Global Certificate in ISO 13485 Audit Readiness
-- viewing nowThe Global Certificate in ISO 13485 Audit Readiness course is a comprehensive program designed to equip learners with the necessary skills to excel in medical device quality management. This course is crucial for professionals seeking to understand and implement the ISO 13485 standard, which is a prerequisite for entering the medical device industry or conducting business in international markets.
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Course Details
• ISO 13485 Audit Readiness
• Understanding ISO 13485:2016 Requirements
• Gap Analysis for ISO 13485 Compliance
• Documentation Controls for ISO 13485 Audit
• Internal Audit Process for ISO 13485
• Corrective and Preventive Action (CAPA) Management
• Risk Management in ISO 13485 Audit
• Management Review and Continuous Improvement
• Preparing for the ISO 13485 External Audit
• Handling Nonconformities and Effective Root Cause Analysis
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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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