ISO 9001:2000 Internal Audit: Someone PLEASE find me the "Shall" on "Process Audits"

[Gman2]

I am still being hung up on this process audit NC.
The original write up was 1) The existing audit schedule is based upon the 1994 standard, and does not yet reflect the ISO 9001-2000 process-based approach. 2) No evidence of internal audit plans or reports performed to verify system compliance to the ISO 9001-2000 requirements.
We got a major on this and since the write up I have performed an internal audit to verify our compliance to the new standard. That all went good, we found some problems, wrote them up and are working on fixing them.
But this did not satisfy our auditor.
He is now asking for evidence that we have scheduled and performed "process audits" meaninig they are totally 2 diferent things.
A process audit being specific to problem area or area of concern.
These can be generated from customer complaints, returns, scrap, ect..
And he said the new standard refers to them specifically as "process audits".
Meaning seperate audits althgether and in addition to the required Internal Audits.
I just can't seem to find this anywhere where it states we shall schedule and performs these mini process audits.
Has anyone else had to deal with this?
This is my 2nd company to be registered 2000 and with my last company I never had any problems with audits.

G.

[db]

About the closest I can find is: "An audit programme shall be planned, taking into consieration the status and importance of the processes and areas..." I think there is some direction in the rules for registrars, but I am not sure.

One way I would approach this is to ask for the "shall". Have the auditor show exactly where the requirment comes from. It might be a contractual thing between you and the registrar.

[Bigfoot]

I'm an automotive supplier and the confusion may be interpreting the ISO/TS 16949 specification under section 8.2.2.2 Manufacturing Process Audit. "The organization shall audit each manufacturing process to determine its effectiveness. If you are in automotive you need to show evidence of addressing this, but I think, (bearing in mind it is early on Monday morning) , it is automotive specific.

[Claes Gefvenberg]

Originally Posted by Gman2

But this did not satisfy our auditor.
He is now asking for evidence that we have scheduled and performed "process audits" meaninig they are totally 2 diferent things.
A process audit being specific to problem area or area of concern.
These can be generated from customer complaints, returns, scrap, ect..
----
Has anyone else had to deal with this?

G.

One single question: What clause did your auditor refer to? I can find no such requirement in ISO 9001:2000. Personally, I think your auditor is on a wild goose chase.

Over to the group.

/Claes

P.s. Bigfoot, welcome to the Cove.

[Gman2]

It was written up under 8.2.2

How about that note at the bottom of the clause?
Also what about when it references 7.1?

I have looked at 7.1 but have not seen anything jump out at me.

I am about to raise the BS flag about this but I want to be sure.


G.

[ben sortin]

The process audits are a subset of your internal audits. Audit processes where you add value to your product or service. You only have to fix the system if numerous processes are signaling problems. Start with a process that is well mapped like your manufacturing process design output (7.3.3.2) on your highest volume job.

[Claes Gefvenberg]

Originally Posted by Gman2

It was written up under 8.2.2

How about that note at the bottom of the clause?
Also what about when it references 7.1?

I have looked at 7.1 but have not seen anything jump out at me.

I am about to raise the BS flag about this but I want to be sure.


G.

Forget the note: The standards referred to have been replaced by ISO19011:2002, Guidance for quality and/or environmental management systems auditing, and 7.1 has (IMO) nothing to do with it (except from the need to audit what you have planned acc. to 7.1).

I think your auditor has managed to mix things up in a grand way.

/Claes

[Al Rosen]

See Iso 9004, Guidelines for performance improvements

Para. 8.2.2, Measurement and monitoring of processes.