Module Database Search
| MODULE DESCRIPTOR | |||
|---|---|---|---|
| Module Title | |||
| Quality Assurance, Regulation and Medical Ethics | |||
| Reference | ASM148 | Version | 1 |
| Created | March 2018 | SCQF Level | SCQF 11 |
| Approved | March 2018 | SCQF Points | 15 |
| Amended | ECTS Points | 7.5 | |
| Aims of Module | |||
|---|---|---|---|
| To enable the student to understand quality assurance and regulations within organisations to improve quality. To provide the students with a theoretical knowledge of medical ethics. To enable the student to understand the importance of medical ethics in relation to the use of biomedical technology. | |||
| Learning Outcomes for Module | |
|---|---|
| On completion of this module, students are expected to be able to: | |
| 1 | Critically discuss quality tools and techniques which are employed to assess and improve quality in an organisation. |
| 2 | Critically discuss the importance of medical ethics framework in the context of biomedical technology. |
| 3 | Demonstrate a critical understanding of the use of quality audit procedures. |
| Indicative Module Content |
|---|
| Definitions of Quality; The role of Quality in industry; Cost of poor quality; Calibration; Quality control; Quality assurance; Quality system; Reference materials and method of validation; Traceability; Good laboratory practice; Laboratory accreditation; ISO 9000/9001; ISO 15189; ISO 13845; Cultures of quality; Audit; Continuous quality improvement; External Quality assessment; Corrective action plan; Understanding and complying with FDA and CE marking requirements; Lifecycle of a medical device/pharmaceutical product. Medical ethics; relevance of ethics in the use and testing of medical devices. |
| Module Delivery |
|---|
| This module is delivered with a mix of lectures and tutorials supplemented by directed reading and seminars. |
| Indicative Student Workload | Full Time | Part Time |
|---|---|---|
| Contact Hours | 24 | N/A |
| Non-Contact Hours | 126 | N/A |
| Placement/Work-Based Learning Experience [Notional] Hours | N/A | N/A |
| TOTAL | 150 | N/A |
| Actual Placement hours for professional, statutory or regulatory body |
| ASSESSMENT PLAN | |||||
|---|---|---|---|---|---|
| If a major/minor model is used and box is ticked, % weightings below are indicative only. | |||||
| Component 1 | |||||
| Type: | Coursework | Weighting: | 100% | Outcomes Assessed: | 1, 2, 3 |
| Description: | A quality management report for a particular device. | ||||
| MODULE PERFORMANCE DESCRIPTOR | |
|---|---|
| Explanatory Text | |
| This module is assessed using the one component detailed in the Assessment Plan. To pass this module, candidates must achieve a Module Grade D or better. | |
| Module Grade | Minimum Requirements to achieve Module Grade: |
| A | Final mark of 70% or greater |
| B | Final mark of between 60-69% |
| C | Final mark of between 50-59% |
| D | Final mark of between 40-49% |
| E | MARGINAL FAIL. Final mark of between 35-39% |
| F | FAIL. A mark of less than 35% |
| NS | Non-submission of work by published deadline or non-attendance for examination |
| Module Requirements | |
|---|---|
| Prerequisites for Module | None. |
| Corequisites for module | None. |
| Precluded Modules | None. |
| INDICATIVE BIBLIOGRAPHY | |
|---|---|
| 1 | HOYLE, D. ISO 9000 Quality Systems Handbook - updated for the ISO 9001: 2015 Standard. Current Edition.: Routledge. |
| 2 | SAVAR, M. Quality Assurance and Management. Current Edition.: InTech. |
| 3 | SCHWARTZ, L, PREECE, PE, HENDRY, RA. Medical Ethics: A Case-Based Approach. 2002. Saunders Elsevier |
| 4 | Detailed lists are provided by academic staff to reflect the subject matter. |