Beruflich Dokumente
Kultur Dokumente
1. PURPOSE & SCOPE: The purpose of this procedure to describe the detail activities for design & development
process. The scope of this procedure is limited to design and/or development of new product or modification of
existing products.
2. REFERENCE: ISO 9001: 2008, Clauses – 7.3
3. RESPONSIBILITIES: In charge Design & Development is responsible for implementation of this procedure
5. PROCEDURE:
No. Activity responsibility Record ref.
5.1 Design & Development
planning
5.1.1 Planning shall be done with In charge Design & Development Design &
the concerned
Dev.Plan
departments/personnel.
Area concerned for
planning :
Identification of qualified
personnel
Identification of adequate
resources
The design and
development stages
The review, verification
standards that are
appropriate to each design
& development stage
Review of Design/ No
Development with plan Re planning
Yes
Prototype Manufacturing/
Modification/
Verification / Prototype
Re planning
Testing
Successful
Review of Validation
Re planning
Report
OK
Integration with
manufacturing process