Good Day To All Quality Professionals
I have received conflicting information on the certification bodies (CB's) ability to certify and issue accredited certificates for ISO13485. A brief background about Company XYZ process activity:
1. The finished medical device product is consigned to Company XYZ from overseas. Company XYZ does not do any more manufacturing or assembly activity.
2. Company XYZ does a "Power On" Test to check if the finished product is working.
2. Company XYZ adds product labeling (including affixing expiry dates), putting in warranty booklets and manuals.
3. Company XYZ packs the product into inner and outer packaging.
4. Company XYZ manages the packed product inventory.
5. Company XYZ provides logistics and supply chain management of the packed products.
Some CB's indicate it can issue accredited ISO13485 certificates to Company XYZ, while others indicate it cannot be certified because of the lack of manufacturing activity.
Who is right on this issue?. I hope to receive your response on this enquiry.
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