ISO/IEC 17025:2017: What the New Edition Means for Laboratories
The 2017 edition of ISO/IEC 17025 was published in November 2017. It restructures the standard, introduces risk-based thinking and gives more weight to impartiality.
Key points
- ISO/IEC 17025:2017 was published in November 2017 and replaces the 2005 edition.
- The standard is restructured around general, structural, resource, process and management system requirements.
- Laboratories must manage risks to impartiality and state decision rules when reporting conformity.
A new structure
The two large clauses of the 2005 edition, management requirements and technical requirements, are replaced by a process-based structure. The requirements now follow the flow of work in a laboratory, from the request to the report.
The main changes
- Impartiality and confidentiality have their own clause, and risks to impartiality must be identified continuously.
- Risk-based thinking replaces preventive action.
- Decision rules must be documented when a statement of conformity is given.
- Option A or Option B for the management system: Option B recognises a system that meets ISO 9001.
- Electronic records and laboratory information systems are explicitly recognised.
What laboratories should do
Accredited laboratories have a transition period of three years. Map your current procedures to the new clauses, review how impartiality risks are recorded, and agree with customers the decision rule you will apply to conformity statements.