Hey, first day of our readiness review today. The auditor asked for "every requirement" of TS to be detailed and "addressed" in our quality manual.

We're pretty good here, but we ignored things like infrastructure and plant maintenance in the quality manual. He wants all of that stuff! Yes, we do it, yes, it is not documented, but it is effective, and not product related.

What are your experiences and thoughts in this area. Do we need to regurgatate every sentence of the standard in the Quality Manual?

Hi,

Adressing all items from the standard is something we did for the QS9000, but for TS it is (as I understand it) not necessary.
The requirements for the quality manual are mentioned under 4.2.2, we only have these items in our quality manual plus the quality policy and objectives.
(but we are not (yet) TS certified, our readiness review is scheduled for May, so we will have to see what our auditor thinks about this...)

Myriam

It is not a TS requirement to regurgitate the standard in your quality manual, or indeed state how you address every requirement of TS.

This is a hangover from the old ISO9001:1994 requirement which also dissappeared in ISO9001:2000 thankfully.

and nothing to do with 'ISO' or anything else. It was/is just a figment of a registrar's mind........:rolleyes:

Respectfully advise them to review the nature of their requirement and where it is in the standard.....;)

Andy

More information as we completed our readiness review.

No other issues really, but, he wants to see evidence of compliance at the readiness review.

The error is a line in the standard that says “the organization shall establish and maintain a quality manual that includes ….the documented procedures established for the quality system, or reference to them”. Also in the rules for the readiness review, it says “Evidence that all the requirements of ISO/TS 16949:2002 are addressed by the organizations processes”.

He is asking to see that >not in quality manual< information now. Some of these lower level procedures are being written, others, not well documented but we have the effective processes.

It seems to be one thing to comply, another to prove it at the readiness review. Has everything been addressed? no, I'm sure we missed something or someone is taking shortcuts, but, our docs still seem sound...

There is no requirement for a procedure or any written documentation for infrastructure. Objective evidence is also verbally delivered information. He should simple say..."how do you meet this requirement, get the explanation, and audit to see if he can find evidence that it is true."

Ugh - I hate auditors that make you create paper.

Before the checklist was "banned" I knew a CB that wanted the checklist submitted with every single question answered with the reference in yhe documentation.
We even had some discussion on this in the past

that all the requirements of ISO/TS 16949:2002 are addressed by the organizations processes

tutle diagrams are answers.

Hey, first day of our readiness review today. The auditor asked for "every requirement" of TS to be detailed and "addressed" in our quality manual.

We're pretty good here, but we ignored things like infrastructure and plant maintenance in the quality manual. He wants all of that stuff! Yes, we do it, yes, it is not documented, but it is effective, and not product related.

What are your experiences and thoughts in this area. Do we need to regurgatate every sentence of the standard in the Quality Manual?

The TS requirement is that you address all requirements within your processes. The detailed checklist is no longer required, nor do they have to be in the manual, or even in the procedures. But, all requirements must be addressed within your processes. It is up to you to decide how you want to demonstrate objective evidence that you meet this.

One method you can use, that does it pretty simply, is the matrix in the back of the TS Rules manual. It is a one page matrix with processes listed on one side and clauses listed on the other axis.

I agree with the auditor and the response from hjilling below:

You can exclude only product design from the QMS, nothing else. All other requirements, including any OEM customer specific requirements, must be "addressed" in the structure of the QMS.

The stage one audit is making a recommendation to proceed to certification provided that all requirements have been "addressed".

The "pseudo checklist" in the second edition rules will provide evidence to auditors that things like "infrastructure" are considered in, for example, the execution of your management review activity . The matrix will allow you to connect your processes with the clause numbers that they effect. Make sure you account for all of them. Some auditors will use the matrix during the Stage One and will not recommend proceeding unless all elements are accounted for.

Update here. We rescheduled our audit, and had to perform a readiness review a second time. So, we got a new auditor due to schedule issues. The new auditor said "Why the h*ll did you do that?" He said it was not needed at all (the document detailing where each item is addressed).

No big deal, it is done now!

Update here. We rescheduled our audit, and had to perform a readiness review a second time. So, we got a new auditor due to schedule issues. The new auditor said "Why the h*ll did you do that?" He said it was not needed at all (the document detailing where each item is addressed).

No big deal, it is done now!


Some room for debate here. I would tend to agree with the first auditor, though I would not have stopped the Stage 1 over it.

Annex 5 of the TS Rules states (1st bullet point):
Automotive Process Approach auditing includes the following activities:
§ Identification of the organization’s processes based on quality management system
documentation and any additional information provided by the organization (see section 4.1 a) of ISO/TS 16949:2002), including evidence that all the requirements of ISO/TS 16949:2002 are
addressed by the organization’s processes

To accomplish that, many registrars require that the table in the Rules book (pg 32) or a facsimile of that be prepared to demonstrate that all clauses have been addressed. While it is not a "Stage 1" requirement, something like it has to be considered for certification.

Some room for debate here. I would tend to agree with the first auditor, though I would not have stopped the Stage 1 over it.

Annex 5 of the TS Rules states (1st bullet point):
Automotive Process Approach auditing includes the following activities:
§ Identification of the organization’s processes based on quality management system
documentation and any additional information provided by the organization (see section 4.1 a) of ISO/TS 16949:2002), including evidence that all the requirements of ISO/TS 16949:2002 are
addressed by the organization’s processes

To accomplish that, many registrars require that the table in the Rules book (pg 32) or a facsimile of that be prepared to demonstrate that all clauses have been addressed. While it is not a "Stage 1" requirement, something like it has to be considered for certification.


We submitted ours to the registrar prior to the stage 1 audit

We also had something like the rulebook example done some months ago. That was not sufficient to the first auditor. The second auditor, as I said, said oh my god why did you do this!

There are too many interpretations to the Second Edition Rules. This is a frustration we deal with at all levels, clients/auditors/consultants. I have a client who is converting from QS and received a "not ready" because of no audits and management review. The registrar will proceed with the Stage II provided the internal audits and management review are completed before the opening meeting.

Ready or Not here we come!!! $$$$

There are too many interpretations to the Second Edition Rules. This is a frustration we deal with at all levels, clients/auditors/consultants. I have a client who is converting from QS and received a "not ready" because of no audits and management review. The registrar will proceed with the Stage II provided the internal audits and management review are completed before the opening meeting.

Ready or Not here we come!!! $$$$

Hi Chuck,

In the Plexus refresher training I took in Jan., before taking my auditor recert test, they stressed that a "Not Ready" required that the audit go back to a T0 situation. Meaning that the Stage 1 must be redone. The Rules book states that as well. The registrar is not permitted to go to stage 2 in the situation you described.

I would be concerned, because that would be construed as a serious nonconformity in a witness audit if it comes up.

Helmut