面向未来的质量管理体系——ISO 9001:2015思考二
2014-07-23
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主题二：形成文件的信息如何实现
一. 基本概念- documented information形成文件的信息
documented information形成文件的信息
information (3.50) required to be controlled and maintained by an organization (3.01) and the medium on which it is contained. 一个组织(3.01)需要控制和维护的信息(3.50)和其包含的媒介
Note 1 to entry: Documented information can be in any format and media and from any source.
形成文件的信息可以来自任何来源的任何格式和媒介。
Note 2 to entry: Documented information can refer to:形成文件的信息可以是：
- the quality management system (3.33), including related processes (3.12);
- 质量管理类体系，包括相关过程；
- information (3.50) created in order for the organization (3.01) to operate (documentation);
- 为了组织运行（文件化）而产生的信息
- evidence of results achieved (records).获得结果的证据
[SOURCE: ISO DIS 9000:2014, 3.8.1.1.1]
Information信息
meaningful data (3.49)有意义的数据
[SOURCE: ISO DIS 9000:2014, 3.8.1.1]
二. DIS 版ISO9001:2015 出现“documented information形成文件的信息”条款
-4.3 Determining the scope of the quality management system确定质量管理体系范围
-4.4 Quality management system and its processes质量管理体系和其过程
-5.2 Quality policy质量方针
-6.2 Quality objectives and planning to achieve them质量目标和其实施的策划
-7.1.5 Monitoring and measuring resources监视和测量资源
-7.2 Competence能力
-7.5 Documented information形成文件的信息
-8.1 Operational planning and control运行策划和控制
-8.2.3 Review of requirements related to products and service有关产品和服务的评审要求
-8.3.2 Design and development planning设计和开发策划
-8.3.5 Design and 1299 development outputs设计和开发输出
-8.3.6 Design and development changes设计和开发变更
-8.4 Control of externally provided products and services外部提供产品和服务的控制
-8.4.1 General总则
-8.5.1 Control of production and service provision产品和服务提供的控制
-8.5.2 Identification and traceability标识和可追溯性
-8.5.6 Control of changes变更控制
-8.6 Release of products and services产品和服务放行
-8.7 Control of nonconforming process outputs, products and services
不合格过程输出-产品和服务的控制
-9.1 Monitoring, measurement, analysis and evaluation监视，测量，分析和评价
-9.1.1 General总则
-9.2 Internal audit内部审核
-9.3 Management review管理评审
-10.2 Nonconformity and corrective action不合格和预防措施
三、7.5 Documented information形成文件的信息 条款文本内容
7.5 Documented information
7.5.1 General
The organization’s quality management system shall include
a) documented information required by this International Standard;
b) documented information determined by the organization as being necessary for the effectiveness of the quality management system.
NOTE The extent of documented information for a quality management system can differ from one organization to another due to:
a) the size of organization and its type of activities, processes, products and services;
b) the complexity of processes and their interactions;
c) the competence of persons.
7.5.2 Creating and updating
When creating and updating documented information the organization shall ensure appropriate:
a) identification and description (e.g. a title, date, author, or reference number);
b) format (e.g. language, software version, graphics) and media (e.g. paper, electronic);
c) review and approval for suitability and adequacy.
7.5.3 Control of documented Information
7.5.3.1 Documented information required by the quality management system and by this International Standard shall be controlled to ensure:
a) it is available and suitable for use, where and when it is needed;
b) it is adequately protected (e.g. from loss of confidentiality, improper use, or loss of integrity)
ISO 2014 – All rights reserved 33 ISO/TC 176/SC2/WG24/N111
7.5.3.2 For the control of documented information, the organization shall address the following activities, as applicable:
a) distribution, access, retrieval and use;
b) storage and preservation, including preservation of legibility;
c) control of changes (e.g. version control);
d) retention and disposition.
Documented information of external origin determined by the organization to be necessary for the planning and operation of the quality management system shall be identified as appropriate, and controlled.
NOTE Access can imply a decision regarding the permission to view the documented information only, or the permission and authority to view and change the documented information.
四、7.5 Documented information形成文件的信息，如何应对？
在ISO9001：2015（DIS版)中“documented information形成文件信息”的要求，体现了：
1）新版标准要求的灵活性，不拘泥于以往的手册，程序，作业文件的要求，统一用“形成文件的信息”； “记录”则用“活动结果的证据” 取而代之；
2）标准本身明确要求“documented information形成文件信息”，某种意义就是需要持续监视风险（因与果）一些关键点，是给客户以及相关方展示其有能力满足要求。
既然ISO9001:2015对于“documented information形成文件信息”提出新的要求，作为企业方，为了适应此次标准转版要求，应该如何做呢？建议如下：
1）形成标准转版项目小组，不能只是质量部一己之力，组长负责制，由其确立项目转版的方案书；
2）各个职能对照此次转版标准要求，所有“documented information形成文件信息”是否有对应的内部要求；
3）缺少内部要求，归口不同职能，责任人进行文件化，组长组织文件符合性，有效性评审，评审时候，也要考虑到标准要求风险与机会（备注；风险与机会，后期会进行专题分析）；
4）“documented information形成文件信息”一定不能局限于我们以往的纸质文件要求，更多要结合到现有IT系统，比如客户以及订单管理-CRM系统，物料控制信息控制-ERP系统；研发数据图纸的系统库等等
5）“documented information形成文件信息”要求实现后，应该依照项目转版方案书要求进行实施，经过PDCA的过程，予以验证并持续改进。
以上是关于“documented information形成文件信息”的思考，希望能引发更多的观点和讨论吧。
