ISO 13485

What requirements do the international standards ISO 13485 and ISO 13488 contain?

ISO 13485 and ISO 13488 – international standards containing the requirements for the Quality Management System in enterprises producing medical devices.

ISO 13485 was published in July 2003. It resembles and contains all the basic requirements of ISO 9001 for QMS, but also includes the development of new types of production and services.

In addition to the requirements of ISO 9001, the standard includes specific requirements for the company producing medical products, such as: requirements for the hygiene of personnel, equipment and production premises; requirements for warehouses; ways to withdraw production from the market if it has a negative impact on consumers, etc.

The ISO 13488:1996 standard is the basis for the development, implementation and certification of the Quality Management Systems of enterprises that do not independently design new types of production. The stages of development, implementation and certification of the Quality Management Systems according to the requirements of ISO 13485/ ISO13488 are analogous to the ISO 9001, ISO 14001 QMS and described in detail in the relevant sections of the given prospectus.

Note: What is a medical device?

The term "medical devices" includes all instruments, devices, utensils, materials and other objects that are used alone or in combination /including programmatic provision for flawless functioning of medical devices/ with specific purposes:

• Diagnosis, prevention, monitoring, treatment or pain relief.
• Diagnosis, monitoring, treatment, anesthesia or trauma treatment.
• Research, change or alteration of anatomical structure or physiological process.
• Regulation of conception processes and their main function, with pharmacological, immunological or metabolic means.