ISO/IEC 17025 is the most popular standard used to ensure the competence of testing and calibration laboratories and their ability to generate valid test reports.
It also facilitates cooperation and acceptance of reports among laboratories around the world.
Although there are many similarities with the ISO 9001 standard, ISO 17025 focuses more specifically on laboratories that produce testing and calibration results.
The latest updated version of ISO 17025 puts emphasis on the role and responsibilities of senior management, as well as the specific requirements for continual improvement.
Often, when a standard is updated, questions arise with relation to the changes. Here are some frequently asked questions and answers addressing both testing and calibration laboratories.
10 FAQ’s about ISO/IEC 17025
- When was the Latest Version of ISO/IEC 17025 updated?
The International Organization for Standardization updated the standard on November 29, 2017.
- When was the standard reviewed for the last time?
ISO standards are usually reviewed once every five years. The last review of ISO/IEC 17025 took place in 2010. This time, a decision was made that the standard should not be amended. Before the 2017 version, the 2005 version took place. If we take a look at the history of the standard, we will find that the most remarkable modification was made in 1999, when the ISO/IEC Guide 25 was replaced by ISO/IEC 17025.
- How is the assessment conducted against the new version?
As per the General Accreditation Guideline of ISO/IEC 17025:2017, gap analysis and general accreditation criteria transition policy are two tools through which the assessment is performed. The policy includes a checklist that identifies the new requirements.
Accredited laboratories should complete the implementation checklist and provide the evidence (ie. policies, procedures, and records) demonstrating compliance with the newly revised version. This implementation checklist fulfillment is one of the major requirements of ISO 17025.
- If the laboratories were not transitioned prior to the cut-off date, what would the consequences be?
If a facility is not accredited to the revised version of ISO 17025 within November 29, 2020, it will be categorized under the ILAC MRA.
- What should a laboratory do to transit to the Standard in Advance?
If a laboratory wishes to transit to the new version of the standard in advance, then it can be possible by arranging a chargeable visit as detailed in the general Accreditation Criteria of ISO 17025 certification.
- How should an organization deal with corporate accreditations?
As per the official notification, every facility was notified to be assessed against the new version of the standard after August 1, 2018. Laboratories having corporate accreditations can be assessed after August 1, 2018 as well.
- Should a laboratory rewrite the quality manual in order to maintain the same structures as it is outlined in ISO/IEC 17025:2017?
No, this is not mandatory. However, an organization can rewrite their quality manual, if they believe it to be necessary and beneficial for their business.
- The new version requires participation in external proficiency programs, which was not explicitly stated in the 2005 version. Is it possible to change the general requirements of this standard?
No, there is no such possibility.
- Have the requirements associated with the metrological traceability changed?
No. The metrological traceability requirements remain unchanged in ISO/IEC 17025:2017 version.
- Does the new version of the standard preclude the topmost approach for identifying the measurement uncertainty?
No. The new version does not recommend how uncertainty measurement can be performed.
Click below for a two-minutes video explaining the main changes to ISO/IEC 17025