云南ISO9001认证咨询 审核设计和开发过程(5) - ISO9000 -
ïo·_Ô<l)¢bbs.517hb.comñì¯ }ò« 7. Auditing design and development verification
ïo·_Ô<l)¢bbs.517hb.comñì¯ }ò« 对设计和开发验证的审核
ïo·_Ô<l)¢bbs.517hb.comñì¯ }ò« Design and development verification is aimed at providing assurance
ïo·_Ô<l)¢bbs.517hb.comñì¯ }ò« that the outputs of a design and development activity have met the
ïo·_Ô<l)¢bbs.517hb.comñì¯ }ò« input requirements for this activity as shown in Figure 2 below.
ïo·_Ô<l)¢bbs.517hb.comñì¯ }ò« 设计和开发验证的目的是提供保证，确保下面图2各种各种设计和开发输出活动已经满足输入要求。
ïo·_Ô<l)¢bbs.517hb.comñì¯ }ò« Figure 2 Verification can comprise activities such as:-
ïo·_Ô<l)¢bbs.517hb.comñì¯ }ò« 图2设计和开发验证可能包括的各种活动诸如：
ïo·_Ô<l)¢bbs.517hb.comñì¯ }ò« performing alternative calculations;执行另外的计算方法；
ïo·_Ô<l)¢bbs.517hb.comñì¯ }ò« comparing a new design specification with a similar proven
ïo·_Ô<l)¢bbs.517hb.comñì¯ }ò« design specification;把新设计规范和已经得到证实的设计规范进行对比；
ïo·_Ô<l)¢bbs.517hb.comñì¯ }ò« undertaking demonstrations including prototypes,
ïo·_Ô<l)¢bbs.517hb.comñì¯ }ò« simulations or tests; and,采用包括利用样机、模拟器或各种试验等各种展示方法；以及
ïo·_Ô<l)¢bbs.517hb.comñì¯ }ò« reviewing documents prior to issue.各种文件在发放前加以评审。
ïo·_Ô<l)¢bbs.517hb.comñì¯ }ò« Auditors should determine that the design and development
ïo·_Ô<l)¢bbs.517hb.comñì¯ }ò« verification activities should provide confidence that:-
ïo·_Ô<l)¢bbs.517hb.comñì¯ }ò« 审核员应当确定，设计和开发验证活动应当提供信息，能相信以下方面：
ïo·_Ô<l)¢bbs.517hb.comñì¯ }ò« required verifications are planned and that verification is
ïo·_Ô<l)¢bbs.517hb.comñì¯ }ò« performed as appropriate during the design and development
ïo·_Ô<l)¢bbs.517hb.comñì¯ }ò« process;所要求做的验证是经过策划的，而且验证是在设计和开发过程的适当时候执行的；
ïo·_Ô<l)¢bbs.517hb.comñì¯ }ò« the completed design or development is acceptable and the
ïo·_Ô<l)¢bbs.517hb.comñì¯ }ò« results are consistent with and traceable to the initial
ïo·_Ô<l)¢bbs.517hb.comñì¯ }ò« requirements;已经完成的设计和开发工作是可以接受的，其结果是可以追溯到满足原始要求的；
ïo·_Ô<l)¢bbs.517hb.comñì¯ }ò« the completed design or development is the result of
ïo·_Ô<l)¢bbs.517hb.comñì¯ }ò« implementation of a proper sequence of events, inputs, outputs,
ïo·_Ô<l)¢bbs.517hb.comñì¯ }ò« interfaces, logic flow, allocation of timing,
ïo·_Ô<l)¢bbs.517hb.comñì¯ }ò« etc;已经完成的设计和开发工作是正确执行了各项活动的顺序的结果，这些活动包括各种输入、输出、相互接口、逻辑顺序、时间安排等；
ïo·_Ô<l)¢bbs.517hb.comñì¯ }ò« the design or development provides safety, security, and
ïo·_Ô<l)¢bbs.517hb.comñì¯ }ò« compliance with other requirements and design inputs;
ïo·_Ô<l)¢bbs.517hb.comñì¯ }ò« 设计或开发提供安全、保密的，同时又符合其他各种要求和各种设计输入；
ïo·_Ô<l)¢bbs.517hb.comñì¯ }ò« evidence is available to demonstrate that the verification
ïo·_Ô<l)¢bbs.517hb.comñì¯ }ò« results and any further actions have been recorded and confirmed
ïo·_Ô<l)¢bbs.517hb.comñì¯ }ò« when actions are
ïo·_Ô<l)¢bbs.517hb.comñì¯ }ò« completed.有客观证据可以用来展示验证结果以及验证提出进一步要采取措施都已经有记录，而且肯定这些活动都已经做了，都符合要求的。
ïo·_Ô<l)¢bbs.517hb.comñì¯ }ò« Auditors should determine that only verified design and development
ïo·_Ô<l)¢bbs.517hb.comñì¯ }ò« outputs have been submitted to the next stage, as appropriate.
ïo·_Ô<l)¢bbs.517hb.comñì¯ }ò« 审核员应当确定，只有通过验证合格的设计和开发输出已经，按照适当的，提交到下一阶段。
ïo·_Ô<l)¢bbs.517hb.comñì¯ }ò« 8. Auditing design and development validation
ïo·_Ô<l)¢bbs.517hb.comñì¯ }ò« 对设计和开发确认的审核
ïo·_Ô<l)¢bbs.517hb.comñì¯ }ò« Design and development validation is the confirmation by
ïo·_Ô<l)¢bbs.517hb.comñì¯ }ò« examination, and the provision of evidence, that the particular
ïo·_Ô<l)¢bbs.517hb.comñì¯ }ò« requirements for specific intended use are fulfilled. In other
ïo·_Ô<l)¢bbs.517hb.comñì¯ }ò« words, is the validation process capable of checking that the final
ïo·_Ô<l)¢bbs.517hb.comñì¯ }ò« product and/or service will meet, or does meet, the customer’s needs
ïo·_Ô<l)¢bbs.517hb.comñì¯ }ò« when it is in use ?
ïo·_Ô<l)¢bbs.517hb.comñì¯ }ò« 设计和开发确认是通过检查和提供客观证据来认定特定的意向用途的各项要求都是满足的。换句话说，确认过程能检查出，最终产品和/或服务投入使用的时候是否会满足，或者说的确是满足顾客各种需求的？
ïo·_Ô<l)¢bbs.517hb.comñì¯ }ò«ïo·_Ô<l)¢bbs.517hb.comñì¯ }ò«云南ISO9001认证咨询 审核设计和开发过程(5) - ISO9000 -
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