Planning of product realization

1. Planning product realization processes

2. Consistency of process planning

3. Determining product quality objectives and requirements

4. Establishing product specific processes

5. Providing product specific documents

6. Providing product specific resources

7. Determining product specific verification and validation activities and methods

8. Determining product specific acceptance criteria

9. Determining product specific records

10. Determining process specific records

11. Ensuring suitability of planning output

Customer-related processes

Determination of requirements related to the product

1. Determining customer specified requirements

2. Determining requirements for intended use

3. Determining statutory and regulatory requirements

4. Determining organizational requirements

Review of requirements related to the product

1. Reviewing product requirements

2. Timing of product requirements review

3. Ensuring product requirements are defined

4. Resolving differing requirements

5. Ensuring the organization has the ability to meet requirements

6. Maintaining records of the results of product reviews

7. Confirming undocumented requirements

8. Amending documents affected by changed product requirements

9. Informing personnel of changed requirements

Customer communication

1. Arrangements for communicating product information to customers

2. Arrangements for dealing with customer enquiries

3. Arrangements for dealing with contracts and orders

4. Arrangements for dealing with amendments to contracts and orders

5. Arrangements for dealing with customer feedback

Design and development

Design and development planning

1. Planning product design and development

2. Controlling product design and development

3. Determining design and development stages

4. Determining review, verification and validation for each stage

5. Determining design and development responsibilities and authority

6. Managing design and development interfaces

7. Updating design and development planning

Design and development...