Need to update to ISO 9001:2000, current registered to ISO 9002

[Shaun Daly]

Reading through the GAP analysis our Assessor did for us in 2001, these are the points they said we had to cover as a minimum to become compliant to ISO9000:2000 from ISO9002:1994

1) Determine the sequence & interaction of our processes.
2) Communicate to people about meeting customer, Ststutory & Regulatory requirements.
3) Establish Quality Objectives consistent with the Quality Policy
4) Include Opportunities for Improvement & need for changes to the QMS during Management Review (MR)
5) Include Customer Feedback in the MR
6) Include Follow Up actions from the previous MR in the MR
7) Include competancy needs on Job Descriptions.
8) Evaluate effectiveness of Training.
9) Control Customer Intellectual property.
10) Monitor Customer satisfaction.
11) Use the Quality policy & Objectives to facilitate continual improvement.

Not much in there from 2001 about processess, as already mentioned a lot of assessors just dont understand them.

But since then, I have become a firm believer & supporter of process mapping, as our customers are also pushing us towards TS16949.

You cannot simply pretend your QS procedures are textual processess for TS, they wont accept it. I dont know whether this will extend to ISO9000 registrars, I guess its going to be the luck of the draw whether you get a competent assessor or not.

 

[Cari Spears]

My advise would be to get your auditor to come in and do a pre-transition assessment. That way you will know what your gaps are in the auditors eyes. (then close them)

Don't worry about not understanding the process approach, most auditors don't understand it yet either.

Also don't worry about changing the numbering of your old documentation, that doesn't matter. Just provide a cross reference table somewhere to show where the elements in the old documentation meet the new standard.

Like the others said you probably already have 99% of what is required from your 9002 stuff. Most likely a little look at the process interactions, what goes in - what comes out - what is required to make the input into the output - and what are the next process' that use the output of this process as their input.

Another area that 'we' needed to address was customer satisfaction monitoring. I think it was more our specific area that was causing the problem, but you might want to look at this.

Right On!

I completely rewrote our Policy Manual, but I have not yet converted text procedures to process maps. I did not change our document numbering either, and the last page of the manual is a list of Level II procedures. My plan after the upgrade registration is to review these procedures during Internal Audits throughout next year to determine where process maps will supplement or replace text.

I'm attaching my rough draft policy manual. You will note two areas that are incomplete. Our Auditor is performing our Desk Audit on site for us next Tuesday, the 22nd. I have rough hand sketches that I will run past him before I put all the work into creating these two pages. The measurable objectives and management review were the two biggest implementation challenges for us.

 

[gpainter]

Do not worry, if the system in place is good most is in place. As far as numbering, keep what you have but cross reference it. Lots of info here. Contact your registrar, many have info packets and suggestions to make a smooth transition.
The QM will need to be adjusted, less is best, remember it is generally an introduction to your company's QMS.
The SP's, I would just add to them if they fall short. Since time is limited and you more than likely wear more than one hat. You can reduce and improve them for the surveillance

 

[vpickell]

Thanks everyone for your suggestions and support. I just need to step back, relax and take one day at a time. All the information is here, its just that there is so much of it. Like 75 forms for 10 employees, they wouldn't have time to do anything put paperwork. No wonder most of them don't see the advantage of ISO. But they give me a lot of support, so we will get there, and then they will see the added benefits.

Again Thanks for the support.
Vickie

 

[db]

Thanks everyone for your suggestions and support. I just need to step back, relax and take one day at a time. All the information is here, its just that there is so much of it. Like 75 forms for 10 employees, they wouldn't have time to do anything put paperwork. No wonder most of them don't see the advantage of ISO. But they give me a lot of support, so we will get there, and then they will see the added benefits.

Again Thanks for the support.
Vickie

Vickie:

Here is my take. The biggest difference is in the process ID. Begin with that. Once you do identify your processes, then begin to go through your Level I documents and see which still apply, which you can dump, and which new ones you need to create. Do the same for your Level II. More than likely, your Level III and Level IV will not change in substance. You may want to renumber them, but it is not required.

For each document/form, ask yourself two questions:
1) Is this document/form necessary?
2) Why is it here?

Keep your paperwork to a minimum. With 10 employees, your total documetation should be less than 1 inch thick.

Hope that helps

 

[Aaron Lupo]

Vickie:

Here is my take. The biggest difference is in the process ID. Begin with that. Once you do identify your processes, then begin to go through your Level I documents and see which still apply, which you can dump, and which new ones you need to create. Do the same for your Level II. More than likely, your Level III and Level IV will not change in substance. You may want to renumber them, but it is not required.

For each document/form, ask yourself two questions:
1) Is this document/form necessary?
2) Why is it here?

Keep your paperwork to a minimum. With 10 employees, your total documetation should be less than 1 inch thick.

Hope that helps

DB- I agree with almost everything you said, the only part I disagree with is your last statement. I don't undersatnd how you can say that, do you even know what VP's company does, do you know what the Regulatory requirments are, to make a blanket statement that with 10 people documentation should be less that 1 inch thick IMO is bad advice. They may need lots of documetation based on what they are doing, maybe they only have 10 people but they have 50 different processes they perform. Like I said JMO.

 

[db]

DB- I agree with almost everything you said, the only part I disagree with is your last statement. I don't undersatnd how you can say that, do you even know what VP's company does, do you know what the Regulatory requirments are, to make a blanket statement that with 10 people documentation should be less that 1 inch thick IMO is bad advice. They may need lots of documetation based on what they are doing, maybe they only have 10 people but they have 50 different processes they perform. Like I said JMO.

You are right in your caution that size of the organization does not necessarily equate to complexity. However, my experience is that most organizations have way more documentation than they need. Even though they may have 50 processes, having a goal of 1” thick documentation is not bad advice (IMO). Perhaps my statement was stronger than it should have been, but then again, I’ve worked with many job shops (some were QS) that had far less than 1” of paperwork. Here is a sample breakdown:

QM: 10 pages, including company profile, org chart and master process map.
Procedures: 25 pages (figuring about 15 procedures and some being multi-page)
Forms: Only have masters in the QMS, keeping to the minimum you might have 12?
Work instructions: Once again, only masters, and only those that are “fixed”. Most of the work instructions will be routers, prints, control plans, and things like that, which might not be in the QMS (examples maybe). Once again, perhaps 12.

So now we are up to less than 60 total pages. Note, I have not included documents of external origin or records. But other than that, you’re well below 1”.

 

[Aaron Lupo]

You are right in your caution that size of the organization does not necessarily equate to complexity. However, my experience is that most organizations have way more documentation than they need. Even though they may have 50 processes, having a goal of 1” thick documentation is not bad advice (IMO). Perhaps my statement was stronger than it should have been, but then again, I’ve worked with many job shops (some were QS) that had far less than 1” of paperwork. Here is a sample breakdown:

QM: 10 pages, including company profile, org chart and master process map.
Procedures: 25 pages (figuring about 15 procedures and some being multi-page)
Forms: Only have masters in the QMS, keeping to the minimum you might have 12?
Work instructions: Once again, only masters, and only those that are “fixed”. Most of the work instructions will be routers, prints, control plans, and things like that, which might not be in the QMS (examples maybe). Once again, perhaps 12.

So now we are up to less than 60 total pages. Note, I have not included documents of external origin or records. But other than that, you’re well below 1”.

DB- I agree most companies do have too much documentation, there are also quite a few that do not have nearly enough documentation. I guess it all depends on what industry you are in and how heavily it is regulated. :truce:

 

[Joe Cruse]

Vickie,

I agree with db, start with the process. If you are new to the business of your new company, get with the order entry folks, the shop floor folks, shipping, and management. Find out how your company decides what to make, how to make it, etc. With the small company size, it should not be too hard to get in touch with the process. Look at your current manuals and review them with the people who are doing the stuff documented in them. Condense, flow chart, and/or toss things, as you see the need to fulfill the new standard's requirments.

Sounds like your fellow employees are behind you, and should be able to help you map out exactly what they do and how they interact on a daily basis.

Good luck,

Joe

 

[Cari Spears]

New job, what did I get into? Just love it……….
Need to update to ISO 9001-2000, current registered to ISO 9002
Time is limited (need Quality Manual & Procedures to external auditor by 10/1).

How's it going Vickie?