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  • 1.  ISO 13485 Certification process - Change of physical location

    Posted 27-Nov-2019 06:14
    Hello All:

    We are currently in the process (Final stage Audit in couple of months time) of ISO 13485 Certification and we may be changing physical locations soon.

    However I am looking for information on the following:
    1. Does the process affect in total or can we continue for the final stage at new location set up.

    2. Is the total process (stage 1 and stage 2 Audit)  has to be redone at new location?

    I am in the process of researching all of these answers independently, but the collective intelligence would be greatly appreciated.

    Thanks,
    Bhagya

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    Bhagya Munagoti
    QA Manager & Regulatory Lead
    Cranleigh
    United Kingdom
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  • 2.  RE: ISO 13485 Certification process - Change of physical location

    Posted 27-Nov-2019 08:16
    Hi Bhabya.

    There might be variation between notified bodies but in my experience there would be no change to the process. You can have the stage 1 at X location and have the stage 2 at Y location, without repeating stage 1. 

    If you move after the stage 2 audit, they would have to come back to repeat. 

    Good luck 
    James

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    James
    Head of QARA
    UK
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    Original Message


  • 3.  RE: ISO 13485 Certification process - Change of physical location

    Posted 27-Nov-2019 08:24
    Thanks James

    ------------------------------
    Bhagya Munagoti
    QA Manager & Regulatory Lead
    Cranleigh
    United Kingdom
    ------------------------------

    Original Message


  • 4.  RE: ISO 13485 Certification process - Change of physical location

    Posted 27-Nov-2019 17:09
    Edited by Brittany Gibson 27-Nov-2019 17:09
    Hi Bhabya,

    I agree with James - if your stage 1 audit occurred at the old location, the stage 2 audit should be able to be performed at the new location without having to re-audit the Stage 1 material, so long as no significant procedural changes are occurring because of the move (i.e. new manufacturing process).

    It does depend on your auditing organization/NB, but in my experience make sure you have a solid documented plan in place for the relocation including relabeling of product.  Also if you haven't already, notify your auditing organization of the upcoming move.  I've been through a few moves in the last few years and if you have any more questions I'd be happy to help.  

    Hope this helps,
    Brittany

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    Brittany Gibson BSc
    Director, Quality and Regulatory Affairs
    Winnipeg MB
    Canada
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    Original Message


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