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1、ISO9001：2015 全套程序文件英文版(本人辛苦原创 ) Document Name Control of Documents Procedure Page Code 1/8Version A/0 Document Code QM-COP-01 Edited/Revised Date 2018.10.24 Issued Date 2018.10.24 1.0 Purpose All the documents required by the Company s quality management system should be controlled to ensure the ver
2、sion applied by all the relevant departments is valid. 2.0 Scope It is applicable to all the documents pertaining to the quality management system including external documents. 3.0 Definition 3.1 Controlled document: The document applied in and out of the Company is controlled in modifications, iden
3、tities, versions, version numbers, formats, fonts, etc. 3.2 DCC: Document Controlling Center 3.3 External document: It refers to the document that has been handled by outside individuals like national/international standards, laws and regulations, documents provided by customers or suppliers, materi
4、al certificates, amendment advice, etc. 3.3.1 Administrative documents on quality management system or product, released from local government authorities and regulatory agencies such as the notices from Guangdong Food and Drug Administration. 3.3.2 National laws and regulations such as Product Qual
5、ity Law of the People s Republic of China, Regulation on the Supervision and Administration of Medical Devices, 93/42/EEC, etc. 3.3.3 International standards such as Medical devices Quality management systems Requirements for regulatory purposes. 3.3.4 National standards such as Medical electrical e
6、quipment Part 1: General requirements for safety. 3.3.5 Regulations and standards provided by customers such as agreements and commitments signed with customers. 3.3.6 Drawings provided by customers such as drawings, mold drawings provided by a certain customer. 3.3.7 Other important external docume
7、nts relating to the product, including official materials like customer s notice. 4.0 Duties 4.1 General Manager: Responsible for approval of the Company s quality manual. 4.2 Management Representative: Responsible for the Company s procedure files, quality plans and cross-department three-order fil
8、es and approval of external documents. 4.3 Principals of each department: Responsible for approval of three-order files and all kinds of tables as well as department-related external documents. 4.4 Department: Responsible for compilation, number and review of the documents dominated by the departmen
9、t. If this manual is printed, it is an UNCONTROLLED copy.Document Name Control of Documents Procedure Page Code 2/8Version A/0 Document Code QM-COP-01 Edited/Revised Date 2018.10.24 Issued Date 2018.10.24 4.5 Quality Management Department: Responsible for all the controlled documents of the Company
10、to ensure the electronic document is the latest version, and responsible for the updating of the controlled document list of all the departments. 5.0 Procedures 5.1 Document classification: The management system documents includes four layers and external documents 5.1.1The Quality Manual (including
11、 policies and goals) is a principle-based and master document guiding the implementation of the quality management system. As the first level document, it does not just explain the scope of application but also describe the interaction among all the procedures in the quality management system. 5.1.2
12、 The procedure document is the expansion and specification of the Quality Manual, providing the process, methods and controlling means for carrying out quality management. It belongs to the second level document. 5.1.3 Supporting documents (operation/technical specifications, process/inspection stan
13、dards, technical guidance and position description) specify the quality management goals, duties of the posts of all levels and specific operation methods. It belongs to the third level document. 5.1.4 The table is applied to record the state and result of activities, belonging to the fourth level d
14、ocument. 5.1.5 External document: It refers to the document directly obtained from outside and cited by the Company, including national/international standards, laws and regulations, documents provided by customers or suppliers, material certificates and amendment advice. 5.1.6 The document is drawn
15、 up mainly in written or electronic form, and both shall be under control. 5.2 Document compilation and approval 5.2.1 The formats of the second and third level documents are the same as that of the document. 5.2.2 The date of the document must be written in the form of “ year month day” . 5.2.3 Lim
16、its for examination and approving authority for documents S/N Order Type of document Prepared by Reviewed by Joint reviewed by Approved by Remark 1 First Management Manual Quality Management Department Management Representative Supervisor of each department Top management 2 Second Procedure document
17、 All departmentDepartment Relevant department Management If this manual is printed, it is an UNCONTROLLED copy.Document Name Control of Documents Procedure Page Code 3/8Version A/0 Document Code QM-COP-01 Edited/Revised Date 2018.10.24 Issued Date 2018.10.24 5.3 Document s number and version/version
18、 number 5.3.1 Number: The document compiler numbers the newly compiled documents according to the Basic Rules for Numbering the Controlled Documents and the document list of the department, and confirms the uniqueness of the numbers with the controlling center. 5.3.2 Version/Version number: The vers
19、ion or version number of the controlled document is compiled in s manager manager Representative 3 Third Management document All departments Department manager Relevant department manager and Management Representative Management Representative Job Description of the personnel below the manager level
20、 is reviewed by the department manager and approved by the manager of HR Department. 4 Third Process, inspection standard document and specification (including external document) All departments Quality Management Department Department manager 5 Fourth Tables All departments Quality Management Depar
21、tment Department manager Additional remarks: 1) The document can be compiled by the compilers or above the compiler level but must be approved by the personnel upper than the compiler. 2) The relevant department refers to the departments having ties with others involved in this system. 3) When the a
22、pprover of the above documents is absent, his agent or Management Representative can sign it up instead to make the document effective. If this manual is printed, it is an UNCONTROLLED copy.Document Name Control of Documents Procedure Page Code 4/8Version A/0 Document Code QM-COP-01 Edited/Revised D
23、ate 2018.10.24 Issued Date 2018.10.24 the form of 26 alphabets from A to Z. The initial version number is “ A/0” , the next revised version is “ A/1” and so on. Changing Arabic numbers is enough for minor revisions while changing alphabets, for instance, from “ A” to “ B” , is necessary in case of m
24、ajor revisions. 5.4 Document distribution and storage 5.4.1 The document compiler sends the copy of the approved document and its electronic version to the Quality Management Department where the document will be checked whether it has been approved by designated personnel. After that, the document
25、will be registered, controlled with the controlled document list updated. 5.4.2 The document controller determines the scope of distribution, makes copies of the electronic file in a required number according to the List of distributed controlled documents, add the watermarks of correspondent depart
26、ments on these copies, save them to the folder for controlled documents of each department and notify the departments for making and using the documents by email. 5.4.3 All the department are responsible for checking if the controlled document is correct or not. 5.4.4 The authority for the controlle
27、d document folder of each department shall be set as follows: Document controller is permitted to modify, delete the content or add new content to the document. Each department can only read but cannot delete, modify or add the content of controlled documents. 5.4.5 The document controller must copy
28、 the electronic document as a backup. 5.4.6 Visual management of documents As for the documents which are frequently applied at production site, all the departments should take correspondent measures such as hanging them on the wall, beside the equipment or enveloping them with plastic so to make it
29、 easy for operators to use. 5.5 Document reading 5.5.1 In case of reading the documents, the relevant personnel can open the PDF file which are saved in the Company s share disk. 5.6 Document review, modification, recovery, invalidation and destruction 5.6.1 Review The documents of the quality manag
30、ement system should be reviewed once a year by the Quality Management Department and internal review team organized by the Management Representative along with the Company s internal review and reviewed with the result put down in the internal review record. In case of special circumstances, some do
31、cuments should be reviewed by the relevant department. The review must take into account the influence of both the internal factors like the Companys organization and position changes and the external factors like laws, regulations, relevant standards and market demands upon the sufficiency and appl
32、icability of the documents with the Review Record filled in. 5.6.2 Revision/alteration The director and executor of each unit should check the effect after implementing the documents. If the documents are not applicable or in doubt in addition to the opinions on the content of the documents from oth
33、er units, the documents can be revised or modified by the department which revised or compiled If this manual is printed, it is an UNCONTROLLED copy.Document Name Control of Documents Procedure Page Code 5/8Version A/0 Document Code QM-COP-01 Edited/Revised Date 2018.10.24 Issued Date 2018.10.24 the
34、m last time after the discussion among the relevant departments. Relevant approval process is the same as that in 5.2.2. All the modifications or alterations must be underlined (“_”). In case of version change, the previous underline should be substituted by the latest one. The revision record shoul
35、d be written on the first page of the documents, containing the content of the revision, identification of the affected documents, signature of the approver, date of approval and effective time. The relevant departments shall be notified of review and confirmation of the alteration, and personnel tr
36、aining will be provided if necessary. In the following circumstances that there is any alteration to the documents of the quality management system or the documents relating to the Company s medical device products, the top management or Management Representative of the Company should be notified of
37、 deciding whether to inform the competent authority or notified bodies about it. If it is necessary, the notification should be implemented in accordance with the local laws and administrative regulations. a. Major alterations to the Quality Manual. b. Major alterations to the product s functions, p
38、erformance, safety, reliability and electromagnetic compatibility, caused by altering product standards. c. Major alterations to the product s functions, performance, safety, reliability and electromagnetic compatibility, caused by changing key components of products. d. Stipulated by laws and regul
39、ations. 5.6.3 Once the new version of controlled document is distributed, the old one becomes invalid automatically. The document controller should delete the copies of invalid controlled documents in the controlled document folder, upload the latest version and keep the original documents printed w
40、ith an “ invalid” stamp at the document controlling center till the expiry date (at least five years) before destruction. 5.6.4 As for the invalid original documents, the document controlling center should destruct them uniformly after Document/Record Destruction Registration Form filled in by the c
41、enter is approved by the Management Representative. 5.7 The non-controlled document is identified as the “ Reference” . If a Company s customer or other personnel need it for their jobs, they must have the copies of the Company s controlled documents and get its copies approved by the Management Rep
42、resentative and stamped with the Reference seal by the Quality Management Department. The Reference documents will not be withdrawn or changed to the latest version. 5.8 Temporary document It is not yet official for some reasons but needed by each department. Such document should have a Temporarily
43、Controlled stamp as well as the time limit and distribution department on them. The temporary document cannot be valid for more than 3 months. If this manual is printed, it is an UNCONTROLLED copy.Document Name Control of Documents Procedure Page Code 6/8Version A/0 Document Code QM-COP-01 Edited/Re
44、vised Date 2018.10.24 Issued Date 2018.10.24 5.9 Management of external documents 5.9.1 Each department of the Company can collect external documents through the following channels. a. National, provincial, municipal governments and their relevant functional departments. b. All kinds of meetings, pr
45、ofessional newspapers, magazines, publishers and suppliers. c. Internet, telephone and fax. 5.9.2 The external document collected by each department should be selected timely and delivered to the relevant department to recognize its contents and decide whether make it a controlled document. a. The c
46、ollected technical standards on our products should be delivered to the Technical Department to recognize its year, version and applicable articles. b. The laws, regulations and rules that are issued by the state on the quality and safety of the product should be delivered to the Quality Management
47、Department to identify the required department and scope. c. Policy documents issued by the superior should be delivered to the administration department for recognition. d. The technical documents provided by suppliers or customers should be delivered to the Technical Department and Quality Managem
48、ent Department for recognition. f. The design input documents provided by customers should be delivered by the Market Department to the R&D Department for recognition. Saved in DHF format, they don t have to be controlled by document controller. 5.9.3 Numbering of external documents As for the exter
49、nal documents on technology and standards as well as other external documents, the Quality Management Department should number them in accordance with the Basic rules on numbering controlled documents. 5.9.4 Distribution of external documents a. After being recognized, the external documents should
50、be kept on a file and put down on a list. b. The external documents should be distributed after the distribution scope is confirmed according to 5.4 of this procedure. 5.9.5 Updating of external documents As for the external documents which need updating, the new version should be distributed with t