ISO 9001 Documents for Submission to the Registrar

[AndyN]

Jim- these are not questions for you to respond to, since (as you stated) you do not represent a CB, but purely for the help of our readers who may be presented with a similar situation.

Surely, the point of a Stage 1 is as a readiness review? As ANAB found out, (the hard way) readiness CANNOT be assessed from simply looking at documents in isolation of being in the clients organization! Indeed, ISO/TS has required a staged approach for this exact reason.

What's more, if an output of the stage1 is a plan for the stage 2, how is the client to prepare for something prepared only the day before? If issues are found which cannot be corrected in the time allocated, how does this help the client if they were led to believe that a stage 1 could be followed immediately by the stage 2?

The most effective approach for any client is to have the auditor there, for 8 hours, to ensure it is they who do the work the client is paying for and to get the fullest benefit from that work, which is really what the stage 1 is for!

 

[silentrunning]

Since it is easy to pull a good Quality Policy Manual and excellent procedures off the Post Attachments here on the Cove, I see little to be gained in reviewing just the paperwork. Besides, many if not most newbies to ISO 9001 merely regurgitate the standard anyway.

 

[AndyN]

Agreed, Doug!

Effective audit planning - when the client is paying for it - should be done in collaboration with them! This means going through documents together, not just to see they exist, but that they can "walk through" them, with the auditor! This displays a sense of ownership which is part of the background to the readiness.

Time spent with the client is also very valuable in building relationships. Since a CB is unlike any other supplier, the better each party understands each other, the better the relationship - and "value" for the audits - is likely to be perceived. As we all know, we get emails from people, posts in forums etc which can be taken many different ways from what was intended. So, to Doug's point, just looking at a bunch of documents might not give you a good idea of the client and they of the auditor (if that's who actually does it)

Despite what 17021 actually says, effective, customer oriented CBs do as much of their service as possible, by including their client in that work. It builds trust, partnership and effective systems.

 

[Big Jim]

Big Jim, while I appreciate that you are not "defending the method", there is only 1 reason for this practice of (what the ANAB Heads Up document refer to as) back-to-back stage 1 and 2 audits: be cheaper save costs. By minimizing the travel/mobilization expenses for a stage 1 audit.

In my mind, the practice is just another example of a CB becoming "creative" to circumvent the intent of a well timed stage 1 audit, which, ideally should happen months before the stage 2 audit. It just goes to show that, it does not matter how generic standards are written, some people will always try to find loopholes to gain a commercial advantage.

I don't agree. I don't view it as a back to back audit. All except for the determination that the scope statement matches the site has been fulfilled. Hardly a reason to attempt to nullify the whole thing or attempt to say nothing was done until that very small part is fulfilled by the site visit.

 

[Big Jim]

Jim- these are not questions for you to respond to, since (as you stated) you do not represent a CB, but purely for the help of our readers who may be presented with a similar situation.

Surely, the point of a Stage 1 is as a readiness review? As ANAB found out, (the hard way) readiness CANNOT be assessed from simply looking at documents in isolation of being in the clients organization! Indeed, ISO/TS has required a staged approach for this exact reason.

What's more, if an output of the stage1 is a plan for the stage 2, how is the client to prepare for something prepared only the day before? If issues are found which cannot be corrected in the time allocated, how does this help the client if they were led to believe that a stage 1 could be followed immediately by the stage 2?

The most effective approach for any client is to have the auditor there, for 8 hours, to ensure it is they who do the work the client is paying for and to get the fullest benefit from that work, which is really what the stage 1 is for!

I don't know if they do off site Stage 1 audits for TS 16949 or AS9100. I suspect they do not.

The Stage 2 audit plan is completed as part of the off site Stage 1.

I never said anything about 8 hours. That is your assumption. All of the off site Stage 1 audits I have done were 4 hours. All were small companies. I don't see a need for 8 hours for that activity, and traveling on site AND charging for 8 hours, as you suggest could be considered as an abuse of the client.

 

[Big Jim]

Agreed, Doug!

Effective audit planning - when the client is paying for it - should be done in collaboration with them! This means going through documents together, not just to see they exist, but that they can "walk through" them, with the auditor! This displays a sense of ownership which is part of the background to the readiness.

Time spent with the client is also very valuable in building relationships. Since a CB is unlike any other supplier, the better each party understands each other, the better the relationship - and "value" for the audits - is likely to be perceived. As we all know, we get emails from people, posts in forums etc which can be taken many different ways from what was intended. So, to Doug's point, just looking at a bunch of documents might not give you a good idea of the client and they of the auditor (if that's who actually does it)

Despite what 17021 actually says, effective, customer oriented CBs do as much of their service as possible, by including their client in that work. It builds trust, partnership and effective systems.

It is a mistake to assume that you cannot build that same sort of relationship from a properly handled off site audit. I have returned to some of those that started as off site Stage 1 clients and continue to have a good relationship that started with that Stage 1 off site audit. I guess that may depend on the personality of the auditor, but that would be true if the first contact was on site as well.

 

[Big Jim]

Since it is easy to pull a good Quality Policy Manual and excellent procedures off the Post Attachments here on the Cove, I see little to be gained in reviewing just the paperwork. Besides, many if not most newbies to ISO 9001 merely regurgitate the standard anyway.

So I'm guessing that you think that all that is reviewed off site is the quality manual. That is very shortsighted.

You can tell a great deal from looking over the management review records, the internal audit records, and the quality objective results. From how the records have been developed and maintained an auditor can gain a lot if insight about the company.

The purpose of Stage 1 is to determine if it appears that there is a quality management system in place that is ready for Stage 2. That takes more than looking over the quality manual. Evidence of results are needed.

 

[Big Jim]

For the benefit of the people not familiar with ISO 17021:2011, the following comes from that standard, as it relates to the stage 1 audit:

As for the expected time gap between Stage 1 and stage 2 audits, ANAB has released a Heads Up document, which reads:

I don't see how any of that is violated from the off site Stage 1 audits I have performed. There is time between the off site Stage 1 and the on site Stage 1 / Stage 2 for the issues raised from the off site to be resolved. I don't view that as a "back to back" audit, and if it were considered as one, what you posted doesn't prohibit it.

 

[AndyN]

It's OK, Jim. I have all the information I need, thanks. Since you are not a CB representative, it's OK not to justify or defend what happens with the registrations you take part in. Thanks for clearly describing your process and understanding of the stage 1 and 2 audit process.

 

[Sidney Vianna]

I don't see how any of that is violated from the off site Stage 1 audits I have performed.

Now I am confused. What do you mean by stage 1 audits that you perform? Are you an auditor? You had said before

I do not represent the CB.

As for the stage1/stage 2 bundled activities, in my mind, it clearly goes against the intent of 17021. There is an obvious reason for the standard to state that the certification audit MUST/SHALL be split into Stage 1 and Stage 2. If you bundle the 2 stages together, you are clearly violating both the text and the intent of 17021. And, exactly because of people becoming too creative, ANAB had to clarify the issue with the Heads Up document.

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.