Shivanna Mahabir-Lee In late 2017, the third edition of the ISO/IEC 17025 standard was published. This is the latest revision of the standard on which testing and calibration laboratories base their Quality Management Systems.
Some of the changes to the older 2005 version, such as the new structure and the less prescriptive nature of the 2017 standard, are in keeping with changes to other ISO standards, and with the objective to closer align it to the ISO 9001:2015 standard. In this article, you’ll find a brief ISO/IEC 17025:2017 vs. ISO/IEC 17025:2005 comparison.
Change in the structure
The revised structure split the previous two main clauses 4 and 5 (Management and Technical Requirements) into a more logical flow of requirements, across five clauses (4 to 8). These emphasize the process approach encouraged by ISO. Two Annexes are available, one on Metrological Traceability and the other providing an explanation on the options to integrate an ISO 9001 management system.
Together, clauses 4, 5, and 8 contain the majority of the Management Requirements from the 2005 standard.
- Clause 4 deals with General Requirements, especially with regard to impartiality and confidentiality.
- Clause 5 deals with Structural Requirements, i.e., the organizational structure of the laboratory.
- Clause 8 deals with Management System Requirements, i.e., quality procedures.
Clauses 6 and 7 in the 2017 standard contain most of the Technical Requirements of the older standard, with a few Management Requirements thrown in. These technical clauses are arranged to flow naturally with the process of testing or calibration within a laboratory.
- Clause 6 deals with Resource Requirements, the inputs to the testing or calibration process that impact the laboratory’s ability to consistently and competently provide its services.
- Clause 7 contains the Process Requirements, flowing from the receipt of the request for sampling, testing, or calibration to the issue of the report and any complaints and nonconforming work arising.
Change from procedure-based to performance-based
The ISO/IEC 17025:2017 standard gives laboratories the flexibility to develop their management system as they see fit, as long as they are able to provide evidence that they have met the requirements and can consistently apply and follow their chosen process. Overall, the 2017 version of the standard is more risk-based and less procedure-based. For example, the 2005 standard required a Quality Manual and procedures for document control and internal audits, whereas the newer version does not strictly call for them.
Focus on impartiality, competence, and consistent operations
Throughout the ISO/IEC 17025:2017, there is a focus on the “competence, impartiality and consistent operations of laboratories.” Impartiality is considered so important that it now has its own clause, which is the first in the standard. The focus on all three gives added confidence in accredited laboratories to deliver valid results to their customers.
Addition of sampling to laboratory activities
The definition of a laboratory has also been broadened in the new version of the standard. Previously, the standard was applicable to testing and calibration laboratories, but the newer version allows for organizations that conduct sampling for subsequent testing (at their own facilities or others) to also obtain accreditation for this activity.
Recognition of electronic-based systems and records
A lot has changed in terms of information technology since 2005. The newer version of the standard acknowledges these changes and recognizes that processes, reports, and records may now be electronic-based.
Greater alignment with ISO 9001
The Management System Requirements of clause 8 in ISO/IEC 17025:2017 is now divided into Option A and Option B. The latter allows for laboratories that already have ISO 9001 management systems in place and can show that they consistently fulfill the requirements of clauses 4 to 7 to have inherently satisfied clause 8. Otherwise, a laboratory would select Option A and follow the specified requirements of clause 8.
Risk-based approach
Similar to ISO 9001 and other Quality Management Standards, the new version of the ISO/IEC 17025 standard takes a risk-based approach. Previously, there was a section on preventive action, which required the laboratory to consider possible risks before a nonconformity occurred. The term “preventive action” has now been removed, but laboratories are required to consider both risks and opportunities associated with their activities and take appropriate action. Risks to impartiality must also be considered.
Decision rule
The final new addition to the standard to be discussed is the application of the decision rule to statements of conformity. The laboratory must document and state its decision rule and apply it when determining if test results conform to a specification or standard. The decision rule must consider the level of risk of falsely accepting or rejecting a result, as well as the measurement uncertainty of the result, before reporting whether or not it conforms to the specification.
ISO/IEC 17025:2017 introduces greater flexibility and focus on results
Although most people are not fond of change, the modifications to the ISO/IEC 17025 standard should not be too difficult for laboratories to implement and are actually meant to introduce greater flexibility. Additionally, due to the recognition that important decisions are made based on test results, there is a greater focus in this revision on ensuring that laboratories can produce valid and reliable results.
To learn more about ISO/IEC 17025:2017 implementation, download this free Diagram of ISO 17025 Implementation Process.
