质量管理体系

 

 

本公司规定程序文件由各职能部门制订，由质量部审核，管理者代表批准后颁布实施，属于受控文件。而第三层次文件则由各相关职能部门编制审批实施后交文件管理员编号、备案。文件管理员对体系文件编制清单目录并控制和管理，具体按《文件和资料控制程序》执行。

 

 

本公司质量管理体系范围及过程的相互作用等内容，如本手册4.1.2所述。

 

 

4.2.3文件控制

 

 

本公司制订了《文件和资料控制程序》以保证质量体系文件、技术文件、外来文件等都处于受控状态。

 

 

（1）    本公司所有质量体系文件，应按规定程序经审核、批准后发布、实施。

 

 

（2）    每个型号的产品都应建立一套完整的文件资料，包括技术图纸、工艺文件、检验规范、作业指导书等；

 

 

（3）    技术文件资料按《技术文件会签责任制》的规定进行审批后发布；

 

 

（4）    本公司质量体系文件资料由质量部管理。

 

 

（5）    探头方面的技术文件和资料由换能器部文件管理人员控制和保管。

 

 

（6）    质量体系文件均编有版本号和文件号，以便识别。文件的发布、使用、更改、回收、作废等均受控，由文件管理员负责管理并编制必要的清单，确保各部门都使用有效版本的文件；

 

 

（7）    按规定的发放范围发放文件，以保证各部门获得相应的最新版本文件资料。

 

 

（8）    受控文件的更改须经原审批人审批，若原审批人不在职，则由接替人审批。文件管理员实施更改，并保存更改记录。

 

 

（9）    外来文件（产品技术、图纸资料、有关标准、医疗器械法规等）的控制按《文件和资料控制程序》的规定执行。

 

 

对作废文件应作标识，每一型号产品至少保留一份作废的受控文件，保留期15年，自产品停止生产时起算。

 

 

4.2.4记录的控制

 

 

质量记录是指本质量管理体系运行过程中产生的记录，是证明本公司质量管理体系有效运行和产品质量符合要求的证据，也是追溯产品质量问题的依据。

 

 

（1）    质量记录表式由各使用部门编制使用，交文件管理员统一编号备案；

 

 

（2）    质量记录应做到清晰完整，数据真实，采用法定计量单位，有记录人签名；应有能识别每批产品的数量的记录和产品销售数量的记录。

 

 

（3）    质量记录的管理按《质量记录控制程序》执行；

 

 

（4）    本公司质量记录保存期限为15年；对于技术开发和合同类文件，实施永久保存；

 

 

（5）    当合同有要求时，质量记录可接受顾客的查阅；

 

 

（6）    存于计算机、软盘、光盘的质量记录也应进行有效管理。

 

 

 

 

 

 

 

 

 

 

 

Quality Management System

 

 

It is prescribed that program files, which are controlled, be stipulated by functional departments, audited by Quality Office, issued and implemented after being approved by management representative. However, the level 3 documents should be codified and put on record by file librarian after being compiled, audited and implemented by functional departments. File librarian lists up the system documents, controls and manages them according to Control Procedures of Documents and Materials.

 

 

Contents such as the interaction between scope and process of Quality Management System are stated in article 4.1.2.

 

 

4.2.3 Document Control

 

 

 Control Procedures of Documents and Materials is established to ensure that quality system documents, technical documents and external files, etc. are in controlled state.

 

 

1)     All the quality system documents should be issued and implemented after being audited and approved in accordance with stipulated procedures.

 

 

2)     Each type of product should have a complete set of file and document, including technical drawing, technical paper, inspection specification and operation guidebook, etc.

 

 

3)     Technical documents should be issued after being approved according to Technical Document Countersign Responsibility System.

 

 

4)     Quality system documents are managed by Quality Office.

 

 

5)     Technical files and documents about probe are controlled and kept by file librarian of transducer department.

 

 

6)     Quality system documents have version numbers and file numbers for identification. The issuance, usage, alternation, reclamation and cancellation are all controlled. The file librarian is in charge of management and should compile necessary list to ensure that each department use valid files.

 

 

7)     Documents should be delivered in stipulated scope to ensure that each department obtains materials of the latest version.

 

 

8)     The alternation of controlled files should be audited by the original auditor. If the original auditor is not in service, his/her successor should replace him/her. File librarian makes alternation and keeps records.

 

 

9)     External documents, such as product technology, drawing and document, specification and medical device regulation, should be controlled according to Control Procedures of Documents and Materials.

 

 

Cancelled documents should be marked. At least one controlled cancelled document should be kept for one type of product. The retention period is 15 years, calculating form the time when the production stops.

 

 

4.2.4 Control of Records

 

 

Quality records are these produced in the operation process of quality management system. They are the proof of the system's effective operation and the eligibility of products, as well as the evidence of product's quality when there are problems.

 

 

1)     The type of quality records is decided by each use department, and numbered and kept by file librarian.

 

 

2)     Quality records should be clear, complete and reliable, use legal measurement unit and be signed by the recorder.

 

 

3)     Management of quality records should be in accordance with Control Procedures of Quality Records.

 

 

4)     Quality records of the company will be kept for 15 years; technical development and contracts will be kept eternally.

 

 

5)     Quality records can be consulted by customers if contracts have such stipulations.

 

 

6)     Quality records stored in computers, software and CDs should also be managed effectively.

 

 

 

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