ISO 13485 Lead Implementer​ Training ​Course Outline

Module 1: Introduction to ISO 13485:2016

  • 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

Module 2: ISO 13485 Clauses 1 and 2

  • Clause 1 – Scope
  • Clause 5 - Management Responsibilities
  • Clause 6 - Resource Management
  • Clause 2 - Normative References

Module 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

Module 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

Module 5: Overview of ISO 13485:2016 Requirements

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

Module 6: Implementation Phases of the ISO 13485 Frameworks

  • Stages to Implementation
  • Gap Analysis
  • Process Mapping

Module 7: Conducting an ISO 13485 Certification Audit

  • Certification Audits
  • Exercise

Module 8: Relationship Between ISO 13485 and ISO 9001

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

Module 9: Internal Auditing

  • Internal Auditing
  • Internal Audit Objectives
  • Auditing Skills
  • Steps in Internal Auditing
  • Planning, Preparation, and Management of Audits
  • Internal Audit – PDCA Cycle
  • Types of Audit
  • Audit Techniques
  • Exercise

Module 10: Internal Audit Plan

  • Audit Plan
  • Criteria

Module 11: Audit Process

  • Audit Process
  • Conducting Process Audits
  • Scope
  • Criteria
  • Reporting Audit Findings

Module 12: Internal Audit Evidence and Findings

  • Internal Audit Evidence and Findings
  • Classification
  • Closing Report
  • Nonconformities
  • Documented Procedure
  • Exercise

Module 13: Roles and Responsibilities

  • Internal Auditor Responsibilities
  • Closing Meetings

Module 14: Resource Management and Product Realisation

  • Provision of Resources
  • Infrastructure
  • Planning and Development of Products

Module 15: ISO 13485 and Quality Management Systems

  • ISO 13485
  • Quality Management Systems (QMS)
  • Exercise

Module 16: Principles of Quality Management System

  • Principles of QMS
  • Exercise

Module 17: Fundamentals of Quality Management Systems

  • Fundamentals of Quality Management Systems

Module 18: Measurement, Analysis, and Improvement

  • Measurement, Analysis, and Improvement
  • General Requirements
  • Monitoring and Measurement
  • Control of Nonconforming Product
  • Performance of QMS
  • Analysis of Data
  • Improvement
  • Corrective Action
  • Preventive Action
  • Identification of Improvement Opportunities

Module 19: Risk Management

  • Risk Management
  • Risk Management Principle
  • Risk Management Process
  • Risk Lifecycle
  • Risk Management Tools
  • Risk Management Culture
  • Assessments and Control of Risk Management
  • Exercise
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Who should attend this ISO 13485 Lead Implementer Course?

The ISO 13485 Lead Implementer Course gives employees the knowledge and skills they need to lead the implementation and management of an ISO 13485-based Quality Management System for medical devices. Below are some professionals who can benefit from this course:

  • Quality Managers
  • Regulatory Affairs Professionals
  • Product Managers
  • Compliance Officers
  • Manufacturing Managers
  • Quality Assurance Professionals
  • Internal Auditors

Prerequisites of the ISO 13485 Lead Implementer Course

There are no formal prerequisites for this ISO 13485 Lead Auditor Course. However, prior experience in medical device manufacturing or regulatory compliance will greatly benefit the delegates.

ISO 13485 Lead Implementer Training Course Overview

ISO 13485 Lead Implementer Training is a course that introduces delegates to managing quality in the medical device industry. ISO 13485 Certification is a globally recognised standard that establishes Quality Management System requirements for medical device organisations. Understanding its relevance is crucial to ensuring that organisations consistently meet customer and regulatory requirements in the medical device field.

Mastering ISO 13485 is essential for anyone responsible for implementing and managing Quality Management Systems in the medical device industry. It provides a valuable credential for individuals dedicated to quality assurance and regulatory compliance, opening opportunities for high-profile jobs and enhanced earnings. Its importance lies in improving an organisation's overall performance and mitigating risks associated with medical devices.

The 3-day ISO 13485 Lead Implementer Training Course equips delegates with the knowledge and skills to effectively implement a Quality Management System for medical devices. Participants will gain an in-depth understanding of the auditing process, enabling them to obtain and evaluate audit evidence objectively. They will also learn how to control nonconforming products identified during the inspection process.

Course Objectives

  • To evaluate the expectations and requirements of the customers
  • To improve the quality of medical devices manufactured by a company
  • To promote harmonisation of regulatory requirements for manufacturers
  • To enhance the credibility and image of a company to represent compliance
  • To engage management actively and undertake management system activities
  • To design and develop consultancy for a respiratory inhaler manufacturer

At the end of this training, delegates can implement this ISO standard by specifying company requirements and the scope of medical devices. They will also be able to analyse the data and implement identified opportunities for improvement.

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What’s included in this ISO 13485 Lead Implementer Course?

  • ISO 13485 Lead Implementer Examination
  • World-Class Training Sessions from Experienced Instructors 
  • ISO 13485 Lead Implementer Certificate
  • Digital Delegate Pack

 


You’ll also get access to the MyTKA Training Portal, which will be your go to hub for all your training.
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ISO 13485 Lead Implementer Exam Information

To achieve the ISO 13485 Lead Implementer, candidates will need to sit for an examination. The exam format is as follows: 

  • Question Type: Multiple Choice  
  • Total Questions: 30 
  • Total Marks: 30 Marks 
  • Pass Mark: 50%, or 15/30 Marks 
  • Duration: 40 Minutes  
  • Open Book/ Closed Book: Closed Book
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Experience live, interactive learning from home with The Knowledge Academy's Online Instructor-led ISO 13485 Lead Implementer Course. Engage directly with expert instructors, mirroring the classroom schedule for a comprehensive learning journey. Enjoy the convenience of virtual learning without compromising on the quality of interaction.

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Experience the most sought-after learning style with The Knowledge Academy's ISO 13485 Lead Implementer Course. Available in 490+ locations across 190+ countries, our hand-picked Classroom venues offer an invaluable human touch. Immerse yourself in a comprehensive, interactive experience with our expert-led ISO 13485 Lead Implementer sessions.

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Package deals for ISO 13485 Lead Implementer

Our training experts have compiled a range of course packages on a variety of categories in ISO 13485 Lead Implementer, to boost your career. The packages consist of the best possible qualifications with ISO 13485 Lead Implementer, and allows you to purchase multiple courses at a discounted rate.

ISO 13485 Lead Implementer FAQs

What is ISO 13485 Lead Implementer?

The ISO 13485 Lead Implementer certification equips professionals with the knowledge and skills to implement, manage, and maintain a medical device quality management system (MDQMS) in compliance with ISO 13485 standards. It focuses on ensuring regulatory adherence and quality assurance in the medical device industry.

Are there any prerequisites to attend this ISO 13485 Lead Implementer Training?

There are no formal prerequisites for this ISO 13485 Lead Auditor Course. However, prior experience in medical device manufacturing or regulatory compliance will greatly benefit the delegates.

What are the reasons for implementing ISO 13485 in a company?

Implementing ISO 13485 ensures compliance with global regulatory requirements, improves product quality, reduces risks, and enhances customer confidence. It also streamlines operations, facilitates market access, and establishes a framework for consistent quality management in the medical device industry.

What are the benefits of taking this ISO 13485 Lead Implementer Training?

The training enhances expertise in implementing ISO 13485 standards, boosts career prospects, and prepares professionals to lead quality initiatives in the medical device sector. It also enables organisations to achieve certification and improve their market credibility.

What is included in this ISO 13485 Lead Implementer Training Course?

In this training course, delegates will have intensive training with our experienced instructors, a digital delegate pack consisting of important notes related to this course, and a certificate after course completion, ensuring you gain practical experience and in-depth knowledge.

What is the duration of this ISO 13485 Lead Implementer Training Course?

This course takes 3-day to complete during which delegates participate in intensive learning sessions that cover various course topics.

Who should attend this ISO 13485 Course?

This course is ideal for Quality Managers, Compliance Officers, Regulatory Professionals, Consultants, and anyone involved in implementing or managing medical device quality management systems. It is also suitable for professionals aiming to expand their expertise in ISO standards.

Do you offer 24/7 support for this ISO 13485 Lead Implementer Training?

Yes, The Knowledge Academy offers 24/7 support via phone & email before attending, during, and after the course. Our customer support team is available to assist and promptly resolve any issues you may encounter.

Do you provide self-paced ISO 13485 Lead Implementer Certification Course?

The Knowledge Academy provides flexible self-paced training for this course. Self-paced training is beneficial for individuals who have an independent learning style and wish to study at their own pace and convenience.

Do you provide corporate training for this ISO 13485 Lead Implementer Course?

Yes, we provide corporate training for this course, tailored to fit your organisation’s requirements.

What is the scope of the ISO 13485 Lead Implementer Certification?

The certification validates your ability to lead the implementation of ISO 13485 standards. It opens career opportunities in quality management, compliance, and regulatory roles within medical device manufacturing, auditing, and consultancy.

Is there an examination for this course?

Yes, the course includes an examination to assess your understanding of ISO 13485 principles, implementation strategies, and compliance requirements. Successful candidates are awarded the ISO 13485 Lead Implementer certification.

What will I learn in this ISO 13485 Lead Implementer Training?

Delegates will learn how to implement and manage MDQMS, understand ISO 13485 requirements, conduct audits, and ensure compliance with regulatory standards. The course also covers risk management and documentation processes for quality assurance.

What career opportunities can I avail after completing this ISO 13485 Lead Implementer Course?

Completing this course opens career opportunities as a Quality Manager, Lead Auditor, Regulatory Affairs Specialist, or Compliance Consultant in medical device manufacturing, healthcare, and related industries. It enhances your qualifications for leadership roles in quality management.

Who should I contact if I am unable to access this ISO 13485 Lead Implementer Training Course?

If you are unable to access your training, contact the support team at The Knowledge Academy via their customer service email or phone number provided on their website for prompt assistance and resolution of your issue.

Will I receive a certification after completing this ISO 18001 Lead Implementer Course?

Yes, after completing this course you will receive a certificate of completion to validate your achievement and demonstrate your proficiency in the course material.

Why choose The Knowledge Academy in the United Kingdom over others?

The Knowledge Academy in the United Kingdom stands out as a prestigious training provider known for its extensive course offerings, expert instructors, adaptable learning formats, and industry recognition. It's a dependable option for those seeking this course.

What is the cost/training fees for ISO 13485 Lead Implementer in the United Kingdom?

The training fees for ISO 13485 Lead Implementerin the United Kingdom starts from £2295

Which is the best training institute/provider of ISO 13485 Lead Implementer in the United Kingdom?

The Knowledge Academy is the Leading global training provider for ISO 13485 Lead Implementer.

What are the best ISO 13485 Training courses in the United Kingdom?

Please see our ISO 13485 Training courses available in the United Kingdom

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