QLTY08015 2019 Standards and Compliance Management

General Details

Full Title
Standards and Compliance Management
Transcript Title
Standards and Compliance Manag
N/A %
Subject Area
QLTY - Quality
MENG - Mech. and Electronic Eng.
08 - NFQ Level 8
05 - 05 Credits
Start Term
2019 - Full Academic Year 2019-20
End Term
9999 - The End of Time
Fiona Donovan
Programme Membership
SG_EQLTY_K08 201900 Bachelor of Science (Honours) in Engineering in Quality Management and Tech

The student will have a detailed understanding of what standards are, the different types of standards (global, European and National) and why they are required. They will cover compliance from the point of view of EU law, directives and regulations, CE marking of products, quality auditing and ISO 9001. They will also become familiar with the current standards and laws for environmental and Health and Safety compliance. Students will be able to relate the theory to the "hands on" and practicalities of their workplace/industry.

Learning Outcomes

On completion of this module the learner will/should be able to;


Apply the core ISO9000 series standards to an organisation's quality management system, and explain the underlying quality management principles


Plan and conduct a quality management systems audit


Determine generic EU regulatory compliance requirements for accreditation bodies, notified bodies, manufacturers and importers


Use EU directives, standards and other publications and determine the regulatory compliance regime in a number of product sectors


Understand what the regulations are in relation to Health and Safety and the Environment, and how organisations can use standards to meet requirements.

Teaching and Learning Strategies

Lectures delivered online and recordings made available after live lecture.

Supporting PDF notes available.

Module Assessment Strategies

Where possible and practical, assessments will be linked to the workplace. Students may be able to use examples from their workplace/ or hands on experience which will strengthen their understanding between the theory side of the subject and the real life aspect of the workplace.

Assessments are a combination of online quizzes and resaerch based assignments.

Repeat Assessments


Indicative Syllabus

Introduction to standards: What standards are and why they are important, National, EU and Global standardisation bodies and their role, The roles of the NSAI,  ISO 9000 family of standards, Certification to ISO 9001,

Audits and Audit Management- Quality audits and ISO 19011.

EU Law- Regulations, Directives, New Approach directives, Global approach to conformity assessment , CE marking, Notified bodies and their roles.

Environmental Standards- ISO 14001, ISO 14031 (EPE), EMAS scheme, Eco-labelling schemes

Health and Safety Standards- OHSAS 18001 and 18002, Health and Safety Authority Ireland and their role.


Coursework & Assessment Breakdown

Coursework & Continuous Assessment
30 %
End of Semester / Year Formal Exam
70 %

Coursework Assessment

Title Type Form Percent Week Learning Outcomes Assessed
1 Continuous Assessment essay, SAQ, Research a topic Continuous Assessment Essay 20 % Week 8 1,2,3,4,5
2 MCQ Continuous Assessment Multiple Choice 10 % Week 12 1,3,4,5

End of Semester / Year Assessment

Title Type Form Percent Week Learning Outcomes Assessed
1 Final Exam Written 2.5 hr exam Final Exam Closed Book Exam 70 % End of Term 1,2,3,4,5

Full Time Mode Workload

Type Location Description Hours Frequency Avg Workload
Lecture Distance Learning Suite applicable theory 3 Weekly 3.00
Tutorial Distance Learning Suite tutorials 1 Weekly 1.00
Total Full Time Average Weekly Learner Contact Time 4.00 Hours

Part Time Mode Workload

Type Location Description Hours Frequency Avg Workload
Lecture Distance Learning Suite applicable theory 3 Weekly 3.00
Tutorial Distance Learning Suite tutorials 1 Weekly 1.00
Total Part Time Average Weekly Learner Contact Time 4.00 Hours

Required & Recommended Book List

Required Reading
2017 ISO 9000 Quality Systems Handbook
ISBN 1138188646 ISBN-13 9781138188648

Completely revised to align with ISO 9001:2015, this handbook has been the bible for users of ISO 9001 since 1994, helping organizations get certified and increase the quality of their outputs. Whether you are an experienced professional, a novice, or a quality management student or researcher, this is a crucial addition to your bookshelf. The various ways in which requirements are interpreted and applied are discussed using published definitions, reasoned arguments and practical examples. Packed with insights into how the standard has been used, misused and misunderstood, ISO 9000 Quality Systems Handbook will help you to decide if ISO 9001 certification is right for your company and will gently guide you through the terminology, requirements and implementation of practices to enhance performance. Matched to the revised structure of the 2015 standard, with clause numbers included for ease of reference, the book also includes: Graphics and text boxes to illustrate concepts, and points of contention; Explanations between the differences of the 2008 and 2015 versions of ISO 9001; Examples of misconceptions, inconsistencies and other anomalies; Solutions provided for manufacturing and service sectors. This new edition includes substantially more guidance for students, instructors and managers in the service sector, as well as those working with small businesses. Don't waste time trying to achieve certification without this tried and trusted guide to improving your business - let David Hoyle lead you towards a better way of thinking about quality and its management and see the difference it can make to your processes and profits!

Required Reading
2015-10-16 ISO 9001
ISBN 1932828729 ISBN-13 9781932828726

ISO 9001 hasn't changed much in the last 15 years... until now! ISO 9001:2015 is a MAJOR revision. A LOT has changed. Requirements have been added and removed. Content has shifted to different sections and clauses. ISO 9001:2015 is built upon a completely different structure with the adoption of Annex SL. This may seem like a lot to take in, and it is. Fortunately, bestselling author Craig Cochran has translated ISO 9001:2015 into plain English that anyone can understand. Just as he did with the bestselling ISO 9001 in Plain English Cochran has written a comprehensive yet easily understandable guide to ISO 9001:2015. ISO 9001:2015 in Plain English was written so that anyone at any level of the organization can get to the heart of the standard's requirements and how they apply to the organization quickly and simply. Plus, Cochran shows what has changed between the 2008 and 2015 version. This straightforward book is ideal for people who are new to ISO 9001:2015, experienced ISO coordinators who want to get more out of an established system as they transition to the new standard, and for employees who just need a basic understanding of what ISO 9001:2015 is and how it applies to them. Cochran explains each of ISO 9001:2015's sections and clauses using real-world examples and frequently asked questions.

Recommended Reading
2019-01-22 ISO 14001 Step by Step Itgp
ISBN 1787780325 ISBN-13 9781787780323

Take the first steps to ISO 14001 certification with this practical overview. This easy-to-follow book provides practical advice and sample documents to help you understand how to achieve compliance with ISO 14001:2015, the international standard for an EMS (environmental management system).

Recommended Reading
2015-01-12 Auditing: A Risk Based-Approach to Conducting a Quality Audit Nelson Education

Reflects the clarified auditing standards and the newest PCAOB standards, while discussing the COSO's Internal Control-Integrated Framework and the AICPA's recently issued new audit sampling guidance. In this book, you may find the most recent professional developments with a new integrated emphasis on various fraud risks and ethical challenges.

Module Resources

Non ISBN Literary Resources

Harvard Style 
Hoyle, D., (2017). ISO 9000 Quality Systems Handbook

Harvard Style 
Johnstone, K., Gramling, A., Rittenberg, E., (2015). Auditing: A Risk Based-Approach to Conducting a Quality Audit. Nelson Education.


Journal Resources


URL Resources

All standards are available to students via the IT Sligo library website.

Other Resources


Additional Information