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ISO 13485

This international standard establishes the specific requirements for organizations that provide or manufacture medical devices.

CERTIFICATION

ISO 13485

ISO 13485 describes the requirements for the quality management system of an organization in the field of medical devices, which includes the latest improvements in quality management, technology, and regulations. Organizations may be involved in one or more stages of the life cycle, including design and development, production, storage and distribution, as well as the installation or maintenance of a medical device, and the design and development of associated activities (like technical support).
A medical device is any product used for diagnose, prevent, or treatment of a medical condition. Medical devices can be basic health products used to cover or protect a wound, or dentist chairs, pacemakers, vital support machines, and even in-vitro diagnostic reagents.

ISO 13485:2016 requirements

4. Quality Management System
5. Management Responsibility
6. Resources Management
7. Product Manufacturing
8. Measurement, Analysis, and Improvement

ISO 13485 requirements are applicable to any organization, independently of size, type or location except where explicitly stated otherwise. When the requirements are specified as applicable for medical devices, the given associated services are equally applied by the organization.

*Exclusions are allowed in the management system with a proper justification whenever the applicable regulatory requirements allow it.

Recommendations

To have a documented system in accordance with the applicable norm.
To clearly defined the certification scope.
To have evidence of implementation of the management system for at list 3 months.

*Recommendations:

To keep internal auditors with the competence to perform internal audits.
To keep records associated with at list one internal audit.
To keep implementation evidence associated with the documented process, record control, taken actions, internal audits, and among others.
To keep records associated with the management commitment where ISO 13485 standard, compliance requirements are assured.
To keep policies and defined objectives related and documented in accordance with ISO 13485requirements.