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  • 1.  Referencing ISO 13485 Edition

    Posted 12-Dec-2017 12:25
    Hi all,
    We're currently transitioning from ISO 13485:2003 to ISO 13485:2016.  We are referencing ISO 13485:2016 in our Quality Manual, but can we just reference ISO 13485 in other relevant QS documents, or does the edition/revision need to accompany it in all locations?
    Thanks for your insight!

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    Michael Thomas
    Principal Regulatory Affairs Associate
    Salt Lake City UT
    United States
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  • 2.  RE: Referencing ISO 13485 Edition

    Posted 12-Dec-2017 16:30
    ​

    By convention, when a Standard is referenced with dated version, only the specific edition applies as cited. When a Standard is referenced without the dated revision, the latest edition of the referenced document (including any amendments) is implied.  

    To directly answer your query, so long as you do not intend to point to a specific clause or requirement, leaving out the date revision of ISO 13485 in your Quality documentation should be acceptable.

    See also:

    Using and referencing ISO and IEC standards to support public policy

    https://www.iso.org/files/live/sites/isoorg/files/archive/pdf/en/how-to-write-standards.pdf

    How to write standards

    https://www.iso.org/files/live/sites/isoorg/files/archive/pdf/en/pub100358.pdf



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    Homi Dalal RAC
    Regulatory Affairs Leader
    Dynamic Controls
    Christchurch
    New Zealand
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    Original Message


  • 3.  RE: Referencing ISO 13485 Edition

    Posted 12-Dec-2017 20:44

    I always recommend that companies identify the full standard implemented in all documents. While in some contexts, the version is not important, for manufacturing companies it always is.

     

    Sometimes, I see companies make the argument that the version doesn't matter, since there are no changes in to the SOP. However, the changes from ISO 13485:2003 to ISO 13475:2016 are so extensive, one wonders if any SOP would remain untouched.

     

    Also, while ISO 13845:2016 is appropriate for the quality manual, I question the value of referencing it in lower levels SOPs. In particular I see many companies cite these external standards is SOPs, but never actually refer to them.

     

    Lastly, I recommend that companies be careful in citing standards. For example, some companies may cite ISO 13485:2016 but actually implement EN ISO 13485:2016.

     

    In short, cite the correct version in the quality manual. Most companies will implement EN ISO 13485:2016 which also includes ISO 13485:2016. Don't cite any version of 13485 in a procedure or work instruction unless the SOP requires a specific reference; these are rare cases.



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    Dan O'Leary
    Swanzey NH
    United States
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    Original Message


  • 4.  RE: Referencing ISO 13485 Edition

    Posted 13-Dec-2017 08:30
    Hi Dan,

    To some extent, I disagree.  The referencing of a specific version of a standard is important when it is applied to specific technical reports, CAPA, risk assessments, but the citing of specific versions in QS documents creates an inevitable "churn" in revisions as well as compliance "gotchas" when a QS document references an older version of the standard.  Therefore I believe that standards should be referenced generically unless there is a specific reason for referencing a particular revision.  In those cases, the reason should be explained.  The QS should also have a provision, whether in the Quality Manual or some other QS document, that if the version of a standard is not explicitly referenced the current version applies.

    Regards,
    James




    Original Message


  • 5.  RE: Referencing ISO 13485 Edition

    Posted 13-Dec-2017 08:40
    For the reasons you cite, I don't recommend citing the standard in a QS document unless there is a very specific reference. This avoids the problem of not know what version is implemented and the non-value maintenance of updating referenced standard when there are no references to the standard in the body of the procedure.

    Instead, develop the QMS following a specific version of a standard. For example, in the quality manual cite EN ISO 13485:2016 and not ISO 13485. All the documents at lower levels in QMS don't need to cite any version of 13485. They just need to implement the specific requirements of the standard applied.




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    Dan O'Leary
    Swanzey NH
    United States
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    Original Message


  • 6.  RE: Referencing ISO 13485 Edition

    Posted 14-Dec-2017 07:02
    Dan,

    I agree wholeheartedly with this approach.  In my current position, the previous regime referenced the ISO and FDA QS in EVERYTHING.  It has been quite a task to remove them unless the reference is specifically, not generally relevant.  Even then there is the consideration as to whether the revision is appropriate. I would prefer to have the QS standard references stop at the Quality Manual because by definition every other QS doc flows from the QM.

    Regards,
    James




    Original Message


  • 7.  RE: Referencing ISO 13485 Edition

    Posted 13-Dec-2017 04:25
    Michael's approach sounds reasonable to me.

    Recently we have gone to only mentioning standards by number and having a separate list of current revisions as an annex to the manual reviewed by the management review.

    Recently we have seen divergence in issues between EU and US, the most obvious being ISO 14971 where only the Annex Zs are significantly different. The problem is that there is always a doument of form that makes a passing reference to a general standard and having to find every reference to update it, when a minor change in the standard has occured is a nightmare.

    I believe you do what you think is right for you and if a pedantic audit cites it, you defend your position!

    All the best

    Neil

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    Neil Armstrong FRAPS
    CEO
    MeddiQuest Limited
    Peterborough
    United Kingdom
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    Original Message


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