达州ISO9001认证咨询审核设计和开发过程(3) - ISO9000 -

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烟枪猎手 2010-03-10 12:29 | 只看楼主 树型| 收藏| 小中大楼主 ^#

达州ISO9001认证咨询审核设计和开发过程(3) - ISO9000 -

达州ISO9001认证咨询审核设计和开发过程(3) - ISO9000 -
4. Auditing design and development inputs
对设计和开发输入的审核
When auditing the design and development inputs, auditors should
develop an understanding of how the organization identifies its own
inputs based on:-
当审核设计和开发输入的时候，审核员应当逐步根据以下方面理解组织是如何识别他们自己的各种输入的：
the organization’s products and processes;组织的各种产品和过程；
financial, environmental, health and safety issues;
财务、环境、健康和安全问题；
organizational risks and impacts;组织会遇到的各种风险及其影响；
customer’s requirements and expectations;顾客的各种要求和期望；
statutory and regulatory requirements applicable to the
product.应用于产品的各种法律和条例要求。
Auditors should evaluate the risks, the possible implications for
customer satisfaction and issues that the organization may encounter
if some relevant inputs are not considered.
审核员应当评估组织有可能会遇到的会影响到顾客满意的各种风险和各种问题，是否在某些有关的设计输入中没有被考虑到。
5. Auditing the design and development process and design reviews
对设计和开发过程和设计评审的审核
Auditors should verify that the overall design and development
process is controlled in accordance with the organization’s original
plan being reviewed and that the design and development reviews take
place at appropriate planned stages.
审核员应当验证整个设计和开发过程是得到控制，而且符合正被评审的组织原始计划，同时，按照策划规定的各个阶段是对设计和开发做过评审的。
The following issues should be considered by auditors when examining
the review process:-
当审核员检查评审过程的时候应当考虑以下各种问题：
do reviews occur at planned stages throughout the design
process?整个设计过程中是否按照策划规定的阶段做了评审？
are the reviews carried out in a systematic way involving
representatives of the functions concerned with the stage(s) being
reviewed?各次评审是否是系统的方式加以评审的，其中包括了该评审阶段有关职能的代表都参与了？
have all original and any new inputs been considered
?原来的设计输入以及新增加的各种设计输入是否都加以考虑了？
are the original outputs still relevant or have revised
outputs been identified?原来的设计输出是否仍然有关，要不然的话，是否识别出已经做了更改的设计输出？
have revised inputs and outputs been reviewed and approved
by those with the relevant responsibility and authority (including
the customer where
appropriate)?凡是修改过的设计输入和输出是否加以评审，并且得到有关职责和权限范围（如果适用的话包括顾客）的批准？
does the output demonstrate the suitability, adequacy and
effectiveness of the designed product? 输出是否展示设计出来的产品具有适宜性、充分性和有效性？
are the relevant design objectives being
achieved?有关的设计目标是否正在达成？
are there adequate records of reviews?是否有充分的评审记录？
6. Auditing design and development outputs
对设计和开发输出的审核
The design and development outputs should comply with the identified
needs in order to ensure that the resulting product can fulfil its
intended use. Outputs can include information relevant to the
following:-
设计和开发输出应当符合所识别的需求，以便确保结果产品能满足其意向的用途。输出可能包括有关下列各种信息：
marketing, sales and purchasing;市场、销售和采购；
production;生产；
quality assurance;质量保证；
information for service provision and maintenance of the
product after delivery
and, should be provided in a form that enables verification and
validation activities to be
performed.产品交付后有关产品服务条款以及维护需要的信息应当加以提供，其形式应当是能加以验证和确认的。

Auditors should obtain evidence from the projects selected to
confirm that:-
审核员应当从所选择的项目中获得客观证据来证明符合以下：
information regarding the completion of design and
development stages is available; 有关设计和开发各个阶段已经完成的信息是可以获得的；
the design and development process has been completed for
the stage under review;接受评审的阶段，设计和开发过程已经完成；
design and development outputs have been
confirmed设计和开发各种输出已经肯定符合要求。

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烟枪猎手最后编辑于 2010-03-10 14:08:24

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达州ISO9001认证咨询 审核设计和开发过程(3) - ISO9000 -

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达州ISO9001认证咨询审核设计和开发过程(3) - ISO9000 -

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