Quality Management System

Build quality, reliability, safety, and process control into every part of the product lifecycle.

Quality Management System

QMS is a system that documents the policies, business processes, and procedures that an organization needs to create a product or service and deliver it to its customers, thereby increasing customer satisfaction through the high quality of the product.

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Quality Management System

Product innovation requires speed, agility, and compliance. This is only made possible when product development processes are streamlined and all stakeholders have access to the most accurate data.

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What is quality management

Quality control ensures that quality is incorporated into all products and processes of the company, including external partners. Quality control provides automated failure mode and effects analysis (FMEA), preventive and corrective action (CAPA), and accurate route review analysis (RCA) to identify, include, analyze, and impact problems. Facilitates the detection of received items. Quality control is necessary to meet the regulatory requirements and quality standards of most industries. However, the complexity of distributed teams, disconnected systems, and the changing regulatory environment create barriers to the delivery of quality products. PTC integrates quality control into the PLM process. This allows for better quality control early in the life cycle, reduces late-stage changes, and reduces low-quality costs.

Key product features

Change and configuration management

Communicate changes, requirements, test procedures, and manufacturing controls to downstream teams

CAPAs, SCARS, and change requests

Initiate, evaluate, assign, monitor, review, and approve CAPAs arising from internal or external non-conformances

Risk and reliability

FMEA with direct connection of DFMEA to BOM, Weibull life data analysis, fault tree analysis, risk-based design, prediction, and critical to quality

Document control

With integral training tracking

Customer experience management

Capture all customer feedback, including customer complaints

Standards and compliance

ISO9000, Six Sigma, APQP, CMMI, and medical device standards like FDA 21 CFR Part 820

Closed-loop feedback

Collect product failure and performance data from testing, manufacturing, field/IoT for root cause analysis and feedback to design

Digital product traceability

Standard OSLC, supports certification and qualification ISO26262, DO-178, etc.

Medical device applicability

Pre-configured ISO 13485 processes

Audit

Perform internal and supplier audits to ensure that key corporate processes, requirements, and directives are being followed

Non-conformances, deviations, waivers

Intake, evaluate, resolve, and track product and process nonconformance with integrated change management

Real-time connectivity

Remote monitoring of field products leveraging IoT

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