ISO内部审核员培训课程资料.ppt

7.2.3 Customer communication The organisation must identify and implement arrangements for communication to customers. The relevant information is that which relates to: - product information; - enquiries, contracts or order handling, including amendments; - customer feedback, including customer complaints 7.3 Design and/or development 7.3.1 Design and/or development planning No change in requirements. The design and/or development of the product must be planned and controlled. The planning must determine: - stage of design and/or development processes; - review, verification and validation activities appropriate to each design and/or development stage; - responsibilities and authorities for design and/or development activities. The interfaces between the different groups involved in design and/or development are to be managed to ensure effective communication and clarity of responsibilities. The planning output must be updated as appropriate, as the design and/or development progresses. 7.3.2 Design and/or development inputs Inputs to include: - functional and performance requirements; this is only change in requirements. - applicable regulatory and legal requirements; - information from previous designs; - any other requirements essential for design and/or development. Inputs to be reviewed for adequacy. Incomplete, ambiguous or conflicting requirements must be resolved. 7.3.2 Design and/or development inputs Inputs to include: - functional and performance requirements; this is only change in requirements. - applicable regulatory and legal requirements; - information from previous designs; - any other requirements essential for design and/or development. Inputs to be reviewed for adequacy. Incomplete, ambiguous or conflicting requirements must be resolved. 7.3.4 Design and/or development review Design and/or development reviews shall be conducted to: - evaluate the ability to fulfil require