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One of our training experts will be in touch shortly to go over your training requirements.

ISO 13485 Training courses

Online Instructor-led (1 days)

Online Self-paced (8 hours)

ISO 13485 Foundation Course Outline

The following topics will be taught during this course

Module 1: Introduction to ISO 13485:2016

  • What is ISO 13485:2016?
  • Importance of ISO 13485 for an organisation

Module 2: An Overview of ISO 13485:2016 Requirements

  • 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 ISO 13485 and ISO 9001

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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 prerequisites for this course.

ISO 13485 Foundation Course Overview

The Knowledge Academy's ISO 13485 Foundation course introduces the updated 2016 version of the ISO 13485. This includes: "Medical Devices Quality Management Systems  - Requirements for Regulatory Purposes” - The international reference standard for quality systems for medical device manufacturers in regulatory systems across the globe. During this training experience, delegates will learn the goals and objectives of ISO 13485 and how to implement and manage a Medical Devices Quality Management System (MDQMS). Topics will cover MDQMS policy, processes, performance measures, management commitment, management review, internal audit, and continual improvement. The course aims to ensure that upon completion, delegates will understand the features and functionality of  MDQMS, and be able to recognise the connection between ISO 13485 and other standards and regulatory frameworks. 

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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 
  • Refreshments 

ISO 13485 Foundation Exam Information

  • 30 questions
  • Multiple choice
  • 40 minutes in duration
  • 50% pass mark (15/30)
  • Closed book

 

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Online Instructor-led (3 days)

Online Self-paced (24 hours)

ISO 13485 Lead Implementer​ ​Course Outline

The following subjects will be taught during the ISO 13485 course:

Module 1: Introduction to ISO 13485:2016

  • What is ISO 13485:2016?
  • Importance of ISO 13485 for an organisation

Module 2: A Overview of ISO 13485:2016 Requirements

  • 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 ISO 13485 and ISO 9001

Module 6: Internal Auditing

  • Internal audit objectives
  • Auditing skills
  • Planning, preparation, and management of audits
  • Internal audit – PDCA cycle
  • Types of audit
  • Audit techniques

Module 7: The Internal Audit Plan

  • The audit plan
  • Criteria

Module 8: The Audit Process

  • Conducting process audits
  • Internal audit scope and criteria
  • Reporting audit findings

Module 9: Internal Audit Evidence and Findings

  • Classification
  • The closing report
  • Nonconformities
  • Documented procedure

Module 10: Roles and Responsibilities

  • Internal Auditor responsibilities
  • Closing meeting
  • Management responsibilities

Module 11: Resource Management and Product Realisation

  • Provision of resources
  • Infrastructure
  • Planning and development of products

Module 12: ISO 13485 and Quality Management Systems

Module 13: Principles of Quality Management System

  • Customer and regulatory focus
  • Leadership
  • Involvement
  • The process approach
  • Common tools
  • Decision making
  • Supplier management
  • System management
  • Continuous improvement

Module 14: The Fundamentals of Quality Management Systems

Module 15: Requirements and Quality Systems

Module 16: Measurement, Analysis, and Improvement

  • Monitoring and measurement
  • Control of non-conforming products
  • The performance of the QMS
  • Analysis of data
  • Improvement of quality
  • Corrective action
  • Preventive action
  • Identification of improvement opportunities

Module 17: Risk Management

  • Risk management principles
  • The risk management process
  • Risk lifecycle
  • Risk management tools
  • Risk management culture
  • Assessments and control of risk management

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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​ Course Overview

This ISO course has been designed to provide participants with the knowledge to effectively implement a quality management system in line with the requirements of ISO 13485. Training will also indicate how to develop quality policies, the core characteristics of risk assessments, the significance of legislation, and how to create an efficacious management review process. By attending this ISO course, trainees will gain the capability to follow their Quality Management System and subsequently enhance business performance. Furthermore, with the knowledge gained from this 3-days training course, delegates will be able to find ways to increase efficiency and cost savings through quality management, monitor supply chains in order to achieve continuous improvement, and meet customer and regulatory requirements.

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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 

ISO 13485 Lead Implementer​ ​Exam

This ISO course includes an exam that will be taken by candidates on the final day of the course, the exam follows the structure outlined below:

  • 30 questions
  • Multiple choice
  • 40 minutes in duration
  • 50% pass mark (15/30)
  • Closed book

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Online Instructor-led (2 days)

Online Self-paced (16 hours)

ISO 13485 Internal Auditor Course Outline

The ISO 13485 Internal Auditor training course will cover the following topics

Module 1: Introduction to ISO 13485:2016

  • What is ISO 13485:2016?
  • Importance of ISO 13485 for an organisation

Module 2: A Overview of ISO 13485:2016 Requirements

  • 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 ISO 13485 and ISO 9001

Module 6: Internal Auditing

  • Internal audit objectives
  • Auditing skills
  • Planning, preparation, and management of audits
  • Internal audit – PDCA cycle
  • Types of audit
  • Audit techniques

Module 7: The Internal Audit Plan

  • The audit plan
  • Criteria

Module 8: The Audit Process

  • Conducting process audits
  • Internal audit scope and criteria
  • Reporting audit findings

Module 9: Internal Audit Evidence and Findings

  • Classification
  • The closing report
  • Nonconformities
  • Documented procedure

Module 10: Roles and Responsibilities

  • Internal Auditor responsibilities
  • Closing meeting
  • Management responsibilities

Module 11: Resource Management and Product Realisation

  • Provision of resources
  • Infrastructure
  • Planning and development of products

Show moredown

Prerequisites

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

Who should attend this ISO 13485 Training Course?

This course is aimed at those that will be conducting or taking part in internal audits. It is also beneficial for those involved in developing, maintaining and implementing an internal audit system.

ISO 13485 Internal Auditor Course Overview

This ISO 13485 Internal Auditor training course will teach the delegates about the requirements of the ISO 13485 medical devices standard from the perspective of an auditor. Other fundamental skills that delegates will learn during this course include: understanding the terminology of medical devices and preparing an audit for managers and stakeholders. By completing this course you will be able to implement an internal audit system that complies with ISO 13485. 

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 

ISO 13485 Internal Auditor Examination

  • 30 questions
  • Multiple choice
  • 40 minutes in duration
  • 50% pass mark (15/30)
  • Closed book

Show moredown

Online Instructor-led (5 days)

Online Self-paced (40 hours)

ISO 13485 Lead Auditor Course Outline

The following subjects will be taught during this course

Module 1: Introduction to ISO 13485:2016

  • What is ISO 13485:2016?
  • Importance of ISO 13485 for an organisation

Module 2: A Overview of ISO 13485:2016 Requirements

  • 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 ISO 13485 and ISO 9001

Module 6: Internal Auditing

  • Internal audit objectives
  • Auditing skills
  • Planning, preparation, and management of audits
  • Internal audit – PDCA cycle
  • Types of audit
  • Audit techniques

Module 7: The Internal Audit Plan

  • The audit plan
  • Criteria

Module 8: The Audit Process

  • Conducting process audits
  • Internal audit scope and criteria
  • Reporting audit findings

Module 9: Internal Audit Evidence and Findings

  • Classification
  • The closing report
  • Nonconformities
  • Documented procedure

Module 10: Roles and Responsibilities

  • Internal Auditor responsibilities
  • Closing meeting
  • Management responsibilities

Module 11: Resource Management and Product Realisation

  • Provision of resources
  • Infrastructure
  • Planning and development of products

Module 12: ISO 13485 and Quality Management Systems

Module 13: Principles of Quality Management System

  • Customer and regulatory focus
  • Leadership
  • Involvement
  • The process approach
  • Common tools
  • Decision making
  • Supplier management
  • System management
  • Continuous improvement

Module 14: The Fundamentals of Quality Management Systems

Module 15: Requirements and Quality Systems

Module 16: Measurement, Analysis, and Improvement

  • Monitoring and measurement
  • Control of non-conforming products
  • The performance of the QMS
  • Analysis of data
  • Improvement of quality
  • Corrective action
  • Preventive action
  • Identification of improvement opportunities

Module 17: Risk Management

  • Risk management principles
  • The risk management process
  • Risk lifecycle
  • Risk management tools
  • Risk management culture
  • Assessments and control of risk management

Module 18: Key Terms and Definitions of Lead Auditor

Module 19: Lead Auditor Responsibilities

  • Roles, responsibilities, and authorities

Module 20: Team Leader Skills

Module 21: ISO 13485 Clauses 1 and 2

Module 22: ISO 13485 Clauses 3 and 4

Module 23: Structure and Intent of ISO 13485

Module 24: Medical Devices, Quality, and Auditing Terminology

Module 25: Processes, Procedures, and Records

Module 26: Checklist Development

Module 27: Planning, Preparation, and Management of Audits

Module 28: Interviewing Skills

Module 29: Corrective Action and Verification

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Who Should Attend this ISO 13485 Training Course?

This course has been recommended for professionals who are involved in implementing and/or auditing quality management systems for medical devices, or those leading a supplier quality assurance programme.

Prerequisites

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

ISO 13485 Lead Auditor Course Overview

This highly interactive course enables individuals to plan, lead, and report audits within their own organisation, with their suppliers and with third-party organisations. This course will benefit our delegates by ensuring that they are able to conduct effective audits in any auditing situation. This will be achieved through the attainment of the relevant skills in planning, coordinating, reporting, and reviewing with regards to QMS auditing. By putting these skills into practice, certified individuals can improve overall organisational performance. Our expert instructors will provide informative and engaging sessions and will include a hands-on run through of the complete auditing process, including managing an audit programme and reporting the results. It is essential that our candidates understand the role of an ISO 13485 Lead Auditor, and can explain their role in terms of the entire auditing process outlined in this course. At the end of the course, delegates will be required to take an exam in order to become certified. 

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 

ISO 13485 Lead Auditor Exam

  • 30 questions
  • Multiple choice
  • 40 minutes in duration
  • 50% pass mark (15/30)
  • 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 +44 1344 203999 or Enquire.

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Please arrive at the venue at 8:45am.
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The price for ISO 13485 Training certification in Philippines starts from $1529.

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