如何识别过程

davianren

以下摘录自国际标准化组织网站，供参考。

International Organization for Standardization                        International Accreditation Forum
                        
Date:        5 June 2009
日期：2009年6月5日

ISO 9001 Auditing Practices Group Guidance on:

Identification of processes
如何识别过程

1. Distinguishing between the concepts of a process and an activity
概念上如何区别过程和活动

If an auditee cannot distinguish between the concepts of a process and an activity, the auditor can briefly explain the differences by using the guidance (clause 2.4) and definition ((3.4.1) in ISO 9000 as background information. The auditor must be able to adapt to the auditee’s situation. It is the auditor’s responsibility to understand the auditee’s systems and approach.
如果审核员不能从概念上区别过程和活动的话，那么，就利用本指南文件第2.4条和ISO 9000定义3.4.1条作为基础信息来作简要的说明。审核员必须能接纳被审核方的情况。理解被审核方的各个系统和模式是审核员的责任。

During the audit, the auditor should determine whether there is a problem of difference of terminology only, or whether there is a lack of real implementation of the process approach by the auditee. There may be a need to issue an NCR if the auditee is not fully implementing the requirements stated in ISO 9001, Clause 4.1. If this is simply a terminology problem, there should be no need to issue an NCR, if all the requirements of in Clause 4.1 are satisfied.
在开展审核的时候，审核员应当判定是否仅仅是术语方面的问题呢，还是审核方真的没有贯彻过程模式来管理。如果被审核方的确完全没有贯彻标准第4.1条要求的话，也许有必要开出不符合报告。如果体系是满足标准第4.1条要求的，仅仅是术语叫法上的问题，也就没有必要开不符合报告了。[/size]

The auditee has the right to use its own terminology, provided the requirements of the standard are met. The auditor should mentally develop a cross-reference list to ensure consistency and better understanding.
只要满足标准各项要求，被审核方有权使用他们自己的术语。审核员应当在脑子里建立起一份术语交叉清单来确保更好理解他们的术语和确保一致性。

2. A process has defined objective(s), input(s), output(s), activities, and  resources
过程应当已经定义好目标、输入、输出、活动和资源

If the auditee does not understand that a process must have defined (but not necessarily measurable) objective(s), input(s), output(s), activities, and resources, the auditor should try reformulating the questions to the auditee avoiding the use of QM jargon, e.g. Can you explain to me your operations here? What are the basic jobs carried out in your department? What information do you need to start your work? Where does it come from? Who receives the result of your work? How do you know if you’ve done your job correctly? etc..
假如被审核方不理解，过程必须定义目标（但是不必要可测量的）、输入、输出、活动和资源，审核员应当避免直接采用质量管理体系术语来向被审核方提问，改用他们熟悉的方式提问。譬如，您能否说明一下您门部门在这里如何运作的？您们部门的基本工作任务是什么？您们必须接到什么信息后开始您们的工作的？这些信息来自什么地方？是谁接受您们工作的结果的？您们如何知道您们做的工作是正确的？等等……

This should help the auditor to establish whether the processes (as per ISO 9001) are already defined, have clear inputs, outputs, objectives and so on.
通过这样提问应当能帮助审核员理解这些过程是否已经按照ISO9001标准建立了，已经清楚定义了， 有清楚的目标、输入、输出等等。

3. Processes should be analysed, monitored and/or measured, and improved
各种过程应当加以分析、监视和/或测量以及改进（译者注：这是标准8.2.3条要求。注意是各种过程，不仅限于产品实现过程，也包括管理过程、资源提供过程和测量分析改进过程，都要加以监视，适用的加以测量。）

If after applying the audit techniques outlined above, there is an absence of any records or other proof to demonstrate that the processes are analysed, and/or monitored, and/or measured, and/or improved, there would appear to be non-conformity with part of ISO 9001 Clause 4.1.
假如采用前面所讲的审核技术，如果发现没有任何记录或者其他可以证明这些过程得到分析和/或监视，和/或测量，和/或得到改进的话，那么有可能是不符合标准第4.1条要求了。

4. The auditee/auditor considers that each clause or sub-clause of ISO 9001 must be defined as a separate process
[size=4]被审核方和审核员一起考虑，ISO9001标准每个条款或子条款必须作为独立的过程

If the auditor considers this as the right approach, he should refer to relevant ISO documents, (notably the ISO/TC 176/SC 2 document N544 ISO 9000 Introduction and Support Package: Guidance on the Concept and Use of the Process Approach) which clearly indicates the contrary.
如果审核员考虑这是正确的做法，那么，他应当参考ISO/TC 176/SC 2编写的文件，N544 ISO 9000 指导文件：《关于采用过程模式的概念》这份文件清楚地说明什么是过程模式。

If the auditee considers this as the right approach, it is recommended that the techniques outlined in section 2 (above) should be used.
如果被审核方认为这是正确的做法，建议采用本文前面第2条的技术方法。

5. Is the process approach as described in the 'Introduction' to ISO 9001 a requirement of the standard?
过程模式是否按照ISO9001标准“引言”中所描述的要求 ？

The description of the process approach in the 'Introduction' to ISO 9001 is purely informative and does not introduce a set of additional requirements by itself. Clause 4.1 specifies the steps necessary to implement a process approach with regard to quality management system processes, the Notes to clause 4.1 providing examples of processes needed for the quality management system. Audit methodologies must be oriented, accordingly, towards analyzing the processes of the organization.
ISO9001标准“引言”中 那一节所说的过程模式仅仅是提供信息，不是作为附加的要求。标准第4.1条规定的是执行过程模式质量管理体系所必要的各个步骤，第4.1条后面有一条注说明质量管理体系所必须要有的各个过程实例。审核的时候必须按照过程的模式来审核，分析组织的各个过程。

ISO9001

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