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

Gman2

Involved - Posts
#1
Someone PLEASE find me this "Shall" on "Process Audits"

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.
 
Elsmar Forum Sponsor
#2
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

Involved - Posts
#3
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.
 
#4
Gman2 said:
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. :bigwave:
 
Last edited:

Gman2

Involved - Posts
#5
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.
 
B

ben sortin

#6
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.
 
#7
Gman2 said:
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

Holed-up in a Hotel in South Florida
Staff member
Super Moderator
#8
See Iso 9004, Guidelines for performance improvements

Para. 8.2.2, Measurement and monitoring of processes.
 
#9
Al Rosen said:
See Iso 9004, Guidelines for performance improvements

Para. 8.2.2, Measurement and monitoring of processes.
Yes, normally I would, but those are guidelines (and very sensible ones too), not requirements like in ISO9001...

/Claes
 

Paul Simpson

Trusted Information Resource
#10
Never mind the shall .... think of the should!

Gman2 said: ”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.”

The auditor should have explained the NC before he left but I’ll try to read between the lines. If your audit programme is structured around the old standard then there are significant areas of the new standard that are not covered there. If he has been through your audit reports and there is no evidence that these new requirements have been looked at then they might call it as a major.

The fact that the auditor is still not happy with your audits (“He is now asking for evidence that we have scheduled and performed "process audits" meaninig they are totally 2 diferent things.”) indicates that he feels you haven’t understood the process based approach to quality (see this thread in the cove). Presumably you have processes documented in your system and you have objectives and measures for these processes, if you can show that you have looked at the processes including objective setting and measures of process efficiency and effectiveness you should be able to convince the auditor you have covered the spirit of the audit clause requirement.

My concern with this (and other) threads and postings is that the spirit of the process based approach is being lost in the confrontation with the auditor.
 
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