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MODULE DESCRIPTOR
Module Title
Quality Assurance & Regulations For Industry
Reference AS3147 Version 3
Created April 2019 SCQF Level SCQF 9
Approved February 2018 SCQF Points 15
Amended August 2021 ECTS Points 7.5

Aims of Module
To provide the student with the ability to understand the importance of quality assurance and quality regulations within organisations, and explore approaches to the assurance and improvement of quality.

Learning Outcomes for Module
On completion of this module, students are expected to be able to:
1 Discuss the role of quality, quality systems, and their relevance in bioindustry.
2 Discuss quality tools and techniques which are employed to assess and improve quality in an organisation.
3 Define the purpose of audit, and evaluate the different types of audit.

Indicative Module Content
Definitions of Quality; The role of Quality in industry; Cost of poor quality; Reliable results; Calibration; Quality control; Quality assurance; Quality system; Reference materials and method of validation; Traceability; Measurement of uncertainty; Good laboratory practice; Standard operating procedures; Measuring and monitoring Quality; Quality systems; 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.

Module Delivery
A combined approach utilising formal lectures, seminars, directed reading and tutorials.

Indicative Student Workload Full Time Part Time
Contact Hours 30 N/A
Non-Contact Hours 120 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: The module will be assessed by a coursework evaluating the outcome of an audit.

MODULE PERFORMANCE DESCRIPTOR
Explanatory Text
Component 1 (CW1) comprises 100% of the module grade. A minimum of a Grade D is required to pass the module.
Module Grade Minimum Requirements to achieve Module Grade:
A A
B B
C C
D D
E E
F F
NS Non-submission of work by published deadline or non-attendance for examination

Module Requirements
Prerequisites for Module Successful completion of Stage 2 of the BSc (Hons) Applied Bioscience, MEng Electronic and Biomedical Technology, MEng Mechanical and Biomedical Technology. Successful admission to the MSc Biomedical Technology, or equivalent.
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 Beckford, J. Quality: a critical introduction. Current Edition.: Routledge.
3 OAKLAND, JS. Total quality management and operational excellence. Current Edition.: Routledge.
4 Detailed lists are provided by academic staff to reflect the subject matter.

Robert Gordon University, Garthdee House, Aberdeen, AB10 7QB, Scotland, UK: a Scottish charity, registration No. SC013781