Introduction to Quality Management

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This booklet introduces quality and sets out in a step-wise manner what organisations need to do to Plan, Implement, Check, and Improve quality.

The content is mainly aimed at people, departments, units, and organisations involved in the research and development of pharmaceuticals but can be applied to all industries and professions. 

Contents 

Introduction

1.1 Quality: The Core Principles

2. Quality

2.1 Quality System

2.2 PDCA

3. Plan

3.1 HACCP

4. Do

4.1 Process Flow

4.2 Inputs

4.3 Processes

4.4 Outputs

4.5 Competence

4.6 Quality Management

4.7 ISO 9001

4.8 ISO 9001 Certification

4.9 Business Excellence

4.10 Implementing Quality

4.11 Six Sigma

4.12 Total Quality Management

4.13 Implementing Excellence

5. Check

5.1 Performance Measurement

5.2 Internal Audit

5.3 Self-Assessment

5.4 Approaches to Self-Assessment

5.5 Awards

5.6 Benchmarking

5.7 Management Reviews

6. Act

6.1 Process Improvement

6.2 Business Process Re-Engineering

6.3 Continuous Improvement

6.4 Cost of Quality

ANNEX ONE: Management Gurus

Author

RQA

Published

January 2024