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  • 1.  BS EN ISO 13485:16

    Posted 02-Mar-2016 10:19

    Hello,

    Are there any differences between BS EN ISO 13485:16 and ISO 13485:16?  I'm fairly certain it was adopted without any changes, but just want to be sure before I purchase.

    Thank you!

    Gretchen

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    Gretchen Upton RAC
    San Antonio TX
    United States
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  • 2.  RE: BS EN ISO 13485:16

    Posted 02-Mar-2016 11:37

    There are potentially major changes.

    Just as in EN ISO 13485:2012, there is a set of tables that cover the three directives and each conformity assessment path. They explain the relationship between the required points in conformity assessment and the clauses of ISO 13485:2016. After a quick review, it appears that an implementation of ISO 13485:2016 would not fully satisfy the requirements of, for example, MDD Annex II.

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    Dan O'Leary
    Swanzey NH
    United States

    Original Message


  • 3.  RE: BS EN ISO 13485:16

    Posted 02-Mar-2016 15:36

    Hi Dan,

    Thank you for your quick reply.  

    Yes, I am aware of the conformity annexes, but wasn't sure if remaining content is the same.  

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    Gretchen Upton RAC
    San Antonio TX
    United States

    Original Message


  • 4.  RE: BS EN ISO 13485:16

    Posted 03-Mar-2016 10:26

    ISO 13485:2016 and EN ISO 13485: 2016 contain the exact same "requirements", the differences are, as Dan indicates, the "Z Annexes" which identify the difference between the requirements in the standard (the numbered clauses) and the requirements of the European regulations.  The two documents were parallel voted and approved by ISO and CEN.  Be aware, however, there probably be another version of EN ISO 13485 in the near future as Europe transitions from the directives to the new Medical Device Regulations (which are not yet approved).  New "Z Annexes" will have to be developed to identify the differences between the standard and the final regulations.

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    Edwin Bills RAC, MA
    Principal Consultant
    ELB Consulting
    Overland Park KS
    United States

    Original Message


  • 5.  RE: BS EN ISO 13485:16

    Posted 03-Mar-2016 11:06
    Ed,

    May I use the following terms to your post?

    Normative text (references) (requirements) is the same.
    Informative text (clarification purposes explaining differences) is different. 

    Under the informative text, it should provide the following clarification to the affected industry. 

    Under the which standard, what requirements/criteria, and to what extent, are we subject to when demonstrating compliance to the applicable directive(s)?

    Thank you.  

    s/ David
    ______________________________________________
    Dr. David Lim, Ph.D., RAC, ASQ-CQA 
    Phone (Toll-Free): 1-(800) 321-8567



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    Original Message


  • 6.  RE: BS EN ISO 13485:16

    Posted 04-Mar-2016 09:03

    Yes David you may add the official terminology for my post. It makes my discussion more precise, thank you.  And for Dan, not only will EN ISO 14971 be updated, but I suspect as a result of our meeting of ISO TC 210 JWG1 on risk management in June, the revision process for the base ISO standard (14971) may begin. Of course that is a lengthy process and may take up to 5 years. I probably will mot see that because I will be retired from my over 22 years of standards work. I was brought into standards by the late Mike Schmidt in 1994 for the future Third Edition of IEC 60601. Mike was a visionary and a close friend RIP. 

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    Edwin Bills RAC, MA
    Principal Consultant
    ELB Consulting
    Overland Park KS
    United States

    Original Message


  • 7.  RE: BS EN ISO 13485:16

    Posted 04-Mar-2016 14:50

    I might add that the new ISO 13485:2016 contains two useful informative annexes, A-compares ISO 13485:2003 and ISO 13485:2016; and B-which compares ISO 13485:2016 and ISO 9001:2015.  That will be a good place to quickly identify differences between your current quality system and new requirements.  This will appear in both the Iso and EN versions.

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    Edwin Bills RAC, MA
    Principal Consultant
    ELB Consulting
    Overland Park KS
    United States

    Original Message


  • 8.  RE: BS EN ISO 13485:16

    Posted 03-Mar-2016 10:33

    Ed is right about all he says, including a new version of the EN ISO 13485 to match the new regulations.

    Similarly, I would expect a new version of EN ISO 14971 on risk management because of the alignment issue with the new regulations. This will be very interesting.

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    Dan O'Leary
    Swanzey NH
    United States

    Original Message