ISO/TC 176/SC 2/N1286：ISO 9001:2015 建檔資訊要求指南

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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:  

• to develop a simplified set of standards that will be equally applicable to small as well as medium and large organizations, and
• for the amount and detail of documentation required to be more relevant to the desired results of the organization's process activities.
  

ISO 9001 本次改版最重要的目標之中的兩項為：

• 發展一套簡化的標準組合，可以同時應用於小型與中型和大型組織，和
• 所需文檔的數目與細節，與組織過程活動希望的結果密切關聯。
  

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:

• paper
• magnetic
• electronic or optical computer disc
• photograph
• master sample
  

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:

• documented information required by this International Standard;
• documented information determined by the organization as being necessary for the effectiveness of the quality management system.
  

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:  

• size of organization and its type of activities, processes, products and servises;
• complexity of processes and their interactions;
• competence of persons.
  

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:

• The scope of the quality management system (clause 4.3)
• Documented information necessary to support the operation of processes (clause 4.4)
• The quality policy (clause 5).
• The quality objectives (clause 6).
• This documented information is subject to the requirements of clause 7.5.
  

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:  

• Organization charts
• Process maps, process flow charts and/or process descriptions
• Procedures
• Work and/or test instructions
• Specifications
• Documents containing internal communications
• Production schedules
• Approved supplier lists
• Test and inspection plans
• Quality plans
• Quality manuals
• Starategic plans
• Forms
  

   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:

• Documented information to the extent necessary to have confidence that are processes are being carried out as planned (Clause 4.4).
• Evidence of fitness for purpose of monitoring and measuring resources (clause 7.1.5.1).
• Evidence of the basis used for calibration of the monitoring and measurement resources (when no international or national standards exist) (clause 7.1.5.2).
• Evidence of competence of person(s) doing work under the control of the organization that affects the performance and effectiveness of the QMS (clause 7.2)
• Results of the review and new requirements for the products and services (clause 8.2.3).
• Records needed to demonatrate that design and development requirements has been met (clause 8.3.2).
• Records on design and development inputs (clause 8.3.3)
• Records of the activities of design and development controls (clause 8.3.4)
• Records of design and development outputs (clause 8.3.5).
• Design and development changes, including the results of the review and the authorization of the changes and necessary actions (clause 8.3.6).
• Records of the evaluatoin, selection, monitoring of performance and re-evaluation of external providers and any and actions arising form these activities (clause 8.4.1).
• Evidence of the unique identification of the outputs when traceability is a requirement (clause 8.5.2).
• Records of property of the customer or external provider that is lost, damaged or otherwise found to be unsuitable for use and of its communication to the owner (clause 8.5.3).
• Results of the review of changes for production or service provision, the persons authorizing the change, and necessary actions taken (clause 8.5.6)
• Records of the authorized release of products and services for delivery to the customer including acceptance criteria and traceability to the authorizing person(s) (clasue 8.6)
• Records of nonconformities, the actions taken, concessions obtained and the identification of the authority deciding the action in respect of the nonconformity (clause 8.7).
• Results of the evaluation of the performance and the effectiveness of the QMS (clause 9.1.1).
• Evidence of the implementation of the audit programme and the audit results (clause 9.2.2).
• Evidence of the results of management reviews (clause 9.3.3)
• Evidence of the nature of the nonconformities and any subsequent actions taken (clause 10.2.2).
• Results of any corrective action (clause 10.2.2)
  

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:

• determining the processes necessary for the effective implemetation of the quality management system
• determining the interactions between these processes.
• documenting the processes to the extent necessary to assure their effective operation and control.  (It may be appropriate to document the processes using process mapping tools.  It is emphasized, however, that documented process mapping tools are not a requirement of ISO 9001:2015).
  

- 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:

• An organization with an existing QMS should not need to rewrite all of its documented information in order to meet the requirements of ISO 9001:2015.  This is particularly true if an organization has structured it QMS base on the way it effectively operates, using a process approach.
• An organization may be able to carry out some simplification and/or consolidation of existing documented information in order to simplify its QMS.
  

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。

• Organizations may be able to demonstrate conformity without the need for extensive documented information.
• 組織可能不需要太多的文件資訊，就可以展示符合性 。
• To claim conformity with ISO 9001:2015, the organization has to be able to provide objective evidence of the effectiveness of its processes and its quality management system.  Clause 3.8.3 of ISO 9001:2015 defines "objective evidence" as "data supporting the existence or verity of somethine" and notes that "objective evidence may be obtained through observation, measurement, test, or other means."
• 為了宣稱 ISO 9001:2015 版的符合性，組織必須能夠提供證明其過程和品質管理系統有效性的客觀證據。ISO 9001:2015 版第 3.8.3 節定義「客觀證據」為「支持某項事物存在或真實的資料」，並且注釋說明「客觀證據可能透過觀察、量測、試驗或其他措施而取得」。（註：此段敘述與 ISO 9001:2015 國際標準版的文字有落差！ISO 9001:2015 第 3 章只有章標題，沒有分節。經查證此段文字出自 ISO/CD 9000:2013 3.8.8。）
• Objective evidence does not necessarily depend on the existence of documented information, except where spcifically mentioned in ISO 9001:2015.  In some cases, (for example, in clause 8.1 (e) Operational planning and control, it is up to the organization to determine what documented information is necessary in order to provide this objective evidence.
• Where the organization has no specific documented information for a particular activity, and this is not required by the standard, it is acceptable for this activity to abe conducted using as a basis the relevant clause of ISO 9001:2015.  In these situations, both internal and external audits may use the text of ISO 9001:2015 for confomity assessment purposes.
  

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.