1、目的（Purpose）
規(guī)定了質量管理體系文件、資料管理要求，以保證在質量體系運行中，各部門均持有并適用、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、適用范圍（Scope）
本規(guī)程適用于下列質量體系文件的管理：
This procedure is applicable for managing the following quality system documents: 
質量手冊  Quality Manual;
程序文件  Procedure File;
作業(yè)文件  SOP (Standard operation procedure);
記錄      Record;
外來文件  External File.
 
3、職責（Responsibility）
3.1 總經理：負責質量手冊的批準。
General Manager: Responsible for approve the quality manual;
 
3.2 管理者代表：組織質量體系文件的編制、修訂，質量手冊的審核，程序文件的批準。
Management representative: Organize the draft and revise work of quality management system files, Audit quality manual, approve procedure files.
 
3.3 質量負責人：負責質量手冊編制、修訂；質量手冊和程序文件的發(fā)布、發(fā)放、組織修訂、回收及舊版/作廢等控制管理。
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 各部門負責人：負責本部門所編制作業(yè)文件、記錄的審批，程序文件的審核。
Department Principal: Responsible for draft the department’s SOP, audit record, audit procedure file.
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3.5 各部門：負責本部門業(yè)務相關程序文件、作業(yè)文件及記錄的編制、修訂；負責本部門文件的接收、發(fā)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 銷售部：負責客戶提供文件資料的接收、標識、保管、分發(fā)、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、定義（Definition）
4.1質量手冊（Ⅰ級文件）：公司建立和運行符合ISO9001:2008要求的質量體系、落實質量方針、質量目標的指導性綱要。是質量體系文件的第一級文件
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級文件）：是質量手冊中所描述的管理重點的延伸和引用。是描述質量管理體系中各項重要作業(yè)內容的流程及部門間接口要求。是質量體系文件的第二級文件。
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作業(yè)文件（Ⅲ級文件）：程序文件中的作業(yè)內容的延伸和引用。是描述各職能部門內部某項作業(yè)的具體要求。是質量體系文件的第三級文件。包括流程圖、計劃、管理基準、作業(yè)指導書等。
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 記錄（Ⅳ級文件）：質量體系程序文件、作業(yè)文件中所引用的記錄表格和表單。是質量體系文件的第四級文件。
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：發(fā)放、修訂、回收等須嚴格執(zhí)行本規(guī)程，持有、使用中須隨時保持是最新、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：分發(fā)時是最新版，但修訂時無須再進行新版替換、舊版廢止、回收、銷毀等管理的文件。
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 外來文件：是從公司外部接收或購買到的，非本公司編制的文件。包括顧客發(fā)送的圖紙資料、外來的標準、法律法規(guī)等、第三方審核記錄等.
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 文件的編制要求
Requirement of document drafting.
 
質量管理體系中的各級各類文件的格式、結構應規(guī)范統(tǒng)一，并對文件進行編碼和版本標識，以便于文件的識別和管理。
For identification and management, every file in each level should have unified format, clearly coding and version number,
 
5.2 文件的編制、審核和批準
Draft, Audit and Approve procedure: 
 
5.2.1 質量手冊由質量行政人事部結合本公司的管理特點和實際情況進行編制，管理者代表審核；總經理批準。
Quality manual: Draft by quality Admin/HR department, Audit by manage representative, Approve by General Manager.
 
5.2.2 程序文件由質量行政人事部組織各相關的業(yè)務部門實施編制，經編制部門及相關部門的負責人審核，由管理者代表批準。
Procedure file: quality Admin/HR department organize function department to draft the file, audit by department principal, approve by manage representative.
 
5.2.3作業(yè)文件由各部門依據本部門的實際情況及需要自行組織相關崗位人員編寫；編寫部門及業(yè)務相關部門的負責人審核；管代批準。
SOP file: Draft and organize by department, audit by department principal, approve by manage representative.
 
5.2.4記錄由上述程序文件、作業(yè)文件中提出記錄要求的部門負責編制記錄樣式。記錄樣式后附在相應的程序文件或作業(yè)文件中，對程序文件、作業(yè)文件審批的同時即對記錄的樣式進行了審批。對記錄的填寫內容的審批，依據具體情況進行。詳見《記錄控制程序》。
Record: Format drafted by department, after recorded, it should be attached in procedure file or SOP file,
 
5.3 文件的發(fā)布與發(fā)放
Issue and Handout:
 
5.3.1質量手冊、程序文件由質量行政人事部發(fā)布并發(fā)放，作業(yè)文件及記錄由文件編制部門負責發(fā)布及發(fā)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發(fā)放部門保存文件原稿及電子文件，發(fā)放到各部門的文件應為復印件。復印件首頁加蓋黑色“COPY”印以與原稿進行區(qū)別。
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文件發(fā)布部門確定文件發(fā)放的范圍及是否受控。文件的使用者接收的應為受控文件；只作為參考使用的可作為非受控文件。
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發(fā)放部門應在所發(fā)放的需受控文件的首頁蓋紅色“受控文件”印，并注明不同的發(fā)放號碼，以便于追溯。未蓋“受控文件”印的復印版文件視為非受控文件。
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文件發(fā)放時，發(fā)放部門還應將需受控文件的發(fā)放情況（發(fā)放號、版本號、發(fā)放日期、發(fā)送部門等）記入《文件發(fā)放/回收記錄》，并由文件接收部門簽字確認。
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發(fā)放部門將發(fā)放文件放于公司服務器，將文件及文件路徑以郵件形式發(fā)給相關人員，由部門經理簽收“部門文件接收記錄”，并將此表單保存于各部門指定文件夾中。
 
5.4文件的使用、保管
Usage and reservation of the file.
 
5.4.1各級文件使用部門應建立《部門文件清單》以便于管理及查閱。文件發(fā)生增加、修訂、回收、廢棄等情況時，須對《部門文件清單》及時修訂。
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亂涂、畫、改，以確保文件清晰、易于識別。
For keep the controlled file clean and identified, it is forbidden to mark, write or paint on it.
 
5.5文件的修訂
Revise of the file.
 
5.5.1文件需要更改時，由提出人/部門填寫《文件修訂/廢止申請表》，注明修訂原因及更改內容。
While modification needed, the proposer fill <File revise/abandon application form>, and state revise reason and modified contents.
 
5.5.2文件每次修訂后，文件版本號也要隨之變更：版本號中的修訂順序號加1。此外，作業(yè)指導書類文件須在被修訂處做修訂標識外，其它類文件須在文件修訂記錄中的修訂內容欄內注明修訂處的文件條款號。
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若文件經多次修訂或需進行大幅度修訂時，要進行換版：
In case of the file was revised many times or need to be revised substantially, the version should be changed.
 
1. 質量手冊、程序文件更改5次時；
Five times of quality manual, procedures files
2. 作業(yè)文件更改8次時；
Eight times of SOP;
3. 文件修訂涉及文件全部頁面時。
Substantially revise of files.
 
5.5.4修訂后的文件須按照本規(guī)程中5.2、5.3、5.4條款的要求重新進行審批、發(fā)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文件的廢止
Abolish of the file.
 
文件需要廢止時，由提出人填寫《文件修訂/廢止申請表》，注明廢止原因，經文件的審核、批準責任者審批后，由文件編寫部門實施廢止。
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、銷毀
Recycle, destroy of the file.
 
5.7.1當使用人的文件破損影響使用或丟失，可到文件發(fā)放部門辦理更換、補發(fā)手續(xù)。新文件的發(fā)放號仍沿用原號碼。破損文件由文件發(fā)放部門收回并銷毀
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當組織結構發(fā)生變化時，文件發(fā)放部門要及時回收或補發(fā)相應文件。
In case of the organization chart change, the file handout department should recycle or fulfill the file on time.
 
5.7.3 當文件發(fā)生修訂或廢止時，由文件發(fā)放部門對舊版或廢止文件實施回收并銷毀.
In case of revise of abolish, the file handout department should recycle or destroy the old or abolish file.
 
5.7.4因工作需要須保留的廢止文件，應在文件上加蓋 “作廢參考”印作為標識，并存放在特定的地點隔離保存。
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、銷毀情況須由文件發(fā)放部門記入《文件發(fā)放/回收記錄》
The handout department fill <file handout/recycle record> for the recycled or destroyed file.
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