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Process Improvement

What is Process Improvement?

The systematic approach to identifying, analyzing, and enhancing existing business processes to optimize performance and meet new standards.

Governance

What the standards actually require on process improvement

Requirements naming process improvement across 4 standards, quoted from the control text.

Define and collect measurements to support management decisions and process improvement objectives.

MAN.6 · Measurement

ISO 13485:2016 Section 5 (Management Responsibility) incorporated via §820.10. ELEMENTS: (5.1) MANAGEMENT COMMITMENT to develop + implement + maintain the QMS + improve its effectiveness;

QMSR-ISO13485-Sec5 · Management responsibility (ISO 13485:2016 Section 5 - incorporated via §820.10)

Questions people ask about process improvement

What is Process Improvement?
The systematic approach to identifying, analyzing, and enhancing existing business processes to optimize performance and meet new standards.
Why is Process Improvement important for compliance?
Process Improvement is a key concept in Governance. Understanding process improvement helps organizations meet regulatory requirements, reduce risk, and demonstrate due diligence during audits. Our compliance platform maps 686 frameworks with 311K cross-framework control mappings.
Which compliance frameworks address Process Improvement?
Process Improvement appears in the requirement text of Automotive SPICE (ASPICE) v4.0 - Process Assessment Model, FDA Quality Management System Regulation (QMSR), Japan FSA Cybersecurity Guidelines for Financial Institutions, Kolb Experiential Learning Cycle. Across these standards we have identified 4 controls that name it directly, each linked to the control text on the compliance platform.
Where can I learn more about Process Improvement?
Explore our compliance framework pages to see how process improvement applies across different standards and regulations. Our implementation guides provide step-by-step guidance, and the compliance platform offers AI-powered analysis of how this concept maps across 686 frameworks.

See how Process Improvement applies across compliance frameworks

Our platform maps 686 frameworks with 311K cross-framework control mappings. Explore how this concept is addressed across standards.

Written and maintained by Gerard Blokdyk, The Art of Service.