ISO 9001 Documents for Submission to the Registrar

[Big Jim]

I would love to give it to you specifically, but I don't have the ANAB rule book, only corporate procedure that I will not quote. However, I do have the IATF Rules, which I will quote by saying the CB may conduct (6.3) a single "Pre-audit or pre-assessment" prior to the stage 1 readiness review that is not part of the stage 1 or stage 2. It shall (not verbatim)

1) be conducted in a single visit to one site of a client. If more than one pre-audit is conducted it is considered consultancy.

2) be less than 80% of the time calculated for the initial stage 2 audit and

3) not reduce the combined man-days for stage 1 and stage 2.

6.3 closes by saying the pre-audit may generate non-binding findings without recommending solutions.

Thank you for posting this. It helps to see the overall thinking within the ISO community on the topic.

Please keep in mind though that this thread started concerning ISO 9001:2008 and that the IATF rules deal with the automotive standard, ISO/TS 16949. IATF rules do not apply to ISO 9001:2008.

 

[Big Jim]

Please clarify for me: Why would you not be willing to do the Stage One Audit on the Client's site? For ALL my certified Clients, the Stage One audit was always done on site. I don't want an auditor walking in to perform a Stage Two audit and not having an idea about the organization.

BTW what CB do you work/audit for that would allow such practice??

I would prefer to remain anonymous and not disclose which CB I mostly work with.

I'm not sure what I may have said to give the perception that I'm not willing to do a Stage 1 on the clients site. I have done many full Stage 1 audits on site, and my personal preference would be to do them that way.

As an auditor, I'm not the one that makes that decision. I accept the assignment as offered and perform according to the CBs arrangements. As an auditor, I'm not privy to the decision making process in determining if it should be on site or off site.

This whole thing started when I responded to the OP that one reason a CB may want the documents submitted prior to certification audits was to confirm that the documents do exist, not to review them, simply to see if they existed. Misunderstand upon misunderstanding seems to have developed from there.

I hope it is clear. I perform off site Stage 1 audits when assigned to. I do not have any voice in the decision making about it. I perform Stage 1 audits on site when assigned. I have no voice in the decision making about that either.

From the perspective of an auditor who has done some off-site Stage 1 audits, I can't see any reason for the rancor generated by those who abhor the practice. They go as smoothly as any other audits. Some go better than others. Off site Stage 1 audits still weed out the unprepared just as well as on site ones do. And isn't that the main reason for instituting Stage 1 auditing, to cut down on the times that an auditor appears and finds the client totally unprepared? Before Stage 1 was instituted, I had a few of those. One that really sticks in my mind where the company had been given a manual from one of there customers and told to change the name. That is all they had done. They did not practice any of it nor did they understand any of it. A Stage 1, either on site or off site, would have weeded that one out.

I'll continue to respond as long as I keep getting jabbed, and I will try to respond in a more kindly manner than those who poke and jab.

 

[Big Jim]

I can't imagine doing a Stage 1 and approving for Stage 2 without going onsite and visiting the processes to assure they are meeting the minimum and are apparently as described in the procedures. I would feel very uneasy if I was asked, and I dare say I would decline the assignment. Am I missing something here? :mg: Some things just can't be adequately assured on paper, such as ESD controls.

ESD controls would seem to be a topic better suited for Stage 2.

 

[Big Jim]

On of the outcomes of the stage 1 is a plan (agenda) for the stage 2. Firstly, this is best done in collaboration with the client in person (since they have to prepare to have the right people available and so on. How this can be done remotely without seeing the place (logistics of getting around the site etc) or only a few hours before the stage 2, is - in the name of effective auditing and customer service - impractical at best and unprofessional at worst.

As long as you have not had experience with off site Stage 1 audits you will probably continue to poke about why it won't work.

Creating an audit plan is not rocket science. The most important tool for developing one is the auditee's description of the interaction of processes to facilitate a process based audit. There is seldom an audit I have been on where the audit plan can be rigidly followed like a bus schedule. There is always some flex involved because things show up during the audit. Some processes are very well organized and take less time than anticipated and some processes require more time than anticipated. Allowing for the time to walk a few feet more than anticipated is not nearly as big of a factor.

But who knows, perhaps your audits always do go off with each process audited precisely on schedule. I would think there could be lot missed if an auditor became overly fixed on doing so.

 

[Big Jim]

Jennifer ... I agree.
See this ...

I cannot think how this can effectively be performed hours minutes before the stage 2. :mg:

And yet off site Stage 1 audits are permitted as long as at least part of it is performed on site.

I'm not involved in the decision making as to which ones will be off site and which ones will be on site.

 

[Jen Kirley]

From the perspective of an auditor who has done some off-site Stage 1 audits, I can't see any reason for the rancor generated by those who abhor the practice. They go as smoothly as any other audits. Some go better than others. Off site Stage 1 audits still weed out the unprepared just as well as on site ones do. And isn't that the main reason for instituting Stage 1 auditing, to cut down on the times that an auditor appears and finds the client totally unprepared? Before Stage 1 was instituted, I had a few of those. One that really sticks in my mind where the company had been given a manual from one of there customers and told to change the name. That is all they had done. They did not practice any of it nor did they understand any of it. A Stage 1, either on site or off site, would have weeded that one out.

ESD controls would seem to be a topic better suited for Stage 2.

I just can't agree with either of these, even though I've verified in my procedures that a waiver for offsite Stage 1 can be approved by a Technical Reviewer.

When I visit a client for a Stage 1 it is with the purpose of verifying readiness for the Stage 2. It would be very difficult, if not impossible to be satisfied with implementation without a visit to observe it. If, for example an ESD program has been written and not put into practice the result could be a major NC during the Stage 2 and the audit would have to stop; the client would need to start again with Stage 1. No way would I accept such an offsite Stage 1 and risk this happening.

 

[Big Jim]

I just can't agree with either of these, even though I've verified in my procedures that a waiver for offsite Stage 1 can be approved by a Technical Reviewer.

When I visit a client for a Stage 1 it is with the purpose of verifying readiness for the Stage 2. It would be very difficult, if not impossible to be satisfied with implementation without a visit to observe it. If, for example an ESD program has been written and not put into practice the result could be a major NC during the Stage 2 and the audit would have to stop; the client would need to start again with Stage 1. No way would I accept such an offsite Stage 1 and risk this happening.

Jennifer, I believe you may be imposing requirements for TS 16945, not ISO 9001:2008.

There is no requirement to repeat Stage 1 for finding a Major in Stage 2 in the ISO 9001:2008 program.

As to if you, or others feel that off site Stage 1 audits are a good idea or not, I respect your opinions. What seems to be at issue here is if they are permitted or not. They are permitted.

 

[Jen Kirley]

Jennifer, I believe you may be imposing requirements for TS 16945, not ISO 9001:2008.

You are right - that's a bad habit of mine. My procedures say a Stage 1 can be split if it's decided that more work is needed before readiness for stage 2, but if still not ready when doing the revisit for Stage 1 the Stage 1 must be repeated. Now how is that for confusing?

As to if you, or others feel that off site Stage 1 audits are a good idea or not, I respect your opinions. What seems to be at issue here is if they are permitted or not. They are permitted.

I agree that seems to be the issue here, as I've confirmed my own procedures allow a waiver for Stage 1 to be done offsite. Under what circumstances I cannot say, but I suppose maybe if it's purely an administrative site. I still believe I would be very nervous doing it and would refuse such an audit. It's nice that I can - that's one benefit of working on contract.

 

[Marc]

Well, time to step in...

There are the same issues that have been present in auditor interpretations of clauses in standards like ISO 9001. The same comes into play with ANAB documents and their requirements.

And some stuff like this is opinion:

<snip> Until people understand that CB's are should be in the confidence building business and not in the lobby wall adorning business, we wont have done a good job of educating our interested parties.

My opinion is that it is very simple. CB's should be in the business of providing an audit of compliance to the standard. It should not be confidence building - That's nothing but sales.

The problem is customers pay the CB. If CB's were paid for by a third party and were thus doing truly independent audits, while there would still be interpretation issues the audits would end the lobby wall adorning business.

There is a lot of competition between CB's that is also a problem. To some degree the market is saturated which has each trying to out do the other in areas outside of just providing a fair audit. These days there is a lot of pure advertising bon mots. CB's will not be getting new business unless they get companies to switch CB's.

Think about it.