I.S. EN ISO 15378:2017
Current
The latest, up-to-date edition.
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)
Hardcopy , PDF
English
01-01-2017
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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 |
| 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 11137-2:2013 | Sterilization of health care products — Radiation — Part 2: Establishing the sterilization dose |
| 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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