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Design

The company has established and maintains a procedure to ensure that design activities are completed and verified in accordance with the contract requirements and that suitably qualified personnel perform design activities. Design plan will be established as part of contract review process identifying the responsibility for each design and development activity. Design plan will be updated as the design evolves. The design and verification activities are assigned to qualified personnel equipped with adequate resources. Design plan will define organizational and technical interfaces between different groups involved in the design process. Design input such as customers’ specifications and statutory requirements will be identified, reviewed for adequacy and documented in the plan. Incomplete or conflicting requirements will be resolved by those responsible for imposing such requirements. Design output shall be expressed in terms of requirements, calculations and analysis and identified in the design plan. Design output shall meet design input requirements , make reference to acceptance criteria, comply with statutory requirements and refer to those characteristics that are crucial to the safe and proper functioning of the product. Design review will be performed as indicated on the plan and documented. Design verification will be performed by competent personnel in accordance with the plan and documented. Verification shall ensure that design output met design input requirements. Method of verification will be specified in the procedure Design validation is performed to ensure that the product conforms to defined user needs and requirements. Design validation will be recorded. Design changes or modification to the approved design shall be identified, documented, reviewed, approved prior to implementation.

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