"Outsourcing processes" and ISO 9001 Clause 1.2 "Application"



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.


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.

Rick Goodson

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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