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 Armenia 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 in Armenia 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.
Training Calendar for International Organization for Standardization (ISO)
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ISO 13485 Foundation
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
Target Audience
* Those involved in the implementation of the ISO 13485 standard
* Those involved in operations related to a Quality Management System for Medical Devices
* Members of Medical Devices Quality
* Team Auditors
* Professionals from the medical device industry
IT Includes
* 1 day interactive instructor-led training
* Training provided by highly qualified, certified, and accredited trainers from PECB
* Certificate of ISO 13485 Foundation course by PECB
* Certification
Exam Format
Number of questions: 40
Exam Mode: Online/Web-based Closed book
Duration: 60 mins
Exam format: Essay type
Training Delivery Modes
Mindbel learning offers 4 learning modes to choose
Classroom Training
Interactive sessions by expert and accredited trainers in classroom
Online Training
Industry experienced trainers led online sessions
Corporate group training for corporates
Flexible delivery methods are available depending on your learning style.
Focused One to One training
You will learn from qualified, accredited, certified and highly experienced trainers in classroom
Benefits of ISO 13485 Foundation training with Mindbel
Average Salary
$130K
per annum
Expected Job growth rate
30%
Companies Hiring
Job Roles
- Medical Device Professionals
- Quality Assurance Personnel
- Regulatory Affairs Specialists
- Manufacturing and Production Staff
- Auditors and Assessors
- Biomedical Engineers
- Compliance Officers
- Healthcare Professionals
- Start-ups in Medical Device Industry
Benefits
* The ISO 13485 Foundation course provides a solid foundation for participants, offering a comprehensive understanding of the principles, requirements, and structure of the ISO 13485 standard for medical device quality management.
* Participants gain insights into international quality management standards, ensuring they are well-versed in the globally recognized ISO 13485 standard, which is crucial for organizations operating in the medical device industry.
* The course equips individuals with the knowledge and tools needed to enhance and maintain robust quality assurance practices within their organizations, contributing to the delivery of safe and effective medical devices.
* Understanding risk management is a key aspect of the ISO 13485 standard. Participants learn how to identify, assess, and manage risks effectively, contributing to the overall safety and reliability of medical devices.
* Certification in ISO 13485 is often a requirement for engaging in global medical device markets. Completing the Foundation course gives participants a competitive advantage by demonstrating their commitment to quality and regulatory compliance.
ISO 13485 Foundation Training FAQs
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?
Key requirements of ISO 13485 include a documented quality management system, risk management, design and development processes, control of suppliers, and product traceability.
How is ISO 13485 different from other quality management standards?
ISO 13485 is specific to the medical device industry and focuses on regulatory requirements, while other quality management standards, such as ISO 9001, are more general and focused on customer satisfaction.
What are the benefits of ISO 13485 certification?
Benefits of ISO 13485 certification include improved product quality, increased customer confidence, improved regulatory compliance, and a competitive advantage in the marketplace.
Is ISO 13485 certification mandatory in Armenia?
ISO 13485 certification in Armenia is not mandatory, but it is often required by medical device regulators and customers.
What is the process for obtaining ISO 13485 certification in Armenia?
The process for obtaining ISO 13485 certification in Armenia includes implementing a quality management system, conducting internal audits, and undergoing an external audit by a third-party certification body.
How long does it take to obtain ISO 13485 certification in Armenia?
The time to obtain ISO 13485 certification varies, but it typically takes several months to a year, depending on the size and complexity of the organization.
How often must ISO 13485 certification be renewed?
ISO 13485 certification in Armenia must be renewed every three years through surveillance audits and a recertification audit.
What are the consequences of non-compliance with ISO 13485?
Consequences of non-compliance with ISO 13485 can include loss of certification, increased regulatory scrutiny, and decreased customer confidence.
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 in Armenia 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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