This two-day ISO 13485:2016 Implementation course is for those who want to design and implement an effective Quality Management System (QMS) based on ISO 13485:2016, for companies who are preparing for ISO 13485 certification or those that are looking to improve the effectiveness of their current management system.
This course provides management systems practitioners with the knowledge and skills required to implement a Quality Management System (QMS) based on ISO 13485:2016.
Who should attend?
This ISO 13485:2016 Implementation course provides management systems practitioners with the knowledge and skills required to design and implement an effective Quality Management System (QMS) based on ISO 13485:2016. It is relevant to those who:
- have recently been given the responsibility of their organisation’s ISO 13485 based QMS
- are preparing for ISO 13485 certification
- are involved in starting to implement a QMS based on ISO 13485
- are System Managers who may in future be involved in managing an ISO 13485 based QMS
- are Systems Managers who want to improve the effectiveness of their current system
This training course is designed for those who already possess some knowledge of QMS fundamentals prior to attending this ISO 13485:2016 Implementation course. LRQA’s one-day introductory course, ISO 13485:2016 Appreciation & Interpretation, provides an overview of the standard and gives delegates an understanding of the intent and the requirements for ISO 13485:2016 quality management systems.
You can choose whether to attend our ISO 13485:2016 Implementation as a public course or as an in-company event. Our public courses allow delegates to interact and network with other delegates from various medical devices companies and appreciate how other organisations have interpreted and implemented the ISO 13485 standard. As an in-company event, our ISO 13485:2016 experts come to you. Our ISO 13485: 2016 Implementation course can be tailored to your organisation’s own management system and run at a date and time to suit you.
What you will learn
What will I learn?
- how to implement a QMS based on ISO 13485:2016
- how to develop a quality policy and objectives
- the need for documenting systems, processes and typical methods
- key features of risk assessment as defined in ISO 13485:2016
- the importance and relevance of legislation
- the design requirements in ISO 13485: 2016
- the significance of process and environmental controls (e.g. clean rooms, sterilisation, personnel controls)
- to plan and manage your internal quality auditing activities
- how to eliminate the causes of problems through effective corrective action
- to develop an appropriate management review process and implement processes for improving the effectiveness of the system.