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iso 13485 - medical device qms, procedures (general)
 
 
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Old 23rd June 2008, 03:20 PM
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Let Me Help You Established procedure for Advisory Notices - ISO 13485

I am implementing ISO 13485 and we are currently at 9001:2000. In section 8.5.1 the system states we should have an established procedure for advisory notices. What should this procedure cover. Is there a structure form I should use. I am only developing the procedure to respond back to my customer

We are a manufacturing operation and we make product for different companies.

Could someone give me some direction.

Thank You
Chris
 

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