4.4.1、组织应按本标准的要求，建立、实施、保持和持续改进质量管理体系、包括所需过程及其相互作用。

组织的质量管理体系也应考虑顾客和适用的法律法规对质量管理体系的要求。

组织应确定质量管理体系所需的过程及其在整个组织中的应用，且应：

a）确定这些过程所需的输入和期望的输出；

b）确定这些过程的顺序和相互作用；

c）确定和应用所需的准则和方法（包括监视、测量和相关绩效指标），以确保这些过程的有效运行和控制；

d）确定这些过程所需的资源并确保其可获得；

e）分配这些过程的职责和权限；

f）按照6.1的要求应对风险和机遇；

g）评价这些过程，实施所需的变更，以确保实现这些过程的预期结果；

h）改进过程和质量管理体系。

注：条款a）到h）被认为是对章节0.3中描述的过程方法的采纳。

4.1.1、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’s quality management system shall also address customer and applicable statutory and regulatory quality management system requirements.

The organization shall determine the processes needed for the quality management system and their application throughout the organization, and shall:

a. determine the inputs required and the outputs expected 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;

d. determine the resources needed for these processes and ensure their availability;

e. assign the responsibilities and authorities for these processes;

f. address the risks and opportunities as determined in accordance with the requirements of 6.1;

g. evaluate these processes and implement any changes needed to ensure that these processes achieve their intended results;

h. improve the processes and the quality management system.