Regulatory Open Forum

 View Only
  • 1.  ISO 13485 Lead Auditor Training

    Posted 21-Nov-2018 01:18
    Hello-- 


    I'm currently trying to get certified as an ISO 13485 Lead Auditor as soon as possible. Oriel/Stat-A-Matrix's was recommended to me by a colleague. However, the earliest one in my area (California, USA) isn't until late January. 

    Could someone please and kindly suggest others? I'm specifically interested in becoming certified rather than obtaining a certificate and would really appreciate any leads I could get! 


    Happy Thanksgiving and many thanks,
    Sasha


    ------------------------------
    Sasha Masri
    Los Angeles, CA
    United States
    ------------------------------


  • 2.  RE: ISO 13485 Lead Auditor Training

    Posted 22-Nov-2018 01:48

    Sasha,

    BSi offers the ISO 13485:2016 Lead Auditor (TPECS) four-day training course several times a year in numerous locations. For additional info, contact 800.862.4977 or Support.LMS@BSi.group. You will be provided with a link to the scheduled courses, fees and registration.



    ------------------------------
    Stacey A. Strand, RAC
    Regulatory Manager
    Symmetry Surgical Inc.
    Nashville, TN
    USA
    ------------------------------



  • 3.  RE: ISO 13485 Lead Auditor Training

    Posted 22-Nov-2018 12:08
    Hello Sasha,

    I can recommend Oriel STAT A MATRIX training sessions for obvious reasons, yes we do offer ISO 13485 Lead Auditor public training at various locations in the U.S.  They are scheduled at different times of the year at different locations to provide opportunities for attending.  If there is an immediate need, please feel free to reach out, though hopefully you can find the opportunity to attend the training in January.

    ------------------------------
    Richard Vincins RAC
    Vice President Global Regulatory Affairs
    ------------------------------



  • 4.  RE: ISO 13485 Lead Auditor Training

    Posted 24-Nov-2018 03:01
    Stacey et Richard--


    I appreciate the responses! I'll be sure to look into BSI's training course and to keep Oriel's January session in mind as well. 


    Many thanks,
    Sasha

    ------------------------------
    Sasha Masri
    Los Angeles, CA
    United States
    ------------------------------



  • 5.  RE: ISO 13485 Lead Auditor Training

    This message was posted by a user wishing to remain anonymous
    Posted 24-Nov-2018 07:39
    This message was posted by a user wishing to remain anonymous

    Caliso has an online course.  http://www.caliso9000.com/iso-13485-2016-Auditor-training.html