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  • 1.  Which ISO 13485 Certification is Applicable

    This message was posted by a user wishing to remain anonymous
    Posted 13-Sep-2018 15:53
    This message was posted by a user wishing to remain anonymous

    ​​Hi All!

    There has been lots of discussion lately about which ISO 13485 to reference. Do you use ISO 13485: 2003/2012 or ISO 13485: 2016 or both? Which one is applicable for referencing standards correctly? When do you stop referencing ISO 13485:2003/2012 and only reference ISO 13485: 2016?

    Looking forward to your feedback!

    Thanks!


  • 2.  RE: Which ISO 13485 Certification is Applicable

    Posted 13-Sep-2018 17:28
    ​Hi,

    As per my knowledge  -  The ISO 13485:2016 standard has been published in March 2016 to replace the ISO 13485:2012 version. The 2012 version will be superseded from March 2019 after a transition period of three years. This means that companies that have implemented an ISO 13485:2012 quality management system shall update their system to meet the requirements of an ISO 13485:2016 quality management system by the end of March 2019.

    Best regards,
    Meenakshi

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    Meenakshi Verma
    Regulatory Affairs Professional - Medical Devices
    Ontario
    Canada
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    Original Message


  • 3.  RE: Which ISO 13485 Certification is Applicable

    Posted 13-Sep-2018 17:39
    you reference the one you are compliant to.  However the deadline to switch to the 2016 version is coming soon.  Keep in mind as well if you are selling products in the EU and your Notified Body is a stickler for references you will want to reference EN ISO 13485.  

    In our documentation we don't reference the year except in one Work Instruction, this makes it easier so we don't have to revise all of our documents when a new version is released.

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    Kathaleen DeBarris, RAC
    RAQA Analyst
    Boulder CO
    United States
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    Original Message


  • 4.  RE: Which ISO 13485 Certification is Applicable

    Posted 13-Sep-2018 19:28

    First, recognize that there are many versions available that you could use. They include ISO 13485:2003, ISO 13485:2016, EN ISO 13485:2012, and EN ISO 13485:2016.

     

    There are two cases to consider. In one you have a third party audit and the auditor issues a certificate. The certificate cites the issuing organization, the standard number, and the revision. For example, ISO 13485:2016, ISO 13485:2003, EN ISO 13485:2016, etc. If you update your documentation in advance of the certificate, then you will know which version you asked the third party to use as part of the audit criteria. Use it.

     

    In the second case, you claim conformance to one of the versions without a third party audit and a certificate. You need to be very specific about which one you are using.

     

    Because the various versions have major differences, you should never say things like ISO 13485. You need to specifically identify the standard including the issuing organization and the revision.



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    Dan O'Leary
    Swanzey NH
    United States
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    Original Message


  • 5.  RE: Which ISO 13485 Certification is Applicable

    Posted 14-Sep-2018 01:43
    ISO 13485:2003 and EN ISO 13485:2012 will both be eclipsed or no longer valid after March 2019; the current standards are ISO 13485:2016 and EN ISO 13485:2016.  Please note that EN ISO 13485:2016 is only for European Union and does not apply to any other jurisdiction - except if you are applying CE Marking (like Australia).  EN ISO 13485:2016 also include 'Z' Annexes that link or reference the requirements from the Medical Device Directive (MDD) 93/42/EEC (and AIMDD,IVDD).  The EN ISO 13485:2016 does not address the Medical Device Regulation (MDR) (EU) 2017/745 - this has been supplemented at this time with CEN/TR 17233 which does map the quality system requirements against the MDR, a bit.

    If you are requiring ISO certification in any country beyond Europe you would use ISO 13485:2016 with having a Registrar certify your QMS.  If you are including CE Marking for the European Union then you would use EN ISO 13485:2016 for MDD having a Notified Body certify your QMS.  There are distinctions between the two and certainly there is also cost involved because as you add more requirements to your certification audit, will require more time to audit the QMS and other parts as needed.  There is always possibility to claim compliance to ISO 13485 without a certification, but this really depends on your class of device and where you are marketing your product.  For example, if selling only in the United States it would be sufficient to claim compliance to FDA QSR 820 and ISO 13485 without any type of certification requirement ... yet.

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    Richard Vincins RAC
    Vice President Global Regulatory Affairs
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    Original Message


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