Quality Management System (QMS)

A quality management system is the set of policies, processes, procedures and records an organisation uses to plan, control and improve the quality of its products and services and to meet customer and regulatory requirements consistently.

A QMS defines how an organisation determines customer requirements, plans and controls its processes, manages documents and records, controls non-conforming output, handles corrective action, evaluates performance through audits and management review, and drives continual improvement. ISO 9001 is the most widely used international standard specifying QMS requirements, and the ISO quality management principles behind it include customer focus, leadership, engagement of people, the process approach, improvement, evidence-based decision making and relationship management.

Sector-specific QMS standards include IATF 16949 for automotive production, AS9100 for aviation, space and defence, and ISO 13485 for medical devices. Certification by an accredited third party is often a condition of doing business with large customers. Many organisations run their QMS in dedicated software, sometimes called an eQMS, that manages documents, training records, non-conformances, CAPA, audits and supplier quality.

A QMS delivers value when it reflects how work is actually done rather than existing mainly for audits. Excessive documentation, procedures that are not followed and corrective actions closed without verification are common weaknesses. Effectiveness is judged by results such as customer complaints, internal and external failure costs, delivery performance and audit findings, reviewed regularly by top management.

Key points

Defines how an organisation plans, controls and improves quality.
ISO 9001 is the most widely used QMS requirements standard.
Sector standards include IATF 16949, AS9100 and ISO 13485.
Effective systems reflect real work rather than audit paperwork.

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Related terms

Terms that refer to Quality Management System (QMS)

Production Part Approval Process (PPAP)Industry 4.0 & Manufacturing Operations