ISO 9001 Documents for Submission to the Registrar

[Big Jim]

I'll try to answer your questions with more detail. All of this may be new if you have not experienced off site Stage 1 audits.

Do not confuse Pre-Assessment with Stage 1. Pre-Assessment is an option that some clients choose where the auditor comes on site for a general look-see and for the client to meet the auditor. It is not considered to be an audit. They were pretty common before Stage 1 was introduced to ISO 9001:2008. I have done very few since Stage 1 was introduced.

The gathering of documents before Stage one is not a review of documents, or at least not an in-depth review. It is simply confirming that the documents exist.

When Stage 1 is held off site, the auditor obtains the documents, either from the CB or from the client. This is the first time the auditor has them. At a pre-assigned time and date, the auditor calls the client and an opening meeting is held as a conference call and attendance is recorded. The auditor then does the off site review of the docuements and completes an audit report. When finished, and again at a pre-assigned time, another conference call is held as the closing meeting where the audit findings are discussed. Attendance is recorded. A copy of the audit report is sent to the client. The client signs the report acceptance page and returns it to the auditor with the attendance sheet. The auditor then sends the completed report with the attendance sheet and acceptance report to the CB.

This is not the entirety of the Stage 1, as that cannot be completed off site. The next audit is labeled Stage 1/Stage 2. When the auditor arrives on site for Stage 2, Stage 2 does not proceed until Stage 1 is completed, that is to confirm that all nonconfances and concerns have been resolved and that the scope statement matches the site. The auditor completes that portion of the Stage 1 audit report, and then proceeds to the Stage 2 audit.

I hope this clears it up.

 

[AndyN]

"This is not the entirety of the Stage 1, as that cannot be completed off site. The next audit is labeled Stage 1/Stage 2. When the auditor arrives on site for Stage 2, Stage 2 does not proceed until Stage 1 is completed, that is to confirm that all nonconfances and concerns have been resolved and that the scope statement matches the site. The auditor completes that portion of the Stage 1 audit report, and then proceeds to the Stage 2 audit."

So there's no time between the Stage 1 and the Stage 2, done as you describe or am I missing something? If so, what happens if the client isn't ready? The stage 2 is postponed until they're ready?

 

[Big Jim]

"This is not the entirety of the Stage 1, as that cannot be completed off site. The next audit is labeled Stage 1/Stage 2. When the auditor arrives on site for Stage 2, Stage 2 does not proceed until Stage 1 is completed, that is to confirm that all nonconfances and concerns have been resolved and that the scope statement matches the site. The auditor completes that portion of the Stage 1 audit report, and then proceeds to the Stage 2 audit."

So there's no time between the Stage 1 and the Stage 2, done as you describe or am I missing something? If so, what happens if the client isn't ready? The stage 2 is postponed until they're ready?

You missed something.

For clarity, off site Stage 1 cannot be a complete Stage 1. The last part of Stage 1 is completed when the auditor is on site. This really isn't any different than any other audit. If the client isn't ready to proceed, the reason needs to be resolved before proceeding.

In the very rare event that the scope doesn't match the site, and it cannot be resolved immediately, Stage 2 would not proceed.

I guess that some certification bodies are better organized for handling an off site Stage 1, so even the thought of it let alnone the details of how it is done is foreign to many readers.

 

[AndyN]

For a point of clarification, Jim;

Is there any time elapsed between the on site part of the stage 1 and the commencement of the stage 2?

BTW, I'm fully conversant with the need for at least part of the stage 1 to be performed on site - but I appreciate your concern for my continuing education.

 

[Sidney Vianna]

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:

The stage 1 audit shall be performed to

a) audit the client's management system documentation;

b) evaluate the client's location and site-specific conditions and to undertake discussions with the client's personnel to determine the preparedness for the stage 2 audit;

c) review the client's status and understanding regarding requirements of the standard, in particular with respect to the identification of key performance or significant aspects, processes, objectives and operation of the management system;

d) collect necessary information regarding the scope of the management system, processes and location(s) of the client, and related statutory and regulatory aspects and compliance (e.g. quality, environmental, legal aspects of the client's operation, associated risks, etc.);

e) review the allocation of resources for stage 2 audit and agree with the client on the details of the stage 2 audit;

f) provide a focus for planning the stage 2 audit by gaining a sufficient understanding of the client's management system and site operations in the context of possible significant aspects;

g) evaluate if the internal audits and management review are being planned and performed, and that the level of implementation of the management system substantiates that the client is ready for the stage 2 audit.

For most management systems, it is recommended that at least part of the stage 1 audit be carried out at the client's premises in order to achieve the objectives stated above.

9.2.3.1.2 identification of any areas of concern that could be classified as nonconformity during the stage 2 audit.

9.2.3.1.3 In determining the interval between stage 1 and stage 2 audits, consideration shall be given to the needs of the client to resolve areas of concern identified during the stage 1 audit. The certification body may also need to revise its arrangements for stage 2.

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

Time Interval Between Stage 1 and Stage 2 Audits

What is the expected time period between the stages (stage 1 and stage 2) initial audits? Can these be done back to back?

The expectation and intent is that there be a time period between the stage 1 and stage 2 audits, as specified in ISO/IEC 17021:2006, 9.2.3.1.3, which states: ?In determining the interval between stage 1 and stage 2 audits, consideration shall be given to the needs of the client to resolve areas of concern identified during the stage 1 audit. The certification body may also need to revise its arrangements for stage 2.?

The reason the time period is not specified is because it depends on the results of the stage 1 audit, and the capability of the client and the resources it has available to resolve any areas of concern.

Even though the intent is that there be some period of time between the stage 1 and stage 2 audits, a CB and its client may agree conduct these audits back to back.

ANAB expects a CB to fulfill the intent of the standard and have a process that normally provides for some period of time between the stage 1 and stage 2 audits, and to have reasonable justification for this period of time based on the results of the stage 1 audit. It is ANAB?s expectation, consistent with the intent of the standard, that back-to-back audits be the exception, not the rule. ANAB also expects a CB conducting stage 1 and stage 2 audits back to back to be able to demonstrate that it clearly communicated to the client the increased risk that the initial audit would not be successful because the audits were conducted back to back, and that the client accepted the risk.

Some CBs have informed ANAB that they must do back-to-back audits in some geographic regions to be competitive. This is not considered acceptable justification. (ANAB has heard the same statements about audit duration). ANAB will expect to see technical justification and evidence of agreement by a client for back-to-back audits.

 

[Stijloor]

When in doubt, it's always good to consult the rulebook...
Unfortunately, folks are not always willing and/or able to challenge the 3rd Party auditor's interpretations.

 

[Big Jim]

For a point of clarification, Jim;

Is there any time elapsed between the on site part of the stage 1 and the commencement of the stage 2?

BTW, I'm fully conversant with the need for at least part of the stage 1 to be performed on site - but I appreciate your concern for my continuing education.

I'm not sure what you are looking for. Stage 2 does not start until Stage 1 is completed. What kind of time frame are you expecting?

 

[AndyN]

I'm not sure what you are looking for. Stage 2 does not start until Stage 1 is completed. What kind of time frame are you expecting?

I'm not "expecting" anything, just a straight forward response to the time which - in your experience - elapses between the finish of the stage 1 and the commencement of the stage 2, that's all, Jim. Just your answer.

 

[Big Jim]

I'm not "expecting" anything, just a straight forward response to the time which - in your experience - elapses between the finish of the stage 1 and the commencement of the stage 2, that's all, Jim. Just your answer.

Asked and answered.

Actually what you asked here is not what you asked before. It is more pointed.

There are some points to clear up that perhaps you did not ask. I usually see between two weeks and a month between Stage 1 and Stage 2. When part of Stage 1 is off site, Stage 2 usually immediately follows the second part of Stage 1. When Stage 1 is off site, there is still usually 2 weeks to a month between the first part of Stage 1 and the Stage 1 / Stage 2.

I wish to point out that this is what I have observed. I feel as though you are pushing me to defend it, and I'm not in a position to do so. I do not represent the CB. I will say that I'm reasonably certain the ANAB is well aware of the practice. I will also repeat that it seems that some CBs are more organized on handling off site Stage 1 audits than others.

I do appreciate Sidney posting pertinent information on the topic.

 

[Sidney Vianna]

When the auditor arrives on site for Stage 2, Stage 2 does not proceed until Stage 1 is completed, that is to confirm that all nonconfances and concerns have been resolved and that the scope statement matches the site. The auditor completes that portion of the Stage 1 audit report, and then proceeds to the Stage 2 audit.

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.