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  ISO 9001/4:2000
  "outsourcing processes" and cl. 1.2 "Application"

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Author Topic:   "outsourcing processes" and cl. 1.2 "Application"
Forum Contributor

Posts: 19
From:Saint-Petersburg, Russia
Registered: Apr 2000

posted 15 November 2000 01:02 AM     Click Here to See the Profile for eee   Click Here to Email eee     Edit/Delete Message   Reply w/Quote
This is from cl. 1.2 ISO/FDIS 9001
"Where exclusions are made, claims of conformity to this International Standard are not acceptable unless these
exclusions are limited to requirements within clause 7, and such exclusions do not affect the organization's ability, or
responsibility, to provide product that fulfils customer and applicable regulatory requirements."
And this is from cl. 4.1
"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."

So, if my "outsourcing process" - design or part of manufacturing, can I make an excluson from the scope of my QMS?
If not, how can I control "outsourced" design? I have no such specialists.

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Posts: 48
From:Williamstown, MA
Registered: Oct 2000

posted 16 November 2000 06:17 PM     Click Here to See the Profile for CJacobsen   Click Here to Email CJacobsen     Edit/Delete Message   Reply w/Quote
Different types of exclusion. In section 1.2 they are talking about stating exclusions from the requirements of the ISO document istelf. As in you state exclusion to section 7.3 since you do no design activity in your facitlity.

Section 4.1 is talking about outsourcing a process that is part of your production process in that it contributes to your final product. This is stating a requirement to identify these outsourced processes in your documentation system so you have the freedom to do it.

For example, to control outsourced design activity, you might specify in your Design Control Procedure that "design activites are outsourced to approved design engineers..." and then have a system in place that qualifies and approves or identifies the people who do your design work for you.

Christopher E. Jacobsen

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Rick Goodson
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Posts: 102
From:Wuakesha, Wisconsin, USA
Registered: Aug 2000

posted 20 November 2000 09:56 AM     Click Here to See the Profile for Rick Goodson   Click Here to Email Rick Goodson     Edit/Delete Message   Reply w/Quote
As a follow up to what Christopher has said, assuming that you purchase the design service, you would have to qualify the source. This of course would open up a whole new question regarding supplier qualifications.

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