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

A lot of companies add the issuance of advisory notices to their recall procedure. I don't have an example procedure to post for you, but there's some good discussion here:
http://elsmar.com/Forums/showthread.php?t=10540

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
ChrisYou can find some useful information if you register at

http://www.clinivation.com/pages/resources/downloads.php

ISO/TR 14969, Guidance on the application of ISO 13485:2003, contains some helpful information.

Welcome to the Cove chiefs491 :bigwave:

You could use the search function and will find some additional information on advisory notices - I got Advisory Notice Requirements & Procedure and Form examples (http://elsmar.com/Forums/showthread.php?p=234209#post234209)

I'll take a shot. Let me know if I'm off base, but I presume you're struggling because you aren't the one selling the product and thus it's a bit confusing knowing the intent of the advisory notice?

If this is the case, your customers are the ones to whom you would issue advisory notices. For example, if you found out that one of the parts you use in the manufacturing / assembly of a device (product) failed in certain conditions, you would want to tell your customers about the situation. They would, in turn, determine if product recall or subsequent advisory notices (to the end users) would be necessary. You would want to keep records showing that you, indeed, told your customers about the issues.

Am I in the ballpark?

Yes, you are definelty in the ballpark. We make parts to print. It is our customer who designs the tools. I have focused our procedure to tell our customer of any issues/changes or whatever will need to be required. I do not have a simple for to fill out but I have certain questions that need to be answered.

I felt if something was necessary, we could implement this procedure then document the info via our ERP system.

What do you think?
Chris

We're getting into the area where you have to determine what's reasonable for your company. You just want to be sure that what you do is sustainable. The key is the ability to consistently communicate appropriate information (advisories) to your customers. I'm a little concerned that you say you could implement the procedure and THEN document the info in the ERP system. That sounds a bit backwards and sounds like it could be a step added only to satisfy the standard. Ideally, when you encounter a sitation where you need to advise your customers, the same mechanism to advise them is used to capture the advisory. In other words, you aren't documenting after the fact.

The mechanism isn't as important as the act - as long as it's effective.