1. Basic introduction 

ISO13485: the full name of standard in 2003 is the Medical device-Quality management system-requirements for regulatory. 

The standard is developed by SCA/TC221 medical device quality management and general requirements standardization technical committee. It is an independent standard based on iso9001:2000. The standard stipulates the requirements for the quality management system of related organizations, but it is not the implementation guide of ISO9001 standard in the medical device industry. Since its launch in 1996, the standard has been widely implemented and applied worldwide. The new edition of iso 13485 was officially released on July 3, 2003. Unlike the iso 9001:2000 standard, ISO13485:2003 is the management standard applicable to the regulatory environment: the name is clearly used for the requirements of the quality management system of the regulations. Medical apparatus and instruments in the world is not only just the general public goods in the business environment, it also affected by national and local laws, regulations, supervision, such as the United States FDA, the European Union, the MDD (eu medical equipment instructions), China's "regulations on the administration of medical devices. As a result, the standard must be bound by the law, in the regulatory environment, at the same time, must fully consider the risk of product of medical apparatus and instruments, in medical apparatus and instruments for risk management in the whole process of product realization. Therefore, in addition to the special requirements, it can be said that ISO13485 is actually the ISO9001 in the medical equipment and regulations environment. 

The United States, Canada and Europe generally use ISO 9001, EN 46001 or ISO 13485 as the requirements of quality assurance system, and set up the quality assurance system of medical devices based on these standards. Medical devices to enter North America, European or Asian markets, should comply with relevant regulatory requirements 

2. Historical development 

With the development of history, ISO has revised this standard to ISO13485:2003. Most medical equipment manufacturers have started to consider iso9001:2000 + ISO13485:2003 +CE certification as a package solution when establishing quality management system. The medical device industry has been using the ISO 13485 standard (China equivalent conversion standard number YY/T0287) as the basis for the quality management system certification. This standard, on the basis of ISO 9001:1994, adds to the special requirements of the medical device industry, which is called the 1+1 standard. Therefore, meeting the ISO 13485 standard also meets the requirements of ISO 9001:1994. After the ISO 9001:2000 standard was issued, the ISO/TC 210 issued new ISO 13485:2003 standard (the YY/T 0287-200x standard of the Chinese equivalent conversion is being approved). Recently, BS EN ISO 13485:13485 (the medical device quality management system for regulatory requirements ") has been updated, but the update has not changed the body of the standard content (preface part and accessories modified only) and the scope of the European standard (EN), only subsequent process and pay attention to British standards institution (BSI). 

 

3. Applicable objects 

To fulfill the requirements of international, European and domestic law and regulatory requirements for medical products manufacturers and service providers, and enterprises wishing to implement the document management system according to this standard. Companies that develop, manufacture and sell medical devices want to demonstrate their competitive and performance capabilities in international, European and domestic markets. Suppliers and other service providers in the value-added chain must ensure that their products are consistent with customer requirements. 

 

4. Authentication materials 

1. Application for quality certification application and quality system certification signed by authorized representative of the applicant; 2. Apply for the unit quality manual and provide the enterprise's program documents when necessary; 3. Product standards covered by the product or quality system applied for certification; 4. Declaration of the standards implemented by the applicant; 5. Registration certificate of medical device products (copy); 6. Summarized product production process, product production process, special process and key process description; 7. Product sales and user feedback in the past three years; 8. List of major outsourcing and outsourcing parts; 9. Other materials, such as enterprise product catalog, product profile, product publicity materials, etc. Provide information about the organization and personnel that have been consulted. 

 

5. Certification significance 

1. Improve and improve the management level of enterprises, avoid legal risks and increase the visibility of enterprises; 2. Improve and guarantee the quality level of products, so that enterprises can obtain greater economic benefits; 3. Conducive to the elimination of trade barriers and access to international markets; 4. Conducive to enhancing the competitiveness of products and enhancing the market share of products. 5. Effectively reduce the risk of product quality accidents or adverse events through effective risk management. 6. Improve the sense of responsibility, enthusiasm and dedication of employees.