providers.
• Laboratories operating at permanent facilities, away from permanent facilities, in associated temporary facilities or as mobile laboratories.

3. Relationship with ISO 9001

The original article referred to older ISO 9001/9002 editions and clause 1.6 of an earlier ISO/IEC 17025 edition. Those historical references should not be used as the basis for a current conformity claim. ISO/IEC 17025:2017 includes management system requirements as well as specific requirements for laboratory competence.

ISO 9001 certification alone does not demonstrate a laboratory’s technical ability to produce valid test or calibration results. ISO/IEC 17025 accreditation and ISO 9001 certification have distinct purposes and are separate recognition processes.

ISO/IEC 17025:2017