Development Requirements
ISO 9001 section 7.3 defines the design and development requirements for a compliant quality management system. This section includes Clause 7.3.1 Design and development planning, Clause 7.3.2 Design and development inputs, Clause 7.3.3 Design and development outputs, Clause 7.3.4 Design and development review, clause 7.3.5 Design and development verification, Clause 7.3.6 Design and development validation and Clause 7.3.7 Control of design and development changes. The responsibilities and authorities for design and development should be defined within the quality management system.
Planning and control of the design and development process requires the design and development stages to be defined. Review, verification and validation should occur at each stage and records maintained.