ISO 13485:2016 Summary

ISO 13485:2016 is an international standard that outlines the requirements for a quality
management system (QMS) specific to the medical device industry. Here are the main points
of ISO 13485:2016:

Scope and Application: The standard applies to organizations involved in the design,
development, production, installation, and servicing of medical devices and related services.

Quality Management System (QMS): Organizations must establish, document, and maintain
a QMS that complies with the requirements of ISO 13485. This includes defining processes,
responsibilities, and procedures.

Management Responsibility: Top management is responsible for demonstrating leadership

and commitment to the QMS. This involves establishing a quality policy, ensuring the QMS
meets the organization's needs, and conducting regular management reviews.

Resource Management: Organizations must determine and provide the necessary resources
(human, infrastructure, etc.) for the effective operation of the QMS.

Product Realization: This section outlines the processes for product development, including
design and development planning, validation, and verification. It also covers purchasing,
production, and servicing activities.

Measurement, Analysis, and Improvement: Organizations are required to establish processes

for monitoring and measuring product conformity, customer satisfaction, and the
effectiveness of the QMS. Continuous improvement is emphasized, and corrective and
preventive actions should be implemented as needed.

Documentation and Records: ISO 13485 requires the establishment and maintenance of
documented procedures and records to demonstrate compliance with the standard.

Regulatory Requirements: Organizations must ensure compliance with applicable regulatory

requirements for medical devices in the regions where they operate.
Adhering to ISO 13485:2016 helps organizations in the medical device industry demonstrate
their commitment to quality and regulatory compliance, ultimately contributing to the safety
and effectiveness of medical devices.