Can I conduct Internal Audit for combined ISO 9001, ISO 13485 and ISO 14001?

qmshotpeen said:

I guess when I say interpretation I mean auditor preference. I got my training from our CB agency. Probably need to attend another class somewhere else. - this has all been very helpful information for me to bring back to management however I know the response, it is going to be - just do the audits as we state in our manual which we changed to state that each element would be audited a min of once a year because the auditor wanted it that way.

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If you are the process owner, then change your procedure to something management are vested in - do you know what "status and importance of processes" means, practically, to management? Spell THAT out in the procedure. Frankly - I don't mean to be mean here - but if you take the attitude that management are only doing what they're told, then tell them something different! But make the message IMPORTANT and RELEVANT to something they understand. Clearly your CB doesn't, because they'd have told you in training and also their own auditors would know!

A golden rule that has not let me down:

Try not to ask your auditor for advice.

Because:

1. Your request tells the auditor your system is probably ineffective.

Your system should inform you and make you competent. You may ask questions about CB policy and for their basis for interpreting a requirement.

2. Your request undermines the independence of the audit and, possibly, the auditor.

As soon as your auditor starts advising he or she stops auditing. Implement what they advise and no longer can they impartially audit it.

Mind you, these are possible reasons auditees keep asking for advice!

Yes I agree with both of you and appreciate your feedback. I want to make sure the company is compliant with the requirement of the standards that we are certified to. I do not think that preferences of the auditors should be a part of the audit. I think recommendations or lessons learned are good to share but not required to implement.

I want to be clear - I do not have a degree or even a background in quality - i know what I know from working here and learning as I go and from the owners and past auditors. I am asking to go to some training but I want it to be the right training. Do you think it would be beneficial for me to purchase the ISO19011?

I think you should buy a copy of 9001 so you can start practicing "show me the shall". Have the standard so you can ask auditors to show you where in the standard something is specifically required.

Something else you might consider is taking a Level I Internal Auditor class. You could get the 9001 standard with the cost of the class.

Eredhel - I have a copy of ISO9001 and I have taken level 1 training -

qmshotpeen said:

Yes I agree with both of you and appreciate your feedback. I want to make sure the company is compliant with the requirement of the standards that we are certified to. I do not think that preferences of the auditors should be a part of the audit. I think recommendations or lessons learned are good to share but not required to implement.

I want to be clear - I do not have a degree or even a background in quality - i know what I know from working here and learning as I go and from the owners and past auditors. I am asking to go to some training but I want it to be the right training. Do you think it would be beneficial for me to purchase the ISO19011?

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Me neither - I had to learn this stuff like you! I wouldn't bother with ISO 19011 - far too complicated! Maybe you could rustle up the same kind of money and have someone come in to mentor you - do you have access to state grants for training? It could be used for some "OJT" for setting up and doing process based audits. Maybe one or more of our members here are in your neighborhood and could come by...

Scary, isn't it - you go to the training given by the CB and their auditors go and make stuff up and don't recognize when an internal audit programme isn't effective!

Oh wow - you learned the same way? I am organized and detail orientated which has helped me but when they start saying things in the audit about why don't you have each element accounted for in an audit form I have asked where does it say that each element has to be done - im told its implied. WHAT??? That's what I mean - I am black and white - if it says I have to do something I will do it - if it is specific I will do it to those specifics, if its not specific I will do it but to how our company operates. Am I wrong? When I am looking back as AS9100 now at internal audits it looks like its saying I need to:

A) conforms to the planned arrangements (see 7.1 product realization), to the requirements of this international standard (are there specifics they referring to?) ad our internal quality procedure (what ever we say we will audit in there). RIGHT? We just have to make sure that what we audit is working effectively and is being maintained.

Am I right or wrong? I feel like it seems more complicated than it really is.

Shotpeen,

You could get in touch with your local chapter of the ASQ.

They may have competent auditors available to coach you through the audit planning, investigating, evaluating and reporting process. Then you may see the value of not being trained by a CB.

You could ask for a demonstration of a process audit and of a project audit or order fulfillment audit using all three standards as some of the audit criteria.

But you'll need to provide them with the audit objectives.

Please do not try to mimic your CB auditor. They should have verified that your management system conforms to ISO 9001 already.

John