Quality Management and Control Assessment Brief 2025/2026 | SETU
Assessment Brief 2025/2026
| Programme: | Bachelor of Business in Aviation Management Year 2
Bachelor of Business in Emergency Services Management Year 2 |
| Module: | Quality Management and Control |
| Lecturer: | Christina Donegan |
| Lecturer Email Address: | christina.donegan@setu.ie |
| Assignment Weighting: | 40% |
| Circulation Date: | 4th December 2025 |
| Submission Date: | 5th January 2026, 23.59 hours |
| Submission Details: | Via TURNITIN on Blackboard
Note: Assignments not submitted via Turnitin, will be regarded as a nonsubmission unless approved by Extended Campus |
Module Learning Outcomes Assessed:
On completion of this module students will have a set of skills and tools which will enable them to fulfil their managerial roles more effectively.
Specifically:
L01 – Independent learning.
L02 – Critical thinking/problems solving.
L03 – To gain insights/understand your organisation QMS.
L04 – The creation of a structured report that covers the key learnings required by the Continuous Assignment.
Assignment Brief:
Medimaid, a worldwide manufacturer of medical devices has just opened a manufacturing facility in Ireland. You have been employed as the Quality Manager in this new facility. One of your first task is to implement ISO 13485 2016. ISO 13485 is the global standard for medical device quality management systems established by the international standards organization (ISO). Implementing ISO 13485:2016 involves establishing a quality management system (QMS) tailored for medical device manufacturers. This includes defining processes, conducting risk assessments, and ensuring compliance with regulatory requirements. The process begins with understanding the standard, creating a quality plan, and implementing the necessary procedures. Regular audits and management reviews are crucial for maintaining compliance and continuous improvement.
Question: List and explain the steps you as the Quality Manager would take to achieve accreditation to ISO 13485:2016.
Your answer should include the following:
1. Listing and explaining the key elements of the
ISO13485:2016 standard
2. Defining the scope for your organisation
3. Establishing the Quality Management System
4. Implementing the Quality Management System
5. Maintenance of the Quality Management System
6. Preparation for Certification by the Notified Body (this should include audit preparation for certification)
| Assignment Format: | Font: Times New Roman
Size: 12pt Line spacing 1.5 |
| Word Count: | 2000 – 2500 words
Note: the word count does not include the references or any material included as appendices |
| Academic
Integrity – Summary Policy
|
Plagarism
All work must be original. Assignments found to contain copied material from websites, other authors, students, or any source will receive a grade of zero and be reported to the Head of Department and the Vice President for Academic Affairs. Verbatim copying, even with references, is not permitted. Students may be asked to explain their work to the University’s Plagiarism Panel. Use of Artificial Intelligence Students must review the AI Use AI MATE Summary for this module on Blackboard, which outlines the lecturer’s approach to AI tools. Work will be checked via Turnitin, which provides both Similarity and AI detection reports. Random students may be asked to orally defend their work to support the integrity of the assessment process. |
Additional Information:
- Further information and policies can be accessed in the following blackboards
The EXTENDED CAMPUS blackboard (LLLSC006):
- The Extension Policy
- Appendix 1 (re Plagarism) in the Student Academic
Misconduct and Disciplinary Procedure
The CAP STUDENT HUB blackboard
- Generative AI Hub
- Understanding Academic Integrity online course
Referencing and other resources
Harvard Referencing is the style of referencing to be used in SETU
Academic Writing Resources
SETU Library Support -PACE Programme
https://library.setu.ie/carlow–wexford–supporting–learning/
Key features of critical writing and how to structure your writing https://libguides.westminster.ac.uk/critical–thinking–andwriting/critical–writing
A useful glossary and suggestions on how to develop your ideas https://library.dmu.ac.uk//ld.php?content_id=1879493
(Includes a useful glossary and suggestions on how to develop your ideas)
Tips for writing a great assignment
Structuring different types of assessments
https://www.openpolytechnic.ac.nz/current–students/study–tips–andtechniques/assignments/step–by–step–guide–to–assignment–writing/
Need Expert Help
The Quality Management and Control assignment at SETU demands a clear, structured explanation of ISO 13485:2016 implementation, supported by critical analysis and Harvard-referenced academic writing. Many students struggle to translate ISO standards into practical, audit-ready QMS steps within the 2,000–2,500 word limit. At Ireland Assignment Help, our subject-matter experts deliver 100% human-written, AI-free assignments aligned with Turnitin integrity checks. Get step-by-step guidance on QMS scope, implementation, maintenance, and certification audits. Trust Ireland university assignment help for compliant, well-structured, distinction-ready submissions.
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