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ISO 13485 and GMP

ISO 13485/488 has been specifically designed for production industry and supply of medical equipment helping to build a quality management system based on international standards ISO 13485 was published in July 2003.

This standard specifies requirements for quality management systems of enterprises, elaborating, installing medical products, devices and equipment. ISO 13485 is applicable to any organization manufacturing or providing technical maintenance of various types of medical equipment: devices, tools for diagnosis and treatment, medical examination and anesthesia, etc.

Adoption of ISO 13485 and compliance with the requirements of this standard helps managers to control risks at all stages of the business process starting from design and manufacturing to installation and operation.

Management system requirements are based on the basic principles of ISO 9001, but have been designed specifically for the quality management system (QMS) for the production of medical equipment, its storage, transportation and operation, as well as for well-organized work of personnel and early warning of problems.

Requirements of the standard are divided into the following groups:

  • Requirements to quality management system of a general nature
  • Management’s responsibility
  • Resource management
  • Management of processes of the entire product lifecycle
  • Analysis, measurements, improvements

Adoption of ISO 13485 allows to improve the quality of medical products, to reduce financial costs and risks, help to gain  competitive advantage in the market:

  • authorization for production of medical products in conformity with the relevant safety requirements;
  • improvement in productivity and efficiency in resource utilization;
  • acquisition of additional benefits with participation in tenders for state or municipal bids;
  • improvement of image and investment attractiveness of the company.


In world practice, the GMP (Good Manufacturing Practice for Medicinal Products) is a document that defines the requirements for the production and quality control of medicinal products for patients - ". GMP are the norms for manufacturers that helps to ensure quality control of medicinal products and dietary supplements. They indicate that products are made in conformity with the stated formula (composition), does not contain impurities, marked appropriately, properly packed and retain their properties till specified expiration date.

GMP define the parameters for each manufacturing stage starting from a material, which the shop floor is made from, the number of microorganisms per cubic meter of air, to the clothes of staff and markings applied in packaging. GMP rules establish requirements for quality management system, personnel, premises and equipment, as well as relevant documentation.

Abiding by GMP - is a necessary condition for the development of the domestic industry. Work of enterprises according to GMP standards excludes instability of quality during the manufacturing process and storage. GMP allows certifying the production itself, as well as protects consumers from defective products.

In order to certify the production, engaged in manufacturing of health care products, the certification body periodically inspects the company-manufacturer and confirms that the equipment and production processes comply with the GMP requirements of the World Health Organization (WHO).

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