Quality Systems and Auditing Principles

Course Description:
This course, developed by Mount Wachusett Community College, provides students with an introduction to various (both manufacturing and service industry) international and United States regulatory quality system standards. This course also provides instruction on the audit process and principles. Students learn the components of a quality system used in both manufacturing and service industries. The International Organization of Standardization (ISO) library of standards for Quality Systems and Auditing principles are explored. Students also learn to identify commonality between the standards, along with industry specific differences; demonstrating their knowledge using auditing tools. Students also learn about the formal audit cycle: scope, planning (preparation), execution (performing the audit), reporting, and follow-up actions. Course outcomes include:

1. Demonstrate an ability to identify and interpret the ISO standards (e.g. ISO 9001:2015 or ISO 13485:2016) and FDA regulations (e.g. 21CFR 210/211 or 820) used for a variety of manufacturing and service industries, including automotive (TS/ISO 16949), aerospace (AS9001), food manufacture, pharmaceutical, etc. 
2. Demonstrate the ability to explain and distinguish different audit types. 
3. Demonstrate the ability to differentiate the components of an audit and choose the appropriate tools. 
4. Express and practice audit techniques, utilizing graphs and charts to communicate results. 
5. Demonstrate the ability to write and speak effectively through written assignments and discussions. 

Instructors/Educators will need to contact ANSI Education and Training department regarding their University Outreach program for the availability of copies of the ISO standards. 

Course Contents:
Course materials include a syllabus, five sets of lecture slides, three exam study guides, three exams (with answers), a 1-page common terms guide, and a 2-page project description.

The 2-page syllabus includes a course description, learning outcomes, outcome assessments, and a schedule of classes that includes a list of lecture topics and reading assignments for each week. 

For orientation purposes Syllabus.pdf is included as a separate attachment and offers a sample of the type of material included in this course.

Below is a list of the files contained within the .zip attachment. The size of each file is included in parenthesis. 

AQS 115 - Quality Systems - ISO (18 files, 8.4 MB)

• Common Terms - Quality Management Systems (Common Terms.pdf 105 KB)
• Exams and quizzes
  • Exam 1 (Exam #1 - answer key.pdf 106 KB)
  • Module 1 and 2 Study Guide (Exam 1 Review) (Exam #1 - study guide.pdf 271 KB)
  • Exam 2 (Exam #2 - answer key.pdf 174 KB)
  • Exam 2 Study Guide (Exam #2 - study guide.pdf 351 KB)
  • Exam 3 (Exam #3 - answer key.pdf 264 KB)
  • Exam 3 Study Guide (Exam #3 - study guide.pdf 311 KB)
  • Final Exam (Final exam - answer key.pdf 22 KB)
• Lecture slides
  • Quality Systems and Auditing Principles (Module 1 - Quality Systems and Processes.pdf 2.1 MB)
  • Quality Management Systems (Module 2 -  ISO 9001 clause 4 thru 7.pdf 1.1 MB)
  • Auditing (Module 3A - Auditing Introduction.pdf 656 KB)
  • Conducting and Reporting Audits (Module 3B - Conducting and Reporting Audits.pdf 1 MB)
  • Quality Systems - ISO 9001:2015, Clause 8.0-10.0 (Module 4 - ISO Clauses 8-9-10.pdf 1.4 MB)
• Project Description (Project Outline.pdf 175 KB)
• Syllabus (Syllabus.pdf 87 KB)