ISO 13485 Certificates for the Medical Industry

ISO 13485 and ISO 13488 are international standards that define the requirements for a Quality Management System in companies manufacturing medical devices.

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

ISO 13485 and ISO 13488 are international standards that define the requirements for a Quality Management System (QMS) in companies manufacturing medical devices.
ISO 13485 was published in July 2003. It is similar to and includes all the main requirements of ISO 9001 for QMS, but also includes the development of new types of products and services.
In addition to the requirements of ISO 9001, the standard includes specific requirements for companies producing medical products, such as: requirements for personnel hygiene, equipment and production facilities; requirements for storage areas; methods for recalling products from the market if they have a negative impact on consumers, etc.
The ISO 13488:1996 standard is the basis for the development, implementation, and certification of Quality Management Systems in companies that do not independently design new types of products.
The stages of development, implementation, and certification of Quality Management Systems according to ISO 13485/ISO 13488 are similar to those of ISO 9001, ISO 14001, and are described in detail in the relevant sections of this brochure.

Note: What are medical devices?

The term “medical devices” includes all instruments, apparatus, equipment, materials, and other items used alone or in combination (including software necessary for the proper functioning of medical devices) for the following purposes:

Diagnosis, prevention, monitoring, treatment, or pain relief
Diagnosis, monitoring, treatment, pain relief, or healing of injuries
Investigation, replacement, or modification of anatomical structure or physiological processes
Regulation of conception processes and their primary function through pharmacological, immunological, or metabolic means

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