ISO 9001’s requirements, Section 8.3.1, apply to product and manufacturing process design and development and focus on error prevention rather than detection.
A documented design and development process is required. It was not required in the past, but it is now.
Many organizations are overlapping design and production because of a need for speed to market. This means it is critical to document the process.
Tips for Design & Development
When planning the Design & Development, consider these ISO requirements:
- Nature, duration and complexity
- Required process stages, including reviews
- Required verification and validation activities
- Responsibilities and authorities
- Internal and external resource needs
- Controlling interfaces
- Involving customers
- Requirements for manufacturing/service delivery
- Level of control expected by customers
- Documented information needed to demonstrate requirements have been met
