8.0 Operation

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8.3 Design and development of products and services

8.3.1 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, are they are responsible for design.

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