Regulatory Open Forum

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  • 1.  Auditing

    Posted 05-Jan-2017 15:13

    Can you all weigh in these questions?

    1. We are looking at switching up our auditing body (haven't been overly happy with the service provided by the current one). Who are you using? Do you like them? Would you recommend them? Why?
    2. Second question relating to audits. We currently do not need a notified body (we are exempt) but with the changes to the IVDD it looks like that is changing. Do you use the same organization for your notified body and auditing body? If yes what do you consider the advantages. If no, why not?

    Thanks

    Keri

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    Keri Froese RAC
    Quality Assurance Manager
    Spartan Bioscience
    Dunrobin ON
    Canada
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  • 2.  RE: Auditing

    Posted 06-Jan-2017 11:12

    My current employer uses TUV-Nord and my most recent employer uses SGS. For both notified bodies, I have found the auditors to be consistently extremely competent and thorough. They were also reasonable in their classification of audit findings. They both served as notified body and auditing body for my employers. I believe that there is consistency in interpretation of findings when this is the case. How often do we make a change based on what what is seen during one audit then get written up for that change during another? If you would like an independent auditing body, I can recommend Dr. Erik Myhrberg of Moorhill International < www.moorhill.com >. Good luck.

    ------------------------------
    Lance Coleman
    Quality Audit Program Manager
    Ultradent Products Incorporated
    South Jordan UT
    United States

    Original Message


  • 3.  RE: Auditing

    Posted 06-Jan-2017 11:25

    I would like to suggest a different approach.  I think many potential respondents will hesitate to go on record in this public forum with detailed pros and cons about various registrars.  I certainly would hesitate myself.

    In my previous company I was charged with leading the team to choose a replacement auditor/registrar/NB for the one we were currently using.  We identified the "musts" we required from a replacement, as well as characteristics that were "wants,"  We assessed candidates according to how they fulfilled our wishes.   We were able to narrow this list down to a few candidates.  We then asked the candidates to provide references, which we then contacted for phone interviews.  We narrowed the list further, and brought the finalists in for interviews.

    You will want to take  time to do this right.  At the same time you will want to proceed expeditiously, since NBs are going to be overwhelmed with the workloads ahead for them.  In the end, you may find that your most practical approach would be to carry out corrective action with your current service provider.

    Best of luck.  Feel free to contact me if it would help.

    Bill

    ------------------------------
    William White
    Senior Consultant
    Quality System Strategies LLC
    Elkhart IN
    United States

    Original Message


  • 4.  RE: Auditing

    Posted 08-Jan-2017 08:52

    Dear William,

    indeed this is a hot potato topic with regards to the regulatory thunderstorm going through Europe.

    With regards to IVD you may wish to check on NANDO http://ec.europa.eu/growth/tools-databases/nando/index.cfm?fuseaction=directive.notifiedbody&dir_id=20 the bodies having that scope today, actually 22. A big part of them will NOT survive their joint assessments under MDD / AIMDD also impacting indirectly their designation for IVDD.

    (http://www.doks.nbog.eu/Doks/NBOG_BPG_2016_1.pdf)

    With regards to the IVDR upcoming, it is even worse, this is why the transition period proposed is longer for the IVDR to prepare NBs for this regulation.

    For your IVDs and for preparing a future under the IVDR you may critically assess if your NB will probably be among the survivors. You may find good bodies in Germany, UK and Netherlands - TüV SüD, BSI, Dekra BV, MDC are competent NBs for IVD in my opinion / experience.

    Your NB will perform anyway a QMS audit, so it is nonsense to have another body in for ISO only, that does not have the NBOG Scope for your products. For information about scopes, check out this NBOG best practice guide:

    http://www.doks.nbog.eu/Doks/NBOG_BPG_2009_3.pdf 

    The main question you need to ask yourself is whether the NB you would like to work with has a sufficient customer base in your specific scope - there is a risk that bodies who do not have enough "business" in a certain scope drop the scope as the cost for maintaining competence is too high related to the clients potential.

    All good EU NBs have so much work that you may encounter long delays. If you are already an ISO client of your future NB competent in IVD it may help in future, the later you try to get in business with a competent NB the higher is the probability that you wont find any having capacity left for you. 

    If you have further questions, get in touch with us @ Medidee Services SA

    Best Regards

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    Michael Maier
    Partner
    Medidee Services SA
    Epalinges
    Switzerland

    Original Message


  • 5.  RE: Auditing

    Posted 10-Jan-2017 18:07
    1. "We are looking at switching up our auditing body (haven't been overly happy with the service provided by the current one). Who are you using? Do you like them? Would you recommend them? Why?"
      • I've used TUV Nord (AKA TUV USA, a TUV Nord company) in 3 different companies.  One of the companies was using someone else, didn't like them, and we went and found another NB. 
      • Yes I liked them a lot.  Bradley Chen/Diana Sweeney are my main contacts there. 
      • Yes I would recommend them if your product falls within their expertise. I will use them again.
      • I would recommend them because they have reasonable costs and they have good auditors who wants you to succeed if you can show you're not treating the compliance aspects as token (it shows and they interview the whole company sometimes).  I like their customer service too.  They're not uptight and charging you for every single little thing.  I've met with the actual project managers who give a lot of authority to the auditors.  They don't act like salespeople.  They actually like small companies and start-ups and understand that they are start-ups and small companies.  I see them as a partner in helping a company grow. 
    2. "Second question relating to audits. We currently do not need a notified body (we are exempt) but with the changes to the IVDD it looks like that is changing. Do you use the same organization for your notified body and auditing body? If yes what do you consider the advantages. If no, why not?"
      • Yes.
      • You only need a notified body if you need a CE Mark for Class IIa and above for your product.  To use 2 different companies doesn't make sense as sometimes especially with MDSAP coming along, part of the auditing involves review of the product technical documentation.  This way you get consistent recommendations, findings, etc. and not because they don't like each other or they feel they need to compete with the other.  I've never known any company I worked with who have a different NB vs their ISO 13485 certifying auditing body. 

    Hope that helps,

    ------------------------------
    Clarisa Tate
    Medical Device, RA & QA
    Bay Area, CA
    USA

    Original Message


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