Apply for quality management system certification

How to prepare the contents of the iso9001 internal audit checklist:

Answer: Materials that an enterprise should have before certification

1. Management of documents and records:

1. The office must have a list of all documents and blank forms for records;

2. A list of external documents (quality management, standards related to product quality, technical documents, information, etc.), especially national Mandatory legal and regulatory documents and records of controlled distribution;

3. Document distribution records (all departments must have them)

4. List of controlled documents for each department. Includes: quality manual, procedure documents, supporting documents of each department, external documents (national, industry, and other standards; information that affects product quality, etc.);

5. Quality record list of each department;

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

7. All types of documents must be reviewed, approved and dated;

8. All quality records must be fully signed;

2. Management review:

9. Management review plan;

10. Management review "Sign-in sheet" for the meeting;

11. Management review records (reports from management representatives, discussion speeches by participants or written materials);

12. Management review reports ( Please see the "Procedure Documents" for the content);

13. Rectification plans and measures after management review; records of corrective, preventive and improvement measures.

14. Track verification records.

3. Internal audit:

15. Annual internal audit plan;

16. Internal audit plan and schedule

17 . Appointment letter of the internal audit team leader;

18. Copy of internal audit member qualification certificate;

19. Minutes of the first meeting;

20. Internal audit Checklist (record);

21. Minutes of the final meeting;

22. Internal audit report;

23. Non-conformity report and corrective action verification record;

24. Relevant records of data analysis;

4. Sales:

25. Contract review records;

26. Customers Ledger;

27. Market survey results, customer satisfaction survey results, customer complaints, complaints and feedback information, ledger, records, and statistical analysis, whether the quality objectives are achieved;

28. After-sales service records;

V. Procurement:

29. Qualified supplier assessment records (including assessment records of outsourced agents); and evaluation of supplies Materials for performance evaluation;

30. Qualified supplier evaluation quality ledger (how many materials purchased from a certain supplier and whether they are qualified), statistical analysis of procurement quality, and whether quality objectives have been achieved;

31. Procurement ledger (including outsourcing product ledger)

32. Procurement list (should have approval procedures);

33. Contract (should be approved by the department responsible for person's approval);

6. Warehouse:

34. Detailed ledger of raw materials, semi-finished products and finished products;

35. Detailed ledger of tools;< /p>

36. Detailed ledger of measuring tools (should include measuring tool calibration status, calibration date, re-inspection date) and storage of calibration certificates;

37. Control of unqualified measuring tools and tools ( Scrap procedures);

38. Measuring tool calibration records;

39. Identification of raw materials, semi-finished products, and finished products (including product identification and status identification);

40. Incoming and outgoing procedures;

7. Equipment:

41. Equipment list;

42. Maintenance plan;

43 . Equipment maintenance records;

44. Special process equipment approval records;

45. Identification (including equipment identification and equipment intact status identification);

8 , Production:

46. Annual production plan; and planning (meeting) records for the realization of production and service processes;

47. List of projects to complete the production plan (ledger);

48. Non-conforming product ledger;

49. Disposal records of non-conforming products;

50. Inspection records and statistical analysis of semi-finished products and finished products ( Whether the pass rate reaches the quality target);

51. Product protection, warehousing rules and regulations, identification, safety, etc.;

52. Training of various departments (business technical training , quality awareness training, etc.) plans and records;

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

54. Key processes must have Process procedures;

55. On-site identification (product identification, status identification, equipment identification);

56. Uncertified measuring tools cannot appear on the production site;

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

9. Product delivery:

58. Delivery plan;

59. Shipping list;

60. Evaluation record of the transporter (also included in the evaluation of qualified suppliers);

61. Record of the customer receiving the goods;

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10. Human Resources:

62. Position requirements;

63. Training needs of each department;

64. Annual training plan ;

65. Training records (including: internal auditor training records, quality

Policy and target training records, quality awareness training records, quality management system document training records, skills training records, and inspector on-the-job training records should all have corresponding assessment and evaluation results)

66. List of special types of work ( Approved by the relevant person in charge, and relevant certificates);

67. List of inspectors (appointed by the relevant person in charge, with responsibilities and authorities specified);

11. Safety Management:

68. Various safety rules and regulations (relevant national, industry and enterprise regulations, etc.);

69. List of fire-fighting equipment and facilities;

Instructions:

1. The above content must be well prepared;

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

3. Each department The person in charge must master the quality responsibilities of the department;

4. The quality policy, quality objectives and decomposition goals of each department must be mastered;

5. Job responsibilities require every employee to To master.

6. For the above content, prepare materials according to the division of responsibilities of each special person in charge/team

Contents: 8 quality management principles of the ISO9000 system. Let us look at the four basic principles of zero defects again

They are: clarify needs, take precautions, do it right the first time, and measure scientifically.

The above is just a summary of the essence of zero defects. In order to facilitate employees' learning, Qingyi Company vividly organizes the zero-defect theory into the following items:

One center: taking integrity as oneself customer service;

Two righteousnesses are the basis: do the right thing, do it right the first time;

Three perfections are the most important: devote yourself wholeheartedly, and control the whole process. Comply with standards in all aspects;

Four-in-one: coordinated development of customers, shareholders, employees, and suppliers to achieve a win-win situation;

Five first practices: research first, analysis first, Communicate first, position first, and prevent first;

Six changes of innovation: change the mind, change the mechanism, change the organization, change the standards, change the focus, and change the behavior;

Seven steps of deepening: programming , training, development, regulation, optimization, solidification, improvement;

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What is quality management system certification?

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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 organizations in terms of quality, and usually includes the formulation of quality policies, goals, and activities such as quality planning, quality control, quality assurance, and quality improvement. To achieve the policy objectives of quality management and effectively carry out various quality management activities, a corresponding management system must be established, which is called a quality management system.

Refers to the systematic quality activities established within the enterprise and necessary to ensure product quality or quality objectives. It selects and combines several system elements according to the characteristics of the enterprise to strengthen the quality management activities throughout the entire process from design and development, production, inspection, sales, and use, and institutionalizes and standardizes them, becoming the requirements and activity procedures of the enterprise's internal quality workers.

In modern enterprise management, ISO9001:2000 quality management system is a quality management system commonly adopted by enterprises.

I SO9001:2000 standard is formulated by ISO (International Organization for Standardization) TC176 One of the series of quality management standards.

The connotation of quality management system

The quality management system should be consistent

To effectively carry out quality management, it must be designed, Establish, implement and maintain a quality management system. The top management of the organization is responsible for the decision-making of designing, establishing, implementing and maintaining the quality management system in accordance with ISO9001 international standards, and is responsible for establishing a reasonable organizational structure and providing appropriate resources; management representatives and quality functional departments are responsible for the promotion of the formation of the document. Directly responsible for the formulation and implementation of procedures, and the establishment and operation of processes.

The quality management system should be unique

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

The quality management system should be systematic

The quality management system is a combination of interrelations and functions, including: ① Organizational structure - a reasonable organizational structure and clear responsibilities and authorities and its coordinated relationship; ② Procedures - documented procedures and work instructions that are in place, are the basis for process operation and activities; ③ Process - the effective implementation of the quality management system is through the required processes Achieved by effective operation; ④ Resources - necessary, sufficient and appropriate resources including personnel, funds and facilities. Equipment, materials, energy, technology and methods.

The quality management system should be fully effective

The operation of the quality management system should be comprehensive and effective, which can not only meet the requirements of the organization's internal quality management, but also meet the needs of the organization and customers. Contract requirements can also be met with requirements for second-party identification, third-party certification and registration.

The quality management system should be preventive

The quality management system should be able to adopt appropriate preventive measures and have a certain ability to prevent important quality problems from occurring.

The quality management system should be dynamic

Top management regularly approves internal quality management system audits and conducts regular management reviews to improve the quality management system; it also supports the quality function department (Including workshops) Use corrective and preventive measures to improve the process to improve the system.

The quality management system should be continuously controlled

The processes and activities required by the quality management system should be continuously controlled.

The quality management system should be optimized

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

Characteristics of quality management system

(1) It represents a view of modern enterprises or government agencies thinking about how to truly play the role of quality and how to optimally make quality decisions.

(2) It is the basis for in-depth and detailed quality documentation.

(3) The quality system is the basis for the effective management of a wider range of quality activities within the company.

(4) The quality system is the basis for improving the main quality activities of the entire company in order of importance in a planned and step-by-step manner.

Any organization needs management. When management is related to quality, it is quality management. Quality management is the coordinated activity of directing and controlling organizations in terms of quality, and usually includes the formulation of quality policies, goals, and activities such as quality planning, quality control, quality assurance, and quality improvement. To achieve the policy objectives of quality management and effectively carry out various quality management activities, a corresponding management system must be established, which is called a quality management system. It can effectively achieve quality improvement. ISO 9000 is an internationally accepted quality management system.

Implementation of quality management system

Procurement standards

You need a standard before you prepare to implement it. You need to understand and read through.

Refer to relevant literature and software

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

Build a team to formulate strategies

You formulate strategies with top management and organize and plan the comprehensive implementation of the system. The responsibility for the quality management system lies with senior management, so senior managers need to be involved when starting to implement the system.

Consider training

Whether it is the quality manager or senior manager responsible for implementing the system, they need to improve ISO 9001:2000 and overall awareness. Group activities, workshops and training sessions can help.

Choose a consultant

You can get neutral consultants to advise you on how to better implement your quality management system. They have extensive experience implementing QMS and ensure you avoid detours.

Choose a certification company

The certification company is a third-party organization, such as BSI. Your company's quality management system can be visited and effectively audited, and if the standards are met, BSI will issue a certificate. Choosing a certification company can be a complicated process due to various market reasons. Factors considered include: factory experience, geographical scope, price and service level. The key is to find the certification body that best suits your needs. You may stand higher when looking for BSI.

Write a quality manual

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

Create supporting documentation

Create procedure documentation to support the quality manual. Be clear and concise, listing the key points to complete a task, WHO, WHAT and HOW.

Implementing your quality management system

The key to implementation is communication and training. During the implementation phase, all those executing the procedures must collect records to prove that they have done what is specified and are in compliance with the regulations.

Pre-audit service

The pre-audit service is usually carried out 6 weeks after the implementation of the system. The aim is to find out which areas fail to meet standards. This will allow you to consider areas for improvement before the initial review.

Getting certified

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

Follow-up Audit

Once you are certified and have received your certificate, you can publicize that your business has successfully achieved certification. To maintain certification you need to continue to implement all quality systems. Certification agencies must regularly inspect the implementation of standards.

Steps in establishing a quality management system

Establishing and improving a quality system generally requires the planning and design of the quality system, the preparation of quality system documents, the trial operation of the quality system, and the audit of the quality system. and review, each stage can be divided into a number of specific steps.

Planning and design of quality system

This stage is mainly to make various preparations, including education and training, unified understanding, organization and implementation, formulation of plans; determination of quality policy, formulation of quality Objectives; investigation and analysis of current situation; adjustment of organizational structure, allocation of resources, etc.

1. Education and training, unified understanding

The process of establishing and improving the quality system starts and ends with education. It is also a process of raising awareness and unifying understanding. Education and training It should be carried out in different levels and step by step.

The first level is the decision-making level, including party, government, and technical (technical) leadership. Main training:

1. By introducing the development of quality management and quality assurance and the experience and lessons of the unit, it explains the urgency and importance of establishing and improving the quality system;

2. Through an overall introduction to the ISO9000 family of standards, we will improve our understanding of establishing a quality system based on national (international) standards.

3. Through the explanation of quality system elements (the focus should be on overall elements such as "management responsibilities"), the key position and leading role of decision-making leaders in the construction of the quality system is clarified.

The second level is management, focusing on the heads of management, technology and production departments, as well as staff related to establishing the quality system.

These two levels of personnel are the backbone of the construction and improvement of the quality system, and play a connecting role. To enable them to fully receive training on the relevant contents of the ISO9000 family standards, the method can be combined with explanations and seminars. . The third level is the execution level, which is the staff involved in the entire process of product quality formation. Personnel at this level are mainly trained on content related to the quality activities of their positions, including the tasks they should undertake in quality activities, the authority they should be given to complete tasks, and the responsibilities they should bear if they cause quality errors.

2. Organize implementation and formulate plans

Although the quality system construction involves all departments and all employees of an organization, for most units, it is possible to establish a capable work team. It is necessary. According to the practices of some units, this team can also be divided into three levels.

First level: Establish a quality department construction leading group (or committee) with the top manager (factory director, general manager, etc.) as the team leader and the quality leader as the deputy team leader. Its main tasks include:

1. Overall plan for system construction;

2. Develop quality policies and goals;

3. Decompose quality functions by functional departments.

At the second level, a working team consisting of leaders (or representatives) from each functional department is established. This working team is generally led by the leaders of the quality department and planning department, and its main task is to organize and implement the overall plan of the system construction.

The third level: Establish an element working group. Clarify the responsible units for quality system elements based on the division of labor between functional departments. For example, "design control" should generally be the responsibility of the design department, and the "purchasing" element should be the responsibility of the material procurement department. After the organization and responsibilities are implemented, work plans will be formulated according to different levels. When formulating the work plan, attention should be paid to:

1. Goals should be clear. What tasks are to be accomplished, what are the main problems to be solved, and what goals are to be achieved?

2. To control the process. The main stage of establishing a quality system is to specify the timetable for completing tasks, the main responsible persons and participating personnel, as well as their division of responsibilities and mutual cooperation.

3. To highlight the key points. The focus is mainly on the weak links and the critical few in the system. These few may be one or several elements, or they may be some activities within the elements.

3. Determine the quality policy and formulate quality goals

The quality policy reflects an organization’s pursuit of quality and its commitment to customers. It is the criterion for employee quality behavior and the direction of quality work. . The requirements for formulating a quality policy are:

1. Coordinate with the general policy;

2. Quality objectives should be included;

3. Combined with the characteristics of the organization;

4. Ensure that people at all levels understand and adhere to them.

IV. Current Situation Investigation and Analysis

The purpose of current situation investigation and analysis is to reasonably select system elements, including:

1. System situation analysis. That is to analyze the quality system situation of the organization in order to select the requirements of quality system elements according to the quality system situation.

2. Product feature analysis. That is, analyzing the technology intensity of the product, the objects of use, product safety features, etc., to determine the degree of adoption of the elements.

3. Organizational structure analysis. Whether the organization's management structure meets the needs of the quality system. An organizational structure that is compatible with the quality system should be established and affiliations and contact methods between agencies should be established.

4. Whether the production equipment and testing equipment can meet the relevant requirements of the quality system.

5. Analysis of the composition, structure and level of technical, management and operating personnel.

6. Analysis of basic management work. That is, the analysis of standardization, metrology, quality accountability, quality education and quality information.

The above content can be compared with the quality system element requirements specified in the standard for comparative analysis.

5. Adjust the organizational structure and allocate resources

Because in addition to quality management, there are other types of management in an organization. Since most of the historical evolution of organizational structure does not set up corresponding functional departments according to the objective laws of quality, after completing the implementation of quality system elements and unfolding them into corresponding quality activities, the corresponding work responsibilities and authorities in the activities must be assigned to Various functional departments. On the one hand, it is the objectively carried out quality activities, on the other hand, it is the artificial existing functional departments. The relationship between the two is dealt with. Generally speaking, a quality functional department can be responsible for or participate in multiple quality activities, but do not let one Quality activities are handled by multiple functional departments. At present, the responsibilities and roles played by the existing functional departments of our country's enterprises in quality management activities are generally not ideal and should generally be strengthened. In the process of carrying out activities, corresponding hardware, software and personnel must be involved, and appropriate deployment and enrichment should be carried out as needed.

Preparation of quality system documents

The content and requirements for the preparation of quality system documents, from the perspective of quality system construction, should emphasize several issues:

1 ． System documents should generally be formally formulated after the first phase of work is completed, and can also be carried out cross-cutting if necessary. If the preliminary work is not done, direct preparation of system documents will easily lead to shortcomings such as lack of systematicness, lack of integrity, and being divorced from reality.

2. In addition to the quality manual that needs to be formulated by a unified organization, other system documents should be formulated separately by the responsible functional departments according to the division of labor. The draft should be proposed first and then organized for review. This will facilitate the implementation of future documents.

3. The preparation of quality system documents should be carried out in conjunction with the distribution of quality functions of the unit. According to the requirements of the selected quality system, various quality activities (including direct quality activities and indirect quality activities) are developed one by one, and the quality functions are assigned to various functional departments. Quality activity items and distribution can be expressed in the form of a matrix diagram, and the quality function matrix diagram can also be attached as an attachment to the quality manual.

4. In order to coordinate and unify the quality system documents compiled, a "quality system document detailed list" should be formulated before compilation, and the current quality manual (if it has been compiled), corporate standards, rules and regulations, management methods and record forms should be prepared. Collect together and compare with quality system elements to determine new, addendum or revision quality system document items.

5. In order to improve the efficiency of quality system document preparation and reduce rework, it is necessary to strengthen the coordination between document levels and between documents during the document preparation process. Despite this, a good set of quality system documents must go through many iterations from top to bottom and bottom to top.

6. The key to preparing quality system documents is to emphasize practical results and not follow formalities. It must not only meet the ISO9000 family standards in general and in principle, but also conform to the actual situation of the unit in terms of methods and specific practices.

Trial operation of the quality system

After the preparation of quality system documents is completed, the quality system will enter the trial operation stage. The purpose is to test the effectiveness and coordination of quality system documents through trial operation, and to take improvement and corrective measures for exposed problems to further improve the quality system documents. During the trial operation of the quality system, we must focus on the following tasks:

1. Promote and implement quality system documents in a targeted manner. Make all employees realize that the newly established or improved quality system is a change from the past quality system and is intended to be in line with international standards. To adapt to this change, quality system documents must be carefully studied and implemented.

2. Practice is the only criterion for testing truth. Some problems will inevitably arise after the system documents are put into trial operation. All employees will immediately report the problems and improvement opinions that arise in practice to the relevant departments in a truthful manner so that corrective measures can be taken.

3. Coordinate and improve the problems exposed during the trial operation of the system, such as poor system design and incomplete projects.

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

Quality system audit and review

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

1． The main contents of audit and review generally include:

(1) Whether the specified quality policy and quality objectives are feasible;

(2) Whether the system documents cover all major quality activities, and whether each Whether the interface between documents is clear;

(3) Whether the organizational structure can meet the needs of quality system operation, and whether the quality responsibilities of each department and position are clear;

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

(5) Whether the specified quality records can serve as witnesses

(6) Whether all employees have developed the habit of operating or working according to the system documents habits and how well they are implemented.

2． The characteristics of the system audit at this stage are:

(1) The system audit during normal operation of the system focuses on compliance. In the trial operation stage, compliance and applicability are usually combined;

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(2) In order to expose problems as much as possible during the trial operation stage, in addition to organizing an audit team to conduct a formal audit, the majority of employees should also participate and encourage them to discover and raise problems through the practice of trial operation. ;

(3) After each stage of trial operation, an audit should generally be formally arranged to correct the discovered problems in a timely manner. For some major issues, audits can also be organized in a timely manner as needed. ;

(4) All elements should be reviewed and covered during the trial operation;

(5) Fully consider the guarantee effect of the product;

(6 ) Based on the internal audit, the top management organizes a system review.

It should be emphasized that the quality system is constantly improved and perfected. After the quality system enters normal operation, various means such as internal audits and management reviews must still be adopted to maintain and continuously improve the quality system.