Regulatory Open Forum

 View Only
  • 1.  ISO 13485 Scope Statement

    Posted 27-Feb-2014 09:52
    Hello,

    I am wondering if anyone might be able to direct me to some information on the requirements for the scope statement for ISO13485 UKAS and Directive 93/42/EEC certificates.

    I have found the appropriate document for ISO 13485 CMDCAS but no luck so far with the others. Our auditor is being quite stubborn with respect to generalizing some of verbiage and I would like some supporting documentation to accompany my proposal.


    Thanks,

    Elena
    -------------------------------------------
    Elena Cavaliere
    Regulatory Affairs Specialist
    Barrie ON
    Canada
    -------------------------------------------


  • 2.  RE:ISO 13485 Scope Statement

    Posted 27-Feb-2014 10:22

    In my opinion, you have a case of bad auditing on your hands. My recommendation is to turn the tables. If the auditor is suggesting a change, then one of two things is going on. The auditor understands a requirement that you are not meeting, so you have a nonconformity. In this case, the auditor should specify the requirement. The second case is that the auditor is putting her judgment in place of your, without being able to cite a requirement. This should be written as a suggestion, but should not be an audit nonconformity.

     

    So my suggestion is to get the auditor to specify the requirement, which in this case would be the requirement for scope statements on various certificates. In general, I don't know of any requirements and they may very well be specific to the Notified Body.

     

    You didn't say whether the auditor is internal, a customer, or a Notified Body. A Notified Body auditor should be able to cite the requirement. An internal auditor usually cannot and often falls into the opinion camp.

     

    Regards,

    Dan

    -------------------------------------------
    Dan O'Leary
    Swanzey NH
    United States
    -------------------------------------------








  • 3.  RE:ISO 13485 Scope Statement

    Posted 28-Feb-2014 08:53
    Dear Elena,

    You may check the Notified Body Operations Group (NBOG) website where guidances for the Notified Bodies can be found how they ensure a consistent way of work: http://www.nbog.eu/2.html
    NBOG BPG 2010-3 in particular will address your question what is required for scope statements on the different types of certificates.

    -------------------------------------------
    Henri De Haas
    Philips
    Drachten
    Netherlands
    -------------------------------------------








  • 4.  RE:ISO 13485 Scope Statement

    Posted 28-Feb-2014 09:24
    Thank you Henri.  Very helpful links!

    -------------------------------------------
    Elena Cavaliere
    Regulatory Affairs Student
    Barrie ON
    Canada
    -------------------------------------------








  • 5.  RE:ISO 13485 Scope Statement

    Posted 28-Feb-2014 09:23
    Thank you Dan for your feedback.  I'm fairly new in my career and have often been nervous about challenging NB auditors.  Going forward I will definitely use this approach.  

    -------------------------------------------
    Elena Cavaliere
    Regulatory Affairs Student
    Barrie ON
    Canada
    -------------------------------------------








  • 6.  RE:ISO 13485 Scope Statement

    Posted 28-Feb-2014 09:50
    I have seen a request by BSI to expand a scope statement to include sterile and/or non sterile disposable medical devices (instead of disposable medical devices), but that request did make sense

    -------------------------------------------
    Steven Howell
    Senior Director - Quality & Compliance
    Chula Vista CA
    United States
    -------------------------------------------