Ensure the standardization, compatibility and effectiveness of the preparation and distribution of quality system documents.
2.0 Scope of application
It is applicable to the preparation, review, approval, release, distribution and identification of quality manuals, procedure documents and quality system operation documents. Notices, circulars and other documents are not within the scope of application of these Provisions.
3.0 responsibility
3.0 The General Manager is responsible for approving the quality manual and procedure documents.
3.0 The management representative is responsible for organizing the preparation and review of the operation documents approved by the quality manual and procedure documents.
3.3 The person in charge of each department is responsible for writing or organizing to write and review the operation documents of this department.
3.4 The Quality Department is the organization department for compiling program files and operation files, and is responsible for compiling company program files and general operation files, and auditing company general operation files.
4.0 key points of the plan
4. 1 Definition of file scope. The documents referred to in these Provisions include:
4. 1. 1 quality manual.
"Quality Manual" is the A-level document of the company's documented quality system and the general outline of the documented quality system.
4. 1.2 program file.
The program file is the B-level document of the company's documented quality system, and it is the development and support of the company's quality manual (A-level document). This paper mainly describes how to implement and control the quality system elements selected by the company.
4. 1.3 operation file.
Running file is the C-level file of the company's documented quality system, and it is the development and support refinement of program files. It mainly describes the basis, requirements, regulations and norms of how a specific activity, work and operation are carried out or implemented.
4.2 Components selected according to control needs can be described by one program file or by multiple program files.
4.3 Description form of operation documents. The description form of the job file can be one or any combination of the following forms:
4.3. 1 Documents in the form of words, charts, graphs, symbols and drawings.
4.3.2 Standard operating procedures compiled in the name of laws, regulations, rules, systems, methods, rules, outlines, plans, key points and standards.
4.4 Requirements of document contents.
4.4. 1 The quality manual shall meet the following requirements:
A) meet the requirements of IS09000 standard;
B) Meet the property management (service) requirements provided by the company;
C) in line with the actual situation of the company;
D) Comply with the provisions and requirements of relevant laws and regulations.
4.4.2 The contents of program documents shall meet the following requirements:
A) meet all requirements of IS09000 standard;
B) Covering all stages of management services provided by the company;
C) in line with the actual situation of the company;
D) Comply with the requirements of relevant laws and regulations.
4.4.3 The contents of standard operating procedures shall meet the following requirements
A) meet the provisions of the procedure documents and the relevant requirements of IS09002 standard;
B) It is operable and can be inspected and evaluated;
C) The complexity is suitable for the required skills and the training level/qualification of employees.
4.4.4 The number of derogatory standard operating procedures should meet the needs. Without standard operating procedures, the quality of management and service cannot be guaranteed. Even simple processes and operations should be described and specified in standard operating procedures.
4.5 Structure of quality system documents.
4.5. 1 Program files are described in the following order:
Purpose;
B) Scope of application;
C) responsibility;
D) procedural points;
E) record;
F) Relevant supporting documents;
G) appendix.
4.5.2 The structure of program files is arranged in the following order:
A) cover;
B) inside pages;
C) change the record.
4.5.3 The level and structure of the description of operation documents can be compiled with reference to the level of the description of procedure documents, and can also be arranged according to the form and content of document expression.
4.6 Document clause number:
4.6. The terms of the1document are represented by the combination of Arabic numerals and lowercase English letters.
4.6.2 The terminology of the document is limited to four levels, namely, article, paragraph, item and point.
4.7 Identification of documents.
4.7. 1 Documents in the quality system are identified as follows:
A) Identify the quality manual, program document or operation document given on the cover of the document;
B) Identification shall be made by file coding, which shall be implemented according to the quality system file coding management file.
4.7.2 The identification of the file version is as follows:
A) Give the version identification on the file cover, the first version is A, the second version is B, and so on;
B) Version identification given by the inside page of the document and the document label.
4.7.3 Identification of file change status:
A) Identification given in the file version column.
B) Records made in the change record page in the document.
4.8 Release of documents.
4.8. 1 The document shall be approved by the general manager and the authorized person before release.
4.8.2 The scope of document release, the conformity, completeness, applicability and standardization of the document are the contents examined and approved by the approver.
4.8.3 Before the documents are distributed, the Quality Department shall fill in the Document Distribution Approval Form to ensure that only approved documents can be distributed.
4.9 Distribution of documents.
4.9. 1 Documents shall be distributed by the Quality Department within the approved scope.
4.9.2 Before issuing documents, the controlled documents shall be numbered, and each document shall be stamped with blue seal and controlled document number. Uncontrolled documents are not numbered, only the blue seal of silk E controlled documents is stamped on the cover.
4.9.3 If the distributed documents are duplicate, the original documents shall be filed together with the Document Distribution Approval Form. The archived documents are not numbered and stamped with the seal of controlled status.
4. 10 document reissue. If it is necessary to reissue documents due to work needs or the original documents are lost or damaged, it shall be handled in accordance with the following provisions:
4. 10. 1 The Approval Form for Reissuing Documents filled in by the applicant shall be reviewed by the department head and reissued only after approved by the management representative.
4. 10.2 The relevant regulations on document issuance shall be implemented for document reissue.
4. 1 1 Records formed during document distribution and distribution shall be kept by the record implementation department for 3 years. Records formed by filing documents shall be treated as related documents. This regulation is one of the bases for performance evaluation of relevant personnel.
5.0 record
Document release approval form.
Document issuing and receiving records (1).
Records of sending and receiving documents (2).
Document reissue approval form.
6.0 Relevant supporting documents
Standard operating procedures for management of quality system documents and data.
Standard operating procedures for document coding management of quality system.