How to 3rd Party Audit ISO 9001 Clause 7.1.6

armani

Involved In Discussions
#1
As a 3rd-party auditor, how do I audit 7.1.6?....What audit strategy to use? and who is the process owner for 7.1.6?
 
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Mike S.

Happy to be Alive
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#2
Processes associated with 7.1.6 could be (likely is) owned by many different people/functions depending on how your org. is set-up. Your QM or procedures should specify who is/are the process owner(s).

You can audit it as part of a process audit or a specific procedure audit. For example, maybe you have a key process called “Purchasing”. When auditing that process ask the Purchasing folks “How do you determine the knowledge necessary for the operation of your processes and to achieve conformity of products and services?” “How do you maintain and make available that knowledge?”
 

Big Jim

Super Moderator
#5
Yes, I read it....but some more specific guidance is what I need!
Back to basics. There are no requirements for documented information (documents or records). When there are no such requirements the auditor still needs to determine what the companies practice is. When there are no documents or records to look at because none are required and they have not chosen to have any, auditors need to discover what they do through interview and observation.

In other words, if you can't find it any other way, ask. It is still a requirement for them to practice and you should be able to get them to tell you about it.
 
B

bigqman

#6
In meeting and documenting the requirements of 7.1.6 I have kept in mind that "the ERP system itself can serve as a knowledge management system, since its underlying technology is the relational database." http://erpsolutions.net/knowledge-management-and-erp/ Great article. I have no relationship with this company*.... Assuming of course your client has ERP, but information systems in general can be a source of organizational knowledge especially when integrated well with good business processes. Maybe this can help you determine your audit strategy.


 
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