I am facing frequently during my external audits the following :

When I am auditing the clause 8.2.2 -Internal audit , i find that the quality department was not internally audited . The auditee reply was that
the quality department is audited during the surveillance visits of certification audits and there is no necessary to perform an internal audit on quality department especially that they do not have a qualified internal auditor other than the Quality Manager.

Is it acceptable (by ISO 9001 standard) that an external audit replaces an internal audit on quality department ? or should the company qualify an internal auditor other than the quality manager to perform the internal audit on the quality department ?

I am facing frequently during my external audits the following :

not have a qualified internal auditor other than the Quality Manager.

Is it acceptable (by ISO 9001 standard) that an external audit replaces an internal audit on quality department ? or should the company qualify an internal auditor other than the quality manager to perform the internal audit on the quality department ?

NO! The external audit does not count and YES you should have other qualified auditors

I'am with Randy on this. It is a department/process which affects quality so it needs auditing - how else will you know the conformance/effectiveness of the activity if it is not audited?

An external is just what it says - external. Clause 8.2.2 requires internal audits.

As for not having sufficient resources - there is a clause on that too!;)

As the other guys have said, the external audit doesn't count. Since you got this reply, there's obviously a problem with understanding the purpose of audits. You may not get the help you need from this person to do an audit in future. Can I give some advise to help you?

I notice that you mention auditing the internal audit clause.....

You shouldn't really be auditing by clause, but by process. You could audit by 'department, but that's not very effective, either.

There are many other business processes which you can follow to take you into the Quality Department o ensure they are the subject of some audits.

And, as you said, you still should 'audit the audits'.

And, as you said, you still should 'audit the audits'.Or, even better, you should audit the audit process.:tg:

Or, even better, you should audit the audit process.:tg:

And since QA (in our case the auditor, me) cannot audit itself, this means that there must be at least 2 qualified auditors on staff.

this means that there must be at least 2 qualified auditors on staff.That is an option. Other options are:

for internal audits to be outsourced,
or qualify an individual to be competent specifically to assess the internal audit process. I don't think someone that will assess the internal audit process only needs to undergo the same type of qualification development as someone that will do the audit of all processes, but the internal audit one (to ensure independence).

hI Libnani, :bigwave:
I am facing frequently during my external audits the following :

When I am auditing the clause 8.2.2 -Internal audit , i find that the quality department was not internally audited . The auditee reply was that
the quality department is audited during the surveillance visits of certification audits and there is no necessary to perform an internal audit on quality department especially that they do not have a qualified internal auditor other than the Quality Manager.

Is it acceptable (by ISO 9001 standard) that an external audit replaces an internal audit on quality department ? or should the company qualify an internal auditor other than the quality manager to perform the internal audit on the quality department ?
- No, you cannot replace the external audit by an Internal Audit. There should be other than the QA Manager to audit the Quality Department, otherwise ther will be a bias, and you cannot audit your work.
- The QA Manager shall conduct cross-training representing all department with their representative so that there would an enough number pool of internal auditors.
Best regards,
Raffy :cool:

hi all
you remember me one question libnani:thanx:
the internal audit of my dept ( quality) is conducted by the Quality dept of the back office located abroad. is it allowed even the back office is involved in some of our activities? example, we share the same procedures in some cases : the codes used in our local document control procedure are fixed by them. they got the authority to refuse or accept some of our proposal of change in these procedure. i asked them lastly to change some code in order to cover all activity, the QR there refused for an inconvincing reason for me:mg:

so is it enough to be audited by them in order to cover the 8.2.2 clauses ?

Hi Selena,

It's acceptable for them to audit your internal audit (IA) process as long as they are not auditing their own work. Sometimes this means that the audit content needs to be split up.

For example, the person who wrote or approved the procedure (from your back office) must not audit the procedure itself to verify that it meets the requirements of the standard. That would be auditing their own work. However, this person can audit conformity to the procedure for work being done by people at your site.

i got you howste
this is sensible and thank you so much
:thanx::agree1: