Glossary of PLM and QMS Terms

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• 510(k)

A

• 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
• Assembly
• Asset Management
• Attribute Field
• Authorization

B

• Bill of Materials
• Build to Order

C

• CE Mark
• Change Control Board
• Change Management
• Child Item
• Circular Economy
• Class I Device
• Class II Device
• Class III Device
• Cloud-Enabled Solutions
• Cloud Native
• Cloud Software
• Cloud PLM
• Cloud Product Development
• Cloud QMS
• Commercialization
• Compliance
• Compliance Management
• Compliance Management Software
• Compliance Mark
• Component
• Computer-Aided Design
• Conflict Minerals
• Configuration Management
• Contract Manufacturer
• Corrective Action
• Corrective Action Request
• Corrective and Preventive Action
• Current Good Manufacturing Practice
• Cybersecurity

D

• Defense Federal Acquisition Regulation Supplement (DFARS)
• Design Controls
• Design for Environment
• Design for Manufacturability
• Design History File
• Device History Record
• Device Master Record
• 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
• 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 Request (ECR)
• Enterprise Quality Management System
• Enterprise Resource Planning
• Environmental Compliance
• EUDAMED
• European Union Medical Device Regulation
• 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

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

J

• Just in Time Manufacturing

K

L

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
• 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

• Operational Qualification
• Original Design Manufacturer
• Original Equipment Manufacturer

P

• Parent Item
• Part
• Part Number
• Performance Qualification
• Premarket Approval
• Premarket Notification
• Preventive Action
• Printed Circuit Board Assembly
• Product Analytics
• 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 Inspection
• Quality Management
• Quality Management System
• Quality System Regulation

R

• REACH
• REACH Compliance
• Reference Designator
• Regulatory Compliance
• Requirements Management
• 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
• Software Validation
• Standard Operating Procedure
• Supplier
• Supplier Corrective Action Request
• Supply Chain
• Supply Chain Collaboration
• Supply Chain Disruption
• Supply Chain Resilience
• Sustainability
• Sustainable Development
• Sustainable Development Goals
• 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

• WEEE

X

Y

Z