Table of Contents

Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Context of the organization
5 Leadership
6 Planning
7 Support
8 Operation
9 Performance evaluation
10 Improvement
Annex A (informative) - Clarification of new structure,
        terminology and concepts
Annex B (informative) - Other International Standards
        on quality management and quality management
        systems developed by ISO/TC 176
Annex C (normative) - GMP requirements for printed
        primary packaging materials
Annex D (informative) - Guidance on verification,
        qualification and validation requirements
        for primary packaging materials
Bibliography
Alphabetical index of defined terms used in this document

Abstract

Defines requirements for a quality management system when an organization: a) needs to demonstrate its ability to consistently provide products and services that meet customer and applicable statutory and regulatory requirements, and b) aims to enhance customer satisfaction through the effective application of the system, including processes for improvement of the system and the assurance of conformity to customer and applicable statutory and regulatory requirements.

General Product Information

Published
Document Type	Standard
Status	Current
Publisher	International Organization for Standardization
Pages
ISBN
Committee	TC 76
Supersedes	ISO 15378 : 2015 ISO/DIS 15378 : 50.20 (2017)