Who audits the Quality Manager ?

[software badger]

Time to stop lurking and start posting !

Hello, I'm a QM for a small software company in the UK, we've had our ISO9001 and TickIT certification since 1998 and were certified against ISO9001:2000 last June.

My certification body is one of the larger ones, and at our last audit they raised a non compliance on my internal audit schedule. The text of the non compliance is as follows: "The internal audit schedule was reviewed and was judged appropriate to the requirements of ISO 9001:2000. However there was no independent audit of the quality function identified to show that 8.2.2 paras 3 and 4 are being complied with".

My initial response - senior management provide the appropriate level of checking and authorisation by reviewing and/or setting the companies "policies" on quality, and then hold me accountable for the delivery of them by formally measuring me against my objectives - wasn't well received. Neither was the second response - that as the certification body audit me on a six monthly basis an internal audit was unnecessary.

Being a small company we don't have anybody with the appropriate skill set that could audit the quality function and we don't really want to hire (either temporarily or permanently) or train another QM/auditor. Any comments ?

Thanks in advance
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[Bruce Epstein]

In a similar situation in the past, we had certain customers who audited us on a regular basis; this was judged acceptable by our certification agency.

Otherwise, we always considered the formal audit to be the check on the Quality Manager.

Admittedly, though, I'm not in the UK.

Sounds to me like they're trying to force you into additional audits which might not be necessary.

 

[JRKH]

Based on how I read your post, I think that this finding is a bit nit-picky.

Bruce pretty well covered it, but hear is a couple more ideas.
Take a look at your management review system and see if there is a way to beef up the records etc. from this. I feel this is the area where you really get the most formal audit. Otherwise just bring in one of your internal auditors to check over your records, processes etc to provide the warm fuzzy for the auditor.

Another option would be to bring in a consultant once a year to look over your processes. This may not be too expensive.

Good to see another lurker come out of the shadows.

Welcome to the mad mad mad mad mad mad mad world of the cove.

James

 

[M Greenaway]

Just tell the auditor that your schedule is based on status and importance................and the quality function has neither

Sorry

 

[Al Dyer]

Yes,

For $50-$100/hour/quarter you can hire someone to come in and give an opposing view. Even if it costs a few bucks more, say up to $1,000.00 / year it is well worth the expense.

There are qualified people out there that can cover your situation!!!

I'd love to but I am too far away!!!!

 

[David Mullins]

not again

This topic was discussed, at length, and with some great ideas, just a few short months ago.
Please check out the search engine - it will be worth it.

 

[gpainter]

Without knowing how your audits are conducted, the problem may be that there was no audit of the Quality Department. Since the quality department is a key process it should be audited. Any trained auditor (internal) should be able to audit it. The 00 standard slacks up and just says you can not audit your own work. We do process audits, so just add the Quality Department to your list of departments to audit. MO

 

[Marc]

Re: not again

Originally posted by David Mullins

This topic was discussed, at length, and with some great ideas, just a few short months ago.

Please check out the search engine - it will be worth it.

I couldn't find it. If anyone knows which thread, please do post a link. Thanks!

 

[KenS]

In a prior life I ran into this situation and addressed it by having the QM of one of my customers audit me, and returning the favor when she needed it.

 

[Russ Jackson]

Perhaps not in Software Badger's case, since he notes that it is a small company, but in many systems would it not be acceptable for an internal quality auditor outside of the QM's area to audit relative to par 3 & 4 of 8.2.2? The specific statement of independence has not been carried forth into 9k2k and it now says in par 2, 8.2.2 "Selection of auditors and condcut of audits shall ensure objectivity and impartiallity of the audit process. Auditors shall not audit their own work." Thus, an internal quality auditor from a department or area other than the QM's department should be capable of satisfying this requirement for auditing the QM relative to the two paragraphs in question.

As an auditor I would less likely question the use of an in-house internal auditor for this purpose than a Customer's QM for whom you cannot certify capability unless the the person is a certified auditor.