26, record-clarify the results achieved or provide evidence of completed activities.

27. The role of records is to provide evidence; It shows that the product, process or quality management system meets the requirements and the quality management system has been effectively operated. Analyzing it and taking it as the basis of corrective and preventive measures can provide information for improving the quality management system.

28. Management review-managers should conduct management reviews at planned intervals to ensure the suitability, adequacy and effectiveness of the quality management system. The management review shall evaluate the performance of the system, including the evaluation of the quality policy and quality objectives, evaluate the demand for changes in the organization's quality management system, and put forward improvement requirements.

29, the formulation of quality policy should consider:

(1) should be adapted to the overall business policy of the organization, and the quality policy should be a part of the business policy;

(2) Proceed from the requirements of product quality and customer satisfaction;

(3) continuous improvement should be made;

(4) A framework for formulating and reviewing quality objectives should be provided, and the quality policy should correspond to the quality objectives.

30, management review is mainly to ensure the suitability, adequacy and effectiveness of the quality management system.

3 1, management review input:

(1) audit results;

(2) feedback from customers;

(3) Process performance and product conformity;

(4) For the status of preventive and corrective measures, priority should be given to corrective and preventive measures that have a significant impact on customer satisfaction;

(5) the implementation and effectiveness of the tracking measures of the last management review;

(6) Changes that may affect the quality management system.

32. The output of management review:

(1) Improvement of quality management system and its process;

(2) product improvement related to customer requirements;

(3) the demand for resources.

33. Resources include personnel, information, infrastructure, work, environment and financial resources. GB/T 1900 1 standard puts forward corresponding requirements for personnel, facilities and working environment based on customer satisfaction.

34, the organization in the product realization process planning should be clear:

(1) Quality objectives of products, projects and contracts;

(2) the required processes and documents, and provide resources and facilities for specific products;

(3) Verification and confirmation activities and acceptance criteria;

(4) Records necessary to provide confidence in the conformity of the process and the formed products.

35. Managers' responsibilities in quality management: managers should first instill the quality consciousness and concept of "focusing on customers" into all employees of the organization; Managers should personally formulate quality policies and quality objectives; The manager shall personally preside over the review and provide evidence; Managers should ensure the timely provision of necessary resources;

36. Resources required for quality management system: human resources, infrastructure and working environment.

37, product requirements include:

(1) Define the product requirements of customers;

(2) The customer has no clear product requirements, including the expected and potential requirements of the customer, and the requirements that the customer has not put forward but must be required for a specific purpose;

(3) Requirements of laws and regulations on product-related liabilities;

(4) Any additional requirements determined by the organization.

38. Design and development-a series of processes that transform requirements into specific characteristics or specifications of products, processes or systems.

39, in the design and development planning should consider:

(1) Determine the stages of the design and development process according to the product, including the completion period;

(2) Identify appropriate review, verification and confirmation activities for each of the above stages;

(3) Determine the responsibilities and authority of each activity.

40. The purpose of design and development review is to evaluate the ability of output results in each stage of design and development to meet requirements, identify problems and take measures.

4 1, design and development review objectives:

(1) meets the goal of verification and confirmation;

(2) Assessing the potential hazards and failure modes of products in use;

(3) Life cycle data of product performance;

(4) The possible impact of the product on the environment.

42, design and development verification method:

(1) transformation method for calculation;

(2) Compare the new design with the verified similar design;

(3) Testing and confirmation;

(4) Review the design stage documents before distribution.

43, the procurement process includes:

(1) Identify the influence of purchased products on the products in the subsequent realization process;

(2) Evaluation and selection of suppliers;

(3) ordering;

(4) Evaluate suppliers regularly;

(5) procurement documents;

(6) Verification of purchased products;

(7) Control of unqualified purchased products.

43, supplier evaluation methods are:

(1) Evaluate the related performance of suppliers;

(2) Review supplier's product quality, price, delivery and problem solving;

(3) Review the supplier's quality management system and evaluate its ability to provide the required products as planned;

(4) Investigate the customer satisfaction of suppliers;

(5) Investigate the financial status, service and support capabilities and follow-up capabilities of suppliers.

44, process validation should confirm the ability of the process to meet the planning results, if applicable, the confirmation should include:

(1) Specify the criteria for reviewing and approving these processes;

(2) Equipment approval and personnel qualification;

(3) Using the prescribed methods and procedures;

(4) Record requirements

(5) If there is a problem in the initial confirmation process of production and service, or the product fluctuates abnormally, the process should be reconfirmed after adjustment.

45, corrective action program should stipulate:

(1) Identify and review nonconformities in nonconforming product process and quality management system, and pay special attention to customer measures caused by nonconformities;

(2) Investigate and analyze the unqualified reasons;

(3) Evaluate the demand for corrective measures to prevent nonconformity;

(4) Determine appropriate corrective measures and implement them;

(5) Record the results, including the reasons, contents and completion of the measures;

(6) Review the effectiveness of corrective measures.

46. The procedures for preventive measures shall provide for:

(1) Identify potential nonconformities and their causes;

(2) Evaluate the demand for preventive measures to prevent nonconformity;

(3) Record the results, including the reasons, contents and results of the measures taken;

(4) Evaluate the effectiveness.

47. The basic requirements for establishing a quality management system:

(1) Establish and improve the system according to the actual situation of the institution;

(2) The establishment of quality management system should focus on the improvement of product quality and customer satisfaction, implement ISO9000 family standards, and focus on customer satisfaction as the ultimate goal;

(3) We should not only pay attention to the improvement of quality management system documents-software construction, but also pay attention to the training of personnel and the improvement and improvement of working environment;

(4) Improve and establish the quality management system with systematic management methods;

(5) Highlight the idea of process control;

(6) The establishment of quality management system should have good operability.

48. The general steps of establishing a quality management system: organizing preparation, overall planning, establishing/updating the system, compiling/perfecting documents, and keeping running.

49. Audit-A systematic, independent and documented process of obtaining audit evidence and objectively evaluating it to determine the degree of compliance with audit standards.

50. The characteristics of audit are systematic, independent and cultural.

5 1, audit standard-a set of guidelines, procedures or requirements used as a basis. Audit criteria, also known as audit basis, usually include standards, relevant laws and regulations and the organization's quality management system documents (quality policy, quality manual, procedure documents, etc.). ).

52. Audit evidence-records, implementation statements or other information related to audit standards, which can be verified. Audit evidence can be qualitative or quantitative.

53. Quality management system audit refers to a systematic, independent and documented process of objectively evaluating the conformity and effectiveness of an organization's quality management system according to the quality management system standards and audit criteria. It is of great significance to the continuous improvement of weaving quality management system.

54, the role of internal audit:

(1) Inspect the activities and processes according to the requirements and standards of the quality management system, and evaluate whether the organization's own quality management system meets the requirements of quality policies, procedures, management systems and corresponding laws and regulations.

(2) To verify whether the organization's own quality management system has been continuously and effectively implemented and maintained;

(3) Evaluate the effectiveness and efficiency of managers' decisions, quality policies and objectives, the organization's own regulations and contract requirements;

(4) As an important management method, it can find problems in time, take corrective and preventive measures and provide information for continuous improvement;

(5) Promoting the improvement of product quality, continuous customer satisfaction, meeting the requirements of laws and regulations and continuous improvement of quality management system;

55, the role of the second party audit:

(1) When there is an intention to establish a contractual relationship, make a preliminary evaluation of suppliers;

(2) In the case of contractual relationship, verify whether the supplier's quality management system continuously meets the specified requirements and operates;

(3) As one of the bases for formulating and adjusting the list of qualified suppliers;

(4) Communicate the knowledge of quality requirements between the supply and demand sides.

56, the role of the third party audit:

(1) Determine whether the requirements of the quality management system meet the specified requirements;

(2) Determine whether the requirements of the current quality management system meet the specified requirements;

(3) Determine whether the quality management system of the auditee can be certified/registered;

(4) Provide the auditee with opportunities to improve the quality management system.

57, on-site audit work content:

(1) Hold an audit meeting;

(2) Conduct on-site inspection;

(3) Control of audit process;

(4) Determination of nonconforming items and compilation of nonconforming reports.

(5) Write an audit report.