ISO 9001 2000 and New Product Development ISO

ISO 9001: 2000 and New Product Development ISO Sections 7. 1 – 7. 3 http: //www. managementsupport. com 1

ISO 9001: 2000 Relevant Sections n 7 Product Realization n 7. 1 Planning of product realization n 7. 2 Customer-related processes n n 7. 2. 1 Determination of requirements related to the product 7. 2. 2 Review of requirements related to the product 7. 2. 3 Customer communication 7. 3 Planning of product realization n n n 7. 3. 1 7. 3. 2 7. 3. 3 7. 3. 4 7. 3. 5 7. 3. 6 7. 3. 7 Design and development planning Design and development inputs Design and development outputs Design and development review Design and development verification Design and development validation Control of design and development changes 2

7. 1 Planning of Product Realization (Cont’d) n Role of people within the processes should be evaluated to: n Ensure health & safety n Necessary skills exist n Support coordination of processes n Input from people in process analysis n Promote innovation 3

7. 2. 1 Determination of Requirements Related to the Product (Cont’d) n Examples of relevant process information: n Requirements of interested parties n Market research n Contract requirements n Competitor analysis n Benchmarking n Processes due to statutory or regulatory requirements 4

7. 3. 4 Design & Development Review (Cont’d) n Top management should ensure that appropriate people are assigned to manage & conduct systematic reviews to determine that design & development objectives are achieved. Example of topics for reviews: n Adequacy of input to perform the design & development tasks n Progress on the design & dev. process n Meeting verification goals n Life-cycle data n Development of process improvement n Environmental impact of the product 5