in order to promote the construction of the quality management system of medical device enterprises in Hangzhou, establish and improve the quality management system suitable for the medical devices produced and operated, ensure its effective operation, and improve the self-inspection ability of the quality management system of enterprises, this format is specially formulated for reference.
The compilation principle of the reference format of this self-inspection report is based on Article 24 of the Regulations on the Supervision and Administration of Medical Devices; Chapter IV of the Measures for the Supervision and Administration of Medical Device Production, Chapter III and Article 44 of the Measures for the Supervision and Administration of Medical Device Operation; "Medical device production quality management standard", "medical device management quality management standard" requirements. Hangzhou medical device manufacturing enterprises and third-class medical device trading enterprises can compile the annual quality management system self-inspection report with reference to the compilation principle and the reference format of the self-inspection report in the appendix, and submit the electronic document stamped with the official seal of the enterprise to the district, county (city) market supervision and administration bureau (sub-bureau) where each enterprise is registered before December 15th each year.
The principles for compiling the reference format of the self-inspection report on the quality management system of medical device enterprises in Hangzhou are as follows:
1. Medical device manufacturing enterprises in Hangzhou
(1) Organization and personnel
1. Changes in the organizational structure of enterprises.
2. Evaluation on the authorization, appointment, regulation training and performance of management representatives.
3. Training on laws and regulations and technology and annual evaluation of quality director, production director and technical director. If the above-mentioned personnel changes have not been filed with the market management department, please provide a copy of the resume and education of the new personnel.
4. Training and assessment of quality-related personnel; Management of health records of personnel involved in health requirements.
(II) Plant and facilities
1. Whether the production conditions of the enterprise have changed, and whether there are new or reduced production sites. If yes, whether the enterprise has submitted an application for license change or re-filed.
2. whether the main production facilities and equipment of the enterprise have been added or decreased. If yes, what facilities and equipment are there, and whether the equipment has been confirmed.
3. if the workshop has special requirements, is the daily management organized according to relevant standards, such as whether the clean workshop is organized according to YY/T33.
4. Is the equipment routinely maintained, repaired and reconfirmed according to the requirements of the management system?
5. whether the functional areas of the warehouse are managed according to the requirements and meet the needs of enterprises; Is the storage and distribution of medical devices entrusted to a third-party enterprise? If so, what products are they? Which company? If it has not been filed with the market management department, please provide a copy of the relevant qualification materials of the trustee.
6. check whether the equipment is verified or calibrated in time according to the plan. if it is self-calibrated, whether the calibrator is qualified.
(III) Production management
1. How many product registration certificates does the enterprise have at present, and how many filing vouchers? Which products have been discontinued, how long is the time limit for stopping production, and whether there is a plan to continue production. Whether the enterprise has stopped production or resumed production, if so, how long it has stopped production, and whether it has been inspected by the enterprise or the drug supervision department before resuming production.
2. Does the enterprise organize production and inspection according to standards (technical requirements)?
3. whether the standards cited by the enterprise have been updated, and if so, whether the enterprise has re-registered (put on record) or directly organized production and inspection according to the new standards.
4. whether the instructions and labels of the second and third products of the enterprise have been changed without authorization.
5. Have the suppliers of the main raw materials of the enterprise been audited and evaluated as required, and have there been any changes? If so, which ones? Is there any registration change (or re-filing) after the change of raw materials? Has the supplier of major raw materials changed? If so, what are they?
6. Is the production process of registered (filed) products consistent with that of registered (filed) products? If not, what are they? Has it undergone a complete design change?
7. Has the enterprise commissioned or entrusted a third-party enterprise for production? If so, which products and which enterprise?
8. what is the sales output of medical devices in this year, including the export output value?
9. introduction of new product research and development.
(4) Document records
1. Whether the batch records are complete, complete and true. Whether it can be traced back to the batch of main raw materials.
2. Does the enterprise keep samples? If so, whether the records are complete, complete and true.
3. Whether the document modification is reviewed according to the system, and whether the invalid document is kept according to the system requirements.
4. Whether all kinds of records are kept as required.
(V) Corrective and preventive measures
1. Management review and internal audit, evaluation results, main problems found and preventive and corrective measures taken by the enterprise during the year.
2. Evaluation and handling of customer complaints (including major complaints, major maintenance, serious adverse events and product recall) by enterprises.
3. The situation that the enterprise analyzes the data in the production process (such as rework, repair, environmental data, etc.) and takes preventive and corrective measures.
4. information such as whether the enterprise has a major production accident or quality accident, whether serious adverse events has been found, whether a product has been recalled, whether any product has been sampled for quality inspection (including sampling results), whether it has been subject to administrative punishment, etc.
5. rectification of nonconformities issued during the inspection by the market supervision and management department this year.
(VI) Enterprise Commitment
Enterprises need to make a commitment to the basic information reported and the authenticity of the report.
II. Medical device enterprises in Hangzhou
(I) Organization and personnel
1. Changes in organizational structure of enterprises.
2. Whether the responsibilities of the person in charge of the enterprise are clear.
3. The regulations and technical training and annual evaluation of the quality controller. If the change is not filed with the market management department, please provide a copy of the resume and education of the new employee.
4. training, assessment and inspection of quality-related personnel (such as professional and technical personnel, acceptance personnel, warehouse management personnel, after-sales service personnel, and inspection and distribution personnel). Management of health records of personnel involved in health requirements.
(II) Operation
1. Does the enterprise operate according to the business scope? If some business scope has never been operated, what are it? Will it be operated within the validity period of the license? If all operations are stopped, when will the start time be?
2. Does the enterprise deal in implant intervention products, diagnostic reagents, aseptic products, fitting products, condoms and free experience products? If so, what kinds are they?
3. Does the enterprise have free experience in the licensed business premises?
4. Does the enterprise issue sales power of attorney to the sales staff?
5. how much is the sales this year, and how much is the export?
(3) Hardware facilities and equipment
1. Has the enterprise entrusted a third-party enterprise for storage and distribution? If so, which products and which enterprise? If it has not been filed with the market supervision department, please provide a copy of the qualification certificate and entrustment agreement of the entrusted enterprise.
2. Has the enterprise configured relevant storage and transportation equipment according to the requirements of the product manual? If the enterprise needs to be equipped with equipment with temperature control, such as cold storage and cold chain transportation, is it confirmed and reconfirmed as required?
3. whether the functional areas of the enterprise warehouse are managed according to the requirements and meet the needs of the enterprise.
4. Does the enterprise use the computer system to trace the management products as required? Whether the scope of product traceability meets the requirements of laws and regulations. Does the computer system of an operating enterprise that provides storage and distribution for other enterprises have real-time electronic data exchange and traceability with the entrusting party?
5. if an enterprise entrusts other enterprises to carry out transportation, it shall assess the quality assurance ability of the carrier enterprise and whether an agreement is signed.
6. whether the current warehouse address and business premises of the enterprise are consistent with the license.
(IV) Purchase acceptance and after-sales
1. The enterprise evaluates the supplier in this year.
2. information on the enterprise's request for certificates and the authorization agreement signed.
3. Has the enterprise signed product quality responsibility and after-sales service with the supplier? If the enterprise entrusts a third party to implement product installation, maintenance and technical training services, has the enterprise signed an after-sales service agreement? If the third party does not belong to the supplier, which company is it?
4. whether there were any major production accidents or quality accidents, whether serious adverse events was found, whether there was a product recall, whether there were any product sampling and sampling results, whether there were administrative penalties, etc.
(V) Documentation
1. Implementation and update of enterprise management system.
2. Whether the training records of the enterprise are complete and true.
3. whether the product acceptance records and the warehouse entry and exit records of the enterprise are complete and true, consistent with the physical objects, and meet the requirements of traceability.
4. Whether the sales voucher of the retail enterprise is complete, complete and true, and whether the relevant information about the qualification of the buyer is kept.
5. Are all kinds of records of the enterprise filed according to the requirements of laws and regulations?