Question 1: What is quality system assessment? Quality management system audit has the following characteristics:
(1) Quality management system audit is based on a formalized and documented quality system.
The quality management system audit must judge and evaluate the conformity, effectiveness and suitability of the quality system. First of all, it requires that the quality system must be based on formalization and standardization, and formalization and standardization require documents change. Only by establishing a documented quality system can it be implemented and operated, and comparison and evaluation possible, thereby meeting the necessary conditions for quality system audit.
(2) Systematic quality management system audit.
The systematic nature of the quality management system audit is firstly reflected in the fact that the audit is a formal activity, which requires being organized, planned, step-by-step and carried out according to prescribed procedures. The selection of samples and objective evidence There must be a set of effective procedures and methods for collecting, drawing audit conclusions, and tracking corrective actions. The systematic nature of the quality system audit is also reflected in the fact that the focus of the audit is to find objective evidence of system failure. The problems found in the audit cannot stay on the surface, but must systematically find the causes of non-conformity.
(3) Independence of quality management system audit.
The independence of the quality management system audit refers to the independence of the institutions and personnel who perform the audit. Generally speaking, the review agency must be a department that has no direct responsibility for the quality activities of the review content. It can be a full-time agency or an independent agency. The audit tasks undertaken by the auditor and the objects to be audited must have no direct responsibility relationship with his or her own job position. The independence of audit also requires that auditors should respect objective facts, not be interfered by any pressure or inducement, be free from the influence of bias and emotion, adhere to objectivity and impartiality, and maintain independent judgment.
(4) Risks of quality management system audit.
Quality management system audit is a process of random inspection. The quality system is a "big system". Due to time and personnel constraints, to complete the audit work in a relatively short period of time, only sampling inspection methods can be adopted, including extracting a certain number of system documents and quality records, and questioning a certain number of personnel. , randomly check several pieces of equipment, observe several processes, etc. This audit method, which uses a small number of sample audit results to describe a complete quality system, is bound to be risky.
Question 2: What are the specific contents of the management system? The specific content (system) of enterprise management: 1. Plan management Through forecasting, planning, budgeting, decision-making and other means, the economic activities of the enterprise are effectively organized around the requirements of the overall goal. Plan management embodies management by objectives. 2. Organizational management establishes an organizational structure, stipulates duties or positions, and clarifies the relationship between responsibilities and powers, so that members of the organization can cooperate with each other, work together, and effectively achieve organizational goals. 3. Materials management is important for various production needs of the enterprise. Organize the procurement, supply, storage, economical use and comprehensive utilization of data in a planned manner. 4. Quality management: Supervise, examine and inspect the company's production results. 5. Cost management: Carry out cost forecasting, cost planning, cost control, cost accounting, cost analysis, cost assessment, etc. around the occurrence of all enterprise expenses and the formation of product costs. 6. Financial management: Manage the financial activities of the enterprise, including the formation, distribution and use of fixed funds, working capital, special funds, profits, etc. 7. Labor and personnel management: Comprehensive planning, unified organization, systematic control, and flexible adjustment of labor and personnel in all links and aspects of the enterprise's economic activities. 8. Marketing management. It is the company's management of product pricing, promotion and distribution. 9. Team management. Refers to the formation of various departments in an organization based on the nature and ability of members to participate in the organization's decisions and problem solving to improve organizational productivity and achieve organizational goals. 10. Corporate culture management. It refers to the sorting out, condensation, deepening and improvement of corporate culture. Under the guidance of corporate culture, it matches the company's strategy, human resources, production, operation, marketing and other management lines and modules.
Question 3: What method is used to assess the ISO system to enable the system to operate effectively in the long term? The basic ideas of the ISO standard are two most important: one is the idea of ??control, that is, the entire process of product formation --Control from purchasing raw materials, processing and manufacturing to final product sales and after-sales service. Everything is composed of a process. As long as the entire process of product formation is controlled and the process quality requirements are met, the quality of the final product is guaranteed. The second is the idea of ??prevention. By controlling the entire process of product formation and establishing and effectively operating a self-improvement mechanism, we can prevent unqualified products and fundamentally reduce or eliminate unqualified products
Question 4: Huaguang Certification Quality System Assessment and Drug Supervision What is the difference between certification? One can do system certification for all products, and the other is industry certification for special products.
Question 5: What questions does the Food and Drug Administration ask during the quality system assessment? 5 points. First, accept the quality system assessment. Standards check whether the company meets the standards, and focus on questioning the asterisk items of the acceptance standards, including checking production records, inspection records, personnel qualifications, and asking questions to the operators on the job, whether the production is in accordance with the operating procedures, etc. Generally, questions are asked about quality issues. most.
Question 6: What does the "Three Examinations and One Database" assessment and evaluation system refer to? The performance appraisal system is an evaluation system.
This system is an evaluation system composed of assessment indicators that are both independent and interrelated and can express the evaluation requirements more completely.
The establishment of a performance appraisal system is conducive to the evaluation of employee work conditions. It is the basis for employee appraisal and is also an important factor in ensuring that the appraisal results are accurate and reasonable.
Assessment indicators are data that can reflect the completion of performance goals, work attitude, and ability levels. They are the basic units of the performance assessment system.
Question 7: What does the enterprise architecture include? Marketing system: The value of the marketing system lies in continuously developing the market, exploring customer needs, increasing brand awareness, expanding market share, and increasing gross profit margins. The marketing system structure must highlight the marketing function. The marketing system includes market planning, development, sales planning, sales, operations, after-sales service and other departments. Their main functions are to complete sales targets and realize product value. In addition, logistics distribution (mainly commodity dispatching functions) and finished product warehouses can generally be used as components of the value of the marketing system, thus forming a closed-loop operation model of the marketing system value chain.
Product system: The product system is the production center, logistics center, and technology center, including product development, production planning, procurement, logistics, production, raw material processing, and supporting production departments. It is the main factor in creating product value. Departments, in addition, technology and quality management will generally be used as components of product system value, thus forming a closed-loop operating model of the product system value chain.
Management and control system: The management and control system includes the strategic planning center, administrative center, human resources center, financial center, and audit center. Among them, the performance appraisal function of the human resources center is mainly to conduct daily assessments of the performance of personnel in various departments and positions of the company; the financial center's primary job is to grasp budget and accounting, and achieve sales performance through process control, and based on cost, Cost control is the main focus. Issue a budget variance analysis report at the end of the month to analyze sales, collection rate, profit margin, net equity interest rate and other indicators for monthly business analysis and assessment.
Question 8: What are the regulatory inspections of medical devices? I know that there is a product registration system assessment, on-site inspection of production license 13485 registration system verification, this focus is on the verification and verification of various registration elements of the registered product, such as the test report of the registration test you provided, do you have it? Keep samples to see if your clinical trial is genuine, and we will even call the patients and doctors participating in the clinical trial to verify. The other is the inspection of the production line.
Generally, there is an on-site inspection standard for the inspection of production licenses. This should be more comprehensive, including personnel status, factory warehouse facilities and equipment, training status, production process and inspection process, company organization Institutional and company quality system documents, as well as inspection of some records.
Question 9: What corresponding quality system assessment reports are provided as valid supporting documents for the production quality system assessment (certification) of registered medical device products? 1. System assessment report within the validity period signed by the (food) drug regulatory department of the province, autonomous region, or municipality directly under the Central Government; 2. Medical device production quality management specification inspection report or medical device quality system certification certificate; 3. The country has implemented If the implementation details are produced, a report on inspection and acceptance of the implementation details shall be submitted;
Question 10: What are the valid supporting documents for medical device system assessment (certification)? Each province, municipality directly under the Central Government, and autonomous region Food and Drug Administration applies for system assessment or applies for quality system certification from Beijing Guoyi Huaguang Certification Co., Ltd.