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  • 1.  ISO 9001 certification

    Posted 13-Aug-2020 13:37
    Hello all!
    Does anyone know if ISO 9001:2015 certification is required for medical device sale in any region of the world (specifically Central or South America countries)?  Is there any reason a company would need to be certified to both 13485 and 9001?
    Thanks!

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    Melinda Smith MS, RAC
    Director of Regulatory Affairs and Quality - Americas
    Roswell GA
    United States
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  • 2.  RE: ISO 9001 certification

    Posted 14-Aug-2020 06:59
    Hello Melinda,

    I am not aware of any current regulatory region requiring ISO 9001 as certification for entry into market for medical devices.  There were a couple countries previously like Israel requiring ISO 9001 - but as far as I know most countries utilise ISO 13485 as the recognised standard or have their regulations similar to or built around ISO 13485.  Working with clients over the years, some had both certifications but definitely after ISO 13485:2016 they have dropped the ISO 9001 certification - mainly for the reason the structure and content of the standards are different now.

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    Richard Vincins RAC
    Vice President Global Regulatory Affairs
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    Original Message


  • 3.  RE: ISO 9001 certification

    Posted 14-Aug-2020 09:59
    Hi Melinda,

    I don't know of any requirements for ISO 9001:2015 requirements for medical device sale in any region, especially if you already have 13485 certification.

    One example for holding both certs is if your company sells medical devices as well as products into other markets, such as pharma labs.

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    Hiral Dutia
    Sr. Regulatory Affairs Specialist
    Third Pole Therapeutics
    Waltham, MA
    USA
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    Original Message


  • 4.  RE: ISO 9001 certification

    Posted 14-Aug-2020 10:46
    Hi Melinda,
    ​I agree with Richard. After ISO 13485:2016 was obtained, many companies have allowed their ISO 9001 to lapse due to much of the content and structure now being included as part of the ISO 13485:2016 structure.


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    Jana Fernelius
    Sr Tech Quality Engineer
    Edwards Lifesciences LLC
    Draper, Utah
    USA
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    Original Message


  • 5.  RE: ISO 9001 certification

    Posted 16-Aug-2020 06:55
    Hi Melinda,

    Quite often the request for ISO9001 appears in commercial tenders - hence Marketing / Sales will encounter this - but not Regulatory as a country regulation requirement.

    This may well occur in countries in South America or Africa ; in a way similar to tender requests in Europe about 15 or so years ago...


    Tim

    ---------------------------------
    Tim Lawton
    Regulatory Affairs Principal Consultant

    Aix-en-Provence
    France
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    Original Message


  • 6.  RE: ISO 9001 certification

    Posted 17-Aug-2020 05:26
    Tim is absolutely right the use of ISO 9001 certification may be required in tenders or a contract so this should be clearly reviewed.  In fact, I was working with a company a few years ago, we had to "educate" the receiving customer on use of ISO 9001 and ISO 13485 and managed to get the contract/tender changed to require ISO 13485 instead of ISO 9001 (which the company already had ISO 13485 certification).

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    Richard Vincins RAC
    Vice President Global Regulatory Affairs
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    Original Message


  • 7.  RE: ISO 9001 certification

    Posted 20-Aug-2020 14:35
    Thank you all for the responses!!  During our last audit 9001 & 13485 at our MX facility our BSI auditor mentioned keeping our 9001 for COFEPRIS requirements, but I cannot find anything in the regulations.  I'm wondering if she was talking about what Richard mentioned above regarding tenders/contracts in MX.  Anybody know if I missed something in the MX device regs about 9001?

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    Melinda Smith MS, RAC
    Director of Regulatory Affairs and Quality - Americas
    Roswell GA
    United States
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    Original Message


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