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1 purpose
Control the documents related to the organization's quality management system and ensure that the documents used in relevant places are valid versions.
2 scope
Applicable to document control related to quality management system.
3 responsibility
3. 1 The general manager is responsible for approving the release of the quality manual.
3.2 The management representative is responsible for reviewing the quality manual.
3.3 Each department is responsible for the preparation, use and preservation of relevant documents.
3.4 The Quality Department is responsible for organizing regular review of existing system documents.
3.5 The documenter of each department is responsible for the collection, sorting and filing of documents related to the quality management system of this department.
4 program
4. 1 file classification and preservation
4. 1. 1 The quality manual (including all process control program documents) shall be filed by the quality control department.
4. 1.2 The company's secondary quality management system documents are divided into two categories:
A) Department Workbook, as the common implementation rules for each department to run the quality management system, including management standards (department management system, etc. ); Work standards (post responsibility system and work requirements, etc.). ); Technical standards (national standards, industry standards, enterprise standards and work instructions, inspection specifications, etc.). ); Department quality record documents, etc. Preserved by relevant departments and reported to the Quality Control Department for the record;
B) Other quality documents: they can be quality plans, design output documents or other standards and specifications for specific products, projects and contracts, and the composition of the documents should be suitable for their unique activities. Preserved and used by the corresponding business department.
4. 1.3 Company-level management documents, such as various administrative management systems and some foreign management documents, including policies and regulations related to the quality management system, shall be kept by the office.
4.2 Number of documents
4.2. 1 Number of quality management system documents
A) quality manual
Company name code-ZS-version, and each chapter in the manual is distinguished by chapter number.
For example: XX-ZS-0 1, which means the 1 version of the company's quality manual.
B) Quality record: the code of the main user department-the document chapter number in the quality manual-the record number.
For example: ZG-5. 6-0 1, Quality Manual 5.61Quality Record Document of Quality Management Department in Management Review Control Procedure.
C) Other quality documents of each department: department code-document serial number-year number.
For example, YX-05-2000 means Document No.5 issued by the Marketing Department in 2000.
D) The numbering of design and process documents shall be in accordance with the Regulations on the Management of Design and Process Documents.
Chapter number of document control program. 4. 1
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4.7.3 Borrowing and copying of documents
To borrow and copy documents related to the quality management system, the Document Borrowing and Copy Record shall be filled in, and the person in charge of the relevant department shall borrow and copy them from the data administrator after examination and approval according to the prescribed authority. The copied controlled documents must be registered and numbered by the data manager.
4.8 Control of External Documents
4.8. 1 The department receiving external documents shall identify their applicability and control their distribution to ensure their effectiveness.
4.8.2 The Quality Control Department is responsible for collecting the latest versions of relevant national, industrial and international standards, numbering them uniformly, stamping them with controlled seals, distributing them to relevant departments for use, and recovering the old standards.
4.8.3 Each department shall fill the above-mentioned standards and other external documents related to the quality management system into its List of Controlled Documents and report them to the Quality Management Department for the record.
4.9 In March each year, the Quality Control Department will organize regular review of the current quality management system documents, and all departments will review them in time in combination with the usual use situation, and make amendments when necessary, and implement the provisions of Article 4.5.
4. 10 controls non-paper documents with reference to the above provisions.
4. 1 1 as a quality record, implement the Quality Record Control Procedure.
4. 12 Design and process documents shall be managed in accordance with the Regulations on Management of Design and Process Documents.
5 related documents
5. 1 quality record control program.
5.2 Regulations on Management of Design and Process Documents.
6 quality records
6. 1 Records of document issuance and recovery.
6.2 File borrowing and copying records.
6.3 List of documents controlled by each department.
6.4 Document change application.
6.5 Application for document destruction.
Quality Record Control Procedure Chapter 4.2
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1 purpose
Records needed to control the quality management system.
2 scope
It is applicable to the records that prove that the products meet the requirements and the quality management system operates effectively.
3 responsibility
3. 1 The Quality Control Department is responsible for supervising and managing the quality records of all departments.
3.2 The librarians of each department are responsible for collecting, sorting out and keeping the quality records of their own departments.
3.3 The person in charge of the archives room is responsible for approving the quality record format prepared by this department.
4 program
4. 1 The librarians of each department are responsible for collecting, sorting and keeping the quality records of their own departments.
4.2 Identification number of quality records
The identification number of quality records shall be implemented according to the Document Control Procedure.
4.3 Fill in quality records
4.3. 1 Quality records shall be filled in timely, authentic, complete and clear, and shall not be altered at will; If the project cannot be filled in for some reason, it should be able to explain the reason and cross it out with a horizontal bar; The signature of the person in charge of each relevant column is not allowed to be blank.
4.3.2 If it is necessary to modify the original data due to clerical error or calculation error, the original data should be crossed out with a horizontal bar, and the modified data should be written on it, and the seal, name, date or signature of the modifier should be affixed.
4.4 Preservation and protection of quality records
4.4. 1 The librarians of each department must classify all the quality records, sort them in chronological order, and store them in a ventilated and dry place. All quality records should be kept clean and clear. All departments shall keep records within the prescribed time limit, and records kept for more than one year shall be submitted to the archives for preservation.
4.4.2 The Quality Management Department shall prepare the List of Quality Records, summarizing all records related to the operation of the company's quality management system, including name, serial number (version), shelf life, using department, etc. , submitted to the management representative for approval, and collect the original samples of records.
4.4.3 The Quality Management Department shall check the use and management of quality records of all departments every three months.
4.5 Distribution, borrowing and copying of quality records
A) Each department shall fill in the Document Distribution and Recovery Record and ask the Quality Control Department for the blank form of the required records;
B) The quality records kept by each department should be easy to retrieve. Need to borrow or copy, should be approved by the person in charge of the corresponding department, and fill in the Document Borrowing and Copy Record, which will be registered by the record administrator.
Quality Record Control Procedure Chapter 4.2
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4.6 Destruction of quality records
When the quality records exceed the storage period or need to be destroyed under other special circumstances, the director of the archives room shall fill in the application for document destruction, submit it to the Quality Control Department for review, report it to the management representative for approval, and authorize the person to destroy it.
4.7 Record format
4.7. 1 The quality record format of each department shall be compiled by the department manager, approved by the department manager, and submitted to the Quality Control Department for filing.
4.7.2 Relevant departments can propose changes to the record format design according to the work needs, and implement the provisions on document changes in the Document Control Procedure.
5 related documents
File control program.
6 quality records
6. 1 List of quality records.
6.2 Records of document distribution and recovery.
6.3 File borrowing and copying records.
6.4 Application for document destruction.