ISO 13485 Medical Devices Quality Management System is a system based on ISO 9001 Quality Management System, but it differs from this system at certain points. First of all, the ISO 13485 standard has special requirements for medical devices. It has different requirements, especially in the design stages. For this reason, companies producing medical devices and providing technical service in this field, establish and implement ISO 13485 Medical Devices Quality Management System in their enterprises. The document proving the application of this system is ISO 13485 Certificate.

ISO 13485: 2016 specifies requirements for a quality management system in which an organization must demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable legal requirements. Such organizations may take part in one or more stages of the life cycle, including the design and development or provision of activities related to the design and development, manufacture, storage and distribution, assembly or service of a medical device (eg technical support). ISO 13485: 2016 may be used by suppliers or external parties providing products to such organizations, including quality management system related services.


ISO 13485: 2016 requirements apply to organizations regardless of size and regardless of type unless explicitly specified. If the requirements are specified to apply to medical devices, the requirements apply equally to the services provided by the organization.
ISO 13485: The processes required by 2016, which apply to the organization but are not performed by the organization, are the responsibility of the organization and are accounted for in the organization's quality management system by monitoring, maintaining and controlling the processes.


If applicable regulatory requirements allow the exclusion of design and development controls, this may be used as a justification for removal from the quality management system. These legal requirements may provide alternative approaches to be addressed in the quality management system. ISO 13485: It is the responsibility of the organization to ensure that claims for compliance with 2016 reflect the exclusion of design and development controls.
ISO 13485: If any requirement is not required in paragraphs 2016, 6 or 7 of ISO 8, the organization does not need to be included in these terms due to the activities undertaken by the organization or the nature of the medical device to which the quality management system is applied. a requirement in the quality management system. According to any substance that is found not to be applicable, the organization records the rationale as described in 4.2.2.

The main purpose of the ISO 13485 standard is to harmonize the requirements of the legal regulations on the production of medical devices and providing services with the Quality Management System standard.

Now briefly ISO 13485 standard and the ISO 9001 standard. In practice, these two standards are divided into five different points:

  • The ISO 13485 standard is based on the specific requirements of medical devices and the product conditions are handled more specifically than the ISO 9001 standard.
  • Compliance with legal regulations in the ISO 13485 standard is more effective and compulsory than the ISO 9001 standard.
  • The documentation required by the ISO 13485 standard is much more comprehensive than the ISO 9001 standard.
  • In the ISO 13485 standard, it is sufficient to meet customer requirements and customer requirements, but the ISO 9001 standard requires monitoring customer satisfaction.
  • Continuous improvement is excluded from the ISO 13485 standard. The reason for this is that many medical devices regulations require the continuity of the quality management systems of the firms. However, continuous improvement is essential in the ISO 9001 standard.

As can be seen, quality is essential in the ISO 13485 standard, but different applications are designed according to the conditions of medical devices. The companies have ISO 13485 Certificate and above all they have superiority to their competitors. This competitive advantage also gives the company prestige. Having the USO 13485 Certificate, which has an effect that increases the market share in domestic and international markets, is also important in terms of raising the awareness of quality in the company, adopting a process-oriented production and service mode and standardizing production and service activities.

With this certificate, companies gain a significant advantage especially in exports to European Union countries. The document increases the confidence in medical devices produced in this way.

What is more important is that if the company wants to carry out studies on CE marking and obtain CE Certificate, it is necessary to have ISO 13485 Medical Devices Quality Management System Certificate in advance.

our company TÜRCERT Technical Control and Certification Company provides fast, quality and reliable certification services to all medical device manufacturers who want to establish ISO 13485 Medical Devices Quality Management System and obtain ISO 13485 Certificate. If there are any doubts about ISO 13485 Medical Devices Quality Management System Certificate, we are always at your side as a company.