ISO9001:2008质量认证标准灵活条款的应用准则及要求
ISO9001: 2008 quality certification standard flexible in terms of the application standards and requirements
在一些组织编写的质量手册中，常有照搬ISO 9001：2000标准“必要时’、“适用时”、“适当时’等灵活用词的现象。有的组织为了省事，干脆以“不必要’、“不适用’、不存在“适当时’为由，省略了对其后内容的描述。显然，这样处理是不符合要求的。在标准中，共有这类条款15处，组织可以参照以下情况，结合自身实际在质量手册中作出具体规定。
In some organizations in the preparation of quality manual, often copying ISO 9001 : 2000 standard" when necessary, '" applicable"," appropriate ' flexible word phenomenon. Some organizations in order to save trouble, simply to " unnecessary" does not apply, ' ', does not exist" appropriate ' is omitted, the subsequent content description. Obviously, this treatment is not in line with the requirements of the. In the standard, a total of this kind of Clause 15, organizations can refer to the following circumstance, combinative oneself is actual in the quality manual to make specific provisions.
      4.2.3b）条款：“必要时对文件进行评审与更新，并再次批准”。
4.2.3b ) terms:" when necessary, the document shall be reviewed and updated, and again approved".
     这里的“必要时”，有以下几种情况：内部条件变化，如组织结构、产品结构发生变化；外部条件变儿，如体系依据的标准、法律法规、顾客和市场发生变化；资源配置状况发生变化；新工艺、新技术的采用；质量管理体系运行实践中发现文件不适应；因采取纠正或预防措施，需对文件作永久性更改并导致换版。
Here " when necessary", have the following situations: internal conditions, such as organization structure, product structure produces change; external conditions change, such as the system based on the standard, laws and regulations, customer and market change; resource allocation situation changes; new technology, new technology adoption; quality management system operation practice found in the file does not suit; for corrective or preventive measures, to file for permanent change and cause change version.
     通过评审，确认文件不持续适宜时，应予更新（换版）。
Through the review, confirm file not continuing suitability, should grant update ( version ).
     6.3条款：“适用时，基础设施包括：
Article 6.3:" when applicable, the infrastructure including:
     a）建筑物、工作场所和相关的设施；
A ) buildings, workspace and associated facilities;
     b）过程设备（硬件和软件）；
B ) process equipment ( hardware and software );
     C） 支持性服务（如运输或通讯）”。
C ) support services ( such as transport or communication)".
     每个提供四种通用类产品的组织对基础设置配置的需求是不同的，例如律师事务所工作场所的相关设施比较简单，过程设备也只涉及办公自动化设备，支持性服务中的通讯设施却是比较重要的设施。
Each provides four kinds of generic products organization on the basis of setting configuration needs are different, such as law firms related to workplace facilities is relatively simple, involving only the process equipment and office automation equipment, supporting services in the communications infrastructure is relatively important facilities.
     7.3.1条款：“随设计和开发的进展，在适当时，策划的输出应予更新”。
The 7.3.1 clause:" as the design and development progresses, when appropriate, planning output shall be updated".
     设计和开发策划是一种活动，策划的结果必然形成输出，如设计和开发计划是一个文件（标准并没有要求称作计划）O文件在实施过程中，由于主、客观原因，可能无法实现原策划输出的要求，例如设计和开发阶段以及评审、验证、确认活动发生变化、进度拖后、职责分配和接口管理发生变化，就应及时或适时作出调整，一般可在变化发生前后结合转阶段进行。
Design and development planning is an activity, plan the inevitable result of the formation of output, such as design and development plan is a document ( there is no requirement called a plan ) the O file in the implementation process, due to the subjective and objective reasons, may not achieve the original planning output requirements, such as design and development review, verification and validation activities, change, behind, the distribution of responsibilities and interfaces management change, it should be timely and timely adjustments, generally in the changes that occur before and after combining phase.
     7.3.7条款：“适当时，应对设计和开发的更改进行评审、验证和确认……”
The 7.3.7 clause:" when appropriate, with design and development changes review, verification and validation ... ..."
     这里的“适当时”可考虑以下几种情况（对硬件产品而言）：原经评审、验证和确认的产品特性出现更改；涉及原理或主要结构的更改；操纵、控制方式发生变化；主要材料和配套件变动；产品的功能和性能改变；更改引起对产品组成部分的影响或不能满足互换性要求。