ISO-13485 QMS

Most regulatory agencies require medical device manufacturers to have a Quality Management System (QMS). A QMS is a set of policies, processes and procedures needed for planning and executing an organization's core business. A medical device company's Quality Management System should cover all parts and elements of a manufacturer's organization that deal with the quality of processes, procedures and devices. It manages the structure, responsibilities, procedures, processes and management resources needed to implement the principles and actions necessary to ensure compliance with the regulations of their target markets.

Regulators of different countries conduct audits of manufacturers' Quality Management Systems to determine whether the QMS complies with the quality regulations applicable to medical device companies. Manufacturers in other countries that sell their devices in a specific market are also subject to QMS audits.

The quality system provisions of the European Union are set out in Article 10 of Regulation EC 2017/745 and Annex IX (Regulation EC 2017/746 in the case of in vitro diagnostic devices).

EXCOPAN is pleased to provide an assessment of what is required and what will be included in your Quality Management System in accordance with your corporate needs. Our team will help ensure that all ISO 13485 implementation requirements are addressed in your QMS.


ISO 13485:2016 Clause by Clause

The subject and description of the training: “ISO 13485 Medical Devices Quality Management System Requirements Training” is a comprehensive training in which the ISO 13485 standard, the operation of the Medical devices management system throughout the sector, is explained one by one, with standard items.

The purpose of education; It focuses on the process approach of ISO 13485 and how the standard and GMP rules complement each other. In addition, participants are informed about the risk management principles defined in ISO 14971, which is the "Risk Management Practice in Medical Devices" standard.

Reasons for the necessity of education:

  • Explanation of all the articles of the ISO 13485 standard,

  • Explaining the role of management in the implementation of the ISO 13485 standard,

  • Explaining the relationship between risk management and ISO 14971.

Target audience of the training:

  • Quality Managers

  • Licensing Unit Managers

  • Internal auditors of medical device manufacturers

  • Functional team members involved in the implementation

  • Professionals providing audit services to organizations in the sector

Training duration: 2 days

  • ISO 13485 standardının gerekliliklerinin anlaşılması,

  • ISO 13485 ve GMP kuralları arasındaki ilişki ile ilgili genel bilgilerin edinilmesi.

Outcomes of the training:

  • Understanding the requirements of the ISO 13485 standard,

  • Obtaining general information about the relationship between ISO 13485 and GMP rules.



Smart QMS is a modern quality management software platform built exclusively for the unique needs of the medical device industry. Our platform is currently being used by innovative medical device companies in over 600 cities and 50 countries on 6 continents to bring new products to market faster while simplifying regulatory compliance and reducing risk. Device makers across the globe are replacing their outdated paper-based and general purpose legacy quality systems with Smart QMS. Being the only modern, industry specific, cloud-based eQMS, Smart QMS is easier to implement, easier to use and simply fits medical device processes better allowing companies to innovate faster and be more efficient. To learn more about how we could help your device company or to demo our software.