8.3.1.1 Design & Development of Products and Services

on . Posted in IATF 16949

The requirements of ISO 9001, Section 8.3.1 applies to product and manufacturing process design and development and focuses on error prevention rather than detection.

Documented design and development process is required.  In the past is was not required, but it is now.

Many organizations are overlapping design and production because a need for speed to market.  This means it is critical to document the process.

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

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