Outsourced Processes - Not all identified in the Quality Manual

F

fuji033 - 2006

#1
Hello,

This is my first post. We recently completed an initial registration audit for 13485:2003 and 9001:2000. One minor non conformance we received is that we did not COMPLETELY identify all outsourced processes in our quality manual. We clearly indicate in the manual that we do outsource some processes and identify how we control them. I vigorously objected since we identify them in our approved supplier list - each supplier is identified by their service/product. We also showed that we exercise sufficient control over them. The whole observation seemed to hinge on making a complete list of outsourced processes in the quality manual. Am I missing something or is this a complete misread of the standard? We plan to appease them because they said that if we do not they would issue a Major NC. It seems that in the end we have little recourse to object to such observations.
:thanks:
 
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Al Rosen

Staff member
Super Moderator
#2
fuji033 said:
Hello,

This is my first post. We recently completed an initial registration audit for 13485:2003 and 9001:2000. One minor non conformance we received is that we did not COMPLETELY identify all outsourced processes in our quality manual. We clearly indicate in the manual that we do outsource some processes and identify how we control them. I vigorously objected since we identify them in our approved supplier list - each supplier is identified by their service/product. We also showed that we exercise sufficient control over them. The whole observation seemed to hinge on making a complete list of outsourced processes in the quality manual. Am I missing something or is this a complete misread of the standard? We plan to appease them because they said that if we do not they would issue a Major NC. It seems that in the end we have little recourse to object to such observations.
:thanks:
From ISO 13485 (4.1, in part):
Where an organization chooses to outsource any process that affects product conformity with requirements, the organization shall ensure control over such processes. Control of such outsourced processes shall be identified within the quality management system (see 8.5.1).
I don't think it's necessary, but If you would rather not appeal and ask for an interpretation, reference a procedure in the manual. It's probably easier to revise a procedure if the list of outsourced processes changes.
 

Miner

Forum Moderator
Staff member
Admin
#3
fuji033 said:
Hello,

This is my first post. We recently completed an initial registration audit for 13485:2003 and 9001:2000. One minor non conformance we received is that we did not COMPLETELY identify all outsourced processes in our quality manual. We clearly indicate in the manual that we do outsource some processes and identify how we control them. I vigorously objected since we identify them in our approved supplier list - each supplier is identified by their service/product. We also showed that we exercise sufficient control over them. The whole observation seemed to hinge on making a complete list of outsourced processes in the quality manual. Am I missing something or is this a complete misread of the standard? We plan to appease them because they said that if we do not they would issue a Major NC. It seems that in the end we have little recourse to object to such observations.
:thanks:
This is definitely not a requirement of ISO 9001:2000, but I don't know enough about 13485:2003 to comment on it.

If it is not a requirement of 13485, you have two options. One is to go ahead and do what the auditor demands, as you mentioned. If it is easy to comply with the demand, it may be your best option.

However, if you believe that this is a personal opinion of this particular auditor, you should be able to appeal it. Most, if not all, registrars have a formal appeals process for this situation that should be explained in the Opening Meeting. The down side of this, is that it can start you off on rocky footing with your registrar.

However, I know from experience that an auditor can start throwing more and more unreasonable requirements at you over time. We started out giving in, but over time they got worse. We finally appealed one and won. When the auditor stated that he did not want me present during future audits (for appealing the nonconformance), I asked for a replacement auditor. The registar granted the request without argument, and life got easier.
 

Al Rosen

Staff member
Super Moderator
#4
I just wanted to give this a bump, since it was posted over the weekend. I believe the requirements for outsourced processes are the same for ISO 13485 as they are for ISO 9001:2000. Maybe some of the 3rd party auditors here in the cove can offer an opinion on this.
 
D

Dan LaBelle

#5
Sterilization, installation, & Active Implantable Medical Devices and Implantable Medical Devices requirements is the big difference in 13485:2003. Registrar's are instructed to review these controls as part of their checklist. State what you do, if you don't do installation or AIMD&IMD than state those as exclusions in your quality manual.

Also, if you are outsourcing Sterilization than you better have it stated in your Quality Manual. Eventhough it would be coverd in clause 7.4 you must still answer to it in

Clause 6.4 Work Environment; state that you outsource clean room controls for sterile product.

Clause 7.5.1.2.1 Cleanliness of product and contamination controls; state that you outsource them and how are you as an organization controlling this. (reference back to respective suppliers in clause 7.4 Purchasing......controls).

Hope this helps.
 
D

Duke Okes

#7
Let's see:

- some folks wonder why they can't get top management's buy-in to ISO 9000

- auditors write up dumb nonconformities (often based on the way they would do it, of have seen it done elsewhere) not based on any requirements

Wonder if there's any cause & effect here?
 
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