Code for Quality Management in the Manufacture of Medical Devices
Guiding Principles for On-site Inspection
Chapters
Terms
Contents
Structure and Personnel
1.1.1
There should be established a management organization that is suitable for the production of medical devices, with an organizational chart.
Check the quality manual provided, whether it includes the organization chart of the enterprise, whether it is clear that the interrelationship of each department.
*1.1.2
The duties and responsibilities of each department should be clearly defined, and the quality management function should be clarified.
Check the quality manual, program documents or related documents, whether the duties and responsibilities of each department; quality management department should be able to independently exercise their functions, check the quality management department's documents, whether it is clearly stipulated that the quality of the product has the right to make decisions on matters related to the quality of the product.
1.1.3
The heads of the production management department and the quality management department shall not be in charge of each other.
Check the company's posting documents or authorization documents and against the relevant production, inspection and other records of the performance of duties, to verify whether it is consistent with the authorization.
1.2.1 The person in charge of the enterprise shall be the main person responsible for the quality of medical device products. 1.2.2 The person in charge of the enterprise should be organized to develop quality policy and quality objectives. View the development of quality policy and quality objectives of the program, the approval of personnel.
1.2.3
The person in charge of the enterprise should ensure that the quality management system for the effective operation of human resources, infrastructure and working environment.
1.2.4
The person in charge of the enterprise shall organize the implementation of management review, regular assessment of the operation of the quality management system, and continuous improvement.
View the management review documents and records to verify that the person in charge of the enterprise is organizing the implementation of management review. *1.2.5 The person in charge of the enterprise shall ensure that the enterprise organizes production in accordance with the requirements of laws, regulations and rules. 1.3.1
The person in charge of the enterprise shall identify a manager's representative. View the appointment document of the manager's representative.
*1.3.2
The management representative shall be responsible for establishing, implementing and maintaining the quality management system, reporting on the operation of the quality management system and the need for improvement, and raising the awareness of employees to meet the requirements of laws, regulations and customers.
View whether the above responsibilities are clearly defined. Check the records related to the management representative's reporting on the operation and improvement of the quality management system.
1.4.1
The person in charge of technology, production and quality management departments should be familiar with medical device laws and regulations, with practical experience in quality management, and should have the ability to make correct judgments and deal with actual problems in production management and quality management.
View the qualification requirements of the relevant department head, whether the professional knowledge, work skills, work experience
Chapter
Article Content
Calendar to provide; check the assessment and evaluation records, on-site questioning, to determine whether it meets the requirements.
1.5.1
Specialized technicians, management personnel and operators should be equipped with products compatible with production. Check the qualification requirements for relevant personnel.
*1.5.2
Should have the appropriate quality inspection organization or full-time inspectors.
View the organizational chart, departmental responsibility requirements, post personnel appointment and other documents to confirm compliance.
*1.6.1
Personnel engaged in work affecting product quality should be trained to meet the requirements of their positions, with relevant theoretical knowledge and practical skills.
The positions affecting the quality of medical devices should be identified, and the level of specialized knowledge (including educational requirements), work skills, and work experience necessary for personnel in these positions should be stipulated. Check the training content, training records and assessment records, whether it meets the requirements.
1.7.1 Should be engaged in and product quality has an impact on the health of personnel management, the establishment of health records. Plant and facilities
2.1.1 Plant and facilities should be consistent with the production requirements of the product.
2.1.2 The overall layout of the production, administrative and auxiliary areas should be reasonable, and shall not interfere with each other.
*2.2.1 Plant and facilities should be based on the characteristics of the products produced, the process and the corresponding clean level requirements for rational design, layout and use.
2.2.2
The production environment should be clean, in line with product quality needs and relevant technical standards.
2.2.3
Products with special requirements, should ensure that the external environment of the plant can not have an impact on product quality, if necessary, should be verified.
2.3.1 The plant should ensure that the production and storage of product quality and related equipment performance will not be directly or indirectly affected.
2.3.2
Plant should have appropriate lighting, temperature, humidity and ventilation control conditions.
2.4.1
Plant and facilities should be designed and installed to take the necessary measures according to product characteristics to effectively prevent the entry of insects or other animals.
View on-site to see if the facilities are equipped.
2.4.2
Maintenance and repair of plant and facilities should not affect product quality.
2.5.1
The production area should have enough space and be compatible with the scale and variety of product production.