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The ISO 13485 Foundation course is a training program that provides an overview of the ISO 13485 standard, which sets out the requirements for a quality management system (QMS) for the design and manufacture of medical devices. The ISO 13485 Foundation course in Afghanistan covers the structure and requirements of the standard, the principles of quality management, and the steps involved in implementing and maintaining a QMS that meets the requirements of ISO 13485. The ISO 13485 Foundation course is aimed at individuals who are involved in the design, development, production, or maintenance of medical devices and who want to understand the requirements of the standard. The ISO 13485 Foundation course is also useful for those who want to understand the principles of quality management and the role of a QMS in ensuring the safety and efficacy of medical devices.
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1. Introduction to ISO 13485
• Introduction
• What is ISO 13485:2016?
• Benefits of Implementing ISO 13485
• Applications of ISO 13485
• First Steps to ISO 13485:2016 Compliance
• What is a Medical Device?
• Purpose of a Quality Management System
• Importance of ISO 13485
• Basic Principles of ISO 13485
• Exercise
2. ISO 13485 Clauses
• Scope
• Management Responsibilities
• Resource Management
• Normative References
3. ISO 13485 Clauses 3 and 4
• Clause 3 - Terms and Definitions
• Clause 4 - Quality Management System
• Clause 4.1 General Requirements
• Clause 4.2 Document Requirements
• Exercise
4. Requirements and Quality Systems
• Requirements and Quality Systems
• Clause 5 - Management Responsibilities
• Clause 6 - Resource Management
• Clause 7 - Product Realisation
• Clause 8 - Measurement, Analysis, and Improvement
• Exercise
5. Overview of ISO 13485:2016 Requirements
• Requirements of ISO 13485:2016
• General Requirements
• Documentation Requirements
• Management Responsibility
• Resources
• Product Realisation
• Infrastructure
• Risk Management
6. Implementation Phases of the ISO 13485 Frameworks
• Stages to Implementation
• Gap Analysis
• Process Mapping
7. Conducting an ISO 13485 Certification Audit
• Certification Audits
• Exercise
8. Relationship Between ISO 13485 and ISO 9001
• Scope
• Focus
• Continual Improvement
• Terminology
• Differences Between the Standards
• Similarities Between the Standards
Number of questions: 40
Exam Mode: Online/Web-based Closed book
Duration: 60 mins
Exam format: Essay type
Interactive sessions by expert and accredited trainers in classroom
Industry experienced trainers led online sessions
Flexible delivery methods are available depending on your learning style.
You will learn from qualified, accredited, certified and highly experienced trainers in classroom
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30%
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Benefits
What is ISO 13485 Foundation Course?
ISO 13485 Foundation Course is an international standard that sets out requirements for a quality management system specific to the medical device industry.
Who can benefit from ISO 13485 Foundation certification?
Organizations involved in the design, production, installation, or servicing of medical devices can benefit from ISO 13485 certification.
What are the key requirements of ISO 13485?
How is ISO 13485 different from other quality management standards?
What are the benefits of ISO 13485 certification?
Is ISO 13485 certification mandatory?
What is the process for obtaining ISO 13485 certification?
How long does it take to obtain ISO 13485 certification?
How often must ISO 13485 certification be renewed?
What are the consequences of non-compliance with ISO 13485?
Why is ISO 13485 important?
ISO 13485 is important because it helps medical device manufacturers ensure that their products are safe, effective, and comply with regulatory requirements. It also demonstrates commitment to quality and customer satisfaction.
What is the process approach in ISO 13485?
The process approach in ISO 13485 involves understanding, documenting, and managing processes to ensure consistent and effective product realization and compliance with regulatory requirements.
How does ISO 13485 address risk management?
ISO 13485 requires organizations to establish a risk management process to identify, assess, and mitigate risks associated with medical devices throughout their lifecycle.
Can ISO 13485 certification be used to demonstrate compliance with regulatory authorities?
Yes, ISO 13485 certification is often recognized by regulatory authorities as evidence of a quality management system that complies with medical device regulations.
Is ISO 13485 suitable for both small and large organizations?
Yes, ISO 13485 can be tailored to the size and complexity of the organization, making it suitable for both small and large organizations involved in the medical device industry.
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