CAPA & Non-conformance
Standardized, audit-ready workflow with integrated 8D / 5-Why.
Quality Management System (QMS)
Improve product quality, shorten defect detection and correction time, and reduce cost with cross-functional transparency and built-in automated compliance.
Unified QMS on a PLM foundation
A quality management system integrated with PLM enables closed-loop quality — from defect logging, CAPA, and change control to training, audits, and lot-level traceability.
Every non-conformance, complaint, or audit finding is linked directly to the BOM, supplier, and manufacturing process — ensuring accurate root-cause analysis.
Suited to businesses in automotive (IATF 16949), medical devices (ISO 13485, FDA 21 CFR Part 820), aerospace (AS9100), and general manufacturing (ISO 9001).
−50%
CAPA processing time
−35%
Cost of poor quality
+60%
First-pass audit rate
100%
Lot / serial traceability
Why choose Quality management system?
Training Management
Link documentation, competency, and role-based job requirements.
Standards compliance
ISO 9001, IATF 16949, AS9100, ISO 13485, FDA 21 CFR Part 820.
Customer Complaint
Track customer complaints, linked to CAPA and FMEA.
Audit & Inspection
Manage internal audits, supplier audits, and inspection plans.
Closed loop with PLM
Field failures automatically update FMEA and trigger design change proposals.
Capabilities of Quality management system
Non-conformance Mgmt
Log, classify, and process NCs from every source (production, customer, audit).
CAPA Workflow
8D, 5-Why, and Ishikawa with standardized industry templates.
Document Control
SOPs, work instructions, and control plans with electronic signature.
Training & Competency
Skills matrix, training schedule, and competency assessment.
Audit Management
Plan, execute, and follow up internal and third-party audits.
Customer Complaint
Complaint-handling workflow linked to serial number and batch.
Supplier Quality
Supplier evaluation, PPAP, and quality scorecards.
Inspection & SPC
Plan inspections and run real-time SPC control charts.
Customer testimonials
Johnson Controls — Global supply chain
Unified QMS across 200+ plants, achieving synchronized IATF 16949 certification in 18 months.
Medtronic — Medical devices
Closed-loop quality for implantable devices per FDA 21 CFR Part 820.
Schneider Electric
Cut global CAPA processing time by 40% through automated workflows.
Frequently asked questions
Can QMS run standalone?
Yes. PTC QMS can run standalone (as the Windchill Quality Solutions module) or fully integrated with Windchill PLM, ServiceMax, SAP, and Salesforce.
Does it support electronic signatures under FDA 21 CFR Part 11?
Yes. The system supports electronic signatures, an immutable audit trail, and a validation package meeting FDA requirements.
Does NEAX provide ISO/IATF consulting alongside QMS deployment?
Yes. NEAX combines process consulting to standards (ISO 9001, IATF 16949, ISO 13485) with system deployment — a 'people + process + technology' package.
Discuss Quality management system with a NEAX expert
NEAX is a PTC implementation partner in Vietnam — roadmap consulting, business-driven configuration, training, and operational support.