a) 确定这些过程所需的输入（通过8.2.1）和 预期的输出（通过5.1.2）；
b) 确定这些过程的顺序和相互作用；
c) 确定和应用确保这些过程有效运行和控制所需的准则和方法（包括监视、测量和相关性能指标） ；（通过8.1、8.5.1、9.1.1）
d) 确定这些过程所需的资源并确保它们的可用性（通过7.1.2、7.1.3、7.1.4、7.1.5和7.1.6）；
e) 为这些过程分配职责和权限（通过5.3）
f) 处理根据6.1的要求确定的风险和机遇（通过6.1.1和6.1.2）；
g)评估这些过程（通过9.1.3、9.2.1和9.3.1 ）并 实施所需的任何更改（通过8.5.6）以确保这些过程实现其预期结果；
h)改进过程和质量管理体系。（通过10.3）
Posted by Integrated Safety Inspection System on 6:55 PM with 29 comments
4. CONTEXT OF THE ORGANIZATION
4.4 Quality management system and its processes
4.4.1
The organization shall establish, implement, maintain and continually improve a quality management system, including the processes needed and their interactions, in accordance with the requirements of this International Standard.
The organization shall determine the processes needed for the quality management system and their application throughout the organization, and shall:
a) determine the inputs (via 8.2.1) required and the outputs expected (via 5.1.2) from these processes;
b) determine the sequence and interaction of these processes;
c) determine and apply the criteria and methods (including monitoring, measurements and related performance indicators) needed to ensure the effective operation and control of these processes; (via 8.1, 8.5.1, 9.1.1)
d) determine the resources needed for these processes and ensure their availability (via 7.1.2, 7.1.3, 7.1.4, 7.1.5 & 7.1.6);
e) assign the responsibilities and authorities for these processes (via 5.3)
f) address the risks and opportunities as determined in accordance with the requirements of 6.1 (via 6.1.1 & 6.1.2);
g) evaluate these processes (via 9.1.3, 9.2.1 & 9.3.1) and implement any changes needed (via 8.5.6) to ensure that these processes achieve their intended results;
h) improve the processes and the quality management system. (via 10.3)
