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PRIMARY PACKAGING MATERIALS FOR MEDICINAL PRODUCTS - PARTICULAR REQUIREMENTS FOR THE APPLICATION OF ISO 9001:2015, WITH REFERENCE TO GOOD MANUFACTURING PRACTICE (GMP) (ISO 15378:2017)

Available format(s)

Hardcopy , PDF

Language(s)

English

Published date

01-01-2017

Publisher

National Standards Authority of Ireland

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For Harmonized Standards, check the EU site to confirm that the Standard is cited in the Official Journal.

Only cited Standards give presumption of conformance to New Approach Directives/Regulations.

National Foreword
European foreword
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

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.

DocumentType	Standard
Pages	102
PublisherName	National Standards Authority of Ireland
Status	Current
Supersedes	I.S. EN ISO 15378:2015

Standards	Relationship
EN ISO 15378:2017	Identical
ISO 15378:2017	Identical
NEN EN ISO 15378 : 2017	Identical
BS EN ISO 15378:2017	Identical
UNE-EN ISO 15378:2016	Identical
DIN EN ISO 15378:2016-03	Identical
UNI EN ISO 15378 : 2011	Identical

ISO 10001:2007	Quality management Customer satisfaction Guidelines for codes of conduct for organizations
IEC 61025:2006	Fault tree analysis (FTA)
ISO 11137-1:2006	Sterilization of health care products Radiation Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices
ISO 19011:2011	Guidelines for auditing management systems
ISO 10015:1999	Quality management Guidelines for training
ISO 14644-8:2013	Cleanrooms and associated controlled environments Part 8: Classification of air cleanliness by chemical concentration (ACC)
ISO 14698-2:2003	Cleanrooms and associated controlled environments Biocontamination control Part 2: Evaluation and interpretation of biocontamination data
ISO/TR 10017:2003	Guidance on statistical techniques for ISO 9001:2000
ISO 11135:2014	Sterilization of health-care products Ethylene oxide Requirements for the development, validation and routine control of a sterilization process for medical devices
IEC 60812:2006	Analysis techniques for system reliability - Procedure for failure mode and effects analysis (FMEA)
ISO 14644-2:2015	Cleanrooms and associated controlled environments Part 2: Monitoring to provide evidence of cleanroom performance related to air cleanliness by particle concentration
IEC 60601-1:2005+AMD1:2012 CSV	Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
IEC/ISO 31010:2009	Risk management - Risk assessment techniques
ISO 31000:2009	Risk management Principles and guidelines
IEC 61160:2005	Design review
ISO 13485:2016	Medical devices Quality management systems Requirements for regulatory purposes
ISO 14644-5:2004	Cleanrooms and associated controlled environments — Part 5: Operations
ISO 14937:2009	Sterilization of health care products General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices
ISO 10019:2005	Guidelines for the selection of quality management system consultants and use of their services
ISO 10004:2012	Quality management Customer satisfaction Guidelines for monitoring and measuring
ISO 10014:2006	Quality management Guidelines for realizing financial and economic benefits
ISO 10005:2005	Quality management systems Guidelines for quality plans
ISO 10008:2013	Quality management — Customer satisfaction — Guidelines for business-to-consumer electronic commerce transactions
ISO 10003:2007	Quality management Customer satisfaction Guidelines for dispute resolution external to organizations
ISO 10006:2003	Quality management systems Guidelines for quality management in projects
ISO/IEC Guide 99:2007	International vocabulary of metrology Basic and general concepts and associated terms (VIM)
ISO 14698-1:2003	Cleanrooms and associated controlled environments Biocontamination control Part 1: General principles and methods
ISO 10018:2012	Quality management Guidelines on people involvement and competence
ISO 10002:2014	Quality management Customer satisfaction Guidelines for complaints handling in organizations
ISO 14644-3:2005	Cleanrooms and associated controlled environments Part 3: Test methods
ISO 9004:2009	Managing for the sustained success of an organization A quality management approach
ISO/IEC Guide 73:2002	Risk management Vocabulary Guidelines for use in standards
ISO/TS 11139:2006	Sterilization of health care products Vocabulary
ISO/TR 10013:2001	Guidelines for quality management system documentation
IEC 60300-1:2014	Dependability management - Part 1: Guidance for management and application
ISO 14001:2015	Environmental management systems — Requirements with guidance for use
ISO 14644-7:2004	Cleanrooms and associated controlled environments — Part 7: Separative devices (clean air hoods, gloveboxes, isolators and mini-environments)
ISO 10012:2003	Measurement management systems — Requirements for measurement processes and measuring equipment
ISO 14644-1:2015	Cleanrooms and associated controlled environments Part 1: Classification of air cleanliness by particle concentration
ISO 9001:2015	Quality management systems — Requirements
ISO 37500:2014	Guidance on outsourcing
ISO 14644-4:2001	Cleanrooms and associated controlled environments — Part 4: Design, construction and start-up
ISO/IEC Guide 2:2004	Standardization and related activities General vocabulary
ISO 14971:2007	Medical devices Application of risk management to medical devices
ISO/IEC 90003:2014	Software engineering Guidelines for the application of ISO 9001:2008 to computer software
ISO 10007:2017	Quality management — Guidelines for configuration management

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I.S. EN ISO 15378:2017

PRIMARY PACKAGING MATERIALS FOR MEDICINAL PRODUCTS - PARTICULAR REQUIREMENTS FOR THE APPLICATION OF ISO 9001:2015, WITH REFERENCE TO GOOD MANUFACTURING PRACTICE (GMP) (ISO 15378:2017)

Table of Contents

Abstract

General Product Information

International Equivalents

Standards Referencing This Book

Category

Subcategory