Exclusion of Design and Development - Construction and Renovation of Premises

Helmut Jilling

Auditor / Consultant
#11
No, you're over-complicating things. I'm not quite sure what you mean about the 'exclusion section', but if you aren't excluding any clauses, then you don't need to write anything. The essential thing is: you can't exclude the requirements of this particular section, so in building the system, you (& the people functioning in it) need to know that it applies, and how and where you meet the various requirements in this section.

OK, you outsource the design. Fine. But in that case, you'll need to pay a *lot* of attention to the 'Purchasing' section of ISO 9001, because your supplier is critical here. You'll want to ensure that you can show you've taken care in selecting & monitoring & evaluating/re-evaluating your supplier/s of design. Say it's an architect or a drawing firm: OK, theirs is the professional responsibility. But you'll want to ensure you get clear deliverables from them, manage changes if they occur, ensure everyone's working to the current version of the drawings, etc etc.

The end of Clause 4.1 also adds particular requirements for outsourcing.
 
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