ISO9001-2015文件控制程序(中英文)

文件控制程序

Document Control Procedure

（ISO9001：2015）

1.0 Purpose目的

Define the requirements and responsibilities for Document control.

定义出文件控制的要求和权责。

2.0 S cope范围

This procedure applies to all QMS documentation, including: quality manual, procedure, WI, external document and form.

适用于与质量管理体系有关的所有文件。包括:手册、程序文件、操作指导书、外来文件及表单。

3.0 Definitions定义

3.1 Quality Manual: According to the requirements of International and national standard (such as ISO9001), describe quality management system documentation in Co-active.

3.1质量手册：根据相关国际或国家标准(如ISO9001)要求，阐述本公司质量管理体系的文件。

3.2 Procedure: Define the function of QMS requirement allocation by department. Such as document control, management review, internal audit procedure.

3.2程序文件：描述为实施质量管理体系要求所涉及的各职能部门的活动的文件。如文件控制程序、管理评审控制程序、内部审核控制程序。

3.3 Working Instruction: Operation procedures, inspection standards, design drawing and etc.

3.3操作指导书：操作规程、检验标准、加工图纸等。

3.4 Form: Records of operation results.

3.4表单：用于记录作业结果所用的文件。

4.0 Procedure 程序

4.1 Responsible for the formulation of documents to file the proper approval, and timely send the electronic document and the paper version to DCC, ensure that the relevant departments to understand the change. Once the document released, the relevant departments must follow procedures. When the file changes do not affect the contents of the file (such as correcting typos, wording changes), it will not requires re-approval, but such changes must be notify DCC to ensure the consistency of documentation.

4.1文件的制订者负责使文件得到适当的审批后,及时将文件的电子版本和批准后的纸张版本交给文控,并确保相关部门理解文件。一旦文件发放，各相关部门必须依程序执行。当文件的修改不影响到文件内容(如纠正错别字,措辞修改)时,可以不进行版本升级,也就不需要重新审批,但是类似修改必须经过文控,以确保文件的各种形式保持一致。

4.2 Classification and description of controlled documents 文件的分类及受控说明

4.2.1 Documents classification文件的分类：

Quality management system documents chart as below:质量管理体系文件分为以下几类：

A一级:Quality Manual质量手册→

B二级:Procedure程序文件→

C三级:WI作业指导书→

D四级:Form记录

表单→

External documents, including the customer documents (procedure, products standards, drawing and etc. , standards organization documents (national/ international products/system standards.) laws and regulations, design operational instruction.

外来文件，包括来自顾客的文件（程序文件、产品规范、图纸等）、来自标准化组织的文件（国家和国际的产品标准及体系标准）及来自法制机构的文件、设施操作说明书等。

4.2.2 Document control 文件的受控说明

DCC issue the paper files with `controlled”stamp, issue the electronic files on S drive, Only DCC has the authority to amend the document, other users only has the authority to read.

经文控中心发行的纸档文件，每页均有跨页`受控`章的为受控文件;”受控的电子版文件保存在公共盘上，仅文控中心有修改权限，其它用户仅有只读权限。4.3 Creation and review of documents 文件制定及评审过程

4.3.1 Creation of documents 文件的制定: