ISO 15378:2015 CERTIFICATION

ISO 15378:2015 identify necessities for a quality management system where an organization requirements to demonstrate its capability to give primary packaging materials for medicinal products, which constantly meet client necessities, including regulatory necessities and International Standards applicable to primary packaging materials.

Structure

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
Annexure
A: Clarification of new structure, terminology and concepts
B: Other international standards on quality management and quality management system
developed by ISO/TC 176
C: GMP requirements for printed primary packaging materials
D: Guidance on verification, qualification and validation requirements for primary packaging
materials

How to get / what is Process for ISO certification?

To get the ISO certification, please fill up below given form & our team will contact you. Step-1 Query from the Client Step-2 Filling up the Application form Step-3 Agreement Approval Step-4 Stage-1 Audit Step-5 Stage-1 Audit NC’s Closing Step-6 Stage-2 Audit Step-7 Stage-2 Audit NC’s Closing Step-8 Certificate Release