ISO 9001:2000 Audit Nonconformance - "Failure to have the document ISO 19011"

[michelle8075]

Have a quick question to double check something.
I am a Lead Auditor, and a friend of mine previously was thrown into being a Quality Manager and implement 9K2K. To make a long story short, I helped her through it, and generally do some consultanting for her on the side.

Anyway, they had their Surveillance Audit today, and the auditor wanted to write her up on "Failure to have the document, ISO 19011" This is the GUIDELINE for auditing improvement for Quality / Enviornmental systems....

Anyway, first of all, I don't know where the REQUIREMENT is to have this document on hand, secondly thier company outsources internal auditing and Surviellance auditing. They are a 8 person shop, they have no trained lead auditors, or internal auditors so why do they even need this?

So, with that said.... what is your opinion on this write up. I bascially said for her to ask him to show her where that requirement is from. The only thing I can think of is 4.1.d "ensure the availability of resources and informatoin ncessary to support the operation and monitoring of these processes."

 

[Kevin H]

Hi Michelle - even in ISO/TS 16949 there is no requirement to follow ISO 19011. (Some of the customer specific requirements from the big 3 require following the requirements expressed in 19011) ISO 9001 requires that auditors be competent (section 6.2.2) and that they can't audit their own work. I'm not saying that it would be a bad idea (in fact, I think it's a good idea) to have a copy availbale and to base the training and evaluation for competency on it, but to escalate what at best should be a OFI to a nonconformance is questionable behavior.

We're jointly registered to ISO 9001:2000 & ISO/TS 16949 and are a tier 2 bulk material supplier. We do happen to have ISO 19011 on file, but our auditor has never questioned us regarding that issue, and in fact our training for internal auditors does not meet the requirements in 19011.
Hope the info helps.

 

[Cari Spears]

...The only thing I can think of is 4.1.d "ensure the availability of resources and informatoin ncessary to support the operation and monitoring of these processes."

Even that's a stretch. Your advice is what I would have told her too. Is the audit over and done with? If it is too late to discuss the finding with the auditor - I'd suggest to your friend that they simply respond to the registrar that they do not agree with the finding and that they will not be providing corrective action.

Having said that - I keep a current copy all the time because I specifically state in my procedure that I train our auditors in accordance with ISO19011. I couldn't argue with the same finding if I did not have it in my possession.

 

[Sidney Vianna]

Anyway, first of all, I don't know where the REQUIREMENT is to have this document on hand, secondly thier company outsources internal auditing and Surviellance auditing. They are a 8 person shop, they have no trained lead auditors, or internal auditors so why do they even need this?

Since they outsource internal audits and they are expected to control outsourced processes, do they have an internal requirement (procedure) that requires the people/organization to perform their internal audits to "comply" with ISO 19011? If not, how have they defined the requirements associated with the procurement of the internal audit service?

Have they mentioned ISO 19011 anywhere in their own documentation?

 

[qualitygoddess - 2010]

I think the write-up is asking for something that isn't required by the 9001 standard. I could see a registrar's auditor marking this as an observation, but he would have had to identify a need -- like from an interview with an internal auditor about the auditing process. Even then, it's a stretch.

JMHO, but a company's auditors might actually reference this document, if they had it.

 

[Claes Gefvenberg]

Have they mentioned ISO 19011 anywhere in their own documentation?

There's the rub... Unless they did, there is absolutley nothing to write up. I take it they were audited acc to ISO 9001:2000? There is nothing in it requireing them to have ISO19011 at hand.

/Claes

 

[Zuggy]

Hi,
Where in ISO 9001 that you must either register to a 19011 or have it on file? If I remeber correctly you can not even register to 19011 it is a guidline for auditing, and a guidleine is very subjective. If ISO19011 was a standard in the aspect of auditing every auditor would have to registered to that stnadard. Don't let a external auditor push you around.

Tim

 

[Randy]

Unless they have specified that ISO 19011:2002 is a system document or stated that it will be used as a guideline for their audit process the auditors statement is a load of horse-dung.

I recently had an auditee state that 19011 would be used as part of their audit program procedure and I held their feet to the fire on that statement because they didn't specify how they would or would not apply it. In the absence of clarification, 19011 became all encompasing and they received a N/C for failure to meet their own defined requirement in their audit program.

They need to review what they are saying and then make sure they follow through.

 

[michelle8075]

Thanks to you all for your input! my friend was able to talk the Auditor down to an OFI after speaking with me. Which I think is also more appropriate.

They are a 8 person shop, and I can see where you are getting at when you say a copy should be on hand because they have to control outside processes. However, the copy is supposedly $200 (+) and they can't see spending the money for something that really, they will never use.

I guess after she talked with the auditor, his main concern was that per 19011 you have to have an auditor survey? So, she made a survey just for in the future to have on hand.

I took a RAB Lead Auditor training class, and I was looking though all the notes, binder etc. and cannot find anything about 19011. Maybe I was sleeping during that section?????

 

[Kevin H]

Hi Michelle,
ISO 19011 is available from ASQ as either hard copy or as an electronic standard. The hard copy costs $72 for a member and $90 for a non-member. The price for the e-standard, a downloadable adobe pdf file is the same. Not cheap, but a little better than $200.