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View Full Version : My Company wants to Implement ISO 9001-2000 and become Certified - The Big Start


Andy CDA
20th December 2007, 05:25 PM
Hello Everyone,

My company wants to implement ISO 9001-2000 and become certified. I have been chosen to head this up. We are a metal fabrication and assembly company. Our current quality procedures are pretty much a blank piece of paper. Where do I start? I know I need to write a quality manual and I know there are only a mandatory 6 things that need to be covered but I also know there is a lot more to it than that. Does anyone have a realistic list of things that should be covered? I would also like to know about companies that offer to help like ISO Accel or Oxebridge. Any feedback or advice would be greatly appreciated.

Bobh@pte
20th December 2007, 05:45 PM
Start out by determining what processes take place in your facility and having everyone write down their procedures. You cannot write a Quality Manual or Procedures Manual until you have figured this out.

For a modest sum, if you are going to do this yourself, you could do what I did a buy some templates and so forth from Marc, our host. Then you just have to apply what your company does and fit it into the templates.

Bobh@pte
20th December 2007, 05:57 PM
I would also suggest performing or having a gap analysis performed.

JHagani
20th December 2007, 06:07 PM
Andy,

I wish you best of luck.
Make sure your top management really support you on this task.
and.... Come to cove often, and ask a lot of questions.

I was at the same spot two years ago, and with no budget for a consultant, my only help were the good people at cove.
Don't be afraid to ask any questions. Your questions couldn't be dumber than mine :bonk:

Stijloor
20th December 2007, 06:14 PM
Hello Everyone,

My company wants to implement ISO 9001-2000 and become certified. I have been chosen to head this up. We are a metal fabrication and assembly company. Our current quality procedures are pretty much a blank piece of paper. Where do I start? I know I need to write a quality manual and I know there are only a mandatory 6 things that need to be covered but I also know there is a lot more to it than that. Does anyone have a realistic list of things that should be covered? I would also like to know about companies that offer to help like ISO Accel or Oxebridge. Any feedback or advice would be greatly appreciated.

Andy,

Before you start with documentation etc. you should do the following:

Have the Managers clearly define why they want to become certified/registered to ISO 9001. That will hopefully lead to some common understanding and alignment within the management team.
Conduct training. Explain what a good quality management system consist of and what the requirements are.
Perform a gap analysis. Compare the current state of affairs with the requirements. You may be closer/better than you may think.
Identify the key processes in your organization and its owners. List inputs, transitional activities and outputs. Determine objectives and measurements.
Determine the information required and necessary to support these processes so that anyone can work safe, effective and efficient.
Start the documentation process (Process owners)
Implement.
Audit
Correct
Improve
Etc.
There's a lot more than could be described in a few paragraphs, but you get some sense how it works. Keep in mind that you're developing a management system containing of processes. Don't fall in the over-documentation trap!!

There are many threads and posts here at The Cove and many good people that are always ready to lend you a hand.

Just a few thoughts and ideas.

Stijloor.

David DeLong
20th December 2007, 06:30 PM
I agree that you must have top management support but you do really need help on this. Trying to invent the wheel again just costs too much time and $$.

I have been designing quality systems since 1986 but since about the year 2000, I have only been presenting seminars.

I will attach an outline or index page of a TS company. This will give you some assistance on the topics that one must have. This index includes automotive areas in this such as PPAP, FMEA etc. that are not mandatory in ISO. It will give you some idea.

Start from the first system and go forward. Make sure that the procedure designed are verbally approved by everyone involved or else implementation will be impossible.

I could also give you an outline of a procedure that I have successfully used over the years but I think having a good flow chart today of each system is the way to go.

Good luck! It will take at least a year to obtain.

Helmut Jilling
20th December 2007, 09:39 PM
Hello Everyone,

My company wants to implement ISO 9001-2000 and become certified. I have been chosen to head this up. We are a metal fabrication and assembly company. Our current quality procedures are pretty much a blank piece of paper. Where do I start? I know I need to write a quality manual and I know there are only a mandatory 6 things that need to be covered but I also know there is a lot more to it than that. Does anyone have a realistic list of things that should be covered? I would also like to know about companies that offer to help like ISO Accel or Oxebridge. Any feedback or advice would be greatly appreciated.


Please read Stijloor's advice carefully. He offers a very good sequence of steps, in the right order.

Do not begin with procedures, begin with reading and learning what this is about. Read ISO 9001 and ISO 9004. It provides a lot of insight.

Get a good consultant for at least a couple days of overview training. It will be money well-spent. In fact, it probably won't cost you anything, net, because it will save you much time and money. There are a number of us consultants here on this forum. Read some of what I and others have written, and make your own selection.

Then, begin by defining your processes and slowly wade in from there. Writing procedures and manuals comes later, when the framework is beginning to take shape.

best wishes...from all of us.

Colpart
21st December 2007, 06:07 AM
There is some excellent advice already in this thread so I will just add that I find it useful to have a simple plan similar to the one attached (feel free to use and modify it if it helps) to define the sequence of the project.

How long the project takes depends on lots of things such as size and complexity of your company, resources available, etc but I normally look to do it in 6 - 9 months.

Andy CDA
21st December 2007, 08:07 AM
Thanks to everyone for your advice - it's greatly appreciated! I want to wish all a happy and safe holiday!:thanx:

Andy CDA
21st December 2007, 08:12 AM
I agree that you must have top management support but you do really need help on this. Trying to invent the wheel again just costs too much time and $$.

I have been designing quality systems since 1986 but since about the year 2000, I have only been presenting seminars.

I will attach an outline or index page of a TS company. This will give you some assistance on the topics that one must have. This index includes automotive areas in this such as PPAP, FMEA etc. that are not mandatory in ISO. It will give you some idea.

Start from the first system and go forward. Make sure that the procedure designed are verbally approved by everyone involved or else implementation will be impossible.

I could also give you an outline of a procedure that I have successfully used over the years but I think having a good flow chart today of each system is the way to go.

Good luck! It will take at least a year to obtain.
Dave,

Thanks for your advice. You mentioned a couple of attachments. I was wondering if I could get those from you? This is such a major task and our company needs some major improvements. Again, I really appreciate the help.:thanx:

Stijloor
21st December 2007, 08:12 AM
Thanks to everyone for your advice - it's greatly appreciated! I want to wish all a happy and safe holiday!:thanx:

Thank you Andy!

Do you want to keep us posted on your progress? Some of us Covers are always curious how the folks do that came here for ideas. ;)

And please, do come back with more questions and possible suggestions for others.

Happy Holidays!

Stijloor.

David DeLong
21st December 2007, 09:45 AM
Dave,

Thanks for your advice. You mentioned a couple of attachments. I was wondering if I could get those from you? This is such a major task and our company needs some major improvements. Again, I really appreciate the help.:thanx:

Yes, I tried to attach an index page and here goes again. I will check it out prior to posting it.

Andy CDA
21st December 2007, 09:52 AM
I will definately keep you posted on my progress and I'll try not to be too much of a pain in the neck - no promises there though :)

David DeLong
21st December 2007, 10:00 AM
Dave,

Thanks for your advice. You mentioned a couple of attachments. I was wondering if I could get those from you? This is such a major task and our company needs some major improvements. Again, I really appreciate the help.:thanx:

I hope that I can attach an index page of an ISO company that I worked with in the Toronto area.

I do agree that you should get some consulting assistance. You could be spinning your wheels and getting no where or on the wrong track entirely. A good consultant should be able to keep you on track.

BradM
21st December 2007, 11:05 AM
Andy,

Before you start with documentation etc. you should do the following:

Have the Managers clearly define why they want to become certified/registered to ISO 9001. That will hopefully lead to some common understanding and alignment within the management team.
Conduct training. Explain what a good quality management system consist of and what the requirements are.
Perform a gap analysis. Compare the current state of affairs with the requirements. You may be closer/better than you may think.
Identify the key processes in your organization and its owners. List inputs, transitional activities and outputs. Determine objectives and measurements.
Determine the information required and necessary to support these processes so that anyone can work safe, effective and efficient.
Start the documentation process (Process owners)
Implement.
Audit
Correct
Improve
Etc.

Now, notice how I took Stijloor's post and split it? Because many times, the first section is so often ignored, and many just jump into the second part. But the first section is so vitally important. If you spend much time here at the Cove, you will read about people struggling to get ready for the next audit; or goofy quality policies; no management support, etc. IMHO, that's because the first section was skipped.

MAIN POINT: It is so essential that upper management understands they will need to spend time on the QMS. The QMS needs to support/facilitate management's goals/strategy for the organization. Otherwise, the system will become a lost boat; floating around in the water, making circles, with nowhere to go.

Also, as Stijloor, Helmut, and the others stated, proper planning and good consulting will pay off at the beginning. Making sure you start this initiative out correctly will save so much time, money, and heartache later on.

vanputten
21st December 2007, 02:50 PM
First get a very clear understanding of where top managmenet wants to be in the future. What is the aim, or goal, or future state that is desired.

My suggestion above could be re-wroded as follows: Have the Managers clearly define why they want to become certified/registered to ISO 9001. That will hopefully lead to some common understanding and alignment within the management team.

Read all of ISO 9000, and 90001 and 9004. Read them mnay times to understand the text.

Starting with things like documenting processes is an ineffective approach. Understand the target before you shoot the arrow.

vanputten
21st December 2007, 04:36 PM
Hello Andy:

ISO published a document called N613 Selection and Use Brochure. Document N613 was issued in November 2000 as a means to guide users on the selection of standards in the ISO quality management standards portfolio.

N613 is currently being reviewed. The following text is from N613R1 (rev. 1)which is under review....

The implementation process is important in achieving the full benefits of the quality management system. Most new users will obtain measurable payback early in the process.

For a successful implementation of your QMS these 7 steps are recommended:
1. Fully engage top management to:
�� Define why you want to implement ISO 9001
�� Define your mission, vision, and values
�� Define your business’s stakeholders: customers, suppliers, stockholders, employees, society, etc.
�� Define and align business objectives and related product/service quality objectives
2. Identify key processes and the interactions needed to meet defined business and quality objectives
3. Implement and manage the QMS and its processes (using process management techniques)
4. Build your ISO 9001-based QMS
�� Identify ISO 9001 requirements
�� Map these requirements with your implemented QMS, where applicable
�� Make a gap analysis: Identify where in your existing system the requirements are fulfilled, and where they are not
�� Include in your QMS processes the activities, procedures and controls needed
5. Implement the system, train company staff and verify effective operation of your processes
6. Manage your QMS
�� Focus on customer satisfaction
�� Monitor and measure the operation of your QMS
�� Strive for continual improvement
�� Consider implementing business excellence models in the company operations
7. If necessary, seek third party certification/registration of the QMS or alternatively, issue a self-declaration of conformity.

The N613 document also has a listing of all of the ISO 9000 family of standards. One document is ISO 10019:2005 Guidelines for the selection of quality management system consultants and use of their services. ISO 10019 may help you with part of your question related to consultants.

Unfortunaley, I cannot find a copy of this public document (N613.) I cannot find it on the ISO website. There is a link to the document on the following important website but the link does not appear to work.

http://isotc.iso.org/livelink/livelink/fetch/2000/2122/138402/755901/1069636/customview.html?func=ll&objId=1069636&objAction=browse&sort=name