This 1-day practical course provides a basic background to the structure and requirements of ISO 13485 and how it relates to frameworks such as the Medical Device Regulations (MDR). Students benefit from interactive sessions where they can develop the knowledge they gain.
Gain an understanding of the role of quality standards for the medical device industry within your organisation on our Introduction to ISO 13485 for Medical Devices training course.
Overview
This 1-day practical course provides a basic background to the structure and requirements of ISO 13485 and how it relates to frameworks such as the Medical Device Regulations (MDR). Students benefit from interactive sessions where they can develop the knowledge they gain.
Upon completion of the course, delegates will have the skills to review their organisation’s current processes and systems, understand the benefits and challenges of a process approach to managing a quality management system, and consider how to implement ISO 13485 within their organisation.
Who should attend?
This course is suitable for anyone seeking a detailed overview of ISO 13485 and the process approach to managing a company’s quality system, including:
executives and senior management
general managers and business unit managers
quality and regulatory professionals
management representatives
internal and external auditors
This course is the ideal introduction for those who are planning to attend our ISO 13485 Internal Auditor training course but first need to develop their understanding of ISO 13485. We can offer a discount of £100 to those who book both courses at the same time.
Key topics
Topics covered on the course include:
the purpose and intent of ISO 13485
the origins of the standard and the different versions, including latest ISO 13485:2016+A11 2021
structure and content of the standard and the PDCA cycle
key terms and definitions
how the standard supports medical devices regulations and an overview of:
UK Medical Device Regulations 2002
European Medical Device Regulations 2017
USA Food and Drug Administration quality system requirements
Medical Devices Single Audit Programme
the process approach and process-related requirements of ISO 13485
requirement for documenting the QMS and maintaining records
overview of all of the ‘auditable’ requirements of ISO 13485, sections 4-8, with in-depth coverage of key requirements
technique for conducting an in-depth analysis of the requirements
an approach to implementing an ISO 13485 QMS
Skills gained
By the end of this ISO 13485 training course, delegates will be able to:
explain the purpose, structure and content of ISO 13485
define key terminology from ISO 13485
identify key medical devices regulations and explain their relationship with ISO 13485, including:
EU MDR
UK MDR
USA FDA
MD SAP
analyse and apply ISO 13485 requirements
outline steps for implementing an ISO 13485 QMS
Delegates will also receive a certificate of completion which serves as evidence of their new understanding of ISO 13485.
Bywater is the UK’s leading independent provider of management systems and business improvement training and consultancy with one of the largest ranges of online and public courses certified by professional bodies including CQI and IRCA, IEMA, RSS and IOSH.
We have a committed team that go above and beyond to provide a service and learning experience that surpasses customer expectations.
By reacting to demand, tightly monitoring feedback and relentlessly analysing our performance with the aim of improving our service, we continue to help organisations run more effective management systems, improve the quality of their products and services and support them in achieving their goals.
The standard is based on the ISO 9001 standards but places a more significant focus on regulatory compliance, requiring risk management to be in place for all stages of product realisation, training and supervision of staff, project site specs, and prevention of contamination.
This two-day course provides an in-depth understanding of ISO 13485:2016. It’s designed specifically for those who are looking to further their knowledge of the management system.
The aim of this course is to provide delegates with the knowledge and skills required to perform an audit of part of a quality management system based on ISO 13485 and report on the effective implementation and maintenance of the management system in accordance with ISO 19011.
During this ISO 13485 Internal Auditor training course, the tutor will lead informative sessions alongside interactive exercises, which help to facilitate a fun and engaging learning environment.
The ISO 13485:2016 Medical Devices Quality Management Systems Lead Implementer course empowers professionals with the knowledge and skills necessary to lead the implementation of ISO 13485 within their organizations.
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