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  • 1.  ISO 9001 and 13485

    Posted 01-Nov-2017 17:05
    Our company maintains dual certification for ISO 9001 and 13485.  I am considering not re certifying to the new ISO 9001 and maintain only the ISO 13485 certification.  Some of our customers are not medical device related so I do not know if they would care if we dropped the 9001.  Has anyone had a similar situation or does anyone have advice/opinions on carrying both certifications?

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    Nicole Allison

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  • 2.  RE: ISO 9001 and 13485

    Posted 02-Nov-2017 05:06
    ​Dear Nicole

    I had several such cases during the last years both as a consultant but also as a Notified Body auditor. Keeping up both certifications is a hassle for many companies because, as you know, the structure of ISO 9001:2015 is different from ISO 13485 and often there is no added value.

    Switzerland has many suppliers that manufacture products for medical device manufacturers but also (e.g.) for the watch making industry. My recommendation was always to check with their key non-medical customers if that would be an issue and actually it never was. Most customers feel comfortable if a supplier is certified according to ISO 13485 and don't require an additional certificate according to ISO 9001.

    Hope this helps.

    Cheers, Beat


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    Beat U. Steffen
    Founder & CEO
    confinis ag
    Duedingen
    Switzerland
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    Original Message


  • 3.  RE: ISO 9001 and 13485

    Posted 03-Nov-2017 07:47
    I would not use the different structure as a reason to not pursue both certifications. I have been lucky to serve on the ISO working groups for both standards and as a liaison member, my role was to ensure there were no conflicts between the two standards. Myself and the other couple of people worked very hard to ensure this is the case and went so far as to insert language in the introduction to both standards to outline that there is no need for organizations to conform to the structure of the standard.

    This decision needs to be a strategic decision. Both standards outline requirements for a quality management system and there might be reasons for each to be in place from a strategic standpoint. ISO 13485 is specific to medical devices and the regulatory purposes. ISO 9001 gives the flexibility and is more recognized in other sectors (consumer products). If you have to explain the use of 13485 to current customers, how will it affect potential new customers? Use your business strategy and your intended market to make the decision.

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    Regards,
    Mark Swanson, ASQ CBA, CMQ/OE, CQE MBA
    Becker MN
    United States
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    Original Message


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