ISO 13485 Training - United Kingdom

Who should attend this ISO 13485 Lead Auditor Course?

The ISO 13485 Lead Auditor Course provides the knowledge and skills required to conduct audits of medical device Quality Management Systems against the requirements of ISO 13485. This course can be beneficial for professionals, including:

• Lead Auditors
• Quality Control Managers
• Regulatory Affairs Managers
• Compliance Officers
• Manufacturing Managers
• Quality Assurance Professionals
• Internal Auditors

Prerequisites of the ISO 13485 Lead Auditor Course

There are no formal prerequisites for this ISO 13485 Lead Auditor Course. However, some knowledge of Quality Management Systems, auditing techniques, regulatory requirements, and practical experience in medical device manufacturing would significantly benefit the delegates.

ISO 13485 Lead Auditor Training Course Overview

ISO 13485 sets the standards for a Quality Management System (QMS) in scenarios where organisations must consistently demonstrate their ability to provide medical devices and related services that meet customer and regulatory requirements. This training equips learners with the skills required to implement a Quality Management System for medical devices and conduct audits to ensure organisational performance. Acquiring knowledge from this training benefits organisations by streamlining processes and lowering operational challenges. Delegates pursuing this training can improve their expertise and capabilities, opening new career opportunities and potential income growth. Professionals responsible for Quality Management Systems will find mastering ISO 13485 Lead Auditor Training highly advantageous.

The Knowledge Academy provides a 5-day ISO 13485 Lead Auditor Training Course that offers a comprehensive understanding of quality management and the art of auditing systems. Delegates will delve into the implementation phases of ISO frameworks and gain expertise in gap analysis to support various clauses. They will also explore risk management, learning to map identified risks and monitor continuous improvement.

Course Objectives

• To improve the quality of medical devices manufactured by a company
• To promote harmonisation of regulatory requirements for manufacturers
• To provide access and evidence in accordance with regulatory requirements
• To engage management actively and undertake management system activities
• To protect the confidentiality of all documents and information obtained in the audit
• To obtain quality objectives from the manufacturer and pass them to the organisation

After completing this training, delegates can implement this ISO standard by specifying company requirements and the scope of medical devices. They will also be able to take on responsibilities associated with auditing authority for the management and performance of all audit activities.

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

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

ISO 13485 Lead Auditor Exam Information

To achieve the ISO 13485 Lead Auditor, candidates will need to sit for an examination. The exam format is as follows: 

• Question Type: Multiple Choice 
• Total Questions: 30 
• Total Marks: 30 Marks 
• Pass Mark: 50%, or 15/30 Marks 
• Duration: 40 Minutes  
• Open Book/ Closed Book: Closed Book

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 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

ISO 13485 Internal Auditor Exam Information

To achieve the ISO 13485 Internal Auditor, candidates will need to sit for an examination. The exam format is as follows: 

• Question Type: Multiple Choice  
• Total Questions: 30 
• Total Marks: 30 Marks 
• Pass Mark: 50%, or 15/30 Marks 
• Duration: 40 Minutes  
• Open Book/ Closed Book: Closed Book

Who should attend this ISO 13485 Lead Implementer Course?

The ISO 13485 Lead Implementer Course gives employees the knowledge and skills they need to lead the implementation and management of an ISO 13485-based Quality Management System for medical devices. Below are some professionals who can benefit from this course:

• Quality Managers
• Regulatory Affairs Professionals
• Product Managers
• Compliance Officers
• Manufacturing Managers
• Quality Assurance Professionals
• Internal Auditors

Prerequisites of the ISO 13485 Lead Implementer Course

There are no formal prerequisites for this ISO 13485 Lead Implementer. However, prior experience in medical device manufacturing or regulatory compliance will greatly benefit the delegates.

ISO 13485 Lead Implementer Training Course Overview

ISO 13485 Lead Implementer Training is a course that introduces delegates to managing quality in the medical device industry. ISO 13485 Certification is a globally recognised standard that establishes Quality Management System requirements for medical device organisations. Understanding its relevance is crucial to ensuring that organisations consistently meet customer and regulatory requirements in the medical device field.

Mastering ISO 13485 is essential for anyone responsible for implementing and managing Quality Management Systems in the medical device industry. It provides a valuable credential for individuals dedicated to quality assurance and regulatory compliance, opening opportunities for high-profile jobs and enhanced earnings. Its importance lies in improving an organisation's overall performance and mitigating risks associated with medical devices.

The 3-day ISO 13485 Lead Implementer Training Course equips delegates with the knowledge and skills to effectively implement a Quality Management System for medical devices. Participants will gain an in-depth understanding of the auditing process, enabling them to obtain and evaluate audit evidence objectively. They will also learn how to control nonconforming products identified during the inspection process.

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 develop consultancy for a respiratory inhaler manufacturer

At the end of this training, delegates can 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 Lead Implementer Course?

• ISO 13485 Lead Implementer Examination
• World-Class Training Sessions from Experienced Instructors
• ISO 13485 Lead Implementer Certificate
• Digital Delegate Pack

ISO 13485 Lead Implementer Exam Information

To achieve the ISO 13485 Lead Implementer, candidates will need to sit for an examination. The exam format is as follows: 

• Question Type: Multiple Choice  
• Total Questions: 30 
• Total Marks: 30 Marks 
• Pass Mark: 50%, or 15/30 Marks 
• Duration: 40 Minutes  
• Open Book/ Closed Book: Closed Book