ISO 9001:2000 and New Product Development ISO Sections 7. 1 – 7

ISO 9001:2000 Relevant Sections 7 Product Realization 7.1 Planning of product realization 7.2 Customer-related processes 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 7.3.1 Design and development planning 7.3.2 Design and development inputs 7.3.3 Design and development outputs 7.3.4 Design and development review 7.3.5 Design and development verification 7.3.6 Design and development validation 7.3.7 Control of design and development changes

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

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

7.3.4 Design & Development Review (Cont’d) 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: Adequacy of input to perform the design & development tasks Progress on the design & dev. process Meeting verification goals Life-cycle data Development of process improvement Environmental impact of the product