Scope

This training program provides a complete understanding of the international standard ISO 13485:2016, which specifies requirements for a quality management system for medical devices.

The standard applies to any organization involved in one or more stages of the medical device life cycle. These stages include design and development, production, storage and distribution, installation, servicing, and final decommissioning and disposal. The standard also applies to suppliers and external parties that provide products or services to medical device organizations.

The program covers all major requirements of the standard, including documentation, management responsibility, resource management, product realization, design and development, purchasing, production, monitoring, measurement, and improvement.

Objective

Upon completion of this program, learners will be able to do the following:

• Explain the purpose and scope of ISO 13485:2016 and how it applies to their organization.
• Identify the key components of a quality management system.
• Apply the process approach and risk-based thinking to daily quality management activities.
• Implement effective design and development, purchasing, and production controls.
• Establish robust processes for complaint handling, corrective action, and preventive action.
• Maintain proper records and documentation to demonstrate conformity to the standard.

Target Audience

• Quality management system professionals in medical device organizations.
• Medical device manufacturers, suppliers, and external parties.
• Internal and external auditors.
• Regulatory affairs specialists.
• Design and development engineers.
• Production and service personnel.

Certification

Learners who successfully complete the program will receive a dated, traceable certificate that provides verifiable proof of their achievement for professional records.