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ISO 13485 Training

Online Instructor-led (1 days)

Classroom (1 days)

Online Self-paced (8 hours)

ISO 13485 Foundation Exam

ISO 13485 Foundation Course Outline

The following topics will be taught during this course

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

  • Clauses 1 - Scope
  • Clauses 5 - Management Responsibility
  • Clauses 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
  • Clause 6
  • Clause 7
  • Clause 8
  • 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

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Who Should Attend the ISO 13485 Training Course?

This course is intended for:

  • Members of Medical Devices Quality Team
  • Auditors
  • Professionals from the medical device industry
  • Those involved in the implementation of the ISO 13485 standard 
  • Those involved in operations related to a Quality Management System for Medical Devices

Prerequisites

There are no formal prerequisites for attending this ISO 13485 Foundation Training course.

ISO 13485 Foundation Course Overview

ISO 13485 establishes quality management system requirements for organisations that must consistently demonstrate their capacity to supply medical devices and relevant services that meet customer and applicable regulatory requirements. Regulatory requirements apply to all organisations, regardless of size or kind, except as clearly defined. These requirements also apply to linked services provided by an organisation where the criteria relate to medical equipment. This training session equips learners with the requirements of medical devices, implementation phases, and conducting an ISO certification audit. Obtaining the necessary quality management skills through this ISO training will help individuals advance in their careers and get higher job profiles.    

In this 1-day ISO 13485 Foundation Training course, delegates will thoroughly understand quality management systems and how to manage medical devices. During this training, delegates will learn about documentation requirements that define the content of medical device files and a description of the project. They will also learn about the gap analysis checklist to assess running procedures and their compliance with ISO 13485. This course will be led by our highly skilled and professional trainer with years of experience teaching ISO courses.  

Course Objectives

  • To evaluate the expectations and requirements of the customers
  • To raise the quality of medical devices manufactured in a company
  • To enhance the organisational ability and meet customer requirements
  • To promote harmonisation of regulatory requirements for manufacturers
  • To improve the credibility and image of a company to represent compliance
  • To develop an automated quality management system and control the quality

After completing this training, delegates will be able to design and develop medical devices and activities associated with them. They will also be able to promote awareness of regulations company-wide and review the management to identify improvements and regulatory requirements.

Show moredown

What's included in this ISO 13485 Training Course?

This training course includes:

  • The ISO 13485 Foundation Examination
  • The Knowledge Academy ISO 13485 Foundation Manual 
  • Certificate
  • Experienced Instructor 

Show moredown

ISO 13485 Foundation Exam

In order to complete this ISO 13485 Foundation training course, delegates will need to pass the associated examination. The exam is:

  • Multiple choice questions
  • Duration of 40 minutes
  • 50% pass mark
  • Closed book

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Online Instructor-led (5 days)

Classroom (5 days)

Online Self-paced (40 hours)

ISO 13485 Lead Auditor Exam

ISO 13485 Lead Auditor 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

  • Clauses 1 - Scope
  • Clauses 5 - Management Responsibility
  • Clauses 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
  • Clause 6
  • Clause 7
  • Clause 8
  • 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

Module 20: Key Terms and Definitions of Lead Auditor

  • Key Terms Definitions

Module 21: Lead Auditor Responsibilities

  • Lead Auditor Responsibilities
    • Auditing Organisation
    • Auditees

Module 22: Team Leader Skills

  • Team Leader Skills
  • Exercise

Module 23: Structure and Intent of ISO 13485

  • Structure and Intent
  • Clause 5 – Management Responsibility
  • Clause 6 – Resource Management
  • Clause 7 – Product Realisation
  • Clause 8 – Measurement, Analysis, and Improvement

Module 24: Medical Devices, Quality, and Auditing Terminology

  • Medical Devices
  • Quality Management System
  • Auditing Terminology
  • Exercise

Module 25: Processes, Procedures, and Records

  • Processes
  • Procedure
  • Records

Module 26: Checklist Development

  • Purpose
  • Completed Checklist Provides
  • Process Based Audits
  • Checklist
  • Process Checklist

Module 27: Planning, Preparation, and Management of Audits

  • Planning
  • Preparation
  • Management of Audits
  • Exercise

Module 28: Interviewing Skills

  • Key Interviewing Skills
  • Star Technique

Module 29: Corrective Action and Verification

  • Overview
  • Corrective Action
    • Documented Procedure
    • Process

Module 30: Preventative Action

  • Overview
  • Preventive Action: Process
  • Exercise and Questions

Show moredown

Prerequisites

There are no formal prerequisites for attending this ISO 13485 Lead Auditor Training course.

Audience

This course is designed for everyone who wishes to advance their knowledge of implementing quality management systems for medical devices and managing auditing to improve the overall performance of an organisation.

ISO 13485 Lead Auditor Training Course Overview

ISO 13485 defines the requirements for a Quality Management System (QMS) in situations where an organisation must demonstrate its ability to consistently offer medical devices and related services that fulfil customer and applicable regulatory requirements. Studying this training provides learners with the implementation of a quality management system for medical devices and methods to conduct auditing activities to ensure the overall performance of an organisation. Obtaining knowledge of this training assists organisations in eliminating problems and reducing the work burden. Individuals who pursue this training can better acquire the knowledge and abilities that will ultimately expand their employment options and raise their income.

The Knowledge Academy’s 5-day ISO 13485 Lead Auditor Training course provides delegates with comprehensive knowledge of quality management and how to audit the system. During this training, delegates will learn about the implementation phases of ISO frameworks and the gap analysis for support information for several clauses. They will also learn about risk management for mapping identified risks and monitoring continuous improvement. This course will be led by our highly skilled and knowledgeable instructor with years of experience teaching ISO courses.  

Course Objectives

  • To improve the quality of medical devices manufactured by a company
  • To promote harmonisation of regulatory requirements for manufacturers
  • To provide access and evidence in accordance with regulatory requirements
  • To engage management actively and undertake management system activities
  • To protect the confidentiality of all documents and information obtained in the audit
  • To obtain quality objectives from the manufacturer and pass them to the organisation

After completing this training, delegates will be able to implement this ISO standard by specifying company requirements and the scope of medical devices. They will also be able to take on responsibilities associated with auditing authority for the management and performance of all audit activities. 

Show moredown

What's included in this ISO 13485 Training Course?

This training course includes:

  • The ISO 13485 Lead Auditor Examination
  • The Knowledge Academy ISO 13485 Lead Auditor Manual 
  • Certificate
  • Experienced ISO Instructor 
  • Refreshments 

Show moredown

ISO 13485 Lead Auditor Exam

In order to complete this ISO 13485 Lead Auditor training course, delegates will need to pass the associated examination. The exam is:

  • Multiple choice questions
  • Duration of 40 minutes
  • 50% pass mark
  • Closed book

Show moredown

Online Instructor-led (3 days)

Classroom (3 days)

Online Self-paced (24 hours)

ISO 13485 Lead Implementer Exam

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

  • Clauses 1 - Scope
  • Clauses 5 - Management Responsibility
  • Clauses 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
  • Clause 6
  • Clause 7
  • Clause 8
  • 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

Show moredown

Prerequisites

We recommend completing the ISO 13485 Foundation certification before studying this course.

Who should attend this ISO 13485 Training Course?

  • Anyone involved in defining, planning, or Lead Implementer​ an ISO 13485 based Quality Management System
  • Management representatives
  • Implementation team members

ISO 13485 Lead Implementer​ Training Course Overview

ISO 13485 establishes quality management system requirements for organisations that must consistently demonstrate their capacity to supply medical devices and relevant services that meet customer and applicable regulatory requirements. The lead implementer of this standard is responsible for developing, implementing, maintaining, and monitoring a quality management system for medical devices and enhancing an organisation's overall performance. Studying this training allows learners to implement a quality management system for medical devices and strategies for mitigating the risk associated with them. Adding management skills for medical devices to the profile will help individuals to get high-profile jobs in globally recognised corporations and claim upgraded earnings.

This 3-day ISO 13485 Lead Implementer Training course provides delegates with a thorough understanding of managing quality and implementation of respective systems. During this training, delegates will become familiar with the auditing process for obtaining audit evidence and evaluating it objectively. They will also get acquainted with the control of nonconforming products detected through the inspection process. Our highly skilled and professional trainer with years of experience teaching ISO courses will conduct this training. 

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 development consultancy for a respiratory inhaler manufacturer

At the end of this training, delegates will be able to 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.

Show moredown

What's included in this ISO 13485 Training Course?

This training course includes:

  • The ISO 13485 Lead Implementer​ Examination
  • The Knowledge Academy ISO 13485 Lead Implementer​ Manual 
  • Certificate
  • Experienced Instructor
  • Refreshments 

Show moredown

ISO 13485 Lead Implementer Exam

In order to complete this ISO 13485 Lead Implementer training course, delegates will need to pass the associated examination. The exam is:

  • Multiple choice questions
  • Duration of 40 minutes
  • 50% pass mark
  • Closed book

Show moredown

Online Instructor-led (2 days)

Classroom (2 days)

Online Self-paced (16 hours)

ISO 13485 Internal Auditor Exam

ISO 13485 Internal Auditor 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

  • Clauses 1 - Scope
  • Clauses 5 - Management Responsibility
  • Clauses 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
  • Clause 6
  • Clause 7
  • Clause 8
  • 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

 

Show moredown

Prerequisites

There are no formal prerequisites for attending this ISO 13485 Internal Auditor Training course.

Audience

This course is intended for everyone who wants to enhance their knowledge of quality management systems for medical devices and auditing techniques to meet the ISO requirements. 

ISO 13485 Internal Auditor Course Overview

ISO 13485 defines the requirements for a Quality Management System (QMS) in situations where an organisation must demonstrate its ability to consistently offer medical devices and related services that fulfil customer and applicable regulatory requirements. An ISO 13485 audit helps to identify the present state and health of your QMS and processes. It comprises an independent and systematic process audit to determine QMS's conformity or nonconformity. This training session equips learners with the auditing techniques of quality management systems following ISO 13485 and ISO 19011. Individuals with excellent auditing skills in medical devices will get higher designations and expand their professional networks within a short period.  

In this 2-day ISO 13485 Internal Auditor Training course, delegates will gain comprehensive knowledge of quality management systems and how to conduct internal auditing. During this training, delegates will learn about the management's responsibilities for making policy and financial decisions to support QMS. They will also learn how to plan a medical device and quality process audit and the documentation requirements. Our highly skilled and knowledgeable instructor with years of experience teaching ISO courses will conduct this training.  

Course Objectives

  • To carry out activities in order to achieve audit objectives
  • To provide products and services to medical device organisations
  • To enhance the organisational ability and meet customer requirements
  • To identify the context of a company as well as internal and external issues
  • To create a culture of continual improvement and improve decision-making
  • To maintain records and implement quality processes within an organisation

After attending this training, delegates will be able to promote awareness of regulations and review the management to identify improvements and regulatory requirements. They will also be able to evaluate the effectiveness of the quality management system and document each test during processing. 

Show moredown

What's included in this ISO 13485 Training Course?

This training course includes:

  • The ISO 13485 Internal Auditor Examination
  • The Knowledge Academy ISO 13485 Internal Auditor Manual 
  • Certificate
  • Experienced Instructor 
  • Refreshments 

Show moredown

ISO 13485 Internal Auditor Exam

In order to complete this ISO 13485 Internal Auditor training course, delegates will need to pass the associated examination. The exam is:

  • Multiple choice questions
  • Duration of 40 minutes
  • 50% pass mark
  • Closed book

Show moredown

Not sure which course to choose?

Speak to a training expert for advice if you are unsure of what course is right for you. Give us a call on 01344203999 or Enquire.

ISO 13485 Training FAQs

FAQ's

Please arrive at the venue at 8:45am.
Please see our ISO 13485 Training courses available in the United Kingdom
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The price for ISO 13485 Training certification in the United Kingdom starts from £.

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