ISO 9001 Standards Requirements – Design and Development

ISO 9001 Standards Requirements – Design and Development
Design and Development PlanningPlan and control the product design and development. This planning must determine the:Stages of design and developmentAppropriate review, verification, and validation activities for each stageResponsibility and authority for design and developmentThe interfaces between the different involved groups must be managed to ensure effective communication and the clear assignment of responsibility. Update, as appropriate, the planning output during design and development.NOTE: Design and development review, verification, and validation have distinct purposes. They can be conducted and recorded separately or in any combination, as deemed suitable for the product and the organization.
Design and Development InputsDetermine product requirement inputs and maintain records. The inputs must include:Functional and performance requirementsApplicable statutory and regulatory requirementsApplicable information derived from similar designsRequirements essential for design and developmentReview these inputs for adequacy. Resolve any incomplete, ambiguous, or conflicting requirements.
Design and Development OutputsDocument the outputs of the design and development process in a form suitable for verification against the inputs to the process. The outputs must:Meet design and development input requirementsProvide information for purchasing, production, and serviceContain or reference product acceptance criteriaDefine essential characteristics for safe and proper useBe approved before their release
Design and Development ReviewPerform systematic reviews of design and development at suitable stages in accordance with planned arrangements to:Evaluate the ability of the results to meet requirementsIdentify problems and propose any necessary actionsThe reviews must include representatives of the functions concerned with the stage being reviewed. Maintain the results of reviews and subsequent follow-up actions.
Design and Development VerificationPerform design and development verification in accordance with planned arrangements to ensure the output meets the design and development input requirements. Maintain the results of the verification and subsequent follow-up actions.
Design and Development ValidationPerform validation in accordance with planned arrangements to confirm the resulting product is capable of meeting the requirements for its specified application or intended use, where known. When practical, complete the validation before delivery or implementation of the product. Maintain the results of the validation and subsequent follow-up actions.
Control of Design and Development ChangesIdentify design and development changes and maintain records. Review, verify, and validate (as appropriate) the changes and approve them before implementation. Evaluate the changes in terms of their effect on constituent parts and products already delivered. Maintain the results of the change review and subsequent follow-up actions.