We are a design with the workshop for prototype making. we certified ISO 9001 previously and now my boss wants to give up the scope of design area & keep the cert for the workshop and also extend the business for providing prototype / assembly service to other companies from the workshop . :confused:
So........
1) Should I re-apply the cert due to business nature changed? or just change the scope of QM?
2) Surveillance audit is coming in Jun, but we need to change the procedure / WI if we need to achieve new scope, I don't think we can finish them within 1 month. Also, the cert body may need 3 months data for assessment, right?

So...... what I hv to do right now???:(


Thanks

Good question, klluk. Welcome to The Cove.

It should not be a problem to produce prototypes and do work for other companies. A customer is a customer. However, it may be an issue if you are doing this work already without the appropriate controls when the surveillance audit comes.

It shouldn't be necessary to have 3 months of records on new business processes. The registration scheme must work around the demands of the business. A process in development might yet be in the stage of 7.1, planning of product realization. In my opinion it would be unreasonable to expect a company to plan their business around an audit. As long as you are not doing work that is not under control I don't see how an auditor could complain.

However, these are just my opinions and some conversation with the auditor who will be doing the audit is needed.

Welcome again..

--Erik

We are a design with the workshop for prototype making. we certified ISO 9001 previously and now my boss wants to give up the scope of design area & keep the cert for the workshop and also extend the business for providing prototype / assembly service to other companies from the workshop . :confused:
So........
1) Should I re-apply the cert due to business nature changed? or just change the scope of QM?
2) Surveillance audit is coming in Jun, but we need to change the procedure / WI if we need to achieve new scope, I don't think we can finish them within 1 month. Also, the cert body may need 3 months data for assessment, right?

So...... what I hv to do right now???:(


Thanks


You discuss this with your registrar. There are particular details that have to be followed when you decide what is and is not in scope. You cannot just decide without some considerations. Your registrar will ahve to be in agreement with the approach, so you might as well start there.

It does not sound necessary to take design out, and, in some cases, you cannot. The registrar and you have to decide that.