简介
0.3 过程方法
本标准倡导在建立、实施质量管理体系以及提高其有效性时采用过程方法，通过满足顾客要求增强顾客满意。采用过程方法所需满足的具体要求见4.4。
将相互关联的过程作为一个体系加以理解和管理,有助于组织有效和高效地实现其预期结果。这种方法使组织能够对体系过程之间相互关联和相互依赖的关系进行有效控制，以增强组织整体绩效。
过程方法包括按照组织的质量方针和战略方向，对各过程及其相互作用，系统地进行规定和管理，从而实现预期结果。可通过采用PDCA循环（见0.3.2.以及始终基于风险的思维（见0.3.3.对过程和完整的体系进行管理，旨在有效利用机遇并防止发生非预期结果。
在质量管理体系中应用过程方法能够：
a. 理解并持续满足要求；
b. 从增值的角度考虑过程；
c. 获得有效的过程绩效；
d. 在评价数据和信息的基础上改进过程。
过程的各要素及其相互作用如图1所示。每一过程均有特定的监视和测量检查点，以用于控制，这些检查点根据不同的风险有所不同。
图1：过程要素示意图(略)
0.3 Process Approach
This International Standard promotes the adoption of a process approach when developing, implementing, and improving the effectiveness of a quality management system, to enhance customer satisfaction by meeting customer requirements. Specific requirements considered essential to the adoption of a process approach are included in 4.4.
Understanding and managing interrelated processes as a system contributes to the organization’s effectiveness and efficiency in achieving its intended results. This approach enables the organization to control the interrelationships and interdependencies among the processes of the system, so that the overall performance of the organization can be enhanced.
The process approach involves the systematic definition and management of processes, and their interactions, so as to achieve the intended results in accordance with the quality policy and strategic direction of the organization. Management of the processes and the system as a whole can be achieved using the PDCA cycle (see 0.3.2. with an overall focus on risk-based thinking (see 0.3.3. aimed at taking advantage of opportunities and preventing undesirable results.
The application of the process approach in a quality management system enables:
a. understanding and consistency in meeting requirements;
b. the consideration of processes in terms of added value;
c. the achievement of effective process performance;
d. improvement of processes based on evaluation of data and information.
Figure 1 gives a schematic representation of any process and shows the interaction of its elements. The monitoring and measuring check points, which are necessary for control, are specific to each process, and will vary depending on the related risks.
Figure 1 – Schematic representation of the elements of a single process.
