The ISO/IEC 17025 standard was revised in 2017, twelve years after the 2005 edition. The revision aligned the quality-management-system approach with ISO 9001:2015 and introduced a risk-based framework.
1. The Structure of the Standard Changed
The 2005 edition was structured under two main headings, “Management Requirements” and “Technical Requirements.” The 2017 edition is divided into five main headings:
- General requirements (impartiality, confidentiality)
- Structural requirements
- Resource requirements
- Process requirements
- Management system requirements
2. Risk-Based Thinking
The most critical new element is the systematic management of risks and opportunities. Laboratories must now identify risks that could affect their impartiality, the validity of their activities and customer satisfaction, and plan preventive actions.
3. Decision Rule
On certificates that include a statement of conformity, the decision rule must be clearly defined. The criterion by which “conforming/non-conforming” statements are made — taking measurement uncertainty into account — must be stated, and agreed with the customer in advance.
4. Impartiality Assurance
The 2017 edition places much stronger emphasis on the concept of impartiality. Top management must commit to impartiality in writing and continuously monitor impartiality risks.
5. Quality Manual No Longer Mandatory
The 2017 edition removed the requirement for a Quality Manual. Instead, any documentation structure that can demonstrate the laboratory meets the management-system requirements is accepted.
6. Personnel and External Providers
The “subcontractor” concept of the previous edition was replaced by the broader term “externally provided products and services.” The processes for evaluating and monitoring external services were clarified.
Transition tip
For laboratories moving from 2005 to 2017, the biggest challenge is institutionalising risk analysis. Start early and be diligent about keeping records.
Conclusion
ISO/IEC 17025:2017 is a modern standard that increases the quality and reliability of laboratory activities. Fully adopting these new approaches is critical to competing in the calibration sector.