Stage 1 Audit for ISO 9001 and Notifying/Preparing Employees

#11
Re: Stage 1 audit for ISO 9001

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........
 
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Randy

Super Moderator
#12
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
 

Helmut Jilling

Auditor / Consultant
#13
Re: Stage 1 audit for ISO 9001

...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.
 

Anerol C

Trusted Information Resource
#14
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,
 
J

joshua_sx1

#15
...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…)
 
A

amanbhai

#16
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:
 
A

Al Hector

#17
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
 

Big Jim

Super Moderator
#18
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.
 
J

Jon-uk

#19
Re: Stage 1 audit for ISO 9001

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:
as the certification hasn't yet been awarded then no 'non-conformances' can be raised. What i raise during a stage 1 is improvement requests. These are generally related to documetation required by the standard or required by the companies QMS to show conformance to the standard which is missing, in appropriate or would not provide the required evidence of conformity.
In its most basic terms consider a stage 1 assement as a gap analysis of the companies QMS and a review of the allocated EAC code and review of the audit days that will be required for surveillance auditing once the certification has been awarded - but this should not be mistaken for the stage 2 audit wich is the formal certification audit.
 
#20
Re: Stage 1 audit for ISO 9001

as the certification hasn't yet been awarded then no 'non-conformances' can be raised.
I'm not sure that it's a universal truth! A non-conformance can be issued as a result of reviewing the QMS, can't it? If the client doesn't have something which the ISO 9001 (or other standard) says they 'shall' have, that's a non-conformance, isn't it? Certification certainly doesn't have to be awarded before any non-conformances are issued!

A stage 1 audit is performed to determine a number of things, all listed in ISO/IEC 17021 and is certainly not limited to documentation. Also, while the number of days for surveillance might be considered, the need for an appropriate amount of time for the actual stage 2 is more important, at this stage, don't you agree?
 
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