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ISO 9001 and ISO 13485

Discussion in 'ISO 9001:2015 - Quality Management Systems' started by Kishnu Vaarma ROSS, Aug 11, 2022.

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  1. Kishnu Vaarma ROSS

    Kishnu Vaarma ROSS Member

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    Hi distinguished members!

    I would really appreciate your expert advice on this matter that I find myself in.

    The current organisation is ISO 9001:2015 certified and has being doing great for a couple of years.

    Due to expansion, we have ventured into the medical device company and that needs ISO 13485.

    The ask is :

    1. Do I need to create a whole new QMS and the works to get ourselves ISO 13485 certified, on top of ISO 9001?

    2. At that point we would have subsidiaries with engineering and manufacturing, and the other solely for medical device.

    3. Can I cross over documents and procedures that overlap between the 2 ISOs? leading me to only create new ones pertaining ISO 13485?

    Thanks a mil!!

    Kishnu
     
    Kishnu Vaarma ROSS, Aug 11, 2022
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  2. Andy Nichols

    Andy Nichols Moderator Staff Member

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    Hi Kishnu:

    Great questions. On a clause by clause basis, a lot is shared between 9001 and 13485, with some key areas of difference, depending on how you have approached 9001. By that I mean, if you have elected to have documented procedures for much of ISO 9001, a quality manual etc, then those types of issues are already aligned with 13485 and no changes will be required. Of course, there are those areas where 13485, due to it's highly regulated-industry influences - corrective action/preventive actions. regulatory compliance, process validation (IQ/OQ/PQ) etc will need to be addressed, however, they don't necessarily change compliance to your ISO 9001-based QMS and could be incorporated as needed. IQ/OQ/PQ is a good thing regardless of standard, for example.
     
    Andy Nichols, Aug 11, 2022
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  3. Kishnu Vaarma ROSS

    Kishnu Vaarma ROSS Member

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    Hi Andy,

    so the best way forward is to carry out a gap analysis between the two :
    1. Fill in the blanks to best reflect our new company ISO13485.
    2. update / add documents procedures
    3. carry out an internal audit (trial run)
    4. close out issues
    5. call up 3rd party audit

    Outcome of which we can be certified to ISO9001 as a group of companies and ISO13485 specifically to the new company?

    And thanks a mil by the way :)
     
    Kishnu Vaarma ROSS, Aug 11, 2022
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  4. Andy Nichols

    Andy Nichols Moderator Staff Member

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    Sounds good! You are welcome a mil, too!
     
    Andy Nichols, Aug 11, 2022
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  5. Kishnu Vaarma ROSS

    Kishnu Vaarma ROSS Member

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    Also, if I am to carry out the internal audit, should I have to go through the internal auditor training externally as part of staff competency training matrix or as long I am competent and not go externally that would suffice?
    If it is a requirement then I can use this to justify the org to send me out for iso 13485 internal auditor training :)
     
    Kishnu Vaarma ROSS, Aug 12, 2022
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  6. John C. Abnet

    John C. Abnet Well-Known Member

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    Education is always good and I would take advantage of what you can get covered by the company. However, there is NO requirement for training or "certification", etc..etc..etc... Competency and impartiality are the ONLY requirements.

    I provide internal auditor training, so as mentioned, I'm a fan, but at the risk of shooting myself in the proverbial revenue "foot", there is NO requirement.

    Hope this helps.
    Be well.
     
    John C. Abnet, Aug 12, 2022
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  7. Kishnu Vaarma ROSS

    Kishnu Vaarma ROSS Member

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    Super stuff! Thanks John! Have a great one!
     
    Kishnu Vaarma ROSS, Aug 12, 2022
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  8. Andy Nichols

    Andy Nichols Moderator Staff Member

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    Auditing is auditing, more or less. Once you know how, a change of standards doesn’t initiate new auditor training
     
    Andy Nichols, Aug 12, 2022
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  9. Kishnu Vaarma ROSS

    Kishnu Vaarma ROSS Member

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    Hi,
    This is my plan, since the company as a group is certified ISO 9001, I am planning to create a new QMS for the subsidiary company and have it run on its own. I find integrating the ISO into 1 massive file is too much especially when it comes to reporting, document rev controls etc.

    my question is and I believe its fine, is that keep the groups ISO 9001 running and also carry out ISO 13485 certification for this company under the group.

    What you think Andy? sounds logical and do-able?

    Cheers
     
    Kishnu Vaarma ROSS, Aug 15, 2022
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  10. Andy Nichols

    Andy Nichols Moderator Staff Member

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    Sounds good to me! You can do whatever integration you want once that goal - certification - is achieved. I'd use as much of the existing ISO 9001-based QMS as I could, just to reduce the overall workload, as long as a) it is actually compliant and b) it remains an appropriate basis (scaleable) for the subsidiary. Good luck!
     
    Andy Nichols, Aug 15, 2022
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  11. Kishnu Vaarma ROSS

    Kishnu Vaarma ROSS Member

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    Hi, I am now currently developing the QMS for ISO13485, integrated from our HQ QMS. Question is can I just put in reference statement in the new QMS, stating : Please refer to QMS 9001 for this and that.
    Only thing I am going to add in writing is that of whats needed for ISO 13485?
     
    Kishnu Vaarma ROSS, Aug 23, 2022
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  12. Andy Nichols

    Andy Nichols Moderator Staff Member

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    Why would anyone using the QMS need to refer to an ISO standard?
     
    Andy Nichols, Aug 23, 2022
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  13. Kishnu Vaarma ROSS

    Kishnu Vaarma ROSS Member

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    I dont quite follow your statement there?
     
    Kishnu Vaarma ROSS, Aug 23, 2022
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  14. Andy Nichols

    Andy Nichols Moderator Staff Member

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    When you author a QMS and its documentation, why do you feel the need to reference ISO requirements?
     
    Andy Nichols, Aug 23, 2022
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  15. Kishnu Vaarma ROSS

    Kishnu Vaarma ROSS Member

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    In terms of its clauses, for example :

    Clause 4 talks about QMS : can I just state, for this clause it is fulfilled and validated from QMS 9001:2015...etc etc
     
    Kishnu Vaarma ROSS, Aug 23, 2022
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  16. Andy Nichols

    Andy Nichols Moderator Staff Member

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    If you are authoring (designing) a QMS, why do you feel the need to state such things? Are you authoring a Quality Manual, for example?
     
    Andy Nichols, Aug 23, 2022
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