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Quality Management

What is Quality Management?

A systematic approach to ensuring that an organization's products and services consistently meet customer requirements and regulatory standards.

Governance

Each of these is named in at least one of the same controls as quality management. The number is how many controls name both.

What the standards actually require on quality management

Requirements naming quality management across 6 standards, quoted from the control text.

Use defined indicators to compute maturity levels for each data quality management process area.

ISO8000-64 · Data Quality Management Maturity Assessment Indicators
EU AI Act5 controls

Providers must put in place a quality management system that ensures compliance with the Regulation, documented systematically in written policies, procedures and instructions, covering at least: a regulatory compliance strategy including conformity assessment...

EUAI-Art.17 · Quality management system

Define, monitor, and maintain data integrity through profiling, cleansing, matching, and continuous improvement.

DIQ-2 · Data Quality Management

Section 820.10 establishes the substantive QMS requirements by incorporating ISO 13485:2016 SECTIONS 4 THROUGH 8 in full. Manufacturers must implement: ISO 13485:2016 SECTION 4 General QMS requirements + documentation (Quality Manual + Medical Device File + co...

QMSR-820.10 · Requirements for a Quality Management System - ISO 13485:2016 Sections 4-8 incorporation (§820.10)
ISO 9001:20152 controls

Requirement defined in ISO 9001:2015, clause 4.4 (Quality management system and its processes). See licensed source for normative text.

iso-9001-2015::4.4 · Quality management system and its processes

Establish, implement, maintain, and continually improve the QMS and its processes

AS9100D-4.4 · Quality Management System and Its Processes

Questions people ask about quality management

What is Quality Management?
A systematic approach to ensuring that an organization's products and services consistently meet customer requirements and regulatory standards.
Why is Quality Management important for compliance?
Quality Management is a key concept in Governance. Understanding quality management 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 Quality Management?
Quality Management appears in the requirement text of ISO 8000 - Data Quality, EU AI Act, DAMA-DMBOK2 - Data Management Body of Knowledge (2nd Edition), FDA Quality Management System Regulation (QMSR), ISO 9001:2015. Across these standards we have identified 21 controls that name it directly, each linked to the control text on the compliance platform.
Where can I learn more about Quality Management?
Explore our compliance framework pages to see how quality management 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 Quality Management 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.