policy statement for quality management system QMS ISO 9001 FDA PICs

This is the first step to setting up a Quality Management System. Senior management needs to commit and define the importance of a QMS to the company’s performance to produce quality products. The flowchart illustrates the process flow.


This template together with the easy to follow flowchart provide the “big picture” road map and the rationale of a Quality Management System for the Regulated Industry (biotech, pharmaceutical, medical devices).

 The purpose of this policy statement:

  • is to state the company’s philosophy and commitment to implement a quality management system.
  • is to define the importance of QMS in the execution of manufacturing activities or projects to produce quality products.

There are two parts to this document:

  • Part 1 (2 pages) – describes the rationale of why this procedure or standard is required, cross reference relevant regulatory clauses.
  • Part 2 (6 pages) – the document template and attached flowchart in Microsoft Visio format
Quality Management System Flowchart

Q00-0001 Quality Management System Flowchart

Please Click Here to View/Download/Print a PDF format of the flowchart Q00-0001 Quality Management System – Flowchart-4

Related Regulatory References:

Industry groups have recently developed a consensus harmonization of quality systems and cGMP regulations.

This policy statement and QMS Flowchart is based on merging the framework of:

  • 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

Who needs this template?

Senior Management and Site Quality Head who need to design the overall QMS concept.

Related Documents:

Q00-0001 Quality Management System Flowchart

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