CPDEquivalent to 7 hours
CERTIFICATESAll delegates will receive a certificate on completion.
Introduction to ISO 13485:2016 Quality Standard for the Medical Device Industry
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.
- 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.
- 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
- 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.
For Scheduled Training courses, please select from the Course Dates and Venues table below.
Course dates and venues
This course will give you an understanding of the purpose and requirements of ISO 13485, and introduce you to the management of quality systems. The interactive nature of the course means that you will have the opportunity to practise your learning, discuss your experiences with other delegates, and ask questions of the tutor.
With this grounding you can develop your skills further as an internal auditor by attending our ISO 13485 Internal Auditor training course. The 2 courses run consecutively, and you can receive a discount if you book both together.
Medical devices are highly regulated. Design and manufacture of devices being placed in the EU are expected to follow the mandatory European Device Directive and the non-mandatory ISO 13485. In addition they need to comply with local regulations.
While both of these ISO standards relate to quality management systems, there are some significant differences. For example, ISO 9001 focuses on achieving increased customer satisfaction through continuous improvement. Device safety is the important factor in ISO 13485 and medical device regulation (MDR), and the aim is to maintain effectiveness. The two approaches also differ in the demands for documentation, record keeping and risk management.
Thatcham Research|6th Dec, 2023
NWROCU|4th Dec, 2023
Metropolitan Police Service|16th Nov, 2023
Sense Biodetection Ltd|13th Nov, 2023
Premier Partnership|10th Nov, 2023
Sense Biodetection Ltd|8th Nov, 2023
Animal and Plant Health Agency (APHA)|7th Nov, 2023
Animal and Plant Health Agency (APHA)|27th Oct, 2023
Orthoplastics Ltd|27th Oct, 2023
The Royal Mint|25th Oct, 2023
Private|24th Oct, 2023
DSTL|17th Oct, 2023