Quality Management System (QMS)

Quality Management System (QMS) is the logical capability that records, controls, and continuously improves the policies, procedures, records, and decisions that govern product and process quality across the lifecycle. It is the formal system behind ISO 9001 / ISO 13485 / AS9100 / 21 CFR 820 conformance — increasingly delivered as an Enterprise QMS (EQMS) tightly coupled to PLM.

What it covers

• Document control — SOPs, work instructions, forms, and quality manual under revision control.
• Training records linked to document revisions and roles.
• Nonconformance, CAPA, deviation, and audit workflows with closed-loop verification.
• Supplier quality — incoming inspection, supplier scorecards, change notifications.
• Management review and KPIs — defect rates, on-time-in-full, customer complaints, regulatory findings.

Relationships (see sidebar)

• Conforms to ISO 9001, ISO 13485 (medical), 21 CFR 820 (FDA QSR), and AS9100 (aerospace).
• Supports Quality Management, Regulatory Submission, and Warranty and Field Feedback.
• Implemented by PLM/QMS platforms including Siemens Teamcenter (Quality), PTC Windchill (Quality Solutions), Aras Innovator (Quality), and PTC Arena (Arena QMS).