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...
Thank you for the correction! I do need to make sure that I'm using the correct terminology. I appreciate you reminding me!
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...
Thank you Andy! Yeah, I'm on the border about allowing deviations to procedures because an instance may occur requiring a quick adjustment. Part...
Hi everyone - My company currently allows deviations for Engineering controlled documents such as production methods that are product specific,...
Yea, that's the issue I'm running into right now. With so many new standards requiring recertification this year, as well as the Brexit suspense,...
Hi everyone, My company is ISO 13485:2016 MDSAP certified as well as ISO 9001:2015 certified (some of our industrial customers don't understand...
Thank you for looking into this. I was a bit confused and find it odd that companies can certify others to ISO standards without being accredited...
A supplier provided their ISO certifications as requested when approving a new supplier, however the registrar for their ISO 9001:2015 and ISO...
That's a good idea Roxane - and it would easily link with our purchasing process. Thank you for your input!
I'm revamping my company's audit program and documents. Does anyone have any suggestions on creating an audit checklist for on-site supplier...
Hi Mark, From what I understand, ISO 13485/CMDCAS will not be accepted starting in 2019. The long-term intention of the MDSAP is to lower costs...
Thank you all for your responses! My company is stretched a little thin regarding available resources, so it isn't usual for various employees to...
Hello - new to this forum. I have a question regarding internal audit findings and correcting those findings. Is the auditor who identified the...
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