Upgrading an existing Management System into a full-fledge QMS?

[JvdAA]

After a week of reviewing the company and the ISO requirements I have a few questions that could help me on my way again.
First a very basic one:

I understand that the minimum documented requirement is:

Statement of a quality policy and quality objectives
Quality manual
Document procedures required by norm
Document needed by organization
Records required by norm

Where the following are part of the procedures

control of documents
control of records
internal audit
control of NC product
corrective action
preventive action

Now my question is do you need to document, besides within the quality manual, clauses like 6.1 or 6.3 etc. The clauses that do no seem to be part of the required procedures, documents or records. Is it enough to just state in the manual that you are doing exactly that or do you need seperate documents PROVING that it is being done?

Second question on exclusions.

The company in question handles direct mail. In essence this means that the customer supplies the product, through digital and physical ways. The company then prints, folds, package etc etc it. There is no design or development involved in the processes.

Can we exclude clause 7.3?

 

[Helmut Jilling]

....
Now my question is do you need to document, besides within the quality manual, clauses like 6.1 or 6.3 etc. The clauses that do no seem to be part of the required procedures, documents or records. Is it enough to just state in the manual that you are doing exactly that or do you need seperate documents PROVING that it is being done?

records demonstrating it is done is enough. No need to put it in a procedure, the Q manual is also enough.

Second question on exclusions.

The company in question handles direct mail. In essence this means that the customer supplies the product, through digital and physical ways. The company then prints, folds, package etc etc it. There is no design or development involved in the processes.

Can we exclude clause 7.3?

Yes, your quality manual simply has to explain why you exclude it, and that the customers do it.

 

[Martijn]

Hi J,

I just noticed you're from the Netherlands. If you'd like to see how it's done in another company/discuss a bit further, you're more than welcome to visit me. Our office is in Rotterdam.

Groet, Martijn

PS what exactly are you studying in university?

 

[JvdAA]

Hello Martijn,

Thanks for the invitation! I am studying International business and management currently in Breda. I just came back from a 5 month exchange student program in South Korea, and for my graduation project I saw a challenge in the Quality Management field.

I am still trying to get my bearing, and the managements for that matter

I'll let you know if I take you up on that offer in the near future.

 

[Stijloor]

Hello Martijn,

Thanks for the invitation! I am studying International business and management currently in Breda. I just came back from a 5 month exchange student program in South Korea, and for my graduation project I saw a challenge in the Quality Management field.

I am still trying to get my bearing, and the managements for that matter

I'll let you know if I take you up on that offer in the near future.

Hello JvdAA,

Leuk om iemand uit Nederland to ontmoeten hier.

I read your post and noticed that your are studying in Breda. Interesting! I used to live in Etten Leur, before I moved to the USA 26 years ago. If you like to learn/know more about the Quality Management field, please send me a private message. I am going to be in Holland in November. Maybe we can meet and chat. The profile shows our company's web address.

Greetings!

Stijloor.

 

[JvdAA]

Thanks for your invitation as well Stijloor. I'll let you know.

I've got to say this is the most amazing place. I am sure this will be my number one source of information from now on.

Apologies for the off-topic posts btw.

 

[Peter Fraser]

Hello Martijn,

Thanks for the invitation! I am studying International business and management currently in Breda. I just came back from a 5 month exchange student program in South Korea, and for my graduation project I saw a challenge in the Quality Management field.

I am still trying to get my bearing, and the managements for that matter

I'll let you know if I take you up on that offer in the near future.

Goodness - we were on holiday in Breda last month from Scotland (Rosyth - Zeebrugge), and visited my wife's aunt there!

PS I developed the Quality module for a Project Management MSc course for one of the Scottish Universities - if you want another angle on all this, see our website (ref my profile).

Tot ziens!

 

[Stijloor]

Goodness - we were on holiday in Breda last month from Scotland (Rosyth - Zeebrugge), and visited my wife's aunt there!
Tot ziens!

It's a small world after all.....

 

[JvdAA]

OK. Next question:

I did a small gap analysis for the company here and I now have a pretty good idea how to tackle this project. One clause however remains a bit obscure to me. Clause 7.6 I cannot seem to figure out what it exactly means in this company.

These measuring and monitoring tools are actual physical tools or does human monitoring also apply? Could someone give an example as how this could apply to a company which uses a lot of professional printers and machines that handles envelopes and the like?

 

[Helmut Jilling]

OK. Next question:

I did a small gap analysis for the company here and I now have a pretty good idea how to tackle this project. One clause however remains a bit obscure to me. Clause 7.6 I cannot seem to figure out what it exactly means in this company.

These measuring and monitoring tools are actual physical tools or does human monitoring also apply? Could someone give an example as how this could apply to a company which uses a lot of professional printers and machines that handles envelopes and the like?

It would generally apply to manual and automatic gages that measure product. In printing, that would include micrometers, scales, any automatic gages that might check paper weight or thickness, lab equipment, etc. It would also apply to process equipment like counters, gages that monitor ink flow, paper length, automatic cutters, and other gages that must be accurate to control the processes.

That should get you to a good start. Also, you might want to read ISO 9004, the companion guide to ISO 9001. It often gives much better explanation and examples than ISO 9001 alone. They were designed to be used as a pair of books.

Good Luck!