The quality manual is a programmatic document that should be followed for a long period of time for the quality management and quality assurance activities of the enterprise, how to develop a quality manual for medical devices? Below I give you information about the medical device quality manual model, I hope to help you.
The medical device quality manual model is as follows
First, the management functions of the various levels of organization
1, quality management functions of the Department of Quality Management:
2, the quality management functions of the Department of Business
3, the quality management functions of the Department of Warehousing
4, the quality management functions of the Department of Finance
Second, the duties of all levels of personnel
1, the person in charge of the enterprise job responsibilities
2, the quality management department responsible for the job responsibilities
3, the business department manager job responsibilities
4, the finance department manager job responsibilities
5, the quality of the acceptance of the job responsibilities
6, the quality of the administrator's job responsibilities
7, the warehouse custodian job responsibilities
8, purchaser job functions
9, sales staff job functions
10, maintenance, after-sales staff duties
Third, the quality of medical devices management system catalog
1, the first medical device enterprises and the first varieties of audit system
2, validity of the medical device management system
3, the product standard management system
4, medical device procurement management system
5, medical device quality acceptance system
6, medical devices in the warehouse storage, maintenance management system
7, medical devices out of the warehouse, review management system
8, medical device sales management system
9, unqualified medical equipment management system
10, medical device return product management system
11, medical device quality tracking management system
12, medical device adverse event reporting system
13, quality information collection management system
14, quality incident reporting system
15, medical device quality inquiries, complaints management system
16、After-sales service management system
17、User access contact management system
18、Documents, records and vouchers management system
19、Single-use sterile medical device quality management system
Fourth, the quality management department quality management functions
1, the implementation of the quality management system of medical devices, laws and regulations and administrative regulations, within the company on medical devices. Rules and regulations, the quality of medical devices within the company has the right to rule;
2, the drafting of the company's quality management system for medical devices, and guidance and supervision of the implementation of the system;
3, responsible for the first business enterprises and the first varieties of quality audits;
4, is responsible for the establishment of the company's operating medical devices, including the quality of the quality standards and other content of the quality of the file;
5, Responsible for medical device quality inquiries, adverse events, quality accidents or quality complaints, investigation, treatment and on time to the local drug supervision department report;
6, responsible for medical device inspection and acceptance, guidance and supervision of medical devices, storage, maintenance and transportation of the quality of work;
7, responsible for the audit of unqualified medical devices, unqualified medical devices, the implementation of the process of dealing with supervision;
6, responsible for medical devices, medical devices, medical devices, medical devices, medical devices, medical devices, medical devices, medical devices, medical devices, medical devices and other medical equipment. Supervision;
8, collect and analyze the quality of medical equipment information;
9, to assist the company's employees in the quality of medical equipment management education or training;
10, conscientiously carry out the implementation of the national laws, rules and regulations relating to the management of medical devices and the company's quality policy, quality objectives;
11, responsible for the custody of medical equipment, storage, Maintenance process of quality management;
12, do a good job in the warehouse review and inspection;
13, in the process of storage and management of medical devices to seriously implement the "medical device business enterprises
Management Measures", the storage of medical devices should comply with the classification of zoned storage, color-coded management, according to the batch number of far, near the stacking code and other relevant provisions, to maintain a clean and healthy warehouse and to do dust, moisture, water, and other relevant provisions of the law, regulations and rules. Do a good job of dust, moisture, insects, pollution and other work;
14, in accordance with the physical and chemical properties of medical devices to do a good job of stocking medical equipment maintenance, regular quality inspection of medical devices in stock, found that the quality of medical devices have quality questions in accordance with the relevant provisions of the timely treatment;
15, responsible for the expiration date of the medical device management and batch number management, quality tracking;
16, medical devices out of storage should be reviewed to ensure that the quality of medical devices out of storage is normal;
17, responsible for the use of storage facilities, equipment management and maintenance management, improve the quality assurance capabilities of storage;
18, responsible for the management of fire safety facilities in the storage area and maintenance;
19, the standardization of the establishment of medical device files, medical equipment out of storage review records, storage facilities and equipment use, management Records, storage facilities and equipment use, management information files, storage fire safety facilities files and other archives, and according to the provisions of the preservation;
20, seriously do a good job of quality work assessment.
21, other related work.
V. Business Department quality management functions
1, seriously implement the implementation of national laws, rules and regulations relating to the quality management of medical devices and the company's quality policy objectives;
2, in the procurement of medical devices in strict compliance with the national medical device business management laws, regulations and related provisions, the quality of its medical devices is responsible;
3, medical device purchases are carried out in accordance with the provisions of the law, regulations, and relevant provisions;
3, medical device purchases are carried out in accordance with the provisions of the law, regulations and relevant provisions. Incoming goods according to need, choose and buy the best? The principle of medical equipment supply
Goods should be legally qualified units, the purchase of medical equipment must be signed contracts, written purchase contracts must have clear quality terms, purchase contracts if not in writing, should be signed in advance with the supplier of quality assurance agreement, the agreement should be clear the period of validity;
4, the first enterprise, the first varieties of purchases must be handled Relevant approval procedures, after approval before the purchase of medical equipment;
5, responsible for examining the request for medical equipment production (business) license, business license and supplier of sales personnel power of attorney, ID card and other necessary documents and information copies, make good purchasing records, supplier license records;
6, the purchase of imported medical equipment must be requested to comply with the provisions of the original seal of the "imported medical equipment," the supplier of the original seal of the "imported medical equipment. The original seal of the supplier unit of "imported medical equipment registration certificate" and "imported medical equipment inspection report form";
7, to strengthen the quality of all procurement staff awareness education, adhere to the principle of quality first;
8, grasp the quality of the procurement process of the quality of the status of the discovery of quality problems in a timely manner with the quality of contact with the quality department to deal with;
9, do a good job of quality work assessment;
10, the purchase of imported medical devices must be requested to comply with the provisions of the original stamped "imported medical equipment registration certificate" and "imported medical equipment inspection report form".
10, the establishment of a complete record of purchase of medical equipment and supply unit data files, and save according to regulations.
11, seriously implement the relevant national laws and regulations and the company's quality policy, quality objectives;
12, in the process of medical device business in strict compliance with national laws and regulations on the management of medical devices;
13, to the legally qualified units supply of medical devices, sales of medical devices should be entered into a contract, or with the purchase of units to enter into an annual supply agreement Letter of intent;
14, tracking the sales of medical devices and quality information, adverse reactions to medical devices should be reported in a timely manner in accordance with the provisions of;
15, regularly or irregularly to consult the user on the quality of medical devices and quality of service advice and suggestions for improvement;
16, the establishment of medical device sales records and user files and according to the provisions of Preservation.
Six, warehousing quality management functions
1, the organization of the department to study and implement the "supervision and management of medical devices regulations" and related policies and quality management system.
2, is responsible for improving the warehouse, warehouse appearance, environmental hygiene, pay attention to fire prevention, anti-theft, rodent, insect, mildew.
3, supervise the classification of medical equipment storage, adhere to the ? The recent first out?
4, supervise and guide the conservation, custodian strictly in the warehouse, in the warehouse conservation, out of the warehouse, the consequences of laxity in the gate is responsible for the specific responsibility.
5, guide the conservation officer, custodian of the daily work. To assist in the job training of employees in this department.
Seven, the Ministry of Finance quality management functions
1, seriously implement the relevant national laws, regulations and the company's quality policy, quality objectives;
2, with the assessment of the economic objectives of the department's responsibility system;
3, timely reflection of the leadership of the inventory structure, the dynamics of the medical equipment and other financial information, to promote the company's strengthening of the quality of business management.
4, responsible for the company's price management, timely communication of price policy, price information to guide business operations, to prevent violations of the "Price Law" of the business behavior;
5, commitment to payment, should be carefully examined, the procurement of medical equipment does not comply with the provisions of the management of the purchase should be refused to pay the purchase price.
Eight, the person in charge of quality management functions
1, adhere to? Quality first? The concept of quality first, conscientiously implement the national quality policy on medical devices, laws, regulations and other relevant provisions to strengthen quality management, responsible for consumers, the company's quality management is responsible for the overall leadership;
2, presided over the development of the company's quality policy, objectives, planning, and strict implementation of national standards, to support the quality management work, and give full play to its quality control function;
3, presided over the quality system review, regularly convene the company's quality analysis, listen to the quality management department of the company's medical device quality report, the existence of problems in a timely manner to take effective measures to promote quality improvement;
4, correctly deal with the quality and quantity, the relationship between the progress of the implementation of the quality of the right to veto in the operation of the rewards and penalties;
5, pay attention to the consumer's views and complaints processing
6, to create the necessary material and technical conditions, so that it is compatible with the quality requirements of operating medical devices;
7, signed, issued by the quality management system and other quality system documents;
8, leading the quality management of staff, professional knowledge of education and training to improve the quality of all staff. Improve the quality of all staff.
Nine, quality management department responsible for quality management functions
1, seriously implement the "supervision and management of medical devices regulations", "medical device business management approach" and other laws, regulations, and related policies to strengthen the company's overall quality management, effective implementation of the quality of the veto;
2, guiding the departments to carry out the effective quality policy, objectives. Responsible for drafting, compiling annual quality plan indicators, and supervise the completion of the quality objectives;
3, responsible for supervising the quality management agencies to organize the drafting, preparation of quality management system, quality accountability and management of the quality of the operating chain of work management procedures, and ensure the implementation of the document;
4, regularly organize and convene a quality analysis meeting to listen to the quality of the dynamic report and to make the quality of the relevant procedural documents, and to ensure the implementation of the document Documentation, and ensure the implementation of the document;
5, responsible for the first business and the first varieties of quality audit;
6, responsible for coordinating the quality of management work between the departments in an orderly manner;
7, responsible for the implementation of quality training and education. Under the leadership of the deputy general manager in charge of the organization
Department staff to seriously implement the "supervision and management of medical devices regulations", "medical equipment business management approach" and other relevant state laws and regulations, the organization of staff to seriously perform the functions of the department;
8, in the department of the work of the company to seriously implement the implementation of the quality policy and quality objectives, to maintain the quality system link the normal operation of the system;
9, is responsible for coordinating the implementation of quality training and education.
9, supervise the custodian to strictly implement the medical device zoning, classification storage and color-coded management;
10, supervise the medical equipment in the library maintenance work to ensure that the storage of medical equipment safety;
11, to strengthen the return of medical equipment and unqualified medical equipment management and control work;
12, once a month to organize an inventory of inventory to achieve Accounts in line with the accounts, accounts in line with goods;
13, supervise staff to do a good job of the quality of the original records of activities, and properly stored for inspection;
14, the organization of the staff to improve the environmental health of the warehouse and the warehouse area, and do a good job of fire prevention, anti-theft, pest control, rodent control, anti-pollution, mildew prevention and so on;
15, is responsible for the day-to-day management of the warehousing facilities and equipment, and is responsible for the establishment of the warehousing facilities, use, maintenance files and properly stored. Use, maintenance files and properly stored.
X. Business Manager quality management functions
1, conscientiously implement the "supervision and management of medical devices regulations", "Medical Device Business Management Measures" and other relevant state laws and regulations and the company's quality policy and quality objectives;
2, in the procurement process of medical equipment to establish? Quality First The idea of quality first, the implementation of? The purchase of goods in accordance with the needs of?
3, responsible for reviewing the medical equipment procurement contract, the contract should be corrected in accordance with the provisions of the clear quality terms;
4, together with the quality department of the first enterprise and the first varieties of the quality of the audit;
5, often to understand the situation of the inventory of medical equipment to avoid a backlog of blind purchasing of medical equipment caused by backlogs, failure, deterioration of direct responsibility;
5, often to understand the situation of medical equipment stock to avoid backlogs. Procurement of medical equipment caused by the backlog, failure, deterioration of direct responsibility;
6, supervise the procurement staff to collect the supply unit in a timely manner, the legal license, the establishment of the supply customer files.
7, conscientiously implement the "supervision and management of medical equipment regulations", "medical equipment business enterprise management approach" and other relevant state laws and regulations and the company's quality policy and quality objectives;
8, supervise the sales staff in the operation of business activities in earnest to implement the "management of medical equipment business enterprise management approach", the sale of medical equipment should be checked when the purchase of units of legal qualifications, ask for purchase of units of legal licenses;
9, supervise the sales staff in the operating activities of "medical equipment business enterprise management approach", sales of medical equipment should be checked to purchase units of legal qualifications, request for purchase of The legal license of the purchasing unit;
9, supervise the sales staff to sell medical equipment sales or use of tracking to understand the situation, to prevent the sale of medical equipment for a long time after a large number of returns;
10, the organization of the sales staff to actively sell the near-expiry date or in the library of the long time of the qualification of the medical device, to avoid losses;
11, supervise the sales staff on a regular basis or irregularly to consult the user on the quality of medical equipment. To consult the user on a regular or irregular basis on the quality of medical devices, service quality and will be summarized and organized in a timely manner after feedback to the relevant departments;
12, supervise the sales staff to do a good job of sales records, record-keeping should be more than one year after the expiration date of the medical device, but shall not be less than three years;
13, with the quality of quality departments to deal with the quality of medical equipment after sale problems;
14, Found that the sale of medical devices should be immediately reported adverse reactions;
15, the organization to establish customer data files, and properly stored for inspection.
XI, Finance Manager Quality Management Functions
1, under the leadership of the general manager to conscientiously implement the "supervision and management of medical devices regulations", "Medical Device Management Code" and other relevant state laws and regulations, the organization of workers to seriously perform the functions of the department;
2, supervise the financial staff to grasp the good payment commitment;
3, responsible for the company Management of the price of medical equipment, medical equipment inventory structure and provide recommendations to improve the inventory structure;
4, maintenance and management of the original documents and information.
XII, the quality management functions of the acceptance officer
1, establish the concept of quality first, adhere to the principle of quality, good quality of medical equipment warehousing the first level;
2, is responsible for the legal standards for medical equipment and the contract provisions of the quality of the medical equipment purchased, the return of the medical equipment batch by batch acceptance, the effective exercise of the right to veto;
3, the acceptance of medical equipment is not qualified shall not be warehoused. Unqualified medical devices shall not be warehoused, and reported to the Quality Management Department for confirmation;
4, acceptance of medical devices should be carried out in accordance with the provisions of the premises, within the specified time limit;
5, should be in accordance with the ? Medical device acceptance program? The provisions of the acceptance of samples taken to ensure that the quality of representative;
6, acceptance of medical devices should be packaged, labeling, instructions, and the relevant requirements of the documents to be checked one by one, the whole piece of medical equipment packaging should be product certification;
7, acceptance of medical devices for external use, the labeling of the packaging or instructions to be provided with the required marking and warning instructions.
8, acceptance of the first varieties, imported medical devices, medical devices returned after the sale, should be strictly enforced in accordance with the system and procedural requirements;
9, acceptance is complete, the sampling of medical devices should be packaged recovery, and marked with a sampling mark; 10, standardize the filling of acceptance records, so that the handwriting is clear, the content of the real, the project is complete, the number of batch number is accurate, the conclusion of a clear, standardized sign;
xiii, the maintenance of conservation records. p>
thirteen, the caretaker quality management functions
1, adhere to the principle of prevention, in accordance with the provisions of the physical and chemical properties of medical devices and storage conditions, combined with the actual situation of the warehouse, to guide the custodian of the medical device classification, reasonable storage;
2, responsible for the inventory of medical devices for regular quality maintenance checks, and make good records of the maintenance inspection;
3, due to abnormal reasons may be a problem of medical devices, perishable medical devices, has been found in the quality of medical devices adjacent to the batch number, storage of medical devices for a long time, should be strengthened maintenance and the establishment of maintenance records;
4, combined with the stock of maintenance management, to determine the focus of maintenance of varieties;
5, the establishment of the maintenance of medical equipment files, maintenance inspections of medical equipment found to be of questionable quality, should be yellowed. Problems of medical devices, should be suspended yellow card delivery, while contacting the Quality Management Department to deal with;
6, regular summary, analysis and reporting of maintenance checks, near-expiry date or long storage of medical devices and other quality information;
7, do a good job of temperature and humidity management in the warehouse, according to the climate and environmental changes, to take the drying, dehumidification, and other appropriate conservation measures and records;
8, the correct use of conservation equipment, and regular inspection and maintenance to ensure normal operation;
9, responsible for measuring work;
10, consciously learn the business knowledge of medical equipment, improve conservation skills.
14, quality manager job responsibilities
1, establish quality first thought, to assist the quality minister to do a good job in quality management and quality education.
2, seriously study the quality of medical devices related laws, regulations, administrative rules and professional knowledge, strict supervision and management of medical device quality.
3, fulfill the responsibilities of the quality leadership team, with the relevant departments to do a good job of the quarterly quality system inspection and assessment work.
4, responsible for the quality of the department's data archiving.
5, is responsible for the management of quality information, often collect a variety of medical device quality information and quality advice and recommendations, the organization passes the anti-failure, and do a good job of analysis, reporting work. And report to the Quality Management Department;
3, strictly according to the first production first out, recent first out, according to the principle of the batch number delivery for warehousing;
4, according to the batch correctly record the medical equipment into, out of the inventory dynamics, to ensure that the accounts of the goods, the accounts are consistent;
5, handling and stacking should be in strict accordance with the requirements of the medical device packaging illustrations or signs, standardized operation. Fear of pressure medical devices should control the stacking height. Five distance specification, reasonable use of storage capacity;
6, in accordance with the principle of safety, convenience, economy, neat, solid stacking, five distance specification, reasonable use of storage capacity, and in accordance with the provisions of the color-coded management, color-coded obvious;
7, medical devices should be classified according to the batch number, expiration date of the classification of the relative concentration of storage, according to the batch number and validity period of the near and far apart from the stacking, and have a clear sign, the different batch number of medical devices shall not be
8, the sale of returned medical devices, with the sales department issued by the return voucher receipt, stored in the return of medical equipment library (area), and make a good record of the return;
9, is responsible for unqualified medical devices to carry out effective control, special account management;
Remarks: (1) the five spacing: Goods distance is not less than 100 centimeters;
The distance between the stacks and the wall is not less than 30 centimeters. Spacing is not less than 30 cm;
Stacks and roof (beams) spacing is not less than 30 cm;
Stacks and radiators or heating pipes spacing is not less than 30 cm; Stacks and the ground spacing is not less than 10 cm.
(1) color coding: pending inspection warehouse (area), return warehouse (area)? Yellow;
Qualified goods warehouse (area), shipping goods warehouse (area)? Green;
Non-conforming goods warehouse (area)? Red.
The expiration date product library (area) ---- blue
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