Enterprise legal person, the person in charge of the enterprise has not changed.
Quality managers have not changed.
2. Changes in the scope of business, purchase channels, inspection (verification)
1. Increase in the scope of business:
2. Purchase: Purchase products from legal units (with production license or business enterprise license and business license) in accordance with the company's regulations, and require the supplier to
provide the product registration certificate and the product inspection report or certificate of conformity.
3, inspection: (1) check whether the outer packaging is in line with the packaging identification requirements. (2) The implementation of gradual opening verification and work records, (3) does not meet the packaging requirements and the existence of quality problems in a timely manner to deal with the product. (4) strict acceptance of the three types of products, for each batch of incoming goods to the supplier for inspection report form.
Three, the company's registered address, warehouse address changes and storage equipment, facilities, etc.
1, the company's registered address, warehouse address has not changed.
2, the implementation of commodity zoning, classification management.
3, the warehouse goods using shelves, and is equipped with: (1) fire-fighting equipment,
Thermohygrometer, matting, and anti-rodent facilities.
4, divided into qualified, unqualified area, to be inspected area and other areas.
Four, the implementation of relevant laws and regulations, management system
1, in accordance with the "supervision and management of medical devices regulations" to develop the company's quality management system at all levels.
2. Strictly examine the qualification of sub-suppliers (production license or business license),
and sign contract and quality agreement with sub-suppliers.
3, strict examination of the qualifications of the first enterprise, the first varieties.
4, conscientiously do a good job of acceptance of incoming goods, out of the warehouse review and sales records, such as sterile and other three types of products, the implementation of the management of special books.
5, I stipulate that the qualified area of the warehouse can not store expired, expired, no registration
number of products.
5, corporate integrity and market supervision of the sampling test, etc.
Five years, the company operates in the product, there is no unqualified phenomenon, and has not been subjected to any administrative penalties.
The main thing in the table is that these things, right, the personnel situation, get the honor to write their own.