ISO 9001 Qualified Auditor and Internal TS Auditor Requirements

[db]

Re: ISO 9001 qualified auditor and ISO/TS audit

Although FMEA s and control charts are not specifically required by TS,...

Okay this may take some explaining. What the poster meant was that SPC and control charts are not specifically required. TS talks about about statistical tools and concepts and SPC is one type of tool. Not sure why I would type FMEA.
Thanks for catching me on that guys.
You know what they say: even a broken clock is wrong once in a while. Well, maybe that's not what they say......

 

[qusys]

I completely agree with your thoughts on competence, but how do you prove this clause?
In a phase-1 audit of a certification readiness , it is a must to have the list of the qualified internal auditors.
It is clear that the training is not all because it must be also coupled with a solid experience of audit on the field as well as the knowledge and the application of ISO19001.
If an organization is already certified ISO 9001 and wants to embrace ISO/TS, it is certainly favourite because it should already have auditors with a certain know how in auditing techniques and should complete the acquaitance towards ISO TS clauses, including fmea, control plan ect, in case they are not familiar yet.
Anyway if the Customer has a precise requirement in this sense ( i.e.: qualification of the internal auditor by an external recognized body), the organization shall meet this.

I don't believe this is true for many reasons. There is nothing to stop an experienced audit manager from determining the competency of internal auditor candidates! I've personally seen countless people pass an RABQSA auditor class who were still not competent to do an audit! Based on my experience as a Lead Auditor for a very well known CB (I was a supervisor), my 15+ years as a trainer for one of the premier auditor training companies in the USA/UK and development of a number of training courses for auditors etc. I feel very confident in being able to determine and evaluate the competency of a qms auditor........

A training course is just that - training. It is only part of a bigger 'whole' - that of competency!

 

[AndyN]

Demonstrating competence is simple - you draw up a set of criteria and you have the auditor candidates demonstrate their abilities against those criteria, you maintain a record of that and identify/complete those actions which might arise from areas where they are 'not yet competent'........

 

[Phil Huber]

Folks,
This raises another question. Is a trained, competent TS Lead Auditor qualified to do ISO audits?

Also,
I am seeing discussion on FMEA's. TS has specific requirements to perform this activity and, in the past, I have done extensive work with these documents and even included the RPN reduction action plans in management reviews. ISO does not have a specific FMEA requirement (unless I have missed this in the standard), however, in section 7.1 of ISO, there is a note that "a document specifying the processes.....can be refered to as a control plan". I always found the FMEA, or some type of risk assessment, to be very useful in creating control plans. Could this be interpreted by ISO as a requirement for FMEA's?

By the way, I have been a quality professional for over 20 years and find this forum to be VERY interesting and useful!!
Phil Huber

 

[AndyN]

In a phase-1 audit of a certification readiness , it is a must to have the list of the qualified internal auditors.

This is also not true - unless you're talking about a specific Certification Body's requirements or one particular auditor's bias........

 

[db]

Folks,
This raises another question. Is a trained, competent TS Lead Auditor qualified to do ISO audits?

If an auditor is compent for TS that is a step in competence for ISO. My main issue would be whether the auditor puts TS requirements in the audit (where ISO has no such requirement). This could diminish competence.

Also,
I am seeing discussion on FMEA's. TS has specific requirements to perform this activity and, in the past, I have done extensive work with these documents and even included the RPN reduction action plans in management reviews. ISO does not have a specific FMEA requirement (unless I have missed this in the standard), however, in section 7.1 of ISO, there is a note that "a document specifying the processes.....can be refered to as a control plan". I always found the FMEA, or some type of risk assessment, to be very useful in creating control plans. Could this be interpreted by ISO as a requirement for FMEA's?

First of all, my copy uses the word "quality plan" rather than control plan. Normally, I think of a control plan as a single document, whereas a quality plan might be a series of documents. As far as the interpretation of FMEA being required, I would say no. First of all, that statement is in a note. Secondly, ISO is intended for any type of organization, TS is intended stirctly for manufacturers. Although I am a strong proponent of FMEAs (provided they are done right), I'm not sure that a ISO registered church would benefit from an FMEA (of course the thought of an ISO registered church brings up all kinds of questions).

By the way, I have been a quality professional for over 20 years and find this forum to be VERY interesting and useful!!
Phil Huber

I think we are all in agreement here! Marc has done (and continues to do) a wonderful job.

 

[AndyN]

You guys could be a little 'off' here, if we are speaking of internal auditors vs an external - SQA or CB auditor!

An internal auditor doesn't need to get wrapped up in the standard. Indeed, too much emphasis is placed in many courses on internal auditors being able to interpret the standards........

If we are speaking of external auditors, then Dave is correct, they shouldn't bring bias of specific tools into their audits......

 

[Phil Huber]

To Dave B,
Thank you!
Regarding a trained and competent TS lead auditor being qualified for ISO, I am speaking with respect to myself implementing an ISO 9001 compliant QMS at my current employer, auditing implementation progress, making recommendations for further activities, etc. My audit plans would only address those requirements of ISO.

On the quality plan note in ISO 9001 7.1, I stand corrected (not control plan).

I am a strong supporter of FMEA's and find them a very useful tool to assess risk and develop actions to address those risks. When performing audits of ISO registared companies, I would not include FMEA's in the audit scope since ISO did not reference this as a requirement. What if we choose to do DFMEA's? The company I am now with wishes to become ISO 9001 compliant (our customers do not require registration), however, we are doing DFMEA's now and I want to further develop this activity to become more robust.

I welcome further comments,
Phil Huber

 

[db]

An internal auditor doesn't need to get wrapped up in the standard. Indeed, too much emphasis is placed in many courses on internal auditors being able to interpret the standards........

You are very much correct, I think Andy. I normally tell my students, that normally internal auditors work strictly on the local level. Once the "shalls" in the standard are verified, the standard could be put away, and then use only company documents for the audit.

In fact, I advise my clients to not even number their documents to match the standard (I know that numbering documents is not required).

 

[qusys]

I do not put in doubt your experience, AndyN.
I have had experiences in some projects to achieve ISO TS certification for my organizations and in both cases the registrar auditors wanted to see qualifications for internal auditors with a certificate as well as with on the field experience and know how on audit techniques and quality tools , in addition to the knowledge of Customer requirements to audit them internally across the organization. On the contrary, this could carry to a non conformance in an audit.
At now, we should agree on what qualification means and what competence means.

I don't believe this is true for many reasons. There is nothing to stop an experienced audit manager from determining the competency of internal auditor candidates! I've personally seen countless people pass an RABQSA auditor class who were still not competent to do an audit! Based on my experience as a Lead Auditor for a very well known CB (I was a supervisor), my 15+ years as a trainer for one of the premier auditor training companies in the USA/UK and development of a number of training courses for auditors etc. I feel very confident in being able to determine and evaluate the competency of a qms auditor........without attending a 'recognized training course'

A training course is just that - training. It is only part of a bigger 'whole' - that of competency!