Article 31 of the new GSP stipulates that the development of quality management system documents should be in line with the actual enterprise. Documents include quality management system, departmental and post responsibilities, operating procedures, files, reports, records and vouchers.
What is included in the quality management system documents1, Quality Management System (Quality Management System, QMS) refers to the quality of the command and control of the organization's management system;
2, quality management system documents include the following:
Promulgation of the Order of Appointment
Organizational quality and safety system agencies Diagram
Position responsibilities and authority
Position responsibilities and job requirements
Quality and safety management policy, objectives
Documentation and information control procedures
Record control procedures
Factory environment, production workshop hygiene management system
Practitioners' health management system
Training management system<
Laboratory management methods
Laboratory instrument management methods
Monitoring and measuring device management system
Production equipment management system
Measuring instruments management methods
Production line equipment maintenance management procedures
Process quality control system
Process quality control and assessment system.
Raw material warehousing management regulations
Finished product warehousing, shipping management system
Procurement management program
Procurement operations management approach
Supplier management approach
Food safety accident disposal program
Food safety risk monitoring information collection system
Food additives management system
Product protection system
Non-conformity control program
Non-conforming product control program
Non-conforming product recall management system
Marking and traceability control program
Food safety self-inspection system
Equipment cleaning and disinfection operation standard book
Abnormality handling operations
ISO9001 quality management system documents can be divided into four levels: the first level of quality manual (including quality policy and quality objectives); the second quarter: there are six program documents, the standard are described; three-level document is the production of products and process flow charts; four-level document is a number of record documents.
Quality Assurance Department and Quality Control Section need to organize the record documents.
Field quality inspection personnel and human resources need to organize the record documents.
Records to be organized by Power, Purchasing, and Production.
Records that need to be organized in the shop and warehouse.
iso9000 quality management system program document content
Quality system documents generally include: quality manual, program documents, operating instructions, product quality standards, testing specifications and standard methods, quality plans, quality records, test reports and so on. Quality system documents are generally divided into three or four levels, the laboratory can be based on their own monitoring needs and habits to be specified.
The quality system is largely manifested through the form of documentation, or called the establishment of a documented quality system, is the basis for the existence of the quality system and evidence, is to regulate the laboratory test work and the behavior of all personnel to achieve the quality objectives of the quality of the basis. Therefore, the development of quality system documentation is the laboratory legislation.
What is included in the enterprise quality management system documents2, quality management system documents include the following:
Promulgation of the Order of Appointment
Organizational quality and safety system organization chart
Job responsibilities and authority
Job duties and job requirements
Quality and safety management policy, objectives
Documents and information Control Procedures
Record Control Procedures
Factory Environment, Production Workshop Hygiene Management System
Health Management System for Employees
Training Management System
Laboratory Management Measures
Laboratory Instrument Management Measures
Monitoring and Measuring Device Management System
Production Equipment Management System
Measuring Instruments Management Measures
Production Line Equipment Maintenance Management Procedures
Process Quality Control System
Process Quality Control and Evaluation System
Raw Material Warehousing Management Regulations
Finished Goods Warehousing and Shipping Management System
Procurement Management Procedures
Purchasing Operation Management Regulations
Supplier Management Regulations
Food Safety Accident Disposal Program
Food Safety Risk Monitoring Information Collection System
Food Additives Management System
Product Protection System
Unqualified Control Program
Unqualified Products Control Program
Unqualified Products Recall Management System
Marking and Traceability Control Program
Food Safety Self-Inspection System
Equipment Cleaning and Disinfecting Work Standard
Abnormal Handling Operations
What are the Quality Management System DocumentsIn accordance with the quality management system standards, combined with the actual situation of the company, to prepare a quality manual/procedural documents/operational guidance documents and the implementation of these documents need forms. These documents need forms, etc. Procedural documents generally include: documents and information; quality records; human resources; nonconforming products; corrective and preventive measures; traceability; internal quality system audit control procedures.
Which work needs to be done to improve the quality management system of the drug business1, the enterprise to develop a quality management system documents should be in line with the actual enterprise. Documents include quality management system, departmental and post responsibilities, operating procedures, files, reports, records and vouchers.
2, the document drafting, revision, review, approval, distribution, storage, and modification, withdrawal, replacement, destruction, etc. should be carried out in accordance with the document management procedures, and keep relevant records.
3, the document should be labeled title, type, purpose and document number and version number. Text should be accurate, clear and easy to understand.
Documents should be categorized and stored for easy access.
4, the enterprise should be regularly reviewed, revised documents, the use of documents should be the current effective text, has been repealed or invalid documents in addition to the file for inspection, shall not appear on the job site.
5, the enterprise should ensure that all positions to obtain the necessary documents corresponding to their work, and work in strict accordance with the provisions.
What kinds of quality management system documents?The general structure of the quality management system:
1, quality manual
2, procedural documents
3, operating instructions
4, records and forms
Any quality management system is a pyramid structure of the above four types of documents, the records are used to show the organization in the implementation of the quality management system process.
4.1 Classification of documents 4.1.1 Management documents: a) quality manual (including the formation of the document quality policy and quality objectives); b) procedural documents; c) departmental operating instructions; d) other management documents (such as a variety of management systems, job responsibilities, management review reports, internal audit reports and related supporting documents); e) record forms. 4.1.2 Technical documents: a) Process documents; b) Applicable international, national and industry standards; c) Service specifications prepared by the Group or departments, service provision specifications, quality control specifications, technical standards, inspection specifications, quality plans, management regulations, etc. 4.1.3 External documents: a) Laws, regulations, standards and superior documents from outside the Group; b) Drawings, technical data, contracts, agreements, business transaction documents, safety or quality assurance documents provided by customers or suppliers. 4.2 Controlled and non-controlled documents 4.2.1 Documents can be divided into "controlled" and "non-controlled" categories: a) "Controlled" documents refer to documents that are under the control of the Group and can be changed. (a) "Controlled" documents are documents under the control of the group and can be changed, for the version of the change notification, in the event of a change in the document can be traced back to all users, and the implementation of changes to the document to ensure that it is currently effective; (b) "Non-controlled" documents are foreign documents, group system documents that do not need to be changed control (including documents used for bidding, customer off-site use, and other special issuance of documents), production plans, monthly quality reports, monthly quality reports, monthly quality reports, monthly quality reports and other special issuances. b) "Non-controlled" documents refer to foreign documents, group system documents that are not subject to change control (including documents used for bidding, off-site use by customers and other special issuance), production plans, monthly quality reports, seasonal operation documents and other time-sensitive documents that are automatically invalidated upon expiration. 4.2.2 Controlled documents must be stamped with a "controlled" seal, and the distribution should be registered at the time of distribution, with a distribution number. Non-controlled documents are issued after approval by the authorized personnel, and are only registered for issuance without a distribution number. When a group-controlled document is issued as a non-controlled document (e.g., for bidding, off-site use by customers), the "non-controlled" seal shall be affixed. 4.3 Form of documents Documents may be in any form or type of media, e.g. paper, hardcopy, electronic media, etc.
ISO series certification