FAQ: ISO/IEC 17025
Helping you to transition to the new version of ISO/IEC 17025
(Last updated 24 October 2017)
QUESTION 1: When were the last changes to the standard?
The last significant change for laboratories with respect to their quality management systems was in 1999 - the year that ISO/IEC Guide 25 was replaced with ISO/IEC 17025. While there were changes to the standard in 2005, they were minimal and required little effort on the laboratory's part to conform to new or revised requirements. So for many laboratory staff, this is the first time that they are faced with the task of ensuring their documented system continues to meet the new requirements and changes in the newest version of ISO/IEC 17025.
QUESTION 2: When is the start date for accreditation to the revised standard?
Laboratories can be assessed to the revised version of ISO/IEC 17025 one (1) month after publication of the revised standard, subject to assessor availability.
QUESTION 3: Our lab is being assessed in 2018. How does this impact our reassessment?
CALA is in the process of determining how to best approach assessments in 2018. There are numerous challenges and questions to consider prior to making a decision. Laboratories will be informed about plans as soon as they are finalized. That being said, it is recognized that laboratories need time to transition to the revised standard, so for reassessments early in the year, laboratories will have the option of being assessed to ISO/IEC 17025:2005 or the revised version. For reassessments later in the year, the possibility of having to be assessed to the revised version has not been ruled out, as this is one way that CALA can ensure that laboratories conform to the revised standard well in advance of the deadline within their routine reassessment schedule.
QUESTION 4: If our lab is not being assessed until 2019, can I hold off on the transitioning process?
Although laboratories do not have to conform to the new standard until three (3) years after the publication date of the standard, it is not too soon to start planning the transition. In fact, probably the biggest mistake that some laboratories will make is leaving the updates too late. Laboratories need to be mindful of being assessed to the new standard well in advance of the deadline because laboratories have to be accredited to the revised standard by the deadline – not just assessed!
QUESTION 5: Can you assess to 2005 and give B's for new requirements in the 2017 version? Can we get assessed for what is planned and submit proof when complete?
CALA cannot provide a certificate of accreditation to the revised version of ISO/IEC 17025 if a laboratory does not conform to requirements. As noted above, however, CALA is developing plans for the 2018 reassessment cycle and laboratories will be informed of these plans when they are available.
QUESTION 6: Can a transition checklist be added to the process and used as a gap checklist when assessors come on site?
It is the laboratory's responsibility to perform a gap analysis between their documented system and the revised standard. While CALA will be offering training opportunities and providing support to laboratories, the assessment itself is not the best time to be doing this; the purpose of the assessment is to gather objective evidence that requirements are met.
QUESTION 7: In general, what are the steps to start this transition process?
As with any project, the key to a successful transition is planning. Laboratory and quality managers can start planning now, by considering the following steps:
· Plan to purchase the most current version of the standard as soon as possible after it is published. All accredited laboratories must have their own copy of the new version of the ISO/IEC 17025.
· Perform a gap analysis between the laboratory's current system and the new version of the standard. Consider who will be responsible for updating policies and procedures, the timeline, and how the timeline for updates fits in with your reassessment schedule.
· Update documentation and processes as needed.
· Create a training and communications plan.
· Implement the revised system.
QUESTION 8: I've noted that the format of the new version of ISO/IEC 17025 is completely different from the 2005 version. Do I have to re-write my quality manual, so that it's in the same format?
Not at all! There are definitely policies and procedures that will need to be updated, and some new policies and procedures will be required. Remember that the documented quality system is for the laboratory personnel and if you want to maintain the format of your current documented system -- because personnel are familiar and comfortable with it -- you will simply need to update it, create a training and communications plan for laboratory personnel, and then implement the changes.
QUESTION 9: Will CALA policies and procedures (e.g. guidance documents) be updated for assessors?
Yes, we are updating documents for assessors and these will be released as they become available.
QUESTION 10: Is CALA providing interpretive documents?
CALA is updating P07 – CALA Application of Requirements in ISO/IEC 17025:2005. Some of the updates will be simply because of a change in clause number, while other changes may require a more in-depth look at the application in the context of the new wording. Keep in mind that some of the new requirements are new to all stakeholders – including CALA and other accreditation bodies - and that application or interpretation may evolve as we get more familiar with the requirements.
QUESTION 11: If a lab is ISO 9001 certified, my understanding is that their quality system does not need to be assessed? Is this true?
No. Having a system that is certified to ISO 9001 may result in some efficiency during the assessment, but the laboratory must still be able to demonstrate that the system is capable of supporting and demonstrating the consistent fulfillment of the requirements in Clauses 4 to 7. So, while a CALA assessor may not need to assess document control procedures per se, he/she will still need to at least read them during the document review stage, and confirm that the document control procedure used by the laboratory meets the requirements of the ISO 9001 system.
QUESTION 12: If laboratories do not make the cut-off, what is the impact on them?
Three (3) years from the date that the new standard is published, CALA is not allowed to have certificates of accreditation that state conformance to ISO/IEC 17025:2005. Therefore, if a CALA-accredited laboratory is not accredited to the new standard by this deadline, we may have no choice but to suspend the accreditation until the laboratory demonstrates conformance.
QUESTION 13: At what point do labs need to change to 2017 to meet regulatory requirements?
Our advice is to seek clarification from your respective regulators, with reference to the ILAC resolution for a 3-year transition period, as well as the CALA and SCC transition plans.
To assist and support laboratories through the transition, CALA will be offering training opportunities. And remember – the revised standard is new to CALA staff and assessors, too! As we gain more insight into the requirements and more information becomes available, this information will be communicated to laboratories and posted on the CALA web site.