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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
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