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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.

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

ISO 9001 Clauses

ISO 9001:2008ISO 9001:2015
0. Introduction0. Introduction
1. Scope1. Scope
2. Normative References2. Normative References
3. Terms and Definitions3. Terms and Definitions
4. Quality Management System4. Context of the Organization
5. Management Responsibility
5. Leadership
6. Resource Management6. Planning
7. Product Realization7. Support
8. Measurement, Analysis and Improvement8. Operations
9. Performance Evaluations
10. Improvement

Source: https://www.qudos-software.com/image/data/downloads/QudosArticle-NewISO9001clauses-Sept2014.pdf

Clause 4 Overview

Overview of Clause 4

Source: Tricker, Ray (2016)

Clause 4.3 Overview

Clause 4.3 Overview

Source: Tricker, Ray (2016)

Clause 4.3 Details

4.3 - Determing the Scope of the Quality Management Systems

Source: ISO 9001:2015 Manual

The Major Clauses

The Ten Clauses of ISO 9001 in Graphical Form

Source: Tricker, Ray (2016)

Process Schematic

Figure 1 - Schematic representation of the elements of a single process

Sources of inputs - inputs - Activities - Outputs - Receivers of Outputs

Source: ISO 9001:2015 Manual

Plan Do Check Act Cycle

ISO 9000 version of plan-do-check -act cycle

Source: ISO 9001:2015 Manual