Regulatory Open Forum

 View Only

  • 1.  ISO 13485

    This message was posted by a user wishing to remain anonymous
    Posted 07-Sep-2022 08:40
    This message was posted by a user wishing to remain anonymous

    Hello Experts,

    Is there any pre-requisite for ISO 13485 Lead Auditor Certification?
    Is there a mandatory pathway such as first the person needs to be ISO 13485 Internal Auditor certified and then Lead Auditor?

    Thanks in advance.


  • 2.  RE: ISO 13485

    Posted 07-Sep-2022 09:13
    Hello Anon
    In my experience, which type of certification to go for depends on the person's role within the organization. There is no prerequisite to the Lead Auditor certification (e.g., you do not need the internal auditor certification first before the lead auditor certification).

    ------------------------------
    Karen Zhou
    ------------------------------

    Original Message


  • 3.  RE: ISO 13485

    Posted 08-Sep-2022 02:52
    Hi Dear,

    There are no specific prerequisites for taking the ISO 13485 lead auditor course. However, its good if you have some prior experience of medical device QMS implementation.

    As per BSI, 

    Who should attend?

    • Medical device quality professionals interested in conducting first-party, second-party, and/or third-party audits
    • Management representatives
    • Quality directors, managers, and engineers
    • Consultants

    This course teaches auditing principles using ISO 13485, therefore a knowledge of ISO 13485 and its application within a Medical Device organization is strongly recommended together with internal audit experience.

    ISO 13485:2016 Medical Devices Lead Auditor Course | India (bsigroup.com) 

    All the best!



    ------------------------------
    Sravan Kumar Manchikanti, RAC
    Hyderabad
    India
    ------------------------------

    Original Message


Related Content