The medical equipment quality management system is an important means to achieve the whole process of medical equipment. It is also a basic content of the quality and safety of medical equipment products. Therefore, medical equipment manufacturers should comply with the standard requirements and establish and improve their medical equipment. Adapt to the quality management system and maintain its effective operation. In order to help enterprises establish a compliance quality management system, this paper organizes relevant common issues and analytics for your reference.
(1) What are the qualification requirements of the quality management system auditor?
(1) Provisions for the qualifications and capabilities of the auditing group staff, such as training and education, including the system audit, including: whether to know and understand the standards for quality system review; whether to master inspections, questions, assessments and reports Review technology; verbal and written expression ability; whether there is a review and other practical experience.
(2) The auditor should have no direct responsibility with the audited project.
(3) Auditors are usually composed of relevant personnel of various departments, and may also participate in the results, conclusions and recommendations of the factory.
(2) What are the contents of the quality management system audit?
(1) Whether the functions of the system and other elements have been transformed into quality responsibilities and are conscientiously implemented and implemented.
(2) Whether the organization is perfect.
(3) Whether various procedures in the system meet the requirements.
(4) Whether the resources of the elements (such as personnel quality, equipment equipment, financial conditions, etc.) are not guaranteed.
(5) Whether the element is reasonable.
(6) Work on site, whether the operation or process is in line with the norm.
(7) Quality of products.
(8) There is no record in the event, and whether the various documents are complete and clear, keep it properly.
(9) Perform a systematic audit.
(3) What are the validity audits of the quality management system?
(1) Whether the quality awareness of leaders at all levels is enhanced.
(2) Whether the quality awareness of employees is enhanced.
(3) Whether the work quality of each functional department and staff is improved.
(4) Process (or step) quality is stable.
(5) Whether the product quality is stable.
(6) Whether the work efficiency is improved.
(7) Whether the quality management level is improved.
(8) Whether the corporate management level is improved.
(4) What are the contents of the quality management system audit report?
(1) Evaluation of each audited project, clearly indicating the shortcomings, problems, problems, the cause of the system operation, and proposes the measures to be taken, and the responsible person responsible for taking measures.
(2) It is pointed out that the system itself is in order to improve the design of the system.
(3) Indicate the unqualified or defective specific projects, which means possible causes and evidence generated by these defects.
(4) Reflecting the implementation of corrective measures approved by the previous review and its effects, and evaluate this.
(5) A total evaluation of this system audit work.
(6) Form a document and send it to all relevant departments, major personnel, and corporate leaders. The audit report should be archived after the original record is organized.
(5) What are the roles of process audits?
(1) Investigate the implementation and effect of the process quality control plan, which makes it to evaluate whether or not to evaluate the actual, orientation, and clear whether to take corrective and correct measures.
(2) Understanding the status quo of process factors, assessing the level of control levels, the relationship between research factors and process quality fluctuations, which is clear how to make more economical and effective control of process factors.
(3) Quality review of key processes (processes), study problems in quality control activities, strengthen process (process) quality control points management, improve process quality control methods, in order to improve the effectiveness of quality control activities, increase The role of preventive control and the direction of enhanced quality assurance capacity.
(6) What are the contents of management reviews?
(1) According to the quality status, economic benefits of the enterprise, it is not suitable for the current changes in environmental conditions.
(2) Audit the organization's organization, procedures, and the level of environmental conditions and adaptation facing enterprises.
(3) Review the quality record of relevant quality documents.
(4) Evaluation of quality system adaptability and operational effects.
(5) If necessary, the review of the lead quality system is correct, and whether corrective measures are implemented as scheduled and achieved.
(7) What are the steps of management reviews?
(1) Preparation of management reviews.
(2) Establish management review organization.
(3) Perform management reviews.
(4) Write a management review report.
(5) Management review report, file data archive saves.
(8) What are the contents of quality improvement activities?
(1) The need, range and importance of quality improvement.
(2) Relevant background and historical situations, related quality losses, and current status, and as much as possible, quantitative forms.
(3) Regular review of resource allocation and progress.
(9) What is the process of finding the reason for quality improvement?
(1) The collected data should always be carried out in accordance with the formulated plan, and it is important to investigate possible reasons, and not make judgments and decisions with subjective imagination or assumptions.
(2) Through the analysis of data data, you can master the nature of the process of improving the improvement, thereby establishing possible causal relationships, but pay attention to the difference between the coincidence factors and the causal relationship.
(3) For the highly relevant relationship with the data data, it is necessary to test and confirm with the collected data.
(10) What should I pay attention to in the stage of preventive and corrective measures?
(1) Quality Improvement is to obtain more satisfactory efficiency and effects by taking prevention and corrective measures during the process, rather than relying on the revision of the process results, such as rework, repair, and downgrade, etc. to solve the problem.
(2) Quality improvement is the quality change, so it is inevitable that various resistance will be encountered, so pay attention to the work of people, because of the potential, follow
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