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ISO 13485:2016 Procedures in China

Discussion in 'ISO 13485 and ISO 14969 – Medical Devices QMS' started by Lindy, Nov 4, 2019.

  1. Lindy

    Lindy Member

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    Hi everyone,
    I'm hoping somebody has some experience performing on-site supplier audits in China. Last year I performed my first on-site audit for my company's medical device contract manufacturer. This year I just completed an on-site audit of another potential supplier of finished medical devices. I wanted to focus on ISO 13485:2016 requirements as well as 21 CFR 820. The procedures I reviewed from the potential supplier were almost word-for-word as those I was provided by the other Chinese company.

    When I asked the potential supplier about their process and why they aren't following their procedures, he responded that all companies in China that want to be certified to ISO 13485:2016 are required to use one of two consultants in China that write the procedures. The ISO registrars certifying companies to ISO 13485 and perform surveillance audits require these exact procedures and will not certify your company if any changes are made to the procedures. He further stated that the registrar didn't care that his procedures didn't reflect how the process is performed as long as he has a process in place that meet ISO 13485:2016 requirements.

    Has anyone else heard of this happening?
     
  2. Golfman25

    Golfman25 Well-Known Member

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    This is definitely a buyer beware situation.
     
    Lindy likes this.

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