ISO 9001 Implementation and Certification - 6 Years of Advice

[Mecca]

Re: ISO 9001 Implementation and Certification - Some advice

Has anybody read this book:
ISO 9001:2000 FOR SMALL BUSINESS "IMPLEMENTING PROCESS APPROACH QUALITY MANAGEMENT

It has a full QM and a linked QOP and I was wondering if it would be advisable to use it for a design house. It is specifically made for manufacturing firms (includes AS 9000)

I have also noted from this book that there is a big section on Control of Purchases it is here that I have difficulty because I dont know if I need to include a whole massive section on purchases when this design firm doesnt really purchase anything from anyone that directly would affect our product quality... unless Solidworks is deficient or other programs of that sorts. The only way I can see us purchasing items is for the client who would ultimately provide us the funds to do so... but this firm has never had to do that so I dont think that it is worthwhile inserting into the QSM. What is your folks take on it

 

[JaneB]

Re: ISO 9001 Implementation and Certification - Some advice

Has anybody read this book:
ISO 9001:2000 FOR SMALL BUSINESS "IMPLEMENTING PROCESS APPROACH QUALITY MANAGEMENT

I haven't, no.

I would be concerned about using a book that is, you say, focussed on manufacturing when you're not in that space. You could find it a bit confusing and possibly be misled.

And even if it has a 'full QM and a linked QOP', they'll be set up for manufacturing and much won't be applicable to what you're doing. I wouldn't.

I have also noted from this book that there is a big section on Control of Purchases ...

That's an example of why I say you'll get confused. Purchasing is usually v important in manufacturing, hence the focus on it.

Don't do this. Start by focussing on YOUR processes and what YOU do! Don't go off down a side alley.

Re. your plan to manage and control docs electronically, yes, that's a v good way to do it. (But another example of where you'll get confused, because often manufacturing firms aren't as up with technology)


Yes, this thread you started has become somewhat derailed at times. You have to expect/tolerate that in a public forum.

 

[JaneB]

Re: ISO 9001 Implementation and Certification - Some advice

I was arguing from the standpoint of a hypothetical company that has been around for 20 years.

I've rarely found hypothethical questions or comments based on hypothetical companies very interesting or elucidating.

In most cases, the person posing them makes up the hypothesis and the 'data' to support it, most commonly to prove or disprove whatever they're keen to prove/disprove at the time.

Real situations and real examples are truer and more useful.

 

[Mecca]

Re: ISO 9001 Implementation and Certification - Some advice

Okay so here is a question then.

My Company just sat down and did the Gap Analysis and we worked together to put together some solutions together to slowly try to meet this ISO.

I am currently working on some of our pre-existing procedures and we completed process maps for all that we did.

The main issue we still had was with purchasing. As a design firm we dont usually deal with the manufacturing side of things, BUT as my boss mentioned when we design things we look at suppliers such as Mizumi that provide nuts bolts and such. The only thing is we dont purchase the items ourselves... would this be considered outsourcing though... would we need to control these things.

 

[harry]

Re: ISO 9001 Implementation and Certification - Some advice

The only thing is we dont purchase the items ourselves

Purchasing applies to items you purchased for use in your work, especially those which had bearings on the quality of the final output of your product and its ability to satisfy your customers.

we look at suppliers such as Mizumi that provide nuts bolts and such

You are a specifier in this case. It is common sense and good practice to keep a copy of their catalog or spec.

would this be considered outsourcing

If your hands are full and you pass some design jobs to an outside party to complete the project or if some special skills and knowledge are needed then it is outsourcing.

 

[JaneB]

Re: ISO 9001 Implementation and Certification - Some advice

Mecca,

All good advice from Harry, and correct.

The best way to start to understand how to answer these questions for yourself is to keep going back to the Standard, look at what it says, and ask yourself:
1. Do we do this?
2. How do we do it?

Re. purchasing, the Standard mandates 3 basic things in 7.4. You have to make sure that:

1. what you purchase (product/service or components of same) conform to specified purchase requirements -cl. 7.4.1
2. Purchasing information describes what is to be purchased cl 7.4.2
3. Set up & do inspection (or other activities necessary) to make sure that 1 happens. cl 7.4.3

And yes, it adds in a bunch of specific details about those 3 things.

But stay common sense. If what you buy has little/neglible effect on your products/services, don't get too wrapped around the axle (to borrow a phrase from Randy) about purchasing. Again, this thing about PURCHASING being a big deal is an (other?) instance of why using a guide based on manufacturing if you aren't in that field is a Very Bad Idea. You may get overly fussed about things that aren't so important and insufficiently focussed on those that are.

 

[Mecca]

Re: ISO 9001 Implementation and Certification - Some advice

Wow thanks for that help!

I too was quite skeptical about the whole Purchasing section of the Standard, and since Section 7 allows for exemptions I'm pretty sure that we can find ourselves exempted from a few in their granted I provide some solid reasons in the QM.

So my company took the ISO and a Gap Checklist we found for ISO 9001:2000 and noticed that they pretty much request the same things and this was expected from previous reading. So I have the Gap Analysis done and I have supplied some suggestions to meet the needs of the ISO and to further the firm in the implementation of the QMS.

Would anyone want to read the gap analysis... That might be asking for a lot I really dont know the limits to this forum. Perhaps one could just read my suggestions or the notes on what is missing. I dunno its a long shot But thanks for any attempt at it

 

[ISO 9001 Guy]

Re: ISO 9001 Implementation and Certification - Some advice

Mike, whatever you do, don't cut and paste procedures from some other company. It's a mistake all too many organizations make, only to share the same miserable experience with quality management. Don't let the standard define YOUR realization processes!

 

[batman1056]

Re: ISO 9001 Implementation and Certification - Some advice

Wow thanks for that help!

I too was quite skeptical about the whole Purchasing section of the Standard, and since Section 7 allows for exemptions I'm pretty sure that we can find ourselves exempted from a few in their granted I provide some solid reasons in the QM.

So my company took the ISO and a Gap Checklist we found for ISO 9001:2000 and noticed that they pretty much request the same things and this was expected from previous reading. So I have the Gap Analysis done and I have supplied some suggestions to meet the needs of the ISO and to further the firm in the implementation of the QMS.

Would anyone want to read the gap analysis...

yes I would like to read it any chance you can mail it to me - how was the gap checklist created (internally/externally) was it fit for purpose, did it draw upon your resources and did you think it helped?

 

[JaneB]

Re: ISO 9001 Implementation and Certification - Some advice

Would anyone want to read the gap analysis... Perhaps one could just read my suggestions or the notes on what is missing.

Why don't you post it here and see?