REGU09006 2019 Quality Management System

Demonstrate they have a detailed knowledge and understanding of how a medical device is designed and manufactured in line with 20 CFR Part 820 and ISO 13485

Demonstrate and understand the basic overall principles of a QMS system

Review the individual QMS system and understand in terms of management responsibility, auditing, supplier and vendor auditing, training, records, design control, production controls, statistical process control and corrective and preventative action (CAPA).

Understand the role of QMS in terms of regulatory compliance and in achieving market authorisation.

Critique and evaluate a QMS system (own organisation/other)

The educational elements will be provided by the Institute of Technology Sligo, NUI Galway and NIBRT staff. Additional lecturing, as required, may be provided by outside specialists and practitioners. Online/blended programmes are designed for students who want to study part-time at a pace that matches their work-life balance. Through a combination of blended delivery formats including online (synchronous and asynchronous) as well as other technologies we strive to reach the forefront of emerging breakthroughs in the delivery and assessment of online students.

The module will be assessed on the basis of 100% continuous assessment. Some or all of the following assessment modes may apply: examinations, practical work, projects, essays, vivas, seminars, and assignments. These assessments may be organised at different centres throughout the country and a selection of assignments may be assessed.

Sample Technologies in use during assessments
• Moodle
• Adobe connect
• Turnitin
• Panopto
• Microsoft office
• Multimedia including DVDs, webinars, youtube video clips, online videos

The programme allows students to progress to a next stage if they have failed to attain the pass mark for a particular module. A student may be allowed to carry up to 10 credits into a new stage. This policy is at the discretion of the examination board.

The following is a summary of the main topics included in this particular module: CFR 820 or ISO13485. It also aims to provide an overview of compliance assessment in relation to self assessment, external audits, vendor audits and demonstration of ongoing compliance, focusing on Part 11 compliance. The module is broken down as follows: ca 10% Intro/overview of QMS; 75% subsections of CFR 820; 15% Auditing and Part 11 compliance.

Understand and evaluate the principle requirements underlying the
establishment and continuous monitoring of quality systems under ISO 13485
including but not exclusive to: Quality and resource Management, Product
Realization / Risk Management, Customer Related Processes, Design and
Development Process, Purchasing Process Product and Service Provisions,
Control of Monitoring and Measuring Devices, Feedback, Labeling
Requirements, Post Market Surveillance, Vigilance and Recall Processes and
Change Control.

Compile and recognise the importance of documentation as required by a quality system, paying particular attention to the quality manual, medical device master records, Standard operating procedures and Work instruction, batch records and process flows. Understand the review and release of documentation,archiving and destruction, retention requirements and essential elements of Good documentation practice.

Formulate and communicate a competency in statistical methods.