Glossary of PLM and QMS Terms

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• 3D Viewer
• 3D Visualization
• 510 (k)

A

• Agile Hardware Development
• Agile Manufacturing
• Agile Product Development
• Allocated Baseline
• Alphanumeric Character
• Alternative Part
• Altered Item
• Application Integration
• Application Interface
• Application Lifecycle Management
• Approved Manufacturer List
• Application Programming Interface
• Approval
• Approval Notification
• Approved Supplier List
• Approved Vendor List
• Archive
• AS9100
• As-Built Bill of Materials (aBom)
• Assembly
• Asset Management
• Attribute Field
• Authorization
• AWS GovCloud

B

• Bill of Materials (BOM)
• Bill of Materials Management
• BOM Management Software
• Build to Order

C

• CE Certification
• CE Mark
• Change Control Board
• Change Control System
• Change Management
• Change Notice
• Change Order
• Change Order Proposal
• Change Proposal
• Change Order Request
• Change Request
• Child Item
• Circular Economy
• Class I Device
• Class II Device
• Class III Device
• Cloud
• Cloud-Enabled Solutions
• Cloud Native
• Cloud Software
• Cloud PLM
• Cloud Product Development
• Cloud QMS
• Collaborative Product Definition Management
• Commercialization
• Compliance
• Compliance Management
• Compliance Management Software
• Compliance Mark
• Compliance Requirements
• Component
• Computer-Aided Design
• Computer Software Assurance
• Computer Software Validation
• Conflict Minerals
• Configuration Management
• Contract Manufacturer
• Corporate Sustainability Reporting Directive
• Corrective Action
• Corrective Action Reports
• Corrective Action Request
• Corrective and Preventive Action
• Current Good Manufacturing Practice
• Customer Relationship Management
• Cybersecurity
• Cybersecurity Maturity Model Certification

D

• Defense Federal Acquisition Regulation Supplements (DFARS)
• Defense Industrial Base
• Design Controls
• Design for Environment
• Design for Manufacturability
• Design History File
• Device History Record
• Design Input Requirements
• Design Requirements
• Design Revisions
• Device Master Record
• Digital Engineering Instruction
• Digital Product Passport Compliance
• Digital Thread
• Digital Transformation
• Digital Twin
• Document Change Request
• Document Control
• Document Management

E

• EAR Compliance
• Electrical CAD
• Electronic Design Automation Software
• Electronic Quality Management System
• Electronics Manufacturing Services
• Embedded Software
• Engineer to Order
• Engineering Bill of Materials
• Engineering Change Control
• Engineering Change Management
• Engineering Change Notice
• Engineering Change Order
• Engineering Change Order Form
• Engineering Change Process
• Engineering Change Proposal
• Engineering Change Request (ECR)
• Engineering Design
• Enterprise Quality Management System
• Enterprise Resource Planning
• Enterprise Simulation Management
• Environmental Compliance
• Environmental Social Governance
• EUDAMED
• European Union Medical Device Regulation
• EV Manufacturer
• EV Technology
• Export Administration Regulations
• Export Controls Compliance

F

• FDA Compliance
• Federal Risk and Authorization Management Program
• Finished Goods
• Form, Fit, and Function

G

• Good Manufacturing Practice
• Green Tech

H

I

• Industrial Internet of Things
• Information Management
• Installation Qualification
• Integrated Circuit
• Integration
• Internet of Things (IoT)
• Interoperability
• In Vitro Diagnostic Regulation (IVDR)
• IVDR 2017/746 Compliance
• ISO
• ITAR
• Item Master
• ISO 13485
• ISO 14971
• ISO 9000
• ISO 9001 Compliance
• ISO Compliance
• Issue Management
• Issue Management Software
• ITAR Compliance
• Item
• Iteration

J

• Just in Time Manufacturing

K

• Key Performance Indicator (KPI)

L

• Linear Economy

M

• Manufacturer
• Manufacturing Bill of Materials
• Manufacturing Change Process
• Manufacturing Deviation
• Manufacturing Execution Systems
• Manufacturing Routing
• Manufacturing Work Instructions
• Material Disposition Codes
• MEDDEV 2.7/1 Rev. 4
• MDR 2020/561
• MDR 2017/745 Compliance
• Mechanical CAD Software
• Mechanical Computer Aided Design
• Medical Device
• Medical Device Compliance
• Medical Device Law Implementation Act
• Medical Device Regulation
• Medical Device Single Audit Program
• Multilevel BOM
• Multi-tenant Software

N

• Net Zero
• New Product Development
• New Product Introduction
• New Product Development and Introduction
• NIST
• Notified Body

O

• On-Premise Software
• Operational Qualification
• Original Design Manufacturer
• Original Equipment Manufacturer

P

• Parent Item
• Part
• Part Number
• Performance Qualification
• Premarket Approval
• Premarket Notification
• Preventive Action
• Preventive Action Reports
• Printed Circuit Board Assembly
• Product Analytics
• Product Carbon Footprint
• Product Data
• Product Data Exchange
• Product Data Management
• Product Design
• Product Development Process
• Product Launch
• Product Lifecycle
• Product Lifecycle Management
• Product Management
• Product Record
• Project Management
• Prototype

Q

• Quality Assurance
• Quality Control
• Quality Inspection
• Quality Management
• Quality Management System
• Quality System Regulation

R

• REACH
• REACH Compliance
• Redline
• Reference Designator
• Regulatory Compliance
• Regulatory Requirements
• Released Item
• Requirements Management
• Requirements Traceability Matrix
• Restriction of Hazardous Substances
• Return Material Authorization
• Revision Control
• Rework
• Risk Assessment
• Risk Management
• Risk Management Software
• Risk Matrix
• RoHS
• RoHS 2
• RoHS Compliance

S

• SaaS
• SaaS PLM
• SaaS QMS
• Safe Medical Device Act
• Single-Level BOM
• SKU
• Software as a Service
• Standard Operating Procedure
• Supplier
• Supplier Corrective Action Request
• Supplier Quality Management
• Supply Chain
• Supply Chain Collaboration
• Supply Chain Disruption
• Supply Chain Management
• Supply Chain Resilience
• Sustainability
• Sustainable Development
• Sustainable Development Goals
• Sustainable Practices
• Sustainable Product Design
• Sustainable Products

T

• Time to Market
• Title 21 CFR Part 11
• Title 21 CFR Part 820
• Training Management
• Training Record Management

U

• U.S. Food and Drug Administration
• Underwriters Laboratories
• Unique Device Identifier (UDI)
• Unit of Measure

V

• Verification and Validation

W

• Webhook
• WEEE
• Workflow

X

Y

Z