ISO 13485 Training | ISO 13485 Internal Auditor Training in Montreal

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ISO 13485 Training

ISO 13485 Internal Auditor

Montreal

Attain in-depth knowledge of quality management system requirements under ISO 13485
Understand the quality auditing that assures the medical devices conform to the commitment
Learn the roles and responsibilities of an internal auditor while managing the quality

Dates & Prices Dates & Prices

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 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

Why choose us

Our Montreal venue

Includes..

Free Wi-Fi

To make sure you’re always connected we offer completely free and easy to access wi-fi.

Air conditioned

To keep you comfortable during your course we offer a fully air conditioned environment.

Full IT support

IT support is on hand to sort out any unforseen issues that may arise.

Video equipment

This location has full video conferencing equipment.

Montreal is the largest city in the province of Quebec and is the 9^th largest city in the whole of the continent of North America. The city is named after the hill in the heart on the city called Mount Royal. It has and estimated population of roughly 1.65 million people. Education in Canada is mostly free and publicly funded. It is overseen by the federal, provincial and local governments, with the education within provincial jurisdiction and the curriculum overseen by the province. Education is compulsory in most provinces up to the age of 16. Parents can choose between sending their children to one of the public schools or they can sent them to a fee paying private school. Those who live in Montreal and find that picking a secondary school is a fraught decision involving school zones and ratings. Royal West Academy is one of the most prestigious schools in Montreal. It is a public Anglophone secondary school that performs excellently academically. Royal West Academy is part of the English Montreal School Board. The schools mission is to provide a structured environment for those who are committed to academic study. They offer top computer training courses and have an appreciation for the arts, social issues and community responsibilities. To enter this school students must pass an entrance exam due to the limit places that are available. Canada’s higher has a very good reputation. However there is no formal ranking system and students will often choose colleges and universities bases on geographic convenience and the reputation of a particular course. Montreal has the highest concentration of post-secondary students of all major cities in North America. There are 4 universities, seven degree awarding institutions and 12 CEGEPS (publicly funded pre‑university college in the province of Quebec) in a 5 mile radius. The University of Montreal is the second largest research university in the country. It is ranked 115^th in the world and is the 5^th highest ranked Canadian university in the world rankings. The university is affiliated with two other higher education institutions in the area; the École Polytechnique de Montréal (School of Engineering) and HEC Montréal (School of Business). The school of business is widely regarded as being one of the best business schools in Canada. The University of Montreal is a Francophone institute which means the lessons are taught predominantly in French.

Address

Regus,
2001 University Street, Suite 1700
Montreal
Quebec
H3A 2A6

T: +1 6474932992

Ways to take this course

Experience live, interactive learning from home with The Knowledge Academy's Online Instructor-led ISO 13485 Training | ISO 13485 Internal Auditor Training in Montreal. 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 Training | ISO 13485 Internal Auditor Training in Montreal, 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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ISO 13485 Training | ISO 13485 Internal Auditor Training in Montreal 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 in Montreal?

The training fees for ISO 13485 Internal Auditorin Montreal starts from CAD3095

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

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

What are the best ISO 13485 Training courses in Montreal?

Please see our ISO 13485 Training courses available in Montreal

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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