A: the enterprise should have before the certification of the material

A. Documents and records management:

1. Office to have all the documents and records of the blank form lists;

2. External documents (quality management, product quality-related standards, technical documents, information, etc.) List of foreign documents (quality management standards, technical documents, information, etc.), especially the national mandatory laws and regulations of the documents and control the issuance of records;

3. Documentation issuance records (all departments should have)

4. List of controlled documents of each department. Including: quality manual, procedure documents, supporting documents in various departments, foreign documents (national, industry, and other standards; product quality has an impact on the information, etc.);

5. List of quality records in various departments;

6. List of technical documents (drawings, process procedures, inspection procedures and issuance of records);

7. Various types of documents should be reviewed and approved and the date of the document;

8. Date;

8. A variety of quality records should be fully signed;

Two, management review:

9. management review plan;

10. management review meeting "sign-in sheet";

11. management review records (management representatives of the report, discussion statements of the participants or written materials). Records of management review (report of the management representative, discussion statements of the participants or written materials);

12. Management review report (the contents of which are described in the "Procedure Document");

13. Corrective action plans and measures after the management review; records of corrective, preventive and improvement measures.

14. Follow-up verification records.

Third, in terms of internal audit:

15. Annual internal audit plan;

16. Internal audit plan and schedule

17. Appointment letter of the head of the internal audit team;

18. Copies of the qualification certificates of the members of the internal audit;

19. Minutes of the first meeting;

20. Internal audit checklist (records);<

21. minutes of the final meeting;

22. internal audit report;

23. non-conformity report and records of corrective action verification;

24. records related to data analysis;

4. sales:

25. records of contract review;

26. customer ledger;

27. Market survey results, customer satisfaction survey results, customer complaints, grievances and feedback information, ledgers, records, and statistical analysis, whether to fulfill the quality objectives;

28. After-sales service records;

V. Procurement:

29. Qualified supplier evaluation records (including the evaluation records of outsourced substitutes); and the performance of the supply of Evaluation of the material;

30. Qualified supplier assessment of the quality of the ledger (how many materials purchased in a supplier, whether qualified), procurement quality statistical analysis, whether to complete the quality objectives;

31. Purchase ledger (including outsourcing products ledger)

32. Purchase list (should have approval procedures);

33. Contract (should be approved by the head of the department);

34. Sixth, the warehouse:

34. raw materials, semi-finished products, finished products detailed ledger;

35. tools detailed ledger;

36. gauge detailed ledger (should include the status of the gauge test, the date of the test, the date of re-inspection) and the preservation of certificates of inspection;

37. substandard gauges, tools, and the control of the scrapping procedures;

38. Procedures);

38. Gauge calibration records;

39. Raw materials, semi-finished products, finished products marking (including product marking and status marking);

40. Incoming and outgoing procedures;

seven, in terms of equipment:

41. Equipment list;

42. Maintenance records;

44. Special process equipment approval records;

45. Marking (including equipment marking and equipment in good condition marking);

VIII. Production:

46. Annual production plan; and production, service process to achieve the planning (meeting) records;

47. Completion of the production plan for the project list (ledger);

48. (ledger);

48. Non-conforming goods ledger;

49. Disposal records of non-conforming goods;

50. Semi-finished products and finished products inspection records and statistical analysis (whether the pass rate reaches the quality target);

51. Product protection, warehousing rules and regulations, labeling, safety, etc.

52. Training in each department (business and technical training, quality awareness). Training (business and technical training, quality awareness training, etc.) plans, records;

53. operating documents (drawings, process procedures, inspection procedures, operating procedures to the site);

54. key processes must have process procedures;

55. site marking (product marking, status marking, equipment marking);

56. production site There should be no unchecked gauges;

57. Each type of work record of each department should be bound into a book for easy retrieval;

9. Product Delivery:

58. Shipping Plan;

59. Shipping List;

60. Record of evaluation of the transporter (also belongs to the evaluation of the qualified supplier);

61. Records of goods received by customers;

X. Human resources:

62. Job requirements;

63. Training needs of each department;

64. Annual training plan;

65. Training records (including: training records of internal auditors, training records of quality policy and objectives, training records of quality awareness, training records of quality management system documents, training records of skills training, training records of quality management system documents, training records of quality management system documents, training records of quality management system documents, training records of skills training, training records of quality management system documents, training records of quality management system documents, training records of quality management system documents. Training records (including: internal auditor training records, quality policy and objectives training records, quality awareness training records, quality management system documents training records, skills training records, inspector induction training records, should have the appropriate assessment and evaluation results)

66. special jobs list (approved by the person in charge of the induction, and the relevant documents);

67. list of inspectors (appointed by the person in charge of the relevant, and specify the duties and responsibilities);

XI. Safety Management:

68. safety regulations (related to the country, industry and the enterprise's regulations, etc.);

69. list of fire-fighting equipment and facilities;

Note:

1. the above content must be prepared perfectly;

2. emphasize that the quality records of each department must be complete;

3. the person in charge of each department The person in charge of each department must master the quality responsibility of the department;

4. The quality policy, quality objectives and the decomposition of the objectives of each department should be mastered;

5. The post responsibility requirements of each employee should be mastered.

6. The above, according to each special person in charge / shift duties division of responsibility to prepare the material

Contents of the ISO9000 system of 8 quality management principles. Let's look at the four basic principles of zero defects

They are, in order: clear needs, good prevention, do the right thing at a time, scientific measurement.　

The above is only a condensation of the essence of zero defects, Qingyi company for the convenience of the staff to learn, the image of zero defects theory is organized into the following articles:

One center: honesty and integrity for their own customer service;

Two correct as the basis: to do the right thing, the first time to do the right thing;

Three for the importance of the whole: wholeheartedly devoted to the whole process of control, full range of standards;

Three for the importance of: wholeheartedly devoted to the whole process of control, all-round Achieve the standard;

Four-in-one: customers, shareholders, employees, supply-side coordinated development, to achieve *** win;

Five-first as a practice: first research, first analysis, first communication, first positioning, first prevention;

Six-change innovation: change the mind, change the mechanism, change the organization, change the standard, change the center of gravity, change behavior;

Seven-step deepening: programming, training, Nurturing, regulation, optimization, curing, improvement;

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What is quality management system certification?

Baidu Knowledge > Business/Financial Management > Business Management

Definition of Quality Management System

Any organization needs management. When management is related to quality, it is quality management. Quality management is the coordinated activity of directing and controlling an organization in terms of quality, which usually includes the development of quality policy, objectives and activities such as quality planning, quality control, quality assurance and quality improvement. Realize the policy objectives of quality management, effectively carry out the quality management activities, must establish a corresponding management system, this system is called quality management system.

Refers to the establishment of the enterprise, in order to ensure product quality or quality objectives necessary, systematic quality activities. It is based on the characteristics of the enterprise to choose a number of system elements to be combined to strengthen the quality management activities from the design and development, production, inspection, sales, use of the whole process, and institutionalized, standardized, and become the internal quality of the requirements of the work of the enterprise and the activities of the program.

In modern enterprise management, ISO9001:2000 quality management system is the quality management system commonly used by enterprises.

I SO9001:2000 standard is ISO (International Organization for Standardization) TC176 developed a series of quality management standards.

Connotation of quality management system

Quality management system should have compliance

To effectively carry out quality management, must design, establish, implement and maintain quality management system. The organization's top management of the ISO9001 international standard design, establishment, implementation and maintenance of quality management system decision-making is responsible for the establishment of a reasonable organizational structure and the provision of appropriate resources is responsible for; management representatives and quality functions of the formation of the Confederation of the development and implementation of the order of urging the establishment and operation of the process is directly responsible for.

Quality management system should have uniqueness

Quality management system design and establishment, should be combined with the organization's quality objectives, product categories, process characteristics and practical experience. Therefore, different organizations have different characteristics of quality management system.

Quality management system should be systematic

Quality management system is a combination of interrelated and role, including: ① Organizational structure - reasonable organizational structure and clear responsibilities, authority and its coordination of the relationship; ② Procedures - the documented procedures in place; ② Procedures - the documented procedures in place; ③ Procedures - the documented procedures in place; ④ Procedures - the documented procedures in place. -provided in place to form the documented procedures and operating instructions, is the process of operation and the basis for carrying out activities; ③ process - the effective implementation of the quality management system, is through the effective operation of its required processes; ④ resources - necessary, adequate and appropriate resources. -Necessary, adequate and appropriate resources include personnel, funds, facilities. Equipment, materials, energy, technology and methods.

Quality management system should be fully effective

The operation of the quality management system should be fully effective in meeting the requirements of the organization's internal quality management, as well as the requirements of the organization's contract with its customers, and the requirements of second-party accreditation, third-party certification and registration.

The quality management system should be preventive

The quality management system should be able to use appropriate preventive measures and have a certain ability to prevent the occurrence of important quality problems.

The quality management system should be dynamic

The top management regularly approves internal quality management system audits and conducts regular management reviews to improve the quality management system; it should also support the quality function (including workshops) to improve the process by adopting corrective and preventive measures, so as to improve the system.

Quality management system should be continuously controlled

Quality management system required process and its activities should be continuously controlled.

The quality management system should be optimized

The organization should consider the benefits, costs, and risks, and optimize the quality management system through its continuous and effective operation.

Characteristics of a quality management system

(a) It represents a modern view of how a business or government organization thinks about how to make real use of quality and how to make optimal quality decisions.

(ii) It is the basis for in-depth quality documentation.

(iii) The quality system is the basis for enabling the wider quality activities within a company to be managed effectively.

(d) The quality system is the basis for the planned and systematic improvement of the major quality activities throughout the company in order of importance.

Management is necessary in any organization. When management is related to quality, it is quality management. Quality management is the coordinated activity of directing and controlling an organization with respect to quality, and usually includes the development of quality policies and objectives, as well as activities such as quality planning, quality control, quality assurance and quality improvement. To realize the policy and objectives of quality management and effectively carry out various quality management activities, it is necessary to establish a corresponding management system, which is called quality management system. It can effectively achieve quality improvement. ISO 9000 is the international common quality management system.

Implementation of quality management systems

Procurement standards

You need a copy of the standards before you are ready to implement them. You need to read and understand it.

Refer to relevant literature and software

There are many publications on quality, and software tools to help you understand, implement, and register a quality management system.

Build a team to develop a strategy

You organize and plan the full implementation of the system by developing a strategy with top management. The responsibility for the QMS rests with senior management, so you need to involve senior managers when you begin to implement the system.

Consider training

Whether the quality manager or the senior manager is responsible for implementing the system, there is a need to raise awareness of ISO 9001:2000 in general. Group activities, seminars and training sessions can help.

Choosing a consultant

You can get advice from consultants who are neutral on how best to implement a QMS. They have a lot of experience in implementing QMS and make sure that you go through it with less hassle.

Choosing a certification company

A certification company is a third party organization such as BSI that can visit and effectively audit your company's QMS and if it meets the standards, BSI will issue a certificate. Choosing a certification company can be a complex process for a variety of market reasons. Factors to consider include: plant experience, geographic scope, price and service level. The key is to find the certification body that best suits your needs. With BSI you may stand a little taller.

Writing a quality manual

The quality manual is the high-level document that lays out the key points of your approach to quality management.WHAT, WHAY and HOW to implement a quality management system in your business.

Create Supporting Documents

Create procedure documents to support the quality manual. Clear and concise, listing the key points that are required to accomplish a job.

Implementing Your Quality Management System

The key to implementation is communication and training. During the implementation phase, all those who carry out the program are required to collect records have demonstrated that; what is required is done and what is done is in compliance.

Pre-Audit Services

Pre-audit services are usually performed 6 weeks after the system has been implemented. The purpose is to find out which areas are not meeting the standards. This will allow you to consider directions for improvement before the initial audit.

Getting certified

You schedule an initial audit with your certification body. At this stage the certification body will review your quality management system and recommend whether to issue a certificate.

Follow-up audits

Once you are certified and have your certificate, you can advertise to the public that your business has been successfully certified. In order to ensure the qualification of certification you need to continue to implement all quality systems. The certification body regularly on the implementation of standards to be checked.

Steps to establish a quality management system

To establish and improve the quality system should generally go through the quality system planning and design, the preparation of quality system documentation, quality system trial run, quality system audit and review of the four stages, each stage can be divided into a number of specific steps.

Quality system planning and design

The stage is mainly to do a variety of preparatory work, including education and training, unity of understanding, organization and implementation, the development of plans; determine the quality policy, the development of quality objectives; current situation surveys and analyses; adjusting the organizational structure, equipped with resources and other aspects.

One, education and training, unity of understanding

The process of establishing and improving the quality system is the beginning of education, the process of education, but also to raise awareness and unity of understanding of the process, education and training should be divided into levels, step by step.

The first level for the decision-making level, including the party, political, technical (technical) leaders. The main training:

1. By introducing the development of quality management and quality assurance and the unit's experience and lessons learned, explaining the urgency and importance of the establishment and improvement of the quality system;

2. Through the general introduction of the ISO9000 family of standards, to improve the understanding of the establishment of the quality system in accordance with national (international) standards.

3. Through the quality system elements to explain (focus should be explained "management responsibilities" and other elements of the overall), clear decision-making leadership in the construction of the quality system of the key position and leading role.

The second level of management, focusing on management, technology and production department heads, as well as staff related to the establishment of quality systems.

These two levels of personnel is to build and improve the quality system of the backbone of the force, plays the role of the top and the bottom, to enable them to fully accept the ISO9000 family of standards related to the content of the training in the methodology can be taken to explain the combination of seminars. The third level for the implementation of the layer, that is, with the formation of product quality of the whole process related to the operating personnel. This level of personnel training and the quality of the main activities related to the post content, including quality activities should be undertaken in the task, the completion of the task should be given the authority, as well as the quality of the faults caused by the responsibility should be borne.

Two, the organization to implement, draw up plans

Although the quality system involves all departments of an organization and all workers, but for most units, the establishment of a competent work team may be required, according to the practice of some units, this team can also be divided into three levels.

The first level: the establishment of the highest managers (plant manager, general manager, etc.) as the leader, quality leaders in charge of the construction of the quality of the Department of the leading group (or committee) for the vice-chairman. Its main tasks include:

1. overall planning for the construction of the system;

2. the development of quality policy and objectives;

3. the decomposition of quality functions by functional departments.

The second level, the establishment of the functional departments by the leadership (or representatives) to participate in the work team. This working group is generally led by the quality department and planning department leaders *** with the lead, its main task is to build the system in accordance with the overall plan for the specific organization and implementation.

Third level: the establishment of elements of the working group. According to the division of labor of each functional department to clarify the quality system elements of the responsibility of the unit, for example, "design control" should be generally responsible for the design department, "procurement" elements of the material procurement department is responsible for. After the implementation of the organization and responsibility, according to the different levels of work plan, in the development of the work plan should pay attention to:

1. The goal should be clear. What tasks to be accomplished, what are the main problems to be solved, and what purpose to be achieved?

2. To control the process. Establishment of the main stages of the quality system to provide a timetable for the completion of the task, the main person in charge and the participants, as well as their division of responsibilities and collaborative relationships.

3. To focus. The focus is mainly on the system's weak links and the key few. This minority may be a certain element or a few elements, may also be some of the activities in the elements.

Three, to determine the quality policy, the development of quality objectives

Quality policy reflects an organization's pursuit of quality, commitment to customers, is the quality of staff behavior guidelines and quality of the direction of the work. The requirements for the development of quality policy are:

1. Coordinate with the general policy;

2. Should contain quality objectives;

3. Combined with the characteristics of the organization;

4. Ensure that all levels of personnel can understand and adhere to the implementation.

Four, the current situation survey and analysis

The purpose of the current situation survey and analysis is to rationally select the elements of the system, including:

1. system situation analysis. That is, the analysis of the organization's quality system, in order to select the requirements of the quality system elements according to the quality system in the situation.

2. Product characteristics analysis. That is, to analyze the degree of technology-intensive products, the use of objects, product safety features, in order to determine the degree of adoption of elements.

3. Organizational structure analysis. Whether the organization's management structure to adapt to the needs of the quality system. Should be established with the quality system to adapt to the organizational structure and establish the affiliation between the institutions, contact methods.

4. Production equipment and testing equipment to adapt to the quality system requirements.

5. Technical, managerial and operational personnel composition, structure and level of analysis.

6. Analysis of the management infrastructure. That is, the analysis of standardization, measurement, quality accountability, quality education and quality information.

The above content can be taken with the standard quality system elements required for comparative analysis.

Fifth, adjust the organizational structure, equipped with resources

Because in an organization in addition to quality management, there are a variety of other management. Organizational setup due to the historical evolution of the majority is not the formation of the quality of the objective law to set up the corresponding functional departments, so in the completion of the implementation of the quality system elements and the development of quality activities into the corresponding after the activities of the corresponding duties and responsibilities of the work and authority assigned to the various functional departments. On the one hand, the objective development of quality activities, on the one hand, the existing artificial functional departments, the relationship between the two dealt with, in general, a quality function can be responsible for or involved in a number of quality activities, but do not let a quality activity by a number of functional departments to be responsible for. At present, China's enterprises existing functional departments of quality management activities undertaken by the responsibility, the role played by the general lack of ideal in general should be strengthened. In the activities carried out in the process, must involve the corresponding hardware, software and staffing, according to the need should be appropriate deployment and enrichment.

Quality system document preparation

Quality system document preparation content and requirements, from the perspective of the construction of the quality system, should emphasize a few issues:

1. System documents should be generally in the first phase of work is completed before the formal development, and can be cross-cutting when necessary. If the preliminary work is not done, the direct preparation of the system documents are prone to produce systematic and holistic, as well as detached from the actual drawbacks.

2. In addition to the quality of the manual needs to be unified organization, the other system documents should be divided by the functional departments under the responsibility of the development of the first draft, and then the organization of the audit, which is conducive to the future implementation of the document.

3. The preparation of quality system documents should be combined with the quality of the unit's functional allocation. According to the selected quality system requirements, one by one to develop for the quality of activities (including direct quality activities and indirect quality activities), the quality of the functional allocation of the implementation of the functional departments. Quality activity items and allocation can be expressed in the form of a matrix, quality function matrix can also be attached as an annex to the quality manual.

4. In order to make the preparation of quality system documents to achieve coordination and unity, before the preparation of the "quality system should be formulated before the document list", the existing quality manual (if prepared), enterprise standards, rules and regulations, management practices and record forms are collected together, and the quality of the system elements to compare, in order to determine the new, additions or revisions. Determine the new, addendum or revision of the quality system document project.

5. In order to improve the efficiency of the preparation of quality system documents, reduce rework, in the process of document preparation to strengthen the coordination between the levels of documents, documents and documents. Nevertheless, a set of good quality quality system documentation should also go through a number of top-down and bottom-up iterations.

6. The key to the preparation of quality system documents is to seek practical results, not to go through the form. Both in general and in principle to meet the ISO9000 family of standards, but also in the methodology and specific practices in line with the actual unit.

Trial run of the quality system

Quality system documentation is completed, the quality system will enter the trial run stage. Its purpose is to test the effectiveness and coordination of the quality system documents through trial operation, and the problems exposed, to take improvement measures and corrective measures to achieve further improvement of the quality system documents. In the quality system trial run process, to focus on the following work:

1. Targeted publicity of the quality system documents. So that all workers realize that the new or improved quality system is the change of the past quality system, is to international standards, to adapt to this change must be carefully studied, the implementation of the quality system documents.

2. Practice is the only standard for testing the truth. System documents through the trial run will inevitably appear some of the problems, all the workers will be from the practice of the problems and improvement of the views faithfully reflected to the relevant departments, in order to take corrective measures.

3. The system will be exposed in the trial run of the problem, such as the system is not well-designed, incomplete project coordination, improvement.

4. Strengthen information management, not only is the system trial run itself, but also to ensure the success of the trial run of the key. All personnel related to quality activities should be in accordance with the requirements of the system documents, do a good job in the collection of quality information, analysis, transmission, feedback, processing and archiving work.

Quality system audit and review

Quality system audit is often more important in the initial stage of the establishment of the system. In this stage, the focus of the quality system audit, mainly to verify and confirm the applicability and effectiveness of the system documents.

1. Audit and review of the main content generally include:

(1) the provisions of the quality policy and quality objectives are feasible;

(2) the system documents cover all the main quality activities, the interface between the various documents is clear;

(3) organizational structure to meet the need for the operation of the quality system, the quality of the various departments and posts Whether the responsibilities are clear;

(4) Whether the selection of quality system elements is reasonable;

(5) Whether the required quality records can play a witness role

(6) Whether all the workers have developed the habit of operating or working according to the system documents, and how is the implementation.

2. This stage of the system audit is characterized by:

(1) the system audit of the normal operation of the system, focusing on compliance, in the trial run stage, usually a combination of compliance and applicability;

(2) in order to make the problem as far as possible in the trial run stage exposed, in addition to organizing the audit team to carry out a formal audit, there should be a large number of employees to participate, and encourage them to practice through the trial run. Encourage them to find and raise problems through the practice of trial run;

(3) at the end of each stage of trial run, generally should be formally arranged for an audit in order to correct the problems found in a timely manner, for some major issues can also be based on the need to organize audits at the right time;

(4) in the trial run to all elements of the audit to be covered once;

(5) ) give full consideration to the role of product assurance;

(6) on the basis of internal audits, the top management to organize a system review.

It should be emphasized that the quality system is in continuous improvement in order to improve, the quality system into normal operation, we still need to take the internal audit, management review and other means to enable the quality system can be maintained and continuously improved.