The ISO 9001:2015 Implementation Handbook by Milton P. Dentch

Author:Milton P. Dentch
Language: eng
Format: azw3
Published: 2016-07-22T07:00:00+00:00

Clause 8.3

How does the organization determine the design and development stages of a new design, and how does it establish a process to review the progress of the design?

Is there a project plan with timelines defined?

How does the organization determine:

• Verification and validation processes?

• Responsibilities and authorities?

In a design project, how does the organization determine:

• Functional and performance requirements?

• Applicable statutory and regulatory requirements?

• Information derived from previous similar designs, if applicable?

• Other requirements essential for design and development?

How do the design reviews evaluate the ability of the results (or progress) of the design to meet requirements and record problems identified during the design process with actions proposed to resolve them?

How does the organization verify the design?

(Verification = meets requirements of the design input specifications.)

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