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ISO 13485 Internal Auditor Overview
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 includes an independent and systematic process audit to determine QMS's conformity or nonconformity.
This training session will provide delegates with auditing techniques for Quality Management Systems following ISO 13485 and ISO 19011. Individuals with excellent auditing skills in medical devices will quickly get higher designations and expand their professional networks. 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. They will also learn about management's responsibilities for making policy and financial decisions to support QMS, how to plan a medical device, quality process audit, and 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 can 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
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Ways to take this course
Experience live, interactive learning from home with The Knowledge Academy's Online Instructor-led ISO 13485 Internal Auditor. 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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Unlock your potential with The Knowledge Academy's ISO 13485 Internal Auditor, accessible anytime, anywhere on any device. Enjoy 90 days of online course access, extendable upon request, and benefit from the support of our expert trainers. Elevate your skills at your own pace with our Online Self-paced sessions.
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What our customers are saying
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Jayne Lonton
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Aamir Dar
ISO 13485 Internal Auditor FAQs
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.
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.
A Quality Management System (QMS) is important for understanding and meeting objectives, collecting process performance outcomes, and improving processes based on objective assessment.
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.
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.
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.
The training fees for ISO 13485 Internal Auditorin Luxembourg starts from €1995
The Knowledge Academy is the Leading global training provider for ISO 13485 Internal Auditor.
Please see our ISO 13485 Training courses available in Luxembourg
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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 in Luxembourg
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