ISO 9001:2000 Design and Developement

I

intrestedparty

#1
Dear All

We need your help, We are desing, developement and manufacture of Medical Devices. We are plan for ISO 9001:2000 certificaiton. The system effective date (SED) is 01-11-2005. We are in the filed for past 6 years. Form SED we desing one product.

As per ISO 9001:2000 7.3 (Design & Developement) we need to document the design records for all existing products or just the new one product we desined after the SED.

During Audit, the existing designed product is coming into scope, Whether Auditor asks about the existing designed product details

Kindly clarify this Issue

Thanks & Reagrds

Karthi.T
 
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Miner

Forum Moderator
Staff member
Admin
#2
For ISO 9001:2000, you would definitely be expected to comply with your new procedure for any project that starts after the procedure is implemented. If you have a project in process at that time, you MAY have a few options depending on your registrar.

One option would be to scope the procedure to exclude projects that are already in process. However, your registrar will need to see evidence that the system works, so if your only projects are those already in process, you will probably need to include them.

A second option would be to pick the project up mid stream and apply the new procedure from that point forward. However, some downstream items may depend on items that would have been completed earlier in the new process. This would force you to go back and complete those earlier requirements. The further along the project is, the less likely that you would be expected to go back. Again, if these are your only projects, you will still need to show evidence that the process works.

You do not need to go back and generate records on completed projects.
 

Al Rosen

Staff member
Super Moderator
#3
intrestedparty said:
Dear All

We need your help, We are desing, developement and manufacture of Medical Devices. We are plan for ISO 9001:2000 certificaiton. The system effective date (SED) is 01-11-2005. We are in the filed for past 6 years. Form SED we desing one product.

As per ISO 9001:2000 7.3 (Design & Developement) we need to document the design records for all existing products or just the new one product we desined after the SED.

During Audit, the existing designed product is coming into scope, Whether Auditor asks about the existing designed product details

Kindly clarify this Issue

Thanks & Reagrds

Karthi.T
If you are in the Medical Device Industry, you will need to meet ISO 13485 not ISO 9001. You can do both, but ISO 13485 is the standard required for Medical Devices at this time. There are additional requirements above ISO 9001 and some of the requirements are different. Look at the standards and compare them. Do a search here in the cove for ISO 13485 and read some of the threads. You may then have more questions to post.
 
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