News RSS Facebook LinkedIn

Contact | Feedback | Site Map | FAQ |

CALA

S M L

Canadian Association for Laboratory Accreditation Inc.

Building Laboratory Excellence

FAQ 17025:2017

(Last updated 7 February 2018)

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. CHANGE!   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?
  9. Rather than performing a gap analysis, our laboratory is planning to be assessed to ISO/IEC 17025:2017 and have the assessors provide a list of non-conformances.  Provided evidence of conformance is submitted to CALA within 60 days and deemed satisfactory, the laboratory will attain accreditation to ISO/IEC 17025:2017 – Is this correct?
  10. NEW!   Does my completed gap analysis need to be submitted to CALA?

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. CHANGE!  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?
  5. CHANGE!  I feel like I’m in a Catch-22: I do not want to start updating the laboratory’s system until there is more guidance available from CALA, but the main document P07 – CALA Application of Requirements in ISO/IEC 17025 has not yet been updated. 
  6. What is the intent of Clause 4.2.3?  If I work in a laboratory and find out information about a customer, does this clause mean that I have to disclose the information to the customer? 

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

    Back to FAQs

  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.

    Back to FAQs

  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

    Back to FAQs


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.  By taking this approach, CALA would be granting accreditation solely on a desk review of responses.  Because of the differences between ISO/IEC 17025:2005 and ISO/IEC 17025:2017, some assessment work will be necessary to convert accreditation to the new standard. 

  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.  IMPORTANT: A gap analysis must be submitted to CALA six (6) weeks prior to a reassessment.
    • 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.

    Back to FAQs

  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.  That being said, ILAC and ISO have published a joint communiqué noting that during the transition period, both ISO/IEC 17025:2005 and ISO/IEC 17025:2017 are equally valid and applicable.  To read the full communiqué, go to:  http://ilac.org/about-ilac/partnerships/international-partners/iso/

    Back to FAQs

  17. Rather than performing a gap analysis, our laboratory is planning to be assessed to ISO/IEC 17025:2017 and have the assessors provide a list of non-conformances.  Provided evidence of conformance is submitted to CALA within 60 days and deemed satisfactory, the laboratory will attain accreditation to ISO/IEC 17025:2017 – Is this correct?

  18. Not necessarily.  By taking this approach, CALA would be giving accreditation solely on a desk review of responses.  Because of the differences between ISO/IEC 17025:2005 and ISO/IEC 17025:2017, some assessment work will be necessary to convert accreditation to the new standard.  If you choose the approach you are suggesting, there is a risk that accreditation to ISO/IEC 17025:2017 will not be granted until a verification visit is scheduled.  This verification visit will be needed to verify implementation of the responses to any non-conformances identified.  Thus, the risk is two-fold: not attaining accreditation to ISO/IEC 17025:2017 immediately, and incurring the cost of a verification visit. 

    Back to FAQs

  19. Does my completed gap analysis need to be submitted to CALA?

  20. Yes.  Please submit the gap analysis six (6) weeks prior to your assessment, with the normal documents and records that are required.

    Back to FAQs

     



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.  

    Back to FAQs

  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.

    Back to FAQs

  5. Is CALA providing interpretive documents?  

  6. A new version of P07 – CALA Application of Requirements in ISO/IEC 17025:2017 is available on the CALA website.  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.  As such, it is anticipated that this document will be revised frequently over the next 1-2 years.

    Back to FAQs

  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.  

    Back to FAQs

  9. I feel like I’m in a Catch-22: I do not want to start updating the laboratory’s system until there is more guidance available from CALA.  P07 – CALA Application of Requirements in ISO/IEC 17025 has been updated, but I still feel I need more guidance.

  10. Although CALA staff and some volunteers are working hard to get documents updated, we recognize that there is going to be a period where there are gaps. However, that should not prevent a laboratory from transitioning to the new standard. So what can you do in the interim?

    • Undertake some training on ISO/IEC 17025:2017.
    • Do your best to identify the gaps. To assist you with this, CALA has created a cross-reference between the requirements in ISO/IEC 17025:2005 and ISO/IEC 17025:2017. You will find the link to this document on our transition page at: http://cala.ca/17025_2017.html
    • Think about the objective evidence you can show to assessors to demonstrate how the laboratory is meeting new or changed requirements. Remember that an assessment is not a pass/fail approach. If there is a non-conformance against a new or changed requirement, the laboratory will have 60 days to demonstrate conformance (rather than the usual 45 days). As well, there is a disputes process available, should this step be absolutely necessary.

    Back to FAQs

  11. What is the intent of Clause 4.2.3?  If I work in a laboratory and find out information about a customer, does this clause mean that I have to disclose the information to the customer? 

  12. No. Keeping the information confidential between the laboratory the customer is not the same as having to disclose the information to the customer. The intent here is regardless of whether or not you share the information with your customer you must keep the information confidential. The second part of the requirement is that the source of the information (e.g., say a competitor or a regulator) will not be shared with the customer; of course, you can choose to tell the customer what you've learned – you just can't tell them who told you.  

    Back to FAQs

     

     

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).