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When your 13485:2016 certificate has been pulled

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William55401

Quite Involved in Discussions
#2
Welcome to the Cove! Clarifying questions that may help you get a better response.

1. What markets does your firm serve? (What countries do you do business in?)
2. What claims does your firm make regarding QMS compliance? What does your web site say? What does your packaging and labeling say?
3. Where is your firm located?
4. What sort of products and components do you sell?
 

Jen Kirley

Quality and Auditing Expert
Staff member
Admin
#3
When your 13485:2016 certificate has been pulled. Can the company still continue to sell product and replacement parts?
Welcome to the Cove!

In addition to William55401's questions, what do your customers require? Some suppliers have their approval status affected by losing a certificate. Please tell your customers immediately if they had presented you with an agreement that includes this certification. Their supplier control process may allow a medium risk status; you would need to give them time to establish that and put you on a track back to full qualification status if possible.

Do you think you will get your certificate back?
 
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