ISO 13485 Internal Auditor Training | ISO 13485 Training

Name: ISO 13485 Internal Auditor
Brand: The Knowledge Academy
Rating: 4.9 (38503 reviews)

ISO 13485 Internal Auditor - United Kingdom

Course Information

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

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

Who should attend this ISO 13485 Internal Auditor Course?

The ISO 13485 Internal Auditor Course is a programme that allows professionals to conduct ISO 13485-based medical device Quality Management System (QMS) Internal Audits. This course can be beneficial for professionals, including:

Quality Managers
Engineers
Technicians
Regulatory Affairs Professionals
Manufacturing Managers
Compliance Officers
Medical Device Consultants

Prerequisites of the ISO 13485 Internal Auditor Course

There are no formal prerequisites for this ISO 13485 Internal Auditor Course.

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. Professionals in roles such as quality managers, regulatory affairs specialists, quality control officers, and individuals involved in internal quality audits in the medical device industry should aim to master the ISO 13485 Internal Auditor Training Course.

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.

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.

What’s included in this ISO 13485 Internal Auditor Course?

ISO 13485 Internal Auditor Examination
World-Class Training Sessions from Experienced Instructors
ISO 13485 Internal Auditor Certificate
Digital Delegate Pack

Why choose us

Ways to take this course

Our easy to use Virtual platform allows you to sit the course from home with a live instructor. You will follow the same schedule as the classroom course, and will be able to interact with the trainer and other delegates.

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Our fully interactive online training platform is compatible across all devices and can be accessed from anywhere, at any time. All our online courses come with a standard 90 days access that can be extended upon request. Our expert trainers are constantly on hand to help you with any questions which may arise.

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This is the same great training as our classroom learning but carried out at your own business premises. This is the perfect option for larger scale training requirements and means less time away from the office.

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What our customers are saying

Omar was a good instructor - patient, knowledgeable and kept things moving.

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ISO 13485 Internal Auditor FAQs

What is ISO 13485?

ISO 13485 defines the quality management system requirements for organisations that must demonstrate their capacity to supply medical devices and relevant services that meet customer and applicable regulatory requirements consistently.

Who should attend this course?

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.

What is the importance of a Quality Management System (QMS)?

A Quality Management System (QMS) is important for understanding and meeting objectives, collecting process performance outcomes, and improving processes based on objective assessment.

What is internal auditing?

Internal auditing is an impartial and independent assessment of the internal controls of an organisation in order to manage risk effectively across an organisation’s risk appetite.

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

ISO 13485 is essential for a company to improve its credibility, create a culture of continual improvement, improve decision-making, improve employee engagement, and improve customer satisfaction.

What will I learn in this ISO 13485 Internal Auditor Training course?

In this ISO 13485 Internal Auditor Training course, you will learn about how to conduct an audit, maintain continuous improvement, meets the standard requirements, Plan the sequence of interviews, and other essential topics.

What is the cost/training fees for ISO 13485 Internal Auditor certification in the United Kingdom?

The price for ISO 13485 Internal Auditor certification in the United Kingdom starts from £1795

Which is the best training institute/provider of ISO 13485 Internal Auditor in the United Kingdom?

The Knowledge Academy is the Leading global training provider for ISO 13485 Internal Auditor.

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

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

Why choose us

Best price in the industry

You won't find better value in the marketplace. If you do find a lower price, we will beat it.

Many delivery methods

Flexible delivery methods are available depending on your learning style.

High quality resources

Resources are included for a comprehensive learning experience.

"Really good course and well organised. Trainer was great with a sense of humour - his experience allowed a free flowing course, structured to help you gain as much information & relevant experience whilst helping prepare you for the exam"

Joshua Davies, Thames Water

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ISO 13485 Internal Auditor - United Kingdom

Course Information

ISO 13485 Internal Auditor Course Outline

Who should attend this ISO 13485 Internal Auditor Course?

Prerequisites of the ISO 13485 Internal Auditor Course

ISO 13485 Internal Auditor Course Overview

What’s included in this ISO 13485 Internal Auditor Course?