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ISO 9001 Documents for Submission to the Registrar

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silentrunning

#41
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.
Jim, I would think that the QPM and Proceedures would be the two most important aspects for review. As for our Management Review Minutes and Internal Audit records - they will NEVER leave our building. There is far too much inside information discussed in those two items to take a chance on them being "misplaced". If an auditor insisted that I send him those documents, I would be shopping for a new auditor.
 
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Big Jim

Super Moderator
#42
Now I am confused. What do you mean by stage 1 audits that you perform? Are you an auditor? You had said before

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.
I am an auditor. I'm not in a position to fully explain what they do. I have reported on what I do know and what I have observed.

I most certainly do not agree with your assessment. You are entitled to your opinion. I certainly do not need to agree with your interpretation. If it was as you think, I cannot imagine that the accreditation bodies would permit it, and I cannot imagine that they do not know. Do you?

I especially cannot imagine how you can extrapolate that any of this could besmirk their reputation as a confidence building organization.
 

Big Jim

Super Moderator
#43
Jim, I would think that the QPM and Proceedures would be the two most important aspects for review. As for our Management Review Minutes and Internal Audit records - they will NEVER leave our building. There is far too much inside information discussed in those two items to take a chance on them being "misplaced". If an auditor insisted that I send him those documents, I would be shopping for a new auditor.
First of all, you would not be a candidate for an off site Stage 1 audit. You certainly have the right to hold those documents close to your vest. If you do not trust the nondisclosure agreements that auditors are usually required to sign that is your choice. Even if you were offered the choice for an off site Stage 1, you would not need to accept.

Second, it isn't the auditor that asked for them in the scenario offered by the OP, it was the CB.

All of the documents requested for an off site Stage 1 are important. I did not provide a priority. I pointed out that some of the documents you did not mention do indeed provide a great deal of insight about the auditee as well. It was your assessment that the quality manual may not be very useful since it might just be a regurgitation of the standard.
 

Sidney Vianna

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Staff member
Admin
#44
I am an auditor. I'm not in a position to fully explain what they do.
I still don't understand how you can reconcile the comments that you audit for the CB, but you don't represent the CB. If an auditor does not represent the CB s/he works for, there is something amiss.

I most certainly do not agree with your assessment. You are entitled to your opinion. I certainly do not need to agree with your interpretation.
That is why I cut and pasted most of the ISO 17021:2011 as it relates to the intent and requirements for the stage 1. People who are familiar with management system standards can assess for themselves the method you described of bundling (part of) stage 1 and stage 2 into 1 activity. They can certainly determine if that method satisfies ISO 17021 or not. By the way, it is not an "opinion"; it is professional judgement supported by two decades of profound involvement in the accredited certification business.

If it was as you think, I cannot imagine that the accreditation bodies would permit it, and I cannot imagine that they do not know. Do you?
There is a reason why ANAB developed a Heads Up document on that very topic.

I especially cannot imagine how you can extrapolate that any of this could besmirk their reputation as a confidence building organization.
The Accreditation Rules, including ISO 17021, keep getting changed to close loopholes and enhance the confidence in management system certificates. As I already mentioned, the method you described for the stage 1 audit serves ONLY the purpose of avoiding one trip to the registrant, thus, reducing costs. In my estimation, that detracts from the efficacy of a stage 1 audit, as envisioned in ISO 17021. If it detracts from the efficacy in verifying readiness of a registrant to proceed to stage 2, it works against the confidence building process of the certification industry.

The scope of the stage 1 audit, as defined in ISO 17021 includes:
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;

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;

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.);

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

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;
It baffles me that any experienced lead auditor would try to defend the position that you could effectively accomplish that (stage 1) assessment and make a decision to proceed to stage 2 (or not) 4 3 2 1 hours before you start the stage 2 audit.

Your described method of bundling stage 1 and stage 2, in my mind, exists only to make the path to certification cheaper to the registrant and brings no benefit for the auditor who will be hard pressed to abort the audit and will most certainly be forced to proceed with the stage 2 audit, no matter what s/he encounters on his/her first onsite hours with the registrant.
 
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Big Jim

Super Moderator
#45
Now I am confused. What do you mean by stage 1 audits that you perform? Are you an auditor? You had said before

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.
Below are the two items Sidney cited earlier from 17021 and from an ANAB Heads Up. The shall contained therein are in red print for emphasis:

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.



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.


I don't see how any of the three places "shall" as used can clearly be applied in the manner Sidney has stated.

Sidney also said:

"As for the stage 1/stage 2 bundled activities (Sidney's terminology), in my mind (clearly a statement of opinion), it clearly goes against the intent of 17021."

Sidney goes on to state that this is the reason that ANAB issued a Heads Up on the topic, and posted that document.

In fact, the Heads Up does permit them to be (in Sidney's terms) "bundled".
 

Big Jim

Super Moderator
#46
I still don't understand how you can reconcile the comments that you audit for the CB, but you don't represent the CB. If an auditor does not represent the CB s/he works for, there is something amiss.
Certainly you don't believe that because I represent a CB when performing an auditor that I have authority to represent them when discussing policy. I rather doubt that you would be happy if one of your auditors claimed to have the same authority as you to discuss your CB's policy.

I'm baffled that you are baffled.
 

Big Jim

Super Moderator
#47
Your described method of bundling stage 1 and stage 2, in my mind, exists only to make the path to certification cheaper to the registrant and brings no benefit for the auditor who will be hard pressed to abort the audit and will most certainly be forced to proceed with the stage 2 audit, no matter what s/he encounters on his/her first onsite hours with the registrant.
More opinion.
 
#48
It's an interesting discussion. What I know is this:

I hear from clients of other CBs, weekly, about those auditors who arrive to do audits, without preparation, do an incomplete job of planning the audit and so on.

I'll be interested to hear from clients who have experienced this approach to helping them prepare and understand how to ready for a stage 2, get to know their auditor and build a long lasting relationship. I have a feeling they'll be transferring their certification when they discover that the accreditation has been put at risk, or the audit was a mess because of poor planning!
 
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Big Jim

Super Moderator
#50
It's an interesting discussion. What I know is this:

I hear from clients of other CBs, weekly, about those auditors who arrive to do audits, without preparation, do an incomplete job of planning the audit and so on.

I'll be interested to hear from clients who have experienced this approach to helping them prepare and understand how to ready for a stage 2, get to know their auditor and build a long lasting relationship. I have a feeling they'll be transferring their certification when they discover that the accreditation has been put at risk, or the audit was a mess because of poor planning!
What does this have to do with the topic at hand?
 
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