2. Different audit institutions: GMP represents the country to audit, and 13485 is only a certification body.
3. Different concerns: GMP pays the most attention to substantive details, and 13485 is only a general standard, and the specific implementation degree depends on the internal situation of the enterprise.
4.GMP supervisors and auditors are grandfathers, and 13485 auditors act according to the face of the audited enterprise, otherwise there will be no food.
It can be said that GMP originated from 13485, but the detailed requirements are higher than 13485, and there are many vetoes that must be met.
2? CE has passed EU certification. The United States needs to register with the FDA, depending on the product category. O 13485 international certification is the ISO system certification of medical enterprises.
Because medical products are special products to heal the wounded and rescue the dying, prevent and treat diseases, the basic requirement of their quality is safety and effectiveness. It is not enough to standardize medical device manufacturers only according to the general requirements of ISO9000 series standards. Therefore, the ISO 13485 standard issued by ISO puts forward special requirements for the quality management system of medical device manufacturers.
GMP focuses on the conditions of production equipment in the whole process from product planning, research and development to realization; Environmental factors; Personnel; More comprehensive and specific objective requirements such as institutional factors.