| 设计和开发变化的控制 |
| http://www.iso888.com 2018-3-17 10:09:25 |
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应识别设计和开发的更改，并保持记录，在适当时，应对设计和开发的更改进行评审、验证和确认，并在实施前得到批准，设计和开发更改的评审应包括评价更改对产品组成部分和已交付产品的影响。
更改评审结果及任何必要措施的记录应予保持（见4.2.4）。
7.3.7.C.1 Change Management Process – The organization
shall establish and maintain a process to ensure that
all requirements and design changes, which may arise at
any time during the product life cycle, are managed and
tracked in a systematic and timely manner and do not
adversely affect quality, reliability, and design
intent. Management of changes should include:
7.3.7.C.1
变更管理制程－组织应建立和维持一个制程以确保所有的需求和设计变更（在产品生命周期任何时候能出现的）被以一个系统的和即时的方式管理和追踪，不影响质量，可靠度和设计目的。变化的管理应包括：
a) impact analysis, 影响分析
b) planning, 规划
c) implementation, 实施
d) testing, 试验
e) documentation, 文件
f) communication, and 信息
g) review and approval. [5] 评审和批准
7.3.7.C.2 Informing Customers – The organization shall
establish and maintain a documented
procedure(s) to ensure that customers are informed when
design changes affect contractual
commitments. [5]
7.3.7.C.2 通知客户－组织应建立和维持一个程序文件以确保当设计变更影响合同承诺时通知客户。〔5〕
7.3.7.HS.1 Problem Resolution Configuration Management –
The organization shall establish an interface between
problem resolution and configuration management to
ensure that fixes to problems are incorporated in future
revisions. [11]
7.3.7.HS.1
问题解决配置管理－组织应建立一个问题解决和配置管理之间的接口，以确保问题整理合并成将来的版本。
7.3.7.H.1 Component Changes – The organization shall
have a documented procedure(s) in place to ensure that
material or component substitutions or changes do not
adversely affect product quality or performance. The
documented procedure(s) should include:
7.3.7.H.1
组成成分变化－组织应有一个适当的程序文件去确保材料或成分替代或变化不反过来影响产品质量或性能。这个程序文件包括：
a) functional testing, 功能试验
b) qualification testing, 资格试验
c) stress testing, 压力试验
d) approved parts listing, and/or 所列被批准的部分，和/或
e) critical parts listing. 所列关键部分
7.4 Purchasing 采购
7.4.1 Purchasing process 购买过程
组织应确保采购的产品符合规定的采购要求，对供方及采购的产品控制的类型和程度应取决于采购的产品对随后的产品实现或最终产品的影响。
组织应根据供方按组织的要求提供产品的能力评价和选择供方应制定选择、评价和重新评价的准则。评价结果及评价所引起的任何必要措施的记录应予保持（见4.2.4）。
7.4.1.C.1 Purchasing Procedure(s) – The documented
purchasing procedure(s) shall include: 购买程序－购买程序文件包括：
a) product requirements definition, 产品需求定义
b) risk analysis and management, 风险分析和管理
c) qualification criteria, 资格标准
d) contract definition, 合同定义
e) proprietary, usage, ownership, warranty, and
licensing rights are satisfied, 所有权，使用权，保证，和许可权被满足
f) future support for the product is planned, |
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