ISO 10005:2018
Clause 6.9 to 6.17: Content of the quality plan, design to audits – ISO 10005:2018

ISO 10005:2018 6.9.1: Design and development process

What does 6.9.1 require?

The plan should cite the design and development plans that apply, take into account the relevant specifications, codes, industry standards, quality characteristics and legal and regulatory requirements, and set the criteria for accepting design and development inputs and outputs, together with how, at which stages and by whom outputs are reviewed, verified and validated. Where design and development is complex, guidance should be drawn from suitable sources including the organization's own documented information on design; where it is simple, a planned process is still needed so the risks of using its outputs stay under control. In projects the design process can govern both the drawing up and later change control of project plans and the project's intended result. In services it can cover developing the service specification on which delivery is based, and where a service is unique to one customer transaction (research or advisory work, for instance) it can cover the whole of service delivery. ISO/TS 9002 gives general design guidance; software guidance is in ISO/IEC/IEEE 24748-5 and ISO/IEC 90003.

Maintained by Gerard Blokdyk

Other controls in Clause 6.9 to 6.17: Content of the quality plan, design to audits – ISO 10005:2018

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