Hi All,
We had a new customer onsite to perform an audit of our business management system. The customer is in the medical industry and is ISO 13485 certified as a result. We've been very clear with them we are not ISO 13485 certified and have no plans to be, we are ISO 9001:2015 certified. Anyway, we just got the audit report back and it was written to the ISO 13485 spec. What is the recommended response for SCARs they've opened against the ISO 13485 spec that we don't adhere to and are not listed in ISO 9001:2015?
Thanks,
Eddie
We had a new customer onsite to perform an audit of our business management system. The customer is in the medical industry and is ISO 13485 certified as a result. We've been very clear with them we are not ISO 13485 certified and have no plans to be, we are ISO 9001:2015 certified. Anyway, we just got the audit report back and it was written to the ISO 13485 spec. What is the recommended response for SCARs they've opened against the ISO 13485 spec that we don't adhere to and are not listed in ISO 9001:2015?
Thanks,
Eddie