ISO9001-GBT19001-2015FDIS中英文对照版(4)

management system;

h) 鼓励、指导和支持员工为质量管理体系的有效性做出贡献；

i) promoting improvement;

i) 增强改进；

j) supporting other relevant management roles to demonstrate their leadership as it applies to their areas of responsibility.

j) 支持其他相关管理者在其负责的区域证实其领导力。

NOTE Reference to “business” in this International Standard can be interpreted broadly to mean those activities that are core to the purposes of the organization’s existence, whether the organization is public, private, for profit or not for profit.

注：本标准中的“业务”从广义上解释为对于组织的存在而言具有核心价值的活动，组织可以是公有的、私有的、盈利或非盈利的。

5.1.2 Customer focus顾客为关注焦点【5.2】

Top management shall demonstrate leadership and commitment with respect to customer focus by ensuring that:

最高管理者应通过以下方面，证实其对以顾客为关注焦点的领导力和承诺：

a) customer and applicable statutory and regulatory requirements are determined, understood and consistently met;

a)确定、理解和持续满足顾客要求和适用的法律法规要求；

b) the risks and opportunities that can affect conformity of products and services and the ability to enhance customer satisfaction are determined and addressed;

b)确定和应对影响产品和服务符合性以及增强顾客满意能力的风险与机会；

c) the focus on enhancing customer satisfaction is maintained.

c)保持以增强顾客满意为关注焦点。

5.2 Quality policy质量方针【5.3】

5.2.1 制定质量方针Developing the quality policy【5.3】

Top management shall establish, implement and maintain a quality policy that:

最高管理者应建立、实施和保持质量方针，方针应：

a) is appropriate to the purpose and context of the organization and supports its strategic direction;

a) 与组织的宗旨和情境相适应，并支持其战略方向；

b) provides a framework for setting quality objectives;

b) 提供制定质量目标的框架；

c) includes a commitment to satisfy applicable requirements;

c) 包括对满足适用要求的承诺；

d) includes a commitment to continual improvement of the quality management system.

d) 包括对持续改进质量管理体系的承诺。

5.2.2沟通质量方针Communicating the quality policy【5.3】

The quality policy shall:

质量方针应

a) be available and be maintained as documented information;

a) 为可获得的文件化信息；

b) be communicated, understood and applied within the organization;

b) 在组织内得到沟通、理解和应用；

c) be available to relevant interested parties, as appropriate.

c) 适当时，可为相关方所获取。

5.3 Organizational roles, responsibilities and authorities 组织的角色、职责和权限【5.5.1

5.5.2 5.4.2】

Top management shall ensure that the responsibilities and authorities for relevant roles are assigned, communicated and understood within the organization.

最高管理者应确保相关角色的职责和权限在整个组织得到规定、沟通和理解。

Top management shall assign the responsibility and authority for:

最高管理者应规定职责和权限以：

a) ensuring that the quality management system conforms to the requirements of this International Standard;

a) 确保质量管理体系符合本标准的要求；

b) ensuring that the processes are delivering their intended outputs;

b) 确保过程实现其预期的输出；

c) reporting on the performance of the quality management system, on opportunities for improvement and on the need for change or innovation, and especially for reporting to top management;

c) 向最高管理者报告质量管理体系绩效和改进机会；

d) ensuring the promotion of customer focus throughout the organization;

d) 确保在整个组织提高以顾客为关注焦点的意识；

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

e) 对质量管理体系的变更进行策划和实施时，保持质量管理体系的完整性。

6 Planning for the quality management system 策划【5.4.2】

6.1 Actions to address risks and opportunities应对风险和机会的措施【5.4.2 8.5.3】

6.1.1 When planning for the quality management system, the organization shall consider the issues referred to in 4.1 and the requirements referred to in 4.2 and determine the risks and opportunities that need to be addressed to:

6.1.1 策划质量管理体系时，组织应考虑 4.1和 4.2的要求，并确定需要应对的风险和机会以：

a) give assurance that the quality management system can achieve its intended result(s);

a) 确保质量管理体系能够实现其预期的结果；

b) enhance desirable effects;

b) 增强期望的影响；

c) prevent, or reduce, undesired effects;防止或者减少不良效果

c) 预防或减少非预期的影响；

d) achieve improvement.

d) 实现持续改进。

6.1.2 The organization shall plan:

6.1.2组织应策划：

a) actions to address these risks and opportunities;

a) 应对风险和机会的措施；

b) how to:

1) integrate and implement the actions into its quality management system processes (see 4.4);

2) evaluate the effectiveness of these actions.

b) 如何：

1) 在质量管理体系过程中融入和实施这些措施（见 4.4）；

2) 评价这些措施的有效性。

Actions taken to address risks and opportunities shall be proportionate to the potential impact on the conformity of products and services.

所采取的应对风险和机会的措施应与对产品和服务符合性的潜在影响相适应。

NOTE 1 Options to address risks can include avoiding risk, taking risk in order to pursue an opportunity, eliminating the risk source, changing the likelihood or consequences, sharing the risk, or retaining risk by informed decision. 注1：应对风险的选择可以包括：避免风险、为获取机会而接受风险、消除风险源、改变可能性或结果、分担风险或经过决策而保留风险。

NOTE 2 Opportunities can lead to the adoption of new practices, launching new products, opening new markets, addressing new clients, building partners …… 此处隐藏：4516字，全部文档内容请下载后查看。喜欢就下载吧 ……