Global Certificate in ISO 13485: Career Growth
-- viewing nowThe Global Certificate in ISO 13485 is a career-advancing course that focuses on the quality management system requirements for the medical device industry. This certification equips learners with essential skills to meet industry demands for professionals with a solid understanding of ISO 13485, a critical standard for medical device companies.
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Course Details
• Introduction to ISO 13485: Understanding the Standard & Its Importance
• Key Principles & Requirements of ISO 13485:2016 for Medical Devices
• Risk Management in ISO 13485: Implementing ISO 14971 & ISO 31000
• Building & Documenting Quality Management System (QMS) for ISO 13485 Compliance
• Establishing & Managing Processes for Effective Quality Control
• Internal Audits & Management Review: Preparing for Certification
• Managing Supplier Relationships & Ensuring Compliance
• Corrective & Preventive Action (CAPA) in ISO 13485: Root Cause Analysis & Continuous Improvement
• Maintaining & Updating the ISO 13485 Certification: Best Practices for Continual Compliance
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Entry Requirements
- Basic understanding of the subject matter
- Proficiency in English language
- Computer and internet access
- Basic computer skills
- Dedication to complete the course
No prior formal qualifications required. Course designed for accessibility.
Course Status
This course provides practical knowledge and skills for professional development. It is:
- Not accredited by a recognized body
- Not regulated by an authorized institution
- Complementary to formal qualifications
You'll receive a certificate of completion upon successfully finishing the course.
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