Q00-0002 WHITEPAPER – Steps to Implement a Quality Management System


This complementary whitepaper briefly explains the:

  • WHY do we need one?
  • WHAT is it?
  • HOW to implement



This whitepaper is intended as a guide to implementing a Quality Management System (QMS) based on:

  • FDA Guidance for Industry ‐ Quality Systems Approach to Pharmaceutical CGMP Regulations (September 2006)
  • ISO 9001 standards for a Quality Management System (QMS)
  • ICH‐Q10 International Conference on Harmonization – Pharmaceutical Quality Systems

The whitepaper:

  • explains the principles and the hierarchy of the system
  • It only describes the typical processes as the QMS for each organization varies with its unique activities, processes and regulatory and customer requirements.
  • provides the basic steps to implementation
Quality Management system

Q00-0000 Quality Management System Category

Click here to View/Download/Print  the QMS Flowchart in Adobe PDF format Q00-0001 Quality Management System Flowchart-3

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