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  • 1.  ISO 13485 revision.

    Posted 08-Feb-2022 14:49
    Edited by Lance Tovar 08-Feb-2022 14:50
    Hi Everyone,

    Has anybody heard of ISO 13485 coming out with a new revision? I've heard rumors, so I'm curious if any of you have heard the same.



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    Lance Tovar
    RA/QA Specialist
    Roy UT
    United States
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  • 2.  RE: ISO 13485 revision.

    Posted 09-Feb-2022 02:41
    The new ISO13485 is now in status 90.93, which indicated that the revised document is confirmed and indeed close to release.
    Previous version was already from 2016 and normally they are revised every 5 years

    Greetings,

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    Franky Dubois
    QA/RA Manager
    Gent
    Belgium
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    Original Message


  • 3.  RE: ISO 13485 revision.

    Posted 09-Feb-2022 07:43
    The ISO rules call for a vote to reaffirm or revise every 5 years for a standard. We are at that timeframe right now. Watch for information from your national ISO committee on the activity.

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    Edwin Bills MEd, CQA, RAC, BSc, CQE, ASQ
    Principal Consultant
    Overland Park KS
    United States
    elb@edwinbillsconsultant.comPrincipal Consultant
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    Original Message


  • 4.  RE: ISO 13485 revision.

    Posted 10-Feb-2022 16:27
    The A11 amendment includes new Annexes detailing harmonization with the EU-MDR. Many national standards organizations are issuing as a consolidated standard, i.e. full text including all amendments to date.

    If you sell in Europe, the Annexes identify additional items you will need within your Quality System to meet the MDR on top of ISO 13485 requirements.

    If you have MDSAP, the annexes give a useful index of the additional QS regional requirements for Europe!

    Hope that is what you meant and it helps!

    Neil

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    Neil Armstrong FRAPS
    CEO MeddiQuest Limited
    Peterborough
    United Kingdom
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    Original Message


  • 5.  RE: ISO 13485 revision.

    Posted 10-Feb-2022 17:42
    If you get the BS EN ISO 13485:2016 A11:2021 version, which has been out since September, you will also get Annex NZ which includes information on how the standard covers the UK regulations.

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    Edwin Bills MEd, CQA, RAC, BSc, CQE, ASQ
    Principal Consultant
    Overland Park KS
    United States
    elb@edwinbillsconsultant.comPrincipal Consultant
    ------------------------------

    Original Message


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