ISO/IEC 17025:2017

By : Admin
15 October 18, 09:12

The general requirements for the competence of testing and calibration laboratories (ISO/IEC 17025) was updated. Now, twelve years later ISO/IEC 17025 has been updated again to take into account new practices, the evolution of technology, and compatibility with ISO 9001.

Laboratories wishing to demonstrate their technical competence can do so via conformity with the international standard ISO/IEC 17025 ‘General requirements for the competence of testing and calibration laboratories’. If you are a lab currently accredited under ISO/IEC 17025:2005 the big questions are, “what has changed and what do I need to do to maintain my accreditation?”

What has changed?

While there are plenty of minor changes (structural and definitions) there are a few major changes. First, the management system requirements have been expanded (clause 4.2 in 17025:2005 vs clause 8 in 17025:2017)

States that at a minimum your management system must address the following which are further defined in the standard:

Management system documentation
Control of management system documents
Control of records
Actions to address risks and opportunities
Improvement
Corrective action
Internal audits
Management reviews

States that your laboratory is in compliance if

You have established and maintain a management system in accordance with the requirements of ISO 9001
You are capable of supporting and demonstrating the consistent fulfilment of the general requirements, structural requirements, resource requirements and process requirements (clauses 4-7 of 17025:2017)
The intent of the management system documentation and management review requirements (clauses 8.2 and 8.9 of 17025:2017) are fulfilled.

Other key changes have been adopted with consideration to the latest version of other standards. There is an overall theme and new section specifically on risk-based thinking which replaces prescriptive requirements with performance-based requirements. This systematic approach to risk again aligns 17025:2017 with the 2015 revision of ISO 9001.