AS9100C：2009_中英文对照(3)

c) 质量管理体系过程之间的相互作用的表述。

4.2.3 文件控制

质量管理体系所要求的文件应加以控制。记录是一种特殊形式的文件，应依据4.2.4的要求加以控制。

应建立形成文件的程序，以规定以下方面必需的控制：

a) 文件发布前得到批准，以确保文件是充分和

适宜的；

b) 必要时对文件进行评审和更新，并再次批准； c) 确保文件的更改和现行修订状态得到识别；

d) 确保在使用处可获得适用文件的有关版本；

e) 确保文件保持清晰、易于识别；

f) 确保组织所确定的策划和运行质量管理体系所需的外来文件得到识别，并控制其分发；

g) 防止作废文件的非预期使用，若因任何原因而要保留作废文件时，对这些文件进行适当的标识。

4.2.4 Control of records

Records established to provide evidence of conformity to requirements and of the effective operation of the quality management system shall be controlled.

The organization shall establish a documented procedure to define the controls needed for the identification, storage, protection, retrieval, retention and disposition of records.

The documented procedure shall define the method for controlling records that are created by and/or retained by suppliers.

Records shall remain legible, readily identifiable and retrievable.

4.2.4 记录控制

为符合要求和质量管理体系有效运行提供证据而建立的记录，应予以控制。

组织应编制形成文件的程序，以规定记录的标识、贮存、保护、检索、保存和处置所需的控制。

形成文件的程序应规定由供方生成的记录和/或保存的控制方法。

记录应保持清晰，易于识别和检索。

AS9100C

5 Management responsibility

5.1 Management commitment

Top management shall provide evidence of its commitment to the development and implementation of the quality management system and continually improving its effectiveness by

a) communicating to the organization the importance of meeting customer as well as statutory and regulatory requirements,

b) establishing the quality policy,

c) ensuring that quality objectives are established,

d) conducting management reviews, and

e) ensuring the availability of resources.

5.2 Customer focus

Top management shall ensure that customer requirements are determined and are met with the aim of enhancing customer satisfaction (see 7.2.1 and 8.2.1).

Top management shall ensure that product conformity and on-time delivery performance are measured and that

appropriate action is taken if planned results are not, or will not be, achieved.

5 管理职责

5.1 管理承诺

最高管理者应通过以下活动，对其建立、实施质量管理体系并持续改进其有效性的承诺提供证据：

a) 向组织传达满足顾客和法律法规要求的重

要性；

b) 制定质量方针；

c) 确保质量目标的制定；

d) 进行管理评审；

e) 确保资源的获得。

5.2以顾客为关注焦点

最高管理者应以增强顾客满意为目的，确保顾客的要求得到确定并予以满足。 (见7.2.1和8.2.1)。

最高管理者必须确保产品符合性和及时交付业绩被测量，如果策划的结果不能取得时，应当采取适当的措施

5.3 质量方针

最高管理者应确保质量方针

a) 与组织的宗旨相适应，

b) 包括对满足要求和持续改进质量管理体系有

效性的承诺；

c) 提供制定和评审质量目标的框架，

d) 在组织内部得到沟通和理解，以及

e) 在持续适宜性方面得到评审。

5.4 策划

5.4.1 质量目标

最高管理者应确保在组织内部的相关职能和层次上建立质量目标，质量目标包括满足产品要求(见7.1.a)所需的内容。质量目标应是可测量的，并与质量方针保持一致。

5.4.2 质量管理体系策划

最高管理者应确保：

5.3 Quality policy

Top management shall ensure that the quality policy

a) is appropriate to the purpose of the organization,

b) includes a commitment to comply with requirements and continually improve the effectiveness of the quality management system,

c) provides a framework for establishing and reviewing quality objectives,

d) is communicated and understood within the organization, and

e) is reviewed for continuing suitability.

5.4 Planning

5.4.1 Quality objectives

Top management shall ensure that quality objectives, including those needed to meet requirements for product [see 7.1 a)], are established at relevant functions and levels within the organization. The quality objectives shall be measurable and consistent with the quality policy.

5.4.2 Quality management system planning

Top management shall ensure that

AS9100C

a) the planning of the quality management system is carried out in order to meet the requirements given in 4.1, as well as the quality objectives, and

b) the integrity of the quality management system is maintained when changes to the quality management system are planned and implemented.

5.5 Responsibility, authority and communication

5.5.1 Responsibility and authority

Top management shall ensure that the responsibilities and

authorities are defined and communicated within the organization.

5.5.2 Management representative

Top management shall appoint a member of the organization’s management who, irrespective of other responsibilities, shall have responsibility and authority that includes

a) ensuring that processes needed for the quality management system are established, implemented and maintained,

b) reporting to top management on the performance of the quality management system and any need for improvement,

c) ensuring the promotion of awareness of customer requirements throughout the organization, and

d) the organizational freedom and unrestricted access to top management to resolve quality management issues. 决有关质量问题。

NOTE The responsibility of a management representative can

include liaison with external parties on matters relating to the quality 注：管理者代表的职责可 …… 此处隐藏：4127字，全部文档内容请下载后查看。喜欢就下载吧 ……