I've joined a high tech start-up firm. The founders and the Board of Directors want to create all the necessary systems and processes to bring quality products to market right now, even before we have our first product ready to sell and before we have even a single customer. ISO 9000:2000 or bust!

Can it be done? Can we be registered before we have a product or a customer?

You have internal customers, and yes you can do it.

Welcome to the COVE:bigwave:

BTW..Are you located in Carlsbad?

I think it is the optimum time to set up the process need for compliance. There will probably be little need for culture changes, you are small enough to set a a really good group to comply with ISO.

As to registration, I believe you will need at least 1 customer as there are requirements concerning measurables, customer satisfaction, deliver etc.... These can be filled in quickly once a customer is determined and you know their requirements.

A quick search here should give you volumes of ideas about manuals, procedures, instruction, methods etc...

Good luck and keep posting.

MHO

As Randy said, welcome to the Cove! :bigwave:

One additional thought. Set up you system based on what customers usually require in your field. I'm certain the bosses went through some planning and thinking to determine what they want to make and sell. This thought process may be a good start.

One additional additional thought would be to make sure your system has the flexibiltiy to adapt to customer requirements once you get some.

One last thing...not a thought a thing. Keep us informed with your progress!

I totally agree with Al: It is probably a perfect moment to try to do everything in the right way. You have a blank page, from which you can start designing your quality management system. You can enjoy theory from books, practice from your coleagues (for instance in this forum).

Absence of customers should not be a problem. Just think: when you started the business you most probably were focused at the needs of certain potential customers, from whom you expected to get your profits. Just use these needs (even if they are imaginary) as a focus of your QMS. In case you were mistaken defining these needs, you shall have special provisions for learning your customers complying for instance to Clauses 5.2 and 7.2 of 9k2k.

This is how I see it. It might actually be even easier than restructuring existing processes with their advantages and disadvantages.

Anton

I would have thought that registration would be difficult due to the fact that you cannot demonstrate your system working. Also how could you be customer focussed without having any customers to gain feedback from ?

I would have thought that registration would be difficult due to the fact that you cannot demonstrate your system working. Also how could you be customer focussed without having any customers to gain feedback from ?

You're staying inside the box. The standard, as I see it, only requires the mechanism to be in place. It doesn't require that you actually have customers.;)

Randy

We now have to demonstrate effectiveness, how would we do that without some form of data showing the QMS working ? and how would we obtain such meaningful data without servicing proper customers ?

I thought ISO9001 was moving away from being purely a documentation exercise - maybe I am wrong, I havent been through the upgrade process yet.

Doc,

Welcome to the Cove. The way I see it, there is no 100% agreement here, and it is not a cut and dried case IMO. I say you have two choices: Contact the registrar you want to work with, or several you may want to work with, and ask the question. If one or more say it is okay to, for example, just count internal customers, then you have your answer and a way to get certified.

If they all say it can't be done until you have "real" customers, you have two options: Complete all other sections of the 9000-2000 QMS and wait until you have some "real" i.e. external customers to finish it and then go for the certificate or else forget official resistration and use 9000-2000 (or 9004-2000 or whatever QMS you want) the best way you can for your company as it is now and reap the benefits regardless of certification status.

We now have to demonstrate effectiveness, how would we do that without some form of data showing the QMS working ? and how would we obtain such meaningful data without servicing proper customers ?

How do you verify that emergency planning works when you are implementing and EMS? Simulate an emergency, that's how. Test the system!!

Do the same with a theoretical customer base for initially testing portions of your QMS. Come up with some scenarios, document them and the solutions to issues and test what you have in place.

This isn't rocket science.....Been there, done that.

Let's give the guy a break, he's only a PhD. :bonk:

Randy,

A sensible suggestion. Thing is, if they want the cert they have to find a registrar who agrees that this is sensible, right? From what I read and hear, maybe every registrar doesn't fit this description. ;)

He's got a sensible Registrar located in his city, and a couple of others close by here in Southern Cal that I'm familiar with. None are pushovers, but they have their heads out of their a - -.;)