In Reply to Parent Post by azsportsfan
Need a little insight:
Requirement: 4.1 Where an organization chooses to outsource any process that affects product conformity to requirements, the organization shall ensure control over such processes. The type and extent of control to be applied to these outsourced processes shall be defined within the quality management system.
The QM does not identify the processes that are outsourced.
Question: Is the auditor looking for outsources to be defined IN the manual? That just doesn’t sound right…
Thanks in advance
That is a really interesting finding.
It seems that many auditors from several certification bodies think that you need to define the controls for outsourcing in the quality manual. I truly wonder where it is coming from. The standard DOES NOT require it.
First of all, the standard says that this definition needs to be somewhere within the QUALITY MANAGEMENT SYSTEM. Last time I checked your quality manual was not your quality management system.
Second, the standard says that it needs to be defined. Defined does not necessarily mean documented.
How should an auditor determine that you are fulfilling a requirement when it doesn't require that it be a documented procedure or or that records be kept? Well for sure he should not be asking for a documented procedure or records now should he?
What he should be doing is determining what your PRACTICE is through observation and interview. Did he do that?
Now on a practical matter, it does need to be defined, and a good place to do it is either in you quality manual or your procedures. It is often included along with purchasing however that is handled.
This is a protestable finding. You may find resistance in trying to protest it though since it seems to be deeply ingrained. If you choose to just roll with the punches then simply describe how you control outsourcing through purchasing. The clue for that is in the notes 2 & 3, especially note 3 c. The hard part is going to be to come up with an appropriate root cause for a bogus nonconformance.