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ISO 13485 Pre-Assessment

Discussion in 'ISO 13485 and ISO 14969 – Medical Devices QMS' started by QA Bee, Feb 11, 2016.

  1. QA Bee

    QA Bee Member

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    Hi all,


    We are a small Medical Device company with ISO 9001:2008 certification. We are in the process of getting our ISO 13485. Now, We just had our Pre-Assessment done by notified body last week. Before that, I was pretty sure that we were almost ready for our Stage 1 audit in next few months but now the reality is different.

    We have had some major nonconformities like getting fireproof cabinets or scan all our controlled documents, Validation on our equipment (we use Autostainer for our final QC), validation of our processes and creating technical files for our products (we have 1600 products).

    I was also asked to do supplier audits for 2 of our critical suppliers (because of their product criticality to our business). We also need to do Gap Analysis between 9001 and EN ISO 13485:2012 (as we need this) now but we had already done a gap analysis between ISO 9001 and 13485:2003L

    I am also working on Risk Analysis so that will have to be completed for all our product families.

    I am one man QA department here so finally I had a chat with the owner/CEO and he has asked me to hire another person to help me out but I still don’t think it will be doable since he wants to hire a less qualified personnel with only 1-2 years of experience which will not help as much for now. I also have been in Quality Assurance for almost 10 years but I started out as a Document Controller, Training Specialist and then Quality Assurance Specialist and now a QA Manager.

    I handle all Quality processes, CAPA, Nonconformances, Complaints, Management Review, Supplier Qualification, Equipment Calibration, Document Control, Training, Interal Audit Planning, External Audits, Design Files review.

    I obviously would not be able to do validation protocols for any of the equipment or processes. I am already having hard time with Risk Assessment (I have never done this before) and have been learning by reading and educating myself but may not be perfect.

    So, I finally have an approval from our CEO to hire a consultant for the time being to help and guide me in the right direction to achieve all these goals. And, I was wondering if anyone has any reference to anyone? I really need to move on this quick as our deadline is only another 3 months before Stage 1.

    Thanks
     
  2. Andy Nichols

    Andy Nichols Moderator Staff Member

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    Yes, I can help here. Where are you located?
     
    QA Bee likes this.
  3. QA Bee

    QA Bee Member

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    Awesome!
    We are Pleasanton, CA
     
  4. Ronen E

    Ronen E Well-Known Member

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    I suggest you try to contact Sam Lazzara. He's from your area.

    I'm also willing to try and help if you don't need someone on-site (I'm in another continent). I'm sure I can help with establishing your risk management files and validation protocols, from afar. As a minimum I can review them (as well as other outputs) and provide feedback.

    Creating technical files for 1600 products and running all process validations, ++, all in 3 months, while also taking care of your routine tasks, is going to be challenging even for a team of 3 (the consultant, yourself and an assistant).

    EN ISO 13485:2012 and ISO 13485:2003 are identical content-wise. If you've done your gap analysis to ISO 13485:2003 then that's covered.

    Do you have the audit already booked with the NB? If not, I doubt that you'll be able to get it pinned down in such a short notice. There are currently huge delays with a lot of NBs.

    Cheers,
    Ronen.
     
  5. QA Bee

    QA Bee Member

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    Thank you Andy and Ronen.

    Ronen - I think we may need someone local so can work with him/her on a face to face basis as there is lot that I probably need to learn specially with Validation, creating technical files etc.

    I will contact Sam Lazarra for sure. Yes, Our audit is already booked with NB but I have been trying to push it back since we need more time.
     

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