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標題: ISO/TC 176/SC 2/N1286:ISO 9001:2015 建檔資訊要求指南 [打印本頁]

作者: hlperng    時間: 2016-2-23 16:07:50     標題: ISO/TC 176/SC 2/N1286:ISO 9001:2015 建檔資訊要求指南

本帖最後由 hlperng 於 2017-11-8 23:10 編輯

Guidance on the Requirements for Documented Information of ISO 9001:2015
ISO 9001:2015 版文件化資訊要求指南

documented information =(已)建檔資訊、文件化資訊、文檔資訊、形成文件資訊
1. Introduction
1. 簡介
Two of the most important objectives in the revision of the ISO 9000 series of standards have been:  
ISO 9001 本次改版最重要的目標之中的兩項為:


ISO 9001:2015 Quality management systems - Requirements has achieved these objectives, and the purpose of this additional guidance is to explain the intent of the new standard with specific regard to documented information.  

ISO 9001:2015 allows an organization flexibility in the way it chooses to document its quality management system (QMS).  This enables each individual organization to determine the correct amount of documented information needed in order to demonstrate the effective planning, operation and control of its processes and the implementation and continual improvement of the effectiveness of its QMS.

It is stressed that ISO 9001 requires (and always has required) a "Documented quality management system", and not a "system of documents".  
必須強調的是,ISO 9001 要求(而且一直在要求)的是建檔的品質管理系統,而不適文件系統。

2. What is documented information? - Definitions and references
2. 何謂建檔資訊? - 定義與引用資料
The term Documented Information was introduced as part of the common High Level Structure (HLS) and common terms for Management System Standards (MSS).
建檔資訊一詞是共同高階架構 (HLS) 所推動的名詞之一,為管理系統標準 (MSS) 的共用名詞。

The definition of documented information can be found in ISO 9000 clause 3.8.  
建檔資訊的定義參考 ISO 9000 條款 3.8。

Documented information can be used to communicate a message, provide evidence of what was planned has actually been done, or knowledge sharing.  
建檔資訊可用於溝通信息,提供規畫項目實際已達成的證據,或知識分享。

The following are some of the main objectives of an organization's documented information independent of whether or not it has implemented a formal QMS;
a) Communication of Information
b) Evidence of Conformity
c) Knowledge Sharing
d) To disseminate and preserve the organization's experiences.  
下述為一些組織建檔資訊的主要目的,與組織是否實施正式的品質管理系統 (QMS) 無關:
a) 資訊溝通
b) 符合性證據
c) 知識分享
d) 組織經驗的傳播與保存


A typical example would be a technical specification, which can be used as a base for design and development of a new product or service.  

A list of commonly used terms and definitions relating to documented information is presented in ISO 9001:2015 Annex A.   
與建檔資訊相關的常用名詞與定義,參閱 ISO 9001:2015 附錄 A。

It must be stressed that, according to ISO 9001:2015 clause 7.5.3 Control of documented information requirements, documentes may be in any form or type of medium, and the definition of "document" in ISO 9000:2015 clause 3.8.5 gives the following examples:


3. ISO 9001:2015 Documentation Requirements (ISO 9001:2015 版文件化要求)
ISO 9001:2015 clause 4.4 Quality management systems and its processes requires an organization to "maintain documented information to the extent necessary to support the operation of processes and retain documented information to the extent necessary to have confident that the preocesses are being carried out as planned."

Clause 7.5.1 General explains that the quality management system documentation shall include:

The note after this Clause make it clear that the extent of the QMS documented information can differ from one organization to another due to the:  


All the documented information that forms part of the QMS has to be controlled in accordance with clause 7.5 Documented information.  



4. Guidance on Clause 7.5 of ISO 9001:2015 (ISO 9001:2015 版第 7.5 節指南)
The following comments are intended to assist users of ISO 9001:2015 in understanding the intent of the general documented information requirements of the International Standard.  Documented information can refer to:  
a) Documented information needed to be maintained by the organization for the purpose of establishing  a QMS (high level tranversal documents).  This include:

b) Documented information maintained by the organization for purpose of communicating the information necessary for the organization to operate (low level, specific documents).  See 4.4.  Although ISO 9001:2015 does not specifically requires any of form, examples of documents that can add value to a QMS may include:  
   Where it exists, all such documented information, is also subject to the requirements clause 7.5.  

c) Documented information needed to be retained by the organization for the purpose of providing evidence of result achieved (records).  These include:


Organizations are free to develop other records that may be needed to demonatrate conformity of their processes, products and services and quality management system.  Where they exists, all such records are also subject to the requirements clause 7.5.  


5. Organizations preparing to implement a QMS (準備實施品質管理系統之組織)
For organizations that are in the process of implementing a QMS, and wish to meet the requirements of ISO 9001:2015, the following comments may be useful.  
- For organizatoins that are in the process of implementing or having yet to implement a QMS, ISO 9001:2015 emphazised a process approch. This includes:
- Analysis of the processes should be the driving force for defining the amount of documented information needed for the quality management system, taking into account the requirements of ISO 9001:2015.  It should not be the documented information that drives the processes.  

6. Organizations wishing to adapt an existing QMS (希望採用既有品質管理系統之組織)
For organizations that currently have a QMS the following comments are intended to assist in understanding the changes to documented information that may be required or facilitated by the transition to ISO 9001:2015:


7.  Demonstrating conformity with ISO 9001:2015 (展示 ISO 9001:2015 版之符合性)
For organizations wishing to demonstrate conformity with the requirements of ISO 9001:2015, for the purposes of certification/registration, constractual, or other reasons, it is important to remember the need to provide evidence of the effective implementation of the QMS.  
對於為了認證、登錄、合約、或其他理由等之目的,希望展示符合ISO 9001:2015 版的組織而言,必須記住提供品質管理系統 (QMS) 有效執行證據的需要是很重要的。


ISO/CD 9000:2013
3.8.8 Objective evidence
data supporting the existence or verity of something.
NOTE 1 to entry: Objective evidence may be obtained through observation, measurement, test, or other means.












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