ISO 13485 Foundation

The ISO 13485 Foundation course provides professionals with the essential knowledge to implement and maintain quality management systems in the medical device industry, ensuring compliance and improvement.

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Overview

The ISO 13485 Foundation Course is designed for professionals seeking to understand the essential principles and requirements of the ISO 13485 standard for quality management systems in the medical device industry. As quality management is a critical aspect of compliance and product safety, this course equips learners with the knowledge to implement, maintain, and audit an effective quality management system. Delegates will gain the skills necessary to navigate the standard's key requirements and integrate them into their organisations' operations, ensuring they meet both regulatory and customer expectations.

This course provides an in-depth understanding of the ISO 13485 standard, focusing on its structure, requirements, and application. Delegates will learn how to implement risk management practices, document control, and corrective and preventive actions (CAPA), as well as the importance of internal audits and continual improvement. By mastering these key aspects, professionals will be able to contribute to the development and maintenance of an ISO 13485-compliant quality management system, ultimately enhancing product safety and regulatory compliance.

This 1-Day course by MPES offers an engaging and interactive learning environment, featuring case studies and practical exercises that bring the ISO 13485 standard to life. It is ideal for individuals looking to improve their understanding of quality management systems in the medical device sector and advance their careers by ensuring compliance with international standards.

Course Objectives

Understand the ISO 13485 standard and its role in medical device quality management
Learn key requirements for implementing and maintaining a compliant quality management system
Apply risk management principles for improved product safety and compliance
Master document control and management in line with ISO 13485
Gain proficiency in conducting internal audits and ensuring continual improvement
Understand the role of CAPA in maintaining quality standards
Ensure compliance in a regulated medical device environment

Upon completion, delegates will be equipped with the knowledge and skills to confidently implement and maintain an ISO 13485-compliant quality management system, ensuring that their organisations meet regulatory requirements, improve operational efficiency, and contribute to the safety and quality of medical devices.

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1 Month

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Course Details

Develop your understanding of essential financial, business and management accounting techniques with ACCA Applied Knowledge. You'll learn basic business and management principles and the skills required of an accountant working in business.

Entry Requirements

Professional Background: No prior experience with ISO 13485 is required; however, familiarity with quality management concepts or the medical device industry will enhance your learning experience.
Industry Knowledge: Learners should have a basic understanding of the medical device sector, as well as the importance of regulatory standards and quality control processes.
Language Proficiency: Learners must have a strong command of English, as all course content, discussions, and assessments are delivered in English.

Learning Outcomes

Understand ISO 13485 Principles: Gain a thorough understanding of the key principles of ISO 13485, including the structure and requirements for a quality management system in the medical device industry.
Implement QMS Practices: Learn how to implement quality management system practices effectively, ensuring compliance with industry standards, improving product quality, and reducing risks.
Conduct Internal Audits: Understand the process of conducting internal audits within a medical device organisation to assess compliance with ISO 13485, identify areas for improvement, and support continual quality enhancement.
Manage Regulatory Requirements: Gain the knowledge needed to navigate regulatory requirements related to ISO 13485, ensuring products meet safety and quality standards while staying compliant with relevant regulations.

Target Audience

The ISO 13485 Foundation Course is designed for professionals involved in the medical device industry or those seeking to develop a comprehensive understanding of ISO 13485 principles. This course is suitable for:

Quality Managers
Regulatory Affairs Professionals
Compliance Officers
Medical Device Manufacturers
Auditors
Project Managers
Production Managers
Risk Managers
Engineering Professionals
Consultants in the Medical Device Sector

Course content

Module 1: Introduction to ISO 13485:2016

Introduction
What is ISO 13485:2016?
Importance of ISO 13485

Module 2: An Overview of ISO 13485:2016 Requirements

Requirements of ISO 13485:2016
General Requirements
Documentation requirements
Management Responsibility
Resources
Product Realisation
Infrastructure
Risk Management

Module 3: Implementation Phases of the ISO 13485 Frameworks

Stages to Implementation
Gap Analysis
Process Mapping

Module 4: Conducting an ISO 13485 Certification Audit

Certification Audits

Module 5: The Relationship Between ISO 13485 and ISO 9001

Scope
Focus
Continual Improvement
Terminology
Differences Between the Standards
Similarities Between the Standards

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Have Questions? We’ve Got You

If you have any questions, we’re here to help. Find the answers you need in the MPES detailed FAQ section.

Q. What is the primary focus of the ISO 13485 Foundation Course?

This course focuses on providing professionals with a comprehensive understanding of the ISO 13485 standard, specifically designed for organisations involved in the design, production, and maintenance of medical devices. It equips delegates with the essential knowledge and skills to implement and maintain a quality management system (QMS) in compliance with international standards, ensuring that medical devices meet regulatory requirements and quality benchmarks.

Q. What will I learn during the training?

Delegates will learn the core principles and requirements of ISO 13485, including the structure of the standard, key documentation, risk management, and process control. The training will cover the roles and responsibilities within a QMS, audit processes, and how to ensure compliance with regulatory requirements in the medical device industry. Practical exercises will help delegates apply these concepts effectively in real-world scenarios.

Q. Who is this course intended for?

This course is intended for professionals in the medical device industry who want to gain a solid foundation in ISO 13485, including quality managers, compliance officers, regulatory professionals, and anyone involved in quality management or regulatory affairs within organisations producing medical devices.

Q. Will this training provide experience with implementing ISO 13485?

Yes, the course offers practical guidance on how to implement the ISO 13485 standard, including real-life case studies and hands-on exercises. Delegates will gain the experience needed to establish and maintain a compliant quality management system and effectively prepare for audits, ensuring their organisations meet the necessary regulatory and quality standards.

Q. How does this course benefit my career in the medical device industry?

This training provides professionals with the expertise needed to lead quality management initiatives in the medical device sector, ensuring compliance with ISO 13485 and other regulatory requirements. By mastering the standards, delegates enhance their ability to drive continuous improvement, reduce risks, and maintain high-quality standards, positioning themselves for leadership opportunities and career advancement in the medical device industry.

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