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

qmshotpeen said:

I am struggling with a similar issue as Jennifer. I work for a small company that we are currently ISO9001/AS9100 and ISO13485 registered and certified to. Every year we have gotten by on our internal audits and every year they say they could be better.

Click to expand...

Who is "they" and how is the "could be better" reported? Tell me how often do you perform internal audits?

In my opinion the objective is to make we are doing everything according to our procedures be it contract review, purchasing, non conformance. I think that we need to take our procedures and pick a job and say ok in order to start this job what did we need to do first? did we need to order material, yes so lets look at purchasing - and then go through that procedure and make sure we followed all the steps in there in order to purchase the material and so on.

Andy -

They = auditors and it is usually verbally reported because we are compliant in the fact that we are doing them and doing each element as required and we do have quality objectives but we are just sliding by.

My internal audit schedule is broken out by month and element. So each month 1 or 2 elements of the standard is audited. So for February I had to audit 5.1, 5.2, 5.3, March 5.4, 5.5, 5.6, April 4.1 & 4.2 and so on.

qmshotpeen said:

In my opinion the objective is to make we are doing everything according to our procedures be it contract review, purchasing, non conformance. I think that we need to take our procedures and pick a job and say ok in order to start this job what did we need to do first? did we need to order material, yes so lets look at purchasing - and then go through that procedure and make sure we followed all the steps in there in order to purchase the material and so on.

Click to expand...

You could, but what's the point? An audit doesn't HAVE to be a system wide audit and what you describe looks like that - what an external auditor might do.

Do you have clearly defined audit scope(s) and criteria? BTW - it might be your opinion as to why you're doing the audit, but - as John suggests - unless management also have the same objective(s) in mind, you are going to fall down very quickly!

qmshotpeen said:

In my opinion the objective is to make we are doing everything according to our procedures be it contract review, purchasing, non conformance. I think that we need to take our procedures and pick a job and say ok in order to start this job what did we need to do first? did we need to order material, yes so lets look at purchasing - and then go through that procedure and make sure we followed all the steps in there in order to purchase the material and so on.

Click to expand...

Shotpeen,

As auditor you do not decide on the objectives of your audit programme.

Once top management have determined their objectives you can, however, make sure that every audit you do contributes to the fulfillment of the audit programme's objectives.

You can then scope or design your audits so they fulfill their audit objectives.

Please get the objectives from top management.

John

qmshotpeen said:

Andy -

They = auditors and it is usually verbally reported because we are compliant in the fact that we are doing them and doing each element as required and we do have quality objectives but we are just sliding by.

My internal audit schedule is broken out by month and element. So each month 1 or 2 elements of the standard is audited. So for February I had to audit 5.1, 5.2, 5.3, March 5.4, 5.5, 5.6, April 4.1 & 4.2 and so on.

Click to expand...

Which auditor? Internal? CB? Customer?

While it's NOT a requirement, doing "element" audits like this doesn't tell you or - crucially - management, anything of any importance/use. It could take many months to link a finding in one element to another. You *should* be doing them by process. Did you get this approach from any training?

Shotpeen,

Here you'll find some sample objectives for an internal audit programme:

https://elsmar.com/Forums/showpost.php?p=566279&postcount=48

I hope you find them useful in preparing for your meeting with top management.

John

This is what our External CB auditors have been telling us. They told us that EACH element needed to audited once at a min once a year. This is supposed to be black and white and there is so much room for interpretation. Its very frustrating. My top managements objectives are to pass the audit, meet the requirements of the standards and maintain our certification.

qmshotpeen said:

This is what our External CB auditors have been telling us. They told us that EACH element needed to audited once at a min once a year. This is supposed to be black and white and there is so much room for interpretation. Its very frustrating. My top managements objectives are to pass the audit, meet the requirements of the standards and maintain our certification.

Click to expand...

Firstly, your CB auditor is totally incorrect and it's total rubbish. If it isn't in ISO 9001 (and it isn't) and you haven't written it into your procedure for audits, then IGNORE what your CB auditor is telling you - better still, tell your CB management that the auditor is going above ISO 9001 requirements (if you haven't got it in your procedure) and you don't want them back!

There's little to no "interpretation". There's what the standard says, and not what auditors tell you! In the standard you are allowed to audit what you want - to demonstrate the management system complies and is effective. Element audits don't tell you very much, really. Have you had training from a reputable provider?

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.