MODULE: QUALITY MANAGEMENT SYSTEM

Meet Customer Requirements
& Prove Regulatory Compliance

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PROCESS FAILURE MODE EFFECT ANALYSIS

Enable Continuous Improvement

Develop and document part and process failures with PFMEA and FMEA risk mitigation and management plans.
NON-CONFORMANCE MANAGEMENT

Identify Deviations that Fail to Meet Quality Standards

Capture, track and maintain auditable part and process non-conformances with dispositions.

CAPA (CORRECTIVE & PREVENTIVE ACTION)

Eliminate Causes of Defects & Waste

Systematically investigate root causes for identified risks. Develop and implement a plan to prevent occurrence and recurrence, supporting Lean Six Sigma, Kaizen and continuous improvement programs.
DIGITAL CERTIFICATION & STANDARD COMPLIANCE

Produce Critical Information to Meet Customer Quality Requirements

Configure and generate digital Certificates of Conformance and Data Books to ISO, AS9100, NASA, SAE, DNV and EN 13485 workflows and prove customer requirements and regulatory compliances are met.
DOCUMENT CONTROL & MANAGEMENT

Capture, Centralize, Manage & Secure All Manufacturing & Quality Documentation

Collect data and manage manufacturing and quality documentation per part and order across the production lifecycle. Automatically generate quality documents, Certificate of Conformance and Data Books.
EMPLOYEE TRAINING

Prove Employee Qualification

Create and configure training programs to ensure competence of employees performing work that affects the quality of products and/or services based on education, training, skills and experience.
CONFIGURABLE QC WORKFLOWS

Configure Unique & Fixed Workflows

Easily create unique or fixed workflows for series production to ensure production repeatability.
CUSTOMER SATISFACTION MANAGEMENT

Develop a Loyal Customer Base

Configurable customer satisfaction surveys to track corrective actions towards maintaining your customer base.
QMS DATA ANALYTICS & REPORTING

Drive Decision Making

Visualize quality data and KPIs within configurable analytic dashboards.
“Currently, there is no end to end solution that can track a patient specific model, guide or device manufactured at the point of care from order through imaging, segmentation, CAD design, printing and ultimately into the surgeon's hands. Link3D has the opportunity to fill that gap in the point-of-care additive manufacturing ecosystem."

Dr. Jonathan Morris, MD
Neuroradiologist at Mayo Clinic

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