ISO 9001 Implementation and Certification - 6 Years of Advice

[Colin]

Re: Taking my company to ISO 9001 certification - Some advice for me?

It scares me! Its too complicated. This is meant to be an overview of the organisation, no detail. Keep it simple and what's with all the bright colours?

 

[driaadi]

Re: Taking my company to ISO 9001 certification - Some advice for me?

I used so dark colors to highlight because Word 2003 won't let me change highlight colors, and those were the only available.

But I've found out that I can use shading instead, so i've managed to change the colors.

I made it in detail because when I made it simple, I was told it is no good... now I tried to show the interaction, the succession, but also the inputs, the outputs, resources, responsabilities, indicators, references (to clauses of the standard and to procedures).

I could make a simpler map, but then I would have to describe or map each process, which it would mean more pages. This way, I only have one page.

Do you think it works now? I mean, will it work for the auditor?? The boss said he likes it, and he is satisfied with it because it describes almost everything.

I don't know what to do anymore

I'm now attaching it untranslated, but I hope You people can take a look at it, and tell me what you think!

Pease...

Thank you again

 

[Colin]

Re: Taking my company to ISO 9001 certification - Some advice for me?

As stated, the process map is meant to give an overview of the main processes and how they interact. From there, you can produce more process maps or procedures for each process - these describe in more detail how you will control each process.

However, your most important comment is that you and your boss like it as it describes what you do. It is not for the auditor to say what s/he likes or doesn't like - just whether it complies or not.

 

[driaadi]

Re: Taking my company to ISO 9001 certification - Some advice for me?

Well, Colpart, do you think it complies?

I have made a simple for inserted in the QM and I have this one attached as an annex at the end of the QM.

Thanks for your feedback

 

[driaadi]

Re: Taking my company to ISO 9001 certification - Some advice for me?

I also have another few question, if someone can help, that would be great...

4.2.1. a) says the organization must have documented statements of the quality policy and quality objectives.

5.4.1. says quality objectives must be measurable...

We have written our Quality Policy and quality objectives in one Statement.

we only have 2 departments - sales and production - and 10 people, so we have written all objectives in the same document, without distinguishing management, sales and production objectives, they are interrelated, anyway. Is that ok, or should we detail these objectives, separate them in some way?
How?

We also said in the quality policy statement that QO are measurables and we have a document where we say how we measure them and what is level acceptable for each indicator. (I don't know yet how to call this doc?.. or where to place it better)

In our MR procedure we also list what indicators are analyzed.

Is that ok? How else could we cover this? Any better solutions?

in advance

 

[Colin]

Re: Taking my company to ISO 9001 certification - Some advice for me?

Unfortunately, I do not know your organisation well enough to say it complies - its difficult from a distance.

No problem having the objectives in the policy but you may find it a little more difficult to manage as time goes on. Whenever you change your objectives you may have to change your policy. I tend to put high level objectives in the policy and have a separate document containing the objectives and their targets so I can work with it more easily, as you have suggested. Just file it somewhere handy. MR is a good time and place to do a review so just include the outcomes in the minutes.

 

[majorhal - 2009]

Re: Taking my company to ISO 9001 certification - Some advice for me?

Hi mikeb,
First, registrars are now called certification boards or CBs. That's not a biggie but not understanding the terminology of the standard and the program has caused problems.
Second, is your CB accredited by ANAB? If they are there will be 3 audits as follows: 1) Document audit, usually done offsite; 2) Stage 1 audit, done onsite to see if you are ready. This is the old pre-assessment audit. 3) If you pass the Stage 1 audit, your CB will schedule the Stage 2 audit. This is the certification audit. If there are major holes found in the Stage 1 audit you will need to do corrective action and then schedule the Stage 2 audit.

Most common nonconformances and problems found from Stage 1 audits:
*Auditee didn't know that the meaning of the terms define and describe means to write it out (record it some how).
*Preventive action is non-existent or extremely weak. Auditee not using corrective action items as lessoned-learned for preventive action.
*Continual improvement program not formalized and disciplined. Some auditees believe corrective action is continual improvement. It is not! The standard sets out specific input data for continaul improvement (see clause 8.5.1) This action must be recorded as objective evidence for continual improvement.
*Employees at all levels are not aware of the relevance and inportance of their jobs in contributing to the achievement of the quality objectives. Many times employees didn't know the quality objectives.
*The management review doesn't include each topic listed in clauses 5.6.2 and 5.6.3.
*A complete system audit has not been performed and internal audits are not being performed as process effectiveness audits.

There are some more but I don't want to have this reply get too long. I suggest that if you haven't read the following reference guides from ISO that you do so: ISO 9000:2005, ISO 9004:2000 and ISO 19011:2002. You can find some reference materials on my website and links to these documents.

One final thing: ISO 9001 is being revised next year. If you get your certification before the revision is published you will have 3 years to transition to the 2008 revision.

Wishing you all the best,
MajorHal

 

[Colin]

Re: Taking my company to ISO 9001 certification - Some advice for me?

*Continual improvement program not formalized and disciplined. Some auditees believe corrective action is continual improvement. It is not! The standard sets out specific input data for continual improvement (see clause 8.5.1) This action must be recorded as objective evidence for continual improvement.

Are you saying that corrective action is not part of continual improvement? I think it is.

Are you really asking him to read 9000, 9004 and 19011? You must be a sadist!

 

[majorhal - 2009]

Re: Taking my company to ISO 9001 certification - Some advice for me?

I did not say it wasn't part of continual improvement. Corrective action may be an input for continual improvement but, in and of itself it is not continual improvement. Corrective action is self-descriptive. Correct something that is broken. In other words - return it to it's original state.

Yes! I'm saying read the standard and the associated guides. If more people read the published materials there would be fewer posts on quality forums for questions that are covered in these documents. It really is amazing what is contained in those documents. Take a look.

 

[Colin]

Re: Taking my company to ISO 9001 certification - Some advice for me?

Sorry, I read this in your post 'Some auditees believe corrective action is continual improvement. It is not!'

Now, I agree that it is not all of CI but I suggest that it is a good contributory part of it. Also, corrective action includes the need to prevent the problem from recurring, not just fix what was wrong - take a look.

Interesting assumption that I have not read the guidelines - as an auditor, trainer and consultant of 20 years standing, I believe that I have a moderate understanding of the subject.