Internal Audits - Necessary before Stage 1 Audit?

[kellyjo]

Re: Internal audit, necessary before stage 1 audit

I think you're right. Thanks for your help. On a slighly different note, how long can a company expect for certification to take, from start to completion?

 

[AndyN]

Re: Internal audit, necessary before stage 1 audit

I think you're right. Thanks for your help. On a slighly different note, how long can a company expect for certification to take, from start to completion?

Happy to help! The Cove is famous for that!

Do you mean from putting the system in, to certification audit? Or the actual certification process?

 

[Helmut Jilling]

Re: Internal audit, necessary before stage 1 audit

They are accredited.

Very disappointing that an accredited registrar auditor would not follow ISO 17025 for Stage 1. Your company managment might want to reevaluate whether this is a registrar you want to be affiliated with.

 

[Helmut Jilling]

Re: Internal audit, necessary before stage 1 audit

Thanks for the reply.
I was told by our consulting company to do the management review right away, before the internal audit... this is why I'm so confused

I feel for you. You are trying to do a good job, and you are getting poor guidance from both your consultant and your registrar. Your management team may want to consider whether these are companies that you want to be affiliated with.

Keep up your good work, and trust your instincts. You are doing better than the "professionals," so far.

 

[Sidney Vianna]

Re: Internal audit, necessary before stage 1 audit

I have ISO/IEC 17021 open in front of me and, under section 9.2.3.1 it lists a - g, items to be verified, a) being documentation (not just 6 procedures and QM) and g) being audits, management review....

The list includes:

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.

 

[keres]

Hi,
I'm new here. I work for a teeny-tiny (myself and the two bosses) metal fab/manufacturing shop. We are working towards our 9001:2008 certification. We have paid a "consulting company" to help us. There's one spot I'm confused....Do we HAVE to do internal audit before out stage one audit is done?
One piece of their information is saying no and the rest is beating it into my head to have an internal audit done beforehand.
The reason this is a concern is our stage 1 is scheduled for next week. We have fallen slightly behind due to increase in work. I have all my procedures and quality manual done. Thanks for any help.

The right sequence is internal audit-management review-stage 1. If you are do not conduct internal audit or management review before stage 1 the CB will rise a major NC of this on stage 1. But you will have time to resolve it till the stage 2.

 

[phloQS]

In my opinion it is not a big problem not to have the internal audit and managementreview done previous to stage 1 audit. You will get 2 ncs and thats it. Not much to do to reply to them.The fix must be there until stage two audit. Many CBs make stage 1 audits just based on papers. And in many companies this will be sufficient. Management review and first internal audit can just check if the system is basically fitting to the company in regard to less data.
BTW do you want to be certified due to customer requirements or do you want to establish a working QMS to improve your processes?

regards

phloQS

 

[Coury Ferguson]

In my opinion it is not a big problem not to have the internal audit and managementreview done previous to stage 1 audit. You will get 2 ncs and thats it. Not much to do to reply to them.The fix must be there until stage two audit. Many CBs make stage 1 audits just based on papers. And in many companies this will be sufficient. Management review and first internal audit can just check if the system is basically fitting to the company in regard to less data.
BTW do you want to be certified due to customer requirements or do you want to establish a working QMS to improve your processes?

regards

phloQS

I am sorry I don't agree with what you are saying here. The 2 NCR would be Majors. There is a major disconnect on the requirements.

Back to the OP's question: As many have suggested, you may want to rethink your affiliation with the Registrar and the Consultant. The Registrar is not following their requirements to maintain their Accredation by going outside of the 17021. If by chance this was found by ANAB during their review of the Registrar, there is the possibility that the Registrar could be suspended and/or withdrawn which in turn would affect your registration status. The Company (yours) needs to really think about the risks.

It maybe a good idea (since it is your stage 1) to rescehdule the stage one until you have finished the cycle of Internal Audits and the Management Review.

Just my opinion.

 

[Helmut Jilling]

In my opinion it is not a big problem not to have the internal audit and managementreview done previous to stage 1 audit. You will get 2 ncs and thats it. Not much to do to reply to them.The fix must be there until stage two audit. Many CBs make stage 1 audits just based on papers. And in many companies this will be sufficient. Management review and first internal audit can just check if the system is basically fitting to the company in regard to less data.
BTW do you want to be certified due to customer requirements or do you want to establish a working QMS to improve your processes?

regards

phloQS

It is disturbing that so many replies are stating "opinions"...we must follow the rules (see Sidney Vianna's post from ISO 17021). These items are to be reviewed at the Stage 1.

Writing NC's at a Stage 1 misses the point. Stage 1 is a readiness review. The auditee is not ready. In TS, they would have to go back and do another Stage 1.

What if the auditee does the audits and management review after the Stage 1, and they are not complaint. THEN, they get 2 majors at the Stage 2, and that defeats the whole purpose for why IATF created a Stage 1 in the first place.

Registrars need to follow the rules. If they don't, the accreditation bodies should do their jobs.

 

[AndyN]

In my opinion it is not a big problem not to have the internal audit and managementreview done previous to stage 1 audit. You will get 2 ncs and thats it. Not much to do to reply to them.The fix must be there until stage two audit. Many CBs make stage 1 audits just based on papers. And in many companies this will be sufficient. Management review and first internal audit can just check if the system is basically fitting to the company in regard to less data.
BTW do you want to be certified due to customer requirements or do you want to establish a working QMS to improve your processes?

regards

phloQS

Since the system hasn't been audited, how can you predict that only 2 NCs will result? Also, are you offering opinion about the number of CBs who do just 'based on papers' or is this fact based observations?

No company in their correct frame of mind goes into a stage 1 (especially guided by a consultant) knowing there are omissions! What you are suggesting will probably lead to the client having to do the stage 1 over and at greater cost, delays and so on. They run the risk internally of looking unprepared (possibly even stupid to have do it that way)and, to the outside - customers may be watching to see progress.

There are many factors at play, not just the 'fixing of a couple of ncs' as you suggest...