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Module 1: Introduction to ISO 13485:2016
Module 2: ISO 13485 Clauses 1 and 2
Module 3: ISO 13485 Clauses 3 and 4
Module 4: Requirements and Quality Systems
Module 5: Overview of ISO 13485:2016 Requirements
Module 6: Implementation Phases of the ISO 13485 Frameworks
Module 7: Conducting an ISO 13485 Certification Audit
(344 remaining)
The ISO 13485 Foundation Course is designed to provide a fundamental understanding of the ISO 13485 standard, which pertains to Quality Management Systems for medical device manufacturers and suppliers. It benefits a wide range of professionals from this course, including:
There are no formal prerequisites for this ISO 13485 Foundation Course.
The ISO 13485 sets the standards for quality management systems that are crucial for organisations supplying medical devices and related services. It ensures compliance with customer and regulatory requirements, making it an indispensable framework for the medical device industry. This ISO 13485 Foundation Course offers a comprehensive introduction to the vital topic of ISO 13485 and its relevance in the healthcare industry.
Understanding ISO 13485 is of paramount importance for professionals in various roles. Quality managers, regulatory affairs specialists, auditors, manufacturing supervisors, and individuals involved in the design, production, or distribution of medical devices should aim to master ISO 13485. This knowledge empowers them to ensure product quality, safety, and compliance, leading to career advancement and opportunities in the industry.
The Knowledge Academy's 1-day ISO 13485 Foundation Training equips delegates with essential knowledge. It covers the requirements of medical devices, the phases of implementation, and the intricacies of conducting an ISO certification audit. Delegates will gain the skills needed to navigate the complex landscape of medical device quality management.
Course Objectives:
Upon completion of this course, delegates will benefit from a deep understanding of ISO 13485, enhancing their competence in quality management and compliance within the medical device industry. This knowledge will open doors to career progression and a stronger contribution to the sector's growth and safety.
ISO 13485 Foundation Exam Information
To achieve the ISO 13485 Foundation, candidates will need to sit for an examination. The exam format is as follows:
Module 1: Introduction to ISO 13485:2016
Module 2: ISO 13485 Clauses 1 and 2
Module 3: ISO 13485 Clauses 3 and 4
Module 4: Requirements and Quality Systems
Module 5: Overview of ISO 13485:2016 Requirements
Module 6: Implementation Phases of the ISO 13485 Frameworks
Module 7: Conducting an ISO 13485 Certification Audit
Module 8: Relationship Between ISO 13485 and ISO 9001
Module 9: Internal Auditing
Module 10: Internal Audit Plan
Module 11: Audit Process
Module 12: Internal Audit Evidence and Findings
Module 13: Roles and Responsibilities
Module 14: Resource Management and Product Realisation
Module 15: ISO 13485 and Quality Management Systems
Module 16: Principles of Quality Management System
Module 17: Fundamentals of Quality Management Systems
Module 18: Measurement, Analysis, and Improvement
Module 19: Risk Management
(344 remaining)
The ISO 13485 Lead Implementer Course programme 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:
There are no formal prerequisites for this ISO 13485 Lead Auditor Course. However, prior experience in medical device manufacturing or regulatory compliance will greatly benefit the delegates
ISO 13485 Lead Implementer Training is a course that introduces delegates to the aspects of managing quality in the medical device industry. ISO 13485 Certification is a globally recognised standard that establishes quality management system requirements for organisations that produce medical devices. Understanding its relevance is crucial, as it ensures 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 its ability to enhance an organisation's overall performance and mitigate risks associated with medical devices.
The 3-day ISO 13485 Lead Implementer Training Course equips delegates with the necessary knowledge and skills to implement a quality management system for medical devices effectively. Participants will gain an in-depth understanding of the auditing process, enabling them to obtain audit evidence and evaluate it objectively. They will also learn how to control nonconforming products identified during the inspection process.
Course Objectives:
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.
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:
Online Instructor-led (2 days)
Online Self-paced (16 hours)
Module 1: Introduction to ISO 13485:2016
Module 2: ISO 13485 Clauses 1 and 2
Module 3: ISO 13485 Clauses 3 and 4
Module 4: Requirements and Quality Systems
Module 5: Overview of ISO 13485:2016 Requirements
Module 6: Implementation Phases of the ISO 13485 Frameworks
Module 7: Conducting an ISO 13485 Certification Audit
Module 8: Relationship Between ISO 13485 and ISO 9001
Module 9: Internal Auditing
Module 10: Internal Audit Plan
Module 11: Audit Process
Module 12: Internal Audit Evidence and Findings
Module 13: Roles and Responsibilities
Module 14: Resource Management and Product Realisation
(344 remaining)
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:
There are no formal prerequisites for this ISO 13485 Internal Auditor Course.
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:
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.
(344 remaining)
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:
There are no formal prerequisites for this ISO 13485 Lead Auditor Course. However, some knowledge of quality management systems, auditing techniques, and regulatory requirements, along with practical experience in medical device manufacturing, would greatly benefit the delegates.
ISO 13485 sets the standards for a Quality Management System (QMS) in scenarios where organisations need to 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 for implementing a quality management system for medical devices and conducting audits to ensure organisational performance.
Acquiring knowledge from this training benefits organisations by streamlining processes and reducing operational challenges. Individuals pursuing this training can enhance their expertise and capabilities, opening new career opportunities and potential income growth. Professionals in roles that are responsible for quality management systems, should aspire to master ISO 13485 Lead Auditor training.
The Knowledge Academy's 5-day ISO 13485 Lead Auditor Training Course 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 how to map identified risks and monitor continuous improvement.
Course Objectives:
After completing 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 take on responsibilities associated with auditing authority for the management and performance of all audit activities.
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:
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"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