ISO/IEC 17025 Structure, Applicability and Implementation Conditions

ISO lists ISO/IEC 17025:2017 as the current edition. Its main requirement groups cover general, structural, resource, process and management system requirements. The historical discussion below concerns earlier editions; ISO 9001/9002:1994 references are not current implementation requirements.

ISO/IEC 17025:2017

1. Structure and historical development

The original article discusses how laboratory requirements fit organizations that combine calibration with other activities, such as:

• National metrology institutes maintaining and developing national measurement standards and performing calibrations based on them.
• Manufacturers that produce measuring instruments or other products and also perform calibration.
• Organizations combining instrument repair with calibration.

Laboratory activities may be accredited to ISO/IEC 17025 within a defined scope, while a broader organizational management system may address other activities. Integration can avoid unnecessary duplication. Earlier editions organized requirements into two main groups:

• Management requirements, historically aligned with ISO 9001/9002:1994 and including impartiality requirements.
• Technical requirements specific to laboratory and measurement activities.

The historical approach combined relevant ISO 9000:1994 management principles with laboratory-specific ISO/IEC 17025 requirements.

Historical alignment with ISO 9001:2000

The original article describes the transition towards ISO 9001:2000, with transition activities continuing through 2003 and revision work discussed by CASCO/WG25 from 2001. It refers to a planned periodic review around 2004 and contemporary concerns about overlap between accreditation and quality management system certification. These are historical observations, not current implementation requirements.

The historical discussion emphasized that the standards should be compatible while retaining the distinct purpose of laboratory competence assessment. It reported the following revision principles:

• ISO/IEC 17025 should not be treated as a component of ISO 9001.
• ISO/IEC 17025 should remain a stand-alone standard.
• ISO/IEC 17025 should not simply reproduce ISO 9001:2000 in full.
• References to ISO 9001 should remain in ISO/IEC 17025.
• Changes to ISO/IEC 17025 should be limited where practicable.
• The revision discussed at that time did not require changes to the technical requirements.

The original article presents these principles as the viewpoint of accreditation stakeholders and laboratories during that historical revision.

Historical reference: ISO Focus, May 2005

2. Who can use ISO/IEC 17025?

• Testing and calibration laboratories.
• Laboratory customers.
• Regulators and accreditation bodies assessing or recognizing laboratory competence.

3. Conditions for implementation

• Leadership commitment.
• Understanding of ISO/IEC 17025 requirements and relevant technical disciplines.
• Suitable laboratory infrastructure, equipment and testing facilities.