QMS certification registration conditions　

 

　　1.The applying organization shall hold a legal person's business license or document attesting to its legal status.

　　

　　2.A production license or other qualification has been obtained (when required by national or departmental regulations);

　　

　　3.Products covered by the QMS applying for certification shall meet the relevant national, industry, or registered product standards (enterprise standard) ,Product finalization and batch production.

　　

　　4.The organization of the application shall establish a management system that meets the criteria for the proposed application to be certified, and the requirements for the business that is engaged in the production and operation of medical devices should also meet the criteria of ISO 13485:2016, companies that produce three categories of medical devices, the operation time of the QMS shall be no less than 6 months, and other types of organizations, the operation time of the QMS shall be no less than 3 months.

　　

　　5.The applying organization has performed at least one full internal review and one management review.

　　

　　6.No significant customer complaints and quality incidents on the products of the applying organization during the year prior to the filing of the certification application.

 

Risk management system certification registration conditions

 

Recognized business areas for QMS certification

 

　

　　12 Chemicals, chemical products and fibres

　

　　14 rubber and plastic ware

　

　　17 basic metals and metal products

　

　　18 machinery and equipment

　

　　19 electrical and optical equipment

　

　　29 Wholesale and Retail

　

　　36 public administration

　

　　38 health and social services

　

　　" 19.11.00 manufacture of medical, surgical as well as orthopedic devices " in one of the 19 major categories, which are further divided according to the definition of the medical device:

　

　　19.11.00A active medical devices

　

　　19.11.00B passive medical devices

　

　　19.11.00C sterile medical devices

　

　　19.11.00D implantable medical devices

　

　　19.11.00E in vitro diagnostic reagents

　　

 

Recognized business areas for risk management system certification