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[ISO9001] 质量管理文件管理

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发表于 2022-10-15 23:19:39 | 显示全部楼层 |阅读模式

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本帖最后由 gaowenhua 于 2022-10-15 23:27 编辑

质量管理文件的编制和审批程序
质量管理制度、操作规程、岗位职责由质量管理部负责和操作部门共同起草和修订,各部门文件由各职能部门负责人起草和修订,所定的各项制度和文件报质量负责人审核,经企业负责人批准后执行;
为提高工作效率,减少签字时间,公司决定在每个质量管理制度、操作规程、岗位职责上的文件起草人(姓名)、起草日期、审核人(姓名)、审核日期、批准人(姓名)、批准日期在文件流转中直接录入,文件打印出来后,相应人员同时在纸质《文件审批流转记录》上手工签署姓名及日期;
为方便查阅,岗位/制度/操作规程制定文件目录索引,含文件编号、目录内容、页数、页码、实施日期、文件状态。

Preparation and approval procedure of quality management documents

The quality management system, operation procedures and job responsibilities shall be drafted and revised jointly by the quality management department and the operation department. The documents of each department shall be drafted and revised by the heads of the functional departments. The established systems and documents shall be submitted to the quality director for review, and implemented after being approved by the head of the enterprise;

In order to improve work efficiency and reduce signing time, the company decided to directly enter the drafter (name), drafting date, reviewer (name), review date, approver (name), and approval date of each quality management system, operating procedures, and job responsibilities in the document flow. After the document is printed, the corresponding personnel manually sign the name and date in the paper Document Approval Flow Record;

For the convenience of reference, the post/system/operation procedure shall prepare the document directory index, including document number, directory content, page number, page number, implementation date and document status.


 楼主| 发表于 2022-10-15 23:20:42 | 显示全部楼层
本帖最后由 gaowenhua 于 2022-10-15 23:23 编辑

编制制度时应注意:
内容应法律、法规;
文字应准确、清晰、易懂,条理性强、层次分明、结构紧密、用语规范、内容真实、完整(不空格、不漏项),不能随意涂抹,不得用铅笔填写,没有发生的项目记“无”或画“/”,各相关负责人签名处不允许空白,要签全名;如果发生错误需更改,应用“─”划去原内容,写上更改后的内容,需在更改处由更改人签名(章),签名要全名;日期填写要清晰,年月日用8位数标明,如:170401;
文件应标明题目、种类、以及文件编号和版本号;
质量管理制度应结合公司的实际情况,可操作性强;
制度编号后由打字员打印,打印出的文件清样交给拟稿人核稿;
制度打印后,登记、下发、签收;
质量管理部每季度对质量管理体系执行情况进行检查考核,做好《质量管理体系评审记录》;

Attention shall be paid to:

The content shall comply with laws and regulations;

The text shall be accurate, clear, easy to understand, well organized, well structured, standardized in terms, true and complete in content (no blank space or missing items), and shall not be smeared at will or filled in with pencils. Items that do not occur shall be marked with "none" or "/". The signature of each responsible person shall not be blank, but shall be signed in full; If an error occurs and needs to be changed, the original content should be crossed out with "-", and the changed content should be written. The person making the change should sign (seal) at the change place, and the signature should be full name; The date shall be clearly filled in, and the month, month and day shall be marked with 8 digits, such as 170401;

The document shall be marked with title, type, document number and version number;

The quality management system shall be highly operable in combination with the actual situation of the company;

The system number shall be printed by the typist, and the printed document shall be submitted to the drafter for review;

After the system is printed, it shall be registered, issued and signed;

The Quality Management Department shall inspect and assess the implementation of the quality management system quarterly, and make the Quality Management System Review Record;


 楼主| 发表于 2022-10-15 23:21:18 | 显示全部楼层
本帖最后由 gaowenhua 于 2022-10-15 23:26 编辑

质量管理体系文件的修订工作程序:
质量管理体系文件在执行过程中如需调整,或因与国家法律、法规、政策文件相冲突需修订时,由机构负责拟稿,质量负责人核稿,,原制度同时废除,修订原因及变更日期应详细记录在《文件修改审批表》中;
有效文件加盖“有效文件”;
作废文件进行“作废”标识,防止误用,并收回管理;

Procedures for revision of quality management system documents:

If the quality management system documents need to be adjusted in the implementation process, or need to be revised due to conflicts with national laws, regulations and policy documents, the agency shall be responsible for drafting, the quality director shall review the draft, and the original system shall be abolished at the same time. The reasons for revision and the date of change shall be recorded in the Document Revision Approval Form in detail;

Valid documents are stamped with "Valid Documents";

The invalid documents shall be identified as "invalid"
Obsolete documents shall be marked as "Obsolete" to prevent misuse and be taken back for management;
 楼主| 发表于 2022-10-15 23:21:57 | 显示全部楼层
本帖最后由 gaowenhua 于 2022-10-15 23:26 编辑

质量管理制度的撤销程序:
公司制定的制度,由于经营管理不断更新或与国家相关法律、法规政策相违背,已不适应或过时,须进行撤销;
6制度的撤销是在分发新文件是回收旧文件,或每年对发文进行一次清理,对不适当或过时文件填写《文件销毁登记表》,经质量管理部、质量负责人同意后进行销毁;
文件的起草、修订、审核、批准、分发、保管、以及修改、撤销、替换、销毁等应当按照文件管理操作规程进行,并保存相关记录;
文件应当分类存放,便于查阅;
每季度审核、修订文件、使用的文件应当为现行有效的文本,已废止或者失效的文件除留档备查外,不得在工作现场出现;
非本部门执行文件,需要供读时需向人事行政部登记《文件借阅登记表》,填写文件编号、文件名、借出日期、借用途、归还时间。
各岗位获得与工作内容相对应的必要文件,并严格按照规定开展工作
Cancellation procedure of quality management system:

The system formulated by the Company shall be cancelled because of the continuous updating of operation and management or the violation of relevant national laws, regulations and policies;

6 The cancellation of the system is to recycle the old documents when distributing new documents, or to clean up the issued documents once a year, fill in the Document Destruction Registration Form for inappropriate or outdated documents, and destroy them with the consent of the Quality Management Department and the person in charge of quality;

The drafting, revision, review, approval, distribution, storage, modification, cancellation, replacement and destruction of documents shall be carried out in accordance with the document management operating procedures, and relevant records shall be kept;

Documents shall be classified and stored for easy reference;

The documents reviewed, revised and used every quarter shall be the currently valid documents. The obsolete or invalid documents shall not appear on the work site except for keeping files for future reference;

If the documents not executed by the department need to be read, it is necessary to register the Document Borrowing Registration Form with the Personnel Administration Department, fill in the document number, document name, lending date, borrowing purpose and return time.

All posts shall obtain the necessary documents corresponding to the work content and carry out the work in strict accordance with the regulations


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 楼主| 发表于 2022-11-13 20:21:53 | 显示全部楼层
bilywang 发表于 2022-11-12 11:14
感谢分享,学习一下。

好好学习天天向上啊
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