What is the ISO definition for Stage 1 Audit (For ISO 9001:2000)? We will have stage 1 audit next month and I want to send a Notice to all employees with some advices and also provide stage 1 audit definition, I understand that it is for readiness review, but I want to have some more information, because someone in the company is using the word preassesmetn but I think using this word may cause some confusion.
Could you share the boulletins that you are sending out to inform an audit??

Thanks.
AC

What is the ISO definition for Stage 1 Audit (For ISO 9001:2000)? We will have stage 1 audit next month and I want to send a Notice to all employees with some advices and also provide stage 1 audit definition, I understand that it is for readiness review, but I want to have some more information, because someone in the company is using the word preassessment but I think using this word may cause some confusion.
Could you share the bulletins that you are sending out to inform an audit??

Thanks.
AC

Anerol,

Are you referring to ISO 9001:2000 or ISO/TS 16949:2002 certification? Because the Stage 1 audit (readiness review) is currently only required for ISO/TS 16949:2002 certification audits. It is defined in "The Rules, 2nd Ed." on page 14. In addition, there is a reference in ISO 17021.

Now, if you are pursuing ISO 9001:2000 certification, your Registrar may conduct a pre-assessment to determine the current status of your quality management system but this is not mandatory for ISO 9001:2000.

Maybe you got confused about the terminology. Your Registrar should have provided you with a description and purpose of the pre-assessment audit that you could share with folks in your organization.

Hope this helps.

Stijloor.

They provided to me the steps for ISO 9000 certification and Stage 1 audit is in the steps, it doesn't say pre-assessment.

Most CB's are working according to ISO 17021 which requires a stage 1 audit.
According to that standard

9.2.3.1.1
The stage 1 audit shall be performed
a) to audit the client's management system documentation;
b) to 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) to 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) to 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) to review the allocation of resources for stage 2 audit and agree with the client on the details of the stage 2 audit;
f) to 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) to 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.

More details in the standard

Stage one audits are arriving for ISO 9001:2000. I have just received my first assignment for one in early June.

Because the Stage 1 audit (readiness review) is currently only required for ISO/TS 16949:2002 certification audits. It is defined in "The Rules, 2nd Ed." on page 14. In addition, there is a reference in ISO 17021.

Now, if you are pursuing ISO 9001:2000 certification, your Registrar may conduct a pre-assessment to determine the current status of your quality management system but this is not mandatory for ISO 9001:2000.

Maybe you got confused about the terminology. Your Registrar should have provided you with a description and purpose of the pre-assessment audit that you could share with folks in your organization.

Hope this helps.

Stijloor.

Any accredited registrar must be working towards ISO 17021 compliance under ANAB in the USA and will be offering a stage 1/stage 2 audit process. We at NQA have been doing this for some time to be able to demonstrate our process to the accreditors. So, our clients have been seeing this in their quotes for all related registrations, not just ISO/TS 16949.

Although fairly recent, this is not late breaking news. I'm afraid you're incorrect in this respect.

A stage 1 has nothing to do with the (optional) preliminary assessment or 'pre-assessment', it accomplishes a number of things:-

Documentation status and compliance, scope accuracy, head count, locations etc and the state of readiness of the client organization to move to the stage 2 in the timeframe scheduled. This can only be achieved on site and there's no increase in days over the 'old' schedule of days for the audit.

Just clarifying things for those who will see a difference of approach in the coming months.

Are non conformance raised during stage 1 audit? I think so. Could any body provide some of your nonconformances found during stage 1 audit?

Thanks:thanx:

Any accredited registrar must be working towards ISO 17021 compliance under ANAB in the USA and will be offering a stage 1/stage 2 audit process. We at NQA have been doing this for some time to be able to demonstrate our process to the accreditors. So, our clients have been seeing this in their quotes for all related registrations, not just ISO/TS 16949.

Although fairly recent, this is not late breaking news. I'm afraid you're incorrect in this respect.

A stage 1 has nothing to do with the (optional) preliminary assessment or 'pre-assessment', it accomplishes a number of things:-

Documentation status and compliance, scope accuracy, head count, locations etc and the state of readiness of the client organization to move to the stage 2 in the timeframe scheduled. This can only be achieved on site and there's no increase in days over the 'old' schedule of days for the audit.

Just clarifying things for those who will see a difference of approach in the coming months.

What Andy described had been in practiced for a number of years over here.

From the end-user point of view, I see a number of advantages. Less surprises especially for those companies that develop systems on their own and without the help of external parties. Stage one or desktop audit helps to clear doubts, detect inadequacies etc at an early stage. NC's or corrective actions may be issued and it gives the organization adequate time to take appropriate actions including postponing the stage two audit if necessary.

Are non conformance raised during stage 1 audit? I think so. Could any body provide some of your nonconformances found during stage 1 audit?

Thanks:thanx:

NC for stage 1?

If done correctly a NC will normally be against documentation such as the lack or a procedure or doc control and will normally be gainst Level 2 documents, occasionally level 3. The purpose of the stage 1 is to determine the ability of the MS to successfully go thru Stage 2 by looking at its design

MS auditing is 3 dimensional "intent-implementation-effectiveness"

The audit of the 1st dimension is what we call the stage 1 audit where we look at the system design through the high level documentation (level 1 & 2) and from it we can determine "intent". This audit may be done on-site or off ( desk audit some call it)

The audit of the 2nd dimension occurs during stage 2 where we look at the "implementation" of the design. This is an operational audit where we see how the design is put into action and this will also normally cover the level 3 type documents...This is the audit where the auditors have to get out and "LOOK", interview and experience the design in action. This audit has to be onsite.

The audit of the 3rd dimension takes place concurrently with the 2nd dimension and it looks at the effectiveness of the implementation of the design. Much of the information is gathered through the reviewing of the level 4 documents...records. What is being looked for here is whether the system is able to achieve and is achieving what it was planned to achieve.

If you look, really look at clause 8.2.2 of 9001 you'll see where the 3 dimensions are called out..........

8.2.2 Internal audit
The organization shall conduct internal audits at planned intervals to determine whether the quality management system

a) conforms to the planned arrangements (see 7.1), to the requirements of this International Standard and to the quality management system requirements established by the organization, and

b) is effectively implemented and maintained.

This "new" Stage 1 & Stage 2 approach isn't new at all (at least to Registrars), it has been going on for 12 years or more since ISO 14001 came out and OHSAS 18001 is audited that way as well.

If you think about it as auditors we were all taught to review documentation and then go out and see if procedures were being followed and stuff was happening as planned...No big deal, people are just making it that way.

Randy,

At least with the registrar I work with, it has been determined that at least part of the stage one audit must be performed on site. At least that is their intrepretation and approach.

Randy,

At least with the registrar I work with, it has been determined that at least part of the stage one audit must be performed on site. At least that is their intrepretation and approach.

You are correct Jim - (see my post too about it being done on site).

Harry's also got a good point. As a CB auditor in the UK we always did the 'document review' on site. It was way more than just that, and was just like the stage 1 today.

I believe it was the logistics and costs of doing that here in the USA, especially in the early days of CB operations (most were east coast centric), that forced such an effective practice to stop. Many companies see only a cost of doing business with a CB - often simply to get a certificate and didn't want to pay for the expenses.

Today, with so much of the USA covered (we have assessors in over 25 states) most of the country is accessible easily and (relatively) less expensively........

Yeah, I've yet to do a Stage 1 off site for my employer as well and 17021 is going to be a bit more demanding than Guide 62 & 66

...This "new" Stage 1 & Stage 2 approach isn't new at all (at least to Registrars), it has been going on for 12 years or more since ISO 14001 came out and OHSAS 18001 is audited that way as well.

...


TS-16949 requires it as well. It was inevitable that it would filter to ISO 9001.

If I will have a stage 1 audit and I still have some procedures in approval that may not be realease before the audit. May I show them as in "approval" procedures?

Please advise,

...well, procedures that are not approved cannot be used as basis for auditing – that is for sure… you can show to the auditor even in their “for approval” status, but then again, the auditor might ask the approved ones…

…better for you to approve the current one you have now, and tell to auditor that you have another proposed revision that is being reviewed…

…with this approach, the auditor “might” give you a minor or even observation category in case he found nonconformance…

(I added “might” since it is not a 100% sure… but for me, as an auditor, I usually give a lighter category for nonconformance that is acknowledged by the organization specially if the correction / corrective action is on the way…)

Yeah, I've yet to do a Stage 1 off site for my employer as well and 17021 is going to be a bit more demanding than Guide 62 & 66

I know it is recently issued but What exactly is the date of issue of ISO 17021?:thanks:

I think that ISO 17021 was published on 15 September 2006, but there was 2 year allowed to the CB for transition(to obtain the accreditation).

Alin

The full title is ISO 17021:2006 so that should give you a clue that it was released in 2006. The old Guide 62 was given a sunset (would no longer be recognized) of September 15, 2008, so that may also be a clue as to the actual release date.