ISO 13485 Training - United States

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.

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 

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

Prerequisites

There are no formal prerequisites for attending this ISO 13485 Lead Implementer 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.

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

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

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. 

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 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