Student Learning Objective 6
Apply the commonly used quality systems and standards.
Learning Objective B
Analyze business operations using the eight clauses of ISO 9001.
Content
The details of the ISO 9001 quality standard are presented in this module. There are ten requirements or clauses that define ISO 9001.
Supplemental Reading Material
- Excerpts from ISO 9001, 5th edition (2015)
- Excerpts from ISO 9001:2015 Audit Procedures, 4th edition, by Ray Tricker, 2016
Slide 6: ISO 9001:2015 Manual
-
Would like for each to student to have copy; $139 for 29 page booklet is not practical
-
Will share portions from manual and book on ISO 9001 auditing that do not violate copyright law
Slide 7: ISO 9001 Clauses
| ISO 9001:2008 | ISO 9001_2015 |
|---|---|
| 0. Introduction | 0. Introduction |
| 1. Scope | 1. Scope |
| 2. Normative References | 2. Normative References |
| 3. Terms and Definitions | 3. Terms and Definitions |
| 4. Quality Management System | 4. Context of the Organization |
| 5. Management Responsibility | 5. Leadership |
| 6. Resource Management | 6. Planning |
| 7. Product Realization | 7. Support |
| 8. Measurement, Analysis and Improvement | 8. Operations |
| 9. Performance Evaluations | |
| 10. Improvement |
Source: Link to ISO 9001 Clauses
Slide 8: Clause 4 Overview
Source: Tricker, Ray (2016)
Slide 9: Clause 4.3 Overview
Source: Tricker, Ray (2016)
Slide 10: Clause 4.3 Details
Source: ISO 9001:2015 Manual
Slide 11: The Major Clauses
Source: Tricker, Ray (2016)
Process Schematic
Figure 1 - Schematic representation of the elements of a single process
Source: ISO 9001:2015 Manual
Plan Do Check Act Cycle
Source: ISO 9001:2015 Manual