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

2. ISO 9001:2000 Relevant Sections
7 Product Realization
7.1 Planning of product realization
7.2 Customer-related processes
Determination of requirements related to the product
Review of requirements related to the
product
Customer communication
7.3 Planning of product realization
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

3. 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

4. 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

5. 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