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CALA

S M L

Canadian Association for Laboratory Accreditation Inc.

Building Laboratory Excellence

FAQ 17025:2017

(Last updated 15 December 2017)

General

  1. When were the last changes to the standard?
  2. Where can I obtain more information on the changes to the standard?
  3. If an assessor receives a copy of ISO/IEC 17025:2017, does their laboratory need to purchase a copy?
  4. How do I purchase a copy of ISO/IEC 17025:2017?

Transition Questions

  1. When is the start date for accreditation to the revised standard?
  2. Our lab is being assessed in 2018.  How does this impact our reassessment?
  3. Our lab is being assessed in 2019. How does this impact our assessment?
  4. 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?
  5. Can a transition checklist be added to the process and used as a gap checklist when assessors come on site?
  6. In general, what are the steps to start this transition process?
  7. If laboratories do not make the cut-off, what is the impact on them?
  8. At what point do labs need to change to 2017 to meet regulatory requirements?

Guidance on New or Changed Requirements

  1. 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?
  2. Will CALA policies and procedures (e.g. guidance documents) be updated?
  3. Is CALA providing interpretive documents?
  4. If a lab is ISO 9001 certified, my understanding is that their quality system does not need to be assessed?  Is this true?

General

  1. When were the last changes to the standard?

  2. 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.

  3. Where can I obtain more information on the changes to the standard?

  4. For more information, a brochure about ISO/IEC 17025 is available at: https://www.iso.org/publication/PUB100424.html

    As well, please refer to the ISO news at: https://www.iso.org/news/ref2250.html

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  5. If an assessor receives a copy of ISO/IEC 17025:2017, does their laboratory need to purchase a copy?

  6. Yes. CALA is working on an agreement to allow assessors and volunteer committee members to access the new standard. This licence agreement will exclude use by laboratories.

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  7. How do I purchase a copy of ISO/IEC 17025:2017?

  8. Laboratories can purchase a copy of ISO/IEC 17025:2017 by going to http://www.scc.ca/en/standards/buy-standards

    Network laboratories may be interested in the option to have an electrionic format for distribution on an internal network. For this option, laboratoratories can request a licence to reproduce the standard by contacting csd@scc.ca

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Transition Questions

  1. When is the start date for accreditation to the revised standard?

  2. ISO/IEC 17025:2017 was published November 29, 2017.

    Laboratories can be assessed to the revised version of ISO/IEC 17025 anytime after January 1, 2018, subject to assessor availability. All laboratories must be accredited to ISO/IEC 17025:2017 by November 29, 2020.

  3. Our lab is being assessed in 2018.  How does this impact our reassessment?

  4. If the reassessment date is within the period January 01 – August 31, 2018, your laboratory has the option to be assessed to ISO/IEC 17025:2005 or ISO/IEC 17025:2017. If the reassessment date is September 01, 2018 or later the reassessment will be against ISO/IEC 17025:2017. The reassessment must occur to this new version of the standard to ensure that your laboratory is accredited by November 29, 2020 within your normal reassessment cycle.

  5. Our lab is being assessed in 2019. How does this impact our assessment?

  6. Laboratories with an assessment in 2019 will be assessed to the new version of the standard – ISO/IEC 17025:2017. However, just because 2019 seems like it is far away, it is not too soon to start planning the transition. In fact, probably the biggest mistake that some laboratories will make is leaving any updates too late!

  7. 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?

  8. No – laboratories need to be assessed to the new version and demonstrate conformance to requirements in the new version, in order to attain an accreditation certificate that indicates conformance to ISO/IEC 17025:2017. That being said, CALA is still developing plans for the 2018 reassessment cycle and laboratories will be informed of these plans when they are available.  

  9. Can a transition checklist be added to the process and used as a gap checklist when assessors come on site?

  10. 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.

  11. In general, what are the steps to start this transition process?

  12. 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 at http://www.scc.ca/en/standards/buy-standards.   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 time line, and how the time line for updates fits in with your reassessment schedule.
    • Update documentation and processes as needed.
    • Create a training and communications plan.
    • Implement the revised system.  
  13. If laboratories do not make the cut-off, what is the impact on them?

  14. As of November 29, 2020, 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.

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  15. At what point do labs need to change to 2017 to meet regulatory requirements?

  16. 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.

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Guidance on New or Changed Requirements

  1. 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?

  2. Not at all!  There are definitely procedures that will need to be updated, and some and procedures may 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.  

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  3. Will CALA policies and procedures (e.g. guidance documents) be updated?

  4. Yes, we are updating documents and these will be released as they become available.

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  5. Is CALA providing interpretive documents?  

  6. 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.

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  7.  If a lab is ISO 9001 certified, my understanding is that their quality system does not need to be assessed?  Is this true?

  8. 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.  

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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 (http://www.cala.ca/17025_2017.html).