ISO 9001 Internal Audit

mindytanner said:

Of course you did. I am reading through the thread, and I am not understanding why only one a year even if the company is small. Why is there only 1 audit a year?

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It’s the audit of the entire QMS, much like your external audit. Manufacturing is obviously outsourced, so you yourself would do all your supplier audits.

Jane's said:

Absolutely. You also prevent bad blood by having someone external do it, plus it’s probably the only way to avoid ppl auditing their own work (I.e. many hats).

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Tried an external once years ago using a highly recommended consultant............ it did not go well.

qcman said:

Tried an external once years ago using a highly recommended consultant............ it did not go well.

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What didn’t go well, if you don’t mind me asking?

I would only ever get a consultant, they tend to find things we get oblivious too, being too close to the execution end of it.

Jane's said:

What didn’t go well, if you don’t mind me asking?

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She kept no notes, no evidence and report was incomplete. 3RD party rejected the audit and I ended up doing it myself. This is not to say all are bad.

Ouch!!! I’m sure you know this but here it is anyway - tighter supplier control would land you someone more competent. Our consultant works like an intertek auditor, professionally. She runs such a good, tight audit, we are always pretty confident going into the external.

Easily resolved. Change your manual to read internal audits are performed at least once each calendar year.

Golfman25 said:

Really. Many small companies usually have "working management" -- they actually spend time on the floor and are involved with the daily tasks. Issues are generally well know and are readily dealt with as they arise. As a small company with less than 20 employees, a once per year audit push does just fine for us.

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How do you get around the "shall take into consideration the importance of the processes concerned, changes affecting the organization, and the results of previous audits" requirement?

Mike S. said:

How do you get around the "shall take into consideration the importance of the processes concerned, changes affecting the organization, and the results of previous audits" requirement?

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That is not much of a requirement and only requires "consideration." In my view, it really allows a large organization the flexibility it needs to manage their audit process by prioritizing certain areas of concern. For smaller, mature organizations, there isn't much there. We do an audit of our 6 main processes once per year. After 25+ years and low turnover, we are way beyond internal audits "finding" anything substantial.