ISO 9001 Registration for Start-up Company - So Many Questions...

I am working for a manufacturing start-up company that is scheduled to begin full production in January 2001. At the present time, we are in the midst of implementing an ERP system (including a QM module) and establishing our working policies and procedures. Although we have a lot on the go at the moment, I belive that now is the time to be begin our ISO work so we can keep our quality policy/objectives in mind as we move forward.

I am in the process of developing an ISO project plan so that we can get started asap. My project plan tentatively looks like this:
- establish quality policy/objectives/scope with senior mgmt
- allocate resources
- inform/educate employees re: ISO process
- distribute basic ISO requirements to each functional area and have them develop working procedures which comply
- identify registrar
- conduct gap analysis / corrective action
- employee training
- implement quality system
- conduct audit / corrective action
- obtain registration in Fall/Winter 2001

Questions:

- does anyone have any feedback re: this project plan? does is look reasonable? are there any obvious holes in it?
- does anyone have a sample ISO project plan suitable for a start-up company such as ours that they would be willing to share?
- when is the appropriate time to write the quality manual? is there any value in attempting a draft up front (ie once qualiy policies/objectives have been established) or should I wait until we are a little further into production?
- all of the ISO 9001:2000 documents I have seen so far begin at section 4? are there also sections 1, 2 and 3? what are they about?
- does ISO specifiy a particular format for the quality manual, or can we do what ever works for us?

So many questions... any help/advice you can offer would be appreciated.

Thanks.

[David Mullins]

If you would like a sample project plan, Work Breakdown Structure, 9001:2000 (DIS) gap analysis and sample implementation status checklist (9002:1994) then e-mail me.

Your questions suggest you'd better buy a copy of the standard.

There is no fixed format or (dare I say it at this forum) interpretation.

[rrramirez]

Your approach is quite correct. IMO you may:
1) Implement the system (documentation, training, process control, etc.) and after a period of time conduct the gap analysis.
3)Implement the corrective actions, if there is any.
2)Write the quality manual after everything in the system is rigth.
3)Contact the registrar.
I participated in similar case in a methanol plant in Venezuela.

[rrramirez]

Your approach is quite correct. IMO you may:
1) Implement the system (documentation, training, process control, etc.) and after a period of time conduct the gap analysis.
3)Implement the corrective actions, if there is any.
2)Write the quality manual after everything in the system is rigth. If you need a format for your quality manual I can supply one to you.
3)Contact the registrar.
The Changes made in the ISO/FDIS 9001:2000:Numbers of the elements:
Quality Manual (5.5.5), Document Control (5.5.6) and Control of Records (5.5.7) under Section 5, are now under the General Documents Requirements under 4.2.2, 4.2.3 and 4.2.4, respectively. The Section 5.5 was renamed as RESPONSIBILITY, AUTHORITY AND COMMUNICATION.
I participated in similar case in a methanol plant in Venezuela.

Alison,
I recommend taking a slightly different approach. I think it would be beneficial to select a registrar earlier in the process. Registrars have somewhat different philosophies and interpretations of the standard. Better registrars offer "help desks" as a way to communicate to their (potential) clients their specific interpretations of the clauses. This can be extremely benefical in the development of your system.

Next, consider reading ISO 9004-1 (available from ASQ), specifically section 6 - "Financial Considerations of Quality Systems." Typically, from my experience, companies treat obtaining registration as a "project" not as an operational business model. Unfourtunately, companies that do so rarely experience quality improvement as much as they could (again, my opinion based on experience).

Tour some registered companies and learn first hand from other folk's experience. A good question to ask "management reps" is what would you do differently and why as well as what works well? People who have been in your position usually have some interesting stories to tell as well as valuable experience to share.

Have management establish the quality policy early. Apply metrics (performance measurements) to the quality policy. Management should use these metrics as leading operational indicators. This should be what drives your company's quality program.

Lastly, keep your system simple, easy to maintain and comply with, and defined in a way that makes sense for what your organization does. Best of luck....Jim

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