ISO 13485:2003 Documentation Requirements for Outsourced Processes and Services

gdwaikle

Involved In Discussions
#11
Outsourced Processes

In addition to the outsourced processes already mentioned here are a couple of others that you should consider; if they have impact on product:

Facility Cleaning
Pest Control
Facility Maintenence


As you can see you need to look beyond the obvious processes that we normally think about such as Design & Development, Key or Critical Processes that might be done outside more efficiently or more expertly; the most obvious is Sterilization.

In the end you need to show the Notified Body auditor how you control these outsourced processes, through supplier audits, supplier contracts, specifications, etc.

They are extensions of all the processes you need to control to assure your products are not being compromised by one of these Outsourced processes.

:thanx:
 
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T

Teeker

#13
Outsource / Service

We are a new company and I am going through the process of defining our supplier qualification process which includes defining outsourced processes.

I am used to defining "services", but it seems to me that I can't differentiate between a service and an outsourced process. So, I am considering not defining service and defining only outsourced processes, for which the qualification requirements will be unique to each process. Does this make sense?

In addition, in the supplier qual SOP, various requirements are spelled out for types of components, supplies, and consultants.

Thanks. - TK
 
R

Roland Cooke

#14
Don't forget to include:

a) internal subcontractors - this could be other divisions, Corporate HQ etc (these can also simultaneously be customers of course)

b) formal process for supplier re-evaluation
 
C

celeo

#15
Control of subcontractor quality

The attached gives guidance for the European MDD regulatory control of sub contracted suppliers. There has been a much higher focus on the daisy chain of sub contractors making significant assemblies that form part of a medical device, particulalry when these come from countries with low labor cost and many times operating without third party accredited quality systems.
 

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sfkevin

#17
Re: ISO 13485:2003 Documentation Requirements for Outsouced Processes and Services

I have been look though the postings and found this one to be informative. I work for a contract manufacture that does circuit boards, wire harness, and system assemblies. They have decided to add to there current ISO9001:2000 the ISO13485:2003.
I am concerted that eve though they have been passing there ISO9002 review audits with minor findings that there be more issue that they are ready for to just add ISO13485.
I have a copy of ISO13485 and can see a need to update the Quality Manual and then go though all procedures to be removed or correct.
What would be the best way to get them to understand this?
:frust:
 

Al Rosen

Staff member
Super Moderator
#18
Re: ISO 13485:2003 Documentation Requirements for Outsouced Processes and Services

I have been look though the postings and found this one to be informative. I work for a contract manufacture that does circuit boards, wire harness, and system assemblies. They have decided to add to there current ISO9001:2000 the ISO13485:2003.
I am concerted that eve though they have been passing there ISO9002 review audits with minor findings that there be more issue that they are ready for to just add ISO13485.
I have a copy of ISO13485 and can see a need to update the Quality Manual and then go though all procedures to be removed or correct.
What would be the best way to get them to understand this?
:frust:
A "consultant" from the outside. Management always likes to hear it from a paid outsider.
 
S

sfkevin

#19
Re: ISO 13485:2003 Documentation Requirements for Outsouced Processes and Services

Thanks, that was what I had suggested before they went for the GAP analysis. I wanted to have some documentation done to get us started and shorten the time it may take to go though the GAP findings and then an audit or another GAP analysis. Well the management gets what they want, and will do it there way.
:cfingers:
 
S

sfkevin

#20
Re: ISO 13485:2003 Documentation Requirements for Outsouced Processes and Services

:confused: :(
Need some more feedback on section 4.1 in regards to the control over the outsourced manufacturing process from our China facility.
We are a contract manufacture with two plants in San Francisco, CA., one in Richardson, TX. and LiHua China. Only our China plant makes large runs of loaded circuit boards then ships them to the San Francisco plant for further proceeding and test.
Our China facility has its own ISO 9001 approval and they are not in our QMS as one of our production plants. Therefore, do I treat them as a sub-contactor and need to audit them or just identify them as one of the parent companies plants.
 
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