1、目的（Purpose）
规定了质量管理体系文件、资料管理要求，以保证在质量体系运行中，各部门均持有并适用、有效版本的文件。
For provisions the requirements of quality management system files, To ensure the departments hold and usethe suitable, effective version of the file in whole quality management system.
 
2、适用范围（Scope）
本规程适用于下列质量体系文件的管理：
This procedure is applicable for managing the following quality system documents: 
质量手册  Quality Manual;
程序文件  Procedure File;
作业文件  SOP (Standard operation procedure);
记录      Record;
外来文件  External File.
 
3、职责（Responsibility）
3.1 总经理：负责质量手册的批准。
General Manager: Responsible for approve the quality manual;
 
3.2 管理者代表：组织质量体系文件的编制、修订，质量手册的审核，程序文件的批准。
Management representative: Organize the draft and revise work of quality management system files, Audit quality manual, approve procedure files.
 
3.3 质量负责人：负责质量手册编制、修订；质量手册和程序文件的发布、发放、组织修订、回收及旧版/作废等控制管理。
Quality Assurance Principal: Responsible for draft and revise the quality manual, Responsible for the control actions such as issue, handout, organize revise work, recycle and abolish the old version of quality manual and procedure file.
 
3.4 各部门负责人：负责本部门所编制作业文件、记录的审批，程序文件的审核。
Department Principal: Responsible for draft the department’s SOP, audit record, audit procedure file.
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3.5 各部门：负责本部门业务相关程序文件、作业文件及记录的编制、修订；负责本部门文件的接收、发放、回收、保管等方面的受控管理
Department Staff: Responsible for draft and revise the department’s procedure file and SOP; responsible for the controlled work of the department file’s such as receive, handout, recycle, or reserve.
 
3.6 销售部：负责客户提供文件资料的接收、标识、保管、分发、回收等方面的受控管理.
Sales Department: Responsible for the control action such as receive, identify, reserve, handout and recycle work of the file form customer.
 
4、定义（Definition）
4.1质量手册（Ⅰ级文件）：公司建立和运行符合ISO9001:2008要求的质量体系、落实质量方针、质量目标的指导性纲要。是质量体系文件的第一级文件
System Manual (The First Level): General guideline of company for establishing and running quality management system, implement quality management policy and quality management target according to ISO 9001:2008’s requirement.
 
4.2程序文件（Ⅱ级文件）：是质量手册中所描述的管理重点的延伸和引用。是描述质量管理体系中各项重要作业内容的流程及部门间接口要求。是质量体系文件的第二级文件。
Procedure file (The Second level): Description and extension the emphasis part which describe in quality manual. The procedure should be contains important SOP which describe in quality manual, require of departments’ interface. It is belongs to the second level of quality management system.
 
4.3作业文件（Ⅲ级文件）：程序文件中的作业内容的延伸和引用。是描述各职能部门内部某项作业的具体要求。是质量体系文件的第三级文件。包括流程图、计划、管理基准、作业指导书等。
SOP (The Third Level): Description and extension the emphasis part which describe in procedure file. It should be provide specific requirement of task in function department. It is belongs to the third level of quality management system.
 
4.4 记录（Ⅳ级文件）：质量体系程序文件、作业文件中所引用的记录表格和表单。是质量体系文件的第四级文件。
Record (The forth Level): Quotatived forms or tables in procedure files, SOP files. It is belongs to the forth level of quality management system.
 
4.4 受控文件：发放、修订、回收等须严格执行本规程，持有、使用中须随时保持是最新、有效版本的文件。
Controlled file: All the handout, revise, recycle actions should be deal strictly obey this rules, it is required to keep and use the latest, valid version file.
 
4.5 非受控文件：分发时是最新版，但修订时无须再进行新版替换、旧版废止、回收、销毁等管理的文件。
Non-controlled file: while handout, it is the latest version file. But in case of revise, do not need to replace, invalid old version, recycle or destroyed.
 
4.6 外来文件：是从公司外部接收或购买到的，非本公司编制的文件。包括顾客发送的图纸资料、外来的标准、法律法规等、第三方审核记录等.
External file: the files come from external by received or bought, not belongs to the company draft file, which including the drawings from customer, external standard, regulations, or the record from the third part.
 
5、程序（Procedure）                           
5.1 文件的编制要求
Requirement of document drafting.
 
质量管理体系中的各级各类文件的格式、结构应规范统一，并对文件进行编码和版本标识，以便于文件的识别和管理。
For identification and management, every file in each level should have unified format, clearly coding and version number,
 
5.2 文件的编制、审核和批准
Draft, Audit and Approve procedure: 
 
5.2.1 质量手册由质量行政人事部结合本公司的管理特点和实际情况进行编制，管理者代表审核；总经理批准。
Quality manual: Draft by quality Admin/HR department, Audit by manage representative, Approve by General Manager.
 
5.2.2 程序文件由质量行政人事部组织各相关的业务部门实施编制，经编制部门及相关部门的负责人审核，由管理者代表批准。
Procedure file: quality Admin/HR department organize function department to draft the file, audit by department principal, approve by manage representative.
 
5.2.3作业文件由各部门依据本部门的实际情况及需要自行组织相关岗位人员编写；编写部门及业务相关部门的负责人审核；管代批准。
SOP file: Draft and organize by department, audit by department principal, approve by manage representative.
 
5.2.4记录由上述程序文件、作业文件中提出记录要求的部门负责编制记录样式。记录样式后附在相应的程序文件或作业文件中，对程序文件、作业文件审批的同时即对记录的样式进行了审批。对记录的填写内容的审批，依据具体情况进行。详见《记录控制程序》。
Record: Format drafted by department, after recorded, it should be attached in procedure file or SOP file,
 
5.3 文件的发布与发放
Issue and Handout:
 
5.3.1质量手册、程序文件由质量行政人事部发布并发放，作业文件及记录由文件编制部门负责发布及发放。
Quality Admin/HR department is responsible for issue and handout quality manual and procedure file. Department is responsible for issue and handout SOP and record.
 
5.3.2发放部门保存文件原稿及电子文件，发放到各部门的文件应为复印件。复印件首页加盖黑色“COPY”印以与原稿进行区别。
The original version and electrical version should be reserved in issued department, and handout the copy version, the first page of the copy version should be marked’ COPY’ for distinguish with original version.
 
5.3.3文件发布部门确定文件发放的范围及是否受控。文件的使用者接收的应为受控文件；只作为参考使用的可作为非受控文件。
The file issue department should fix the file usage scope and control situation. The file user should receive the controlled version, and the reference user should receive the non-controlled file.
 
5.3.4发放部门应在所发放的需受控文件的首页盖红色“受控文件”印，并注明不同的发放号码，以便于追溯。未盖“受控文件”印的复印版文件视为非受控文件。
The file issue department should chop’ controlled file’ in red color on the front cover page, and mark difference issue number for trace back. The copy version file which do not chop’ controlled file’ should be deal as non-controlled. 
 
5.3.5文件发放时，发放部门还应将需受控文件的发放情况（发放号、版本号、发放日期、发送部门等）记入《文件发放/回收记录》，并由文件接收部门签字确认。
The file issue department should also record controlled file handout situation (issue number, version number, issue date, send department and etc, ) on ‘ file handout/ recycle list’ , and the file should be signed by received department.
 
5.3.6发放部门将发放文件放于公司服务器，将文件及文件路径以邮件形式发给相关人员，由部门经理签收“部门文件接收记录”，并将此表单保存于各部门指定文件夹中。
 
5.4文件的使用、保管
Usage and reservation of the file.
 
5.4.1各级文件使用部门应建立《部门文件清单》以便于管理及查阅。文件发生增加、修订、回收、废弃等情况时，须对《部门文件清单》及时修订。
Department should have’ department file list’ for manage and check. The’ department file list’ should be modified according to the file added, revised, recycled, or abandoned.
 
5.4.2任何人不得在受控文件上乱涂、画、改，以确保文件清晰、易于识别。
For keep the controlled file clean and identified, it is forbidden to mark, write or paint on it.
 
5.5文件的修订
Revise of the file.
 
5.5.1文件需要更改时，由提出人/部门填写《文件修订/废止申请表》，注明修订原因及更改内容。
While modification needed, the proposer fill <File revise/abandon application form>, and state revise reason and modified contents.
 
5.5.2文件每次修订后，文件版本号也要随之变更：版本号中的修订顺序号加1。此外，作业指导书类文件须在被修订处做修订标识外，其它类文件须在文件修订记录中的修订内容栏内注明修订处的文件条款号。
The files’ version number should be changed according to the contents change; added 1 on revise number of version number. Besides, SOP file should be marked at the revised position,  others kinds of files should mark the clause number of the revise.
 
5.5.3若文件经多次修订或需进行大幅度修订时，要进行换版：
In case of the file was revised many times or need to be revised substantially, the version should be changed.
 
1. 质量手册、程序文件更改5次时；
Five times of quality manual, procedures files
2. 作业文件更改8次时；
Eight times of SOP;
3. 文件修订涉及文件全部页面时。
Substantially revise of files.
 
5.5.4修订后的文件须按照本规程中5.2、5.3、5.4条款的要求重新进行审批、发放及使用保管。
The revised file should be re-audit, re-handout, re-reservation according to clauses 5.2, 5.3, 5.4 of this rules.
 
5.6文件的废止
Abolish of the file.
 
文件需要废止时，由提出人填写《文件修订/废止申请表》，注明废止原因，经文件的审核、批准责任者审批后，由文件编写部门实施废止。
In case of abolish needed, the proposer should fill <File abolish application form>, state the abolish reason, after audit, approval, the file was abolished by it draft department.
 
5.7文件的回收、销毁
Recycle, destroy of the file.
 
5.7.1当使用人的文件破损影响使用或丢失，可到文件发放部门办理更换、补发手续。新文件的发放号仍沿用原号码。破损文件由文件发放部门收回并销毁
In case of the file was too broken to use or lost, the user can apply to replace or re-handout action to it handout department. The new files should use the number as the old one. The broken file should be recycle or destroy by handout department.
 
5.7.2当组织结构发生变化时，文件发放部门要及时回收或补发相应文件。
In case of the organization chart change, the file handout department should recycle or fulfill the file on time.
 
5.7.3 当文件发生修订或废止时，由文件发放部门对旧版或废止文件实施回收并销毁.
In case of revise of abolish, the file handout department should recycle or destroy the old or abolish file.
 
5.7.4因工作需要须保留的废止文件，应在文件上加盖 “作废参考”印作为标识，并存放在特定的地点隔离保存。
In case the abolish file should be reserve by work reason, it should marked ‘ abolish for reference’ chop, and reserved in appointed and isolated position.
 
5.7.5 文件的回收、销毁情况须由文件发放部门记入《文件发放/回收记录》
The handout department fill <file handout/recycle record> for the recycled or destroyed file.
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