Quality Management

Quality Management is the cross-lifecycle process of planning, controlling, assuring, and improving product and process quality. It encompasses preventive practices like FMEA and APQP, in-process monitoring with SPC, defect handling via nonconformance and CAPA, and management-system conformance to ISO 9001, IATF 16949, AS9100, or ISO 13485 depending on industry.

Scope

Modern Quality Management is closed-loop: field data and manufacturing nonconformances feed back into engineering to drive corrective and preventive actions, design changes, and FMEA updates. PLM-resident artifacts (requirements, FMEAs, control plans, inspection criteria) link directly to BOMs, drawings, and test results to provide a defensible audit trail.

Relationships (see sidebar)

• Realizes Product Quality and Regulatory Compliance.
• Supported by logical capabilities such as ALM Traceability and Digital Twin.
• Coordinated with Change Management (ECO/ECN) for CAPA-driven design changes.