1. This site uses cookies. By continuing to use this site, you are agreeing to our use of cookies. Learn More.
Dismiss Notice
You must be a registered member in order to post messages and view/download attached files in this forum.
Click here to register.

3rd Party Supplier Audit in China: ISO 13485 & 21 CFR 820

Discussion in 'ISO 13485 and ISO 14969 – Medical Devices QMS' started by Lindy, Apr 17, 2019.

  1. Lindy

    Lindy Member

    Joined:
    Jan 10, 2018
    Messages:
    14
    Likes Received:
    2
    Trophy Points:
    2
    Hello everyone.

    I was wondering if anybody could recommend a good company that can perform an on-site audit in China to ISO 13485 and 21 CFR 820 requirements.

    My company wants to use a medical device manufacturer (for class 1 devices) that is located in China. I was scheduled to travel to China earlier this year to perform the on-site audit, however my company's legal department decided against allowing me and another employee travel to China amid the growing tensions between our two countries.

    After requesting procedures in preparation of the audit I thought I'd be going on earlier this year, I found some discrepancies and concerns. It could be a translation issue, however I would not be comfortable approving this supplier without an on-site audit.

    An audit via Skype isn't ideal since there is a 12-hour time difference. Therefore, the next possible way to perform this audit is by hiring a 3rd party to perform it on our behalf. I want to make sure we use a good company and I'm hoping for any recommendations.

    Thank you!
     
  2. John C. Abnet

    John C. Abnet Well-Known Member

    Joined:
    May 23, 2017
    Messages:
    709
    Likes Received:
    510
    Trophy Points:
    92
    Location:
    Upper Midwest- USA
    Good day Lindy;
    Apologies in advance that I can't answer your specific question.

    I can, however, be "that guy" and point out an error that is more than semantical. Since your organization is intending to audit a potential supplier (external provider), the audit is actually a "2nd party" and not a 3rd party audit. A 3rd party audit is one conducted by an entity with no direct vested interest (i.e. a registrar).

    Apologies again for being "that guy" but this is worth pointing out.

    Best of luck in arranging your audit.

    Be well.
     
    Lindy and Andy Nichols like this.
  3. Lindy

    Lindy Member

    Joined:
    Jan 10, 2018
    Messages:
    14
    Likes Received:
    2
    Trophy Points:
    2
    Thank you for the correction! I do need to make sure that I'm using the correct terminology. I appreciate you reminding me!
     
    John C. Abnet likes this.
  4. Andy Nichols

    Andy Nichols Moderator Staff Member

    Joined:
    Jul 30, 2015
    Messages:
    5,086
    Likes Received:
    2,553
    Trophy Points:
    112
    Location:
    In the "Rust Belt"
    If I may, there are actually 3rd parties who perform inspections, for example. In a previous job, our site company did product inspection and testing. They are normally accredited to ISO/IEC 17020 and perform 3rd part inspections on behalf of a customer at the customer' suppliers. They may also do audits.

    Sorry to be THAT guy, John!
     
    GStough and John C. Abnet like this.