I. Basic information of the enterprise
Name of the enterprise?
economic nature
affiliation?
address?
is it true to send messages by post?
legal representative duties? Job title?
associate personnel? Job title? A list of business managers
Name, gender, age, education level, job title, supervisor
Main products? What kind?
date of establishment?
the floor area is square meters, the building area is square meters
the total number of employees is above the intermediate title
the registered capital is 1, yuan, and the original value of fixed assets is 1, yuan
2. Establish and improve the enterprise quality system plan according to GB/T19 series standards
1. Whether to prepare to follow GB/T191 (or GB/T192); YY/T287 (or YY/T288) standard to establish and improve the quality system of this enterprise? Yes □ No □
2. The enterprise intends to apply for quality system certification in _ _ _ _. Or no plans.
3. there are _ _ _ _ _ people in the enterprise who have received the training of GB/T19 series standards and YY/T288 standards. There are _ _ _ _ _ people who have obtained the certificate of internal auditor.
4. The difficulties for an enterprise to pass the quality system certification are:
Cost □; Unsupervised □; Low management level □; Insufficient understanding □; The urgency is not great □
III. Product name and scope of application of this application for registration
Product name for application for registration: _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _.
this report covers the product range and name: _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _.
IV. Responsibility of enterprise quality management
1. Whether the quality-related management, implementation and verification staff have specified the quality responsibility and documented it. ? Yes □ No □
2. The management representative of the enterprise is _ _ _ _ _ _ _. Or □
3. Can the organization chart of enterprise quality system be provided? Yes □ No □
4. Does the enterprise collect and keep laws, regulations, administrative rules and quality standards related to production and operation? ? Yes □ No □
5. Whether the corporate representative or management representative has been trained in GB/T19 and YY/T287 standards. ? Yes □ No □
V. Design control
1. Does the enterprise establish and maintain documented procedures or corresponding requirements for design control and verification? ? Yes □ No □
2. Did you conduct a risk analysis during the design process? Yes □ No □
3. Whether all technical specifications and applied technical documents of the product have been established and saved (including product technical document list) Yes □ No □
4. Whether the record of design modification of the product after trial production registration has been saved. ? Yes □ No □
VI. Procurement control
1. Whether to establish and maintain documented procedures for controlling the procurement process. ? Yes □ No □
2. Whether the list of main procurement contents of products applying for quasi-production registration has been established and qualified subcontractors have been determined. ? Yes □ No □
3. Whether the purchasing information of this product is clear, definite and complete. Yes □ No □
VII. Process control
1. Whether the key process and special process (working procedure) for applying for quasi-production of registered products have been determined and the corresponding control documents or work instructions have been formulated. ? Yes □ No □
2. Whether the sterile medical devices are produced according to the Production Management Standard for Sterile Medical Devices. Yes □ No □
3. Whether the equipment, tooling and inspection instruments required by the product are available and can meet the requirements of the product manufacturing process. Yes □ No □
4. Whether the construction and manufacturing personnel participating in this product have corresponding qualifications or received targeted training. Yes □ No □
5. Whether the contents, procedures and records of the product process inspection have been determined. Yes □ No □
6. Whether the working environment and product cleanliness required by this product are specified. Yes □ No □
7. Whether the technical data and acceptance criteria for the installation and inspection of this product have been established. Yes □ No □
8. Whether the records to be formed in process control are specified. Yes □ No □
9. Have you determined the traceability scope and degree of the product (materials, components, process and destination) Yes □ No □
1. Can you see the product identification (including the label of the final product) and the identification of the inspection and test status on site? Yes □ No □
VIII. Product inspection and testing
1. Whether there is a full-time inspection and testing institution and its responsibilities and authorities are specified. Whether the identity of inspectors is recorded for active medical devices and implantable medical devices. Yes □ No □
2. Is there a documented procedure for inspection and test? Yes □ No □
3. Whether to conduct incoming inspection and verification. Yes □ No □
List the incoming inspection and verification procedures, name _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _.
4. whether to carry out process inspection. Yes □ No □
List the inspection procedures, names _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _.
5. Does the inspection test of the final product cover all the technical standards of the product before leaving the factory? Yes □ No □
6. Are the above inspection and test records and the latest type test report kept? Yes □ No □
7. Does the enterprise have corresponding test equipment? ? Yes □ No □
8. Has the enterprise established and implemented the specified documents for the control, calibration and maintenance of inspection, measuring and test equipment? Yes □ No □
IX. Other aspects
1. Does the enterprise regularly audit, review and evaluate product quality and quality management? ? Yes □ No □
2. Whether the records of the evaluation activities mentioned in the preceding paragraph are kept. Yes □ No □
3. Whether to stipulate how to evaluate and handle nonconforming products. Yes □ No □
4. Whether to handle customer complaints according to certain procedures and keep records. Yes □ No □
5. Whether there are any specified documents for implementing corrective and preventive measures. Yes □ No.