Internal Audits - Necessary before Stage 1 Audit?

[AndyN]

Randy - not intended for you - but the organization. I don't disagree, there's more than one way of doing things, however, for people to say "do whatever works for you" is to abdicate the rest of the (unspoken) thought which is "as long as it complies and can be shown to be effective"...

Clearly, to comply with ISO 9001 or anything else, you can't just do what you want! That's what gets others confused. The OP had an issue, shared with us, and one of the responses was 'it's OK, just fix the audits by the stage 2", and that comment was soundly smacked down. Similarly, when the auditor was exposed for saying 'I'm just going to look at documents", the CB community reps here, jumped on that, because the stage 1 is more than that.

My point is that often organizations do what they think works - without fully understanding what they should be doing. You know the rhyme "Ring Around the Rosie"? For years kids and others have recited it, word perfectly, as they were taught, without a clue of what it was about! When you explain to them it's about the Black Plague and how it affects people (well, back in the 1600s) they have a different thought about it...

 

[pldey42]

I don't think the management review agenda has to be a literal translation of the requirements 5.6.2.(a) through (g) every time.

For example, in large companies, it takes different people to assess different processes under 5.6.2.c. For example, while there might sometimes be value in having manufacturing attend a software process review (e.g. if they have had issues) if the problems that management need to review are to do with the design process, staffing and skills, manufacturing can save themselves the yawn. Such companies have a hierarchy of management reviews, considering selected inputs from 5.6.2, the easier issues being addressed by more junior managers. There are escalation paths for difficult issues that need senior management attention. As long as all the inputs listed in 5.6.2 are addressed in one or another management review, the system is conformant and the organization is making ISO 9001 work for it, not for its auditors.

One example of when frequent, even daily management reviews make sense is when the company is on the rocks. They focus especially on customer feedback (who's paying their involces? who's complaining and what are we doing about it?) corrective and preventive action, and following up from the previous management review. They might commission audits, to report back urgently to the next management review.

Management reviews can be used to make changes to the QMS for short term course corrections as well as strategic change. They're a formalization of what managers do anyhow.

 

[Randy Lefferts]

Randy - not intended for you - but the organization. I don't disagree, there's more than one way of doing things, however, for people to say "do whatever works for you" is to abdicate the rest of the (unspoken) thought which is "as long as it complies and can be shown to be effective"...

I understand. I guess I thought that "as long as it complies and can be shown to be effective" was a given. Regardless of "what works for us" it still has to comply. Agreed.

Clearly, to comply with ISO 9001 or anything else, you can't just do what you want! That's what gets others confused. The OP had an issue, shared with us, and one of the responses was 'it's OK, just fix the audits by the stage 2", and that comment was soundly smacked down. Similarly, when the auditor was exposed for saying 'I'm just going to look at documents", the CB community reps here, jumped on that, because the stage 1 is more than that.

Not totally sure I understand what you mean when you say you can't do what you want to comply with ISO9001. If I choose to comply with ISO9001 I must have a Quality Manual. How I choose to comply with that is up to me. I can do what I want, as long as it complies. 1 page, 2 page, 15 pages, whatever, as long as it complies.

As far as goes, the response to "Fix it at stage 2" clearly wasn't complying. As was pointed out, there are a number of things reviewed at Stage 1 with audits being one of them.

My point is that often organizations do what they think works - without fully understanding what they should be doing. You know the rhyme "Ring Around the Rosie"? For years kids and others have recited it, word perfectly, as they were taught, without a clue of what it was about! When you explain to them it's about the Black Plague and how it affects people (well, back in the 1600s) they have a different thought about it...

You are right about the rhyme, I didn't know that it was about the plague. And because of that, I had to look it up

According to Snopes, it isn't. Apparently something about it not being made up until 300 years after the plague and that there were a number of other rhymes that were very similar but were not linked to the plague. I don't know, but it can be found at this link.http://www.snopes.com/language/literary/rosie.asp

Edited to add -Sorry about "derailing" the thread. I will stop now.