8.0 Operation

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ISO Navigator Pro™ is a free tool that provides practical, expert guidance for businesses wishing to interpret the fundamentals of ISO 9000:2015 to help understand, and better implement the requirements of ISO 9001:2015, ISO 14001:2015 and ISO 45001:2018. The ISO Navigator Pro™ database divides the requirements into four sequential stages; Plan, Do, Check and Act.

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8.3 Design and development of products and services

8.3.1 Design and development - General

This is a new requirement that mandates the introduction of a design and development process where this activity is required. You should seek and record evidence that, where applicable, your organization has implemented a design and development process to allow effective product or service provision, where the requirements for products and services are not defined by your customers or interested parties.

Many companies perform some enhancements or minor reconfiguration of mature designs, such organizations may have to introduce a comprehensive design system and related or processes. If your organization is ‘design responsible’ but outsourcers all of its design, all records from Section 8.3 must be maintained by your organization, as they are responsible for design.

Determine your organization's arrangements for establishing, implementing and maintaining the design and development process that includes design and development planning, inputs, controls, outputs and changes.

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