Skip to content

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.

ISO 13485:201621 controls

Top management makes sure the quality management system is planned so that it satisfies the general requirements in 4.1 and the quality objectives, and that the system stays intact when changes to it are planned and made.

iso-13485-2016::5.4.2 · Quality management system planning →

Before they go out, the engagement partner reviews formal written communications addressed to regulators, to management or to those charged with governance.

ssae-18-attestation-standards-soc-reporting::105.46 · AT-C 105.46 Quality Management: Leadership Responsibilities for Managing and Achieving Quality →
ISO 10006:201720 controls

The guidance rests on the seven quality management principles of ISO 9000:2015 clause 2.3: (1) customer focus; (2) leadership; (3) engagement of people; (4) process approach; (5) improvement; (6) evidence-based decision making; (7) relationship management.

iso-10006-2017::4.2 · Quality management principles →

Data quality management is built from three processes: Resource Provision, Data-Related Support and Implementation (Figure 1, adapted from the primary, support and organizational processes of ISO 12207:1995 and from the ISO 9001 PDCA cycle).

iso-8000-data-quality::61:5.1 · 5.1 The basic structure of the data quality management process →
COBIT 20199 controls

Quality management centres on customers: their requirements are established and built into quality management practices. Requirements of internal and external customers are determined and I&T standards and practices are brought into line with them, and roles a...

cobit-2019::APO11.02 · APO11.02 Focus quality management on customers →

An effective quality management system governs quality for the system, subsystem or equipment over its life cycle, whose purpose is to minimise human error at each stage and so reduce the risk of systematic faults, applicable throughout the EN 50126-1 life cyc...

en-50126-en-50128-en-50129-railway-applications-rams::50129:5.2 · The quality management process →

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 1,016 frameworks with 316K cross-framework control mappings.
Which compliance frameworks address Quality Management?
Quality Management appears in the requirement text of ISO 13485:2016, SSAE 18 - Attestation Standards (SOC Reporting), ISO 10006:2017, ISO 8000 - Data Quality, COBIT 2019. Across these standards we have identified 98 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 1,016 frameworks.

See how Quality Management applies across compliance frameworks

Our platform maps 1,016 frameworks with 316K cross-framework control mappings. Explore how this concept is addressed across standards.

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