Glossary of PLM and QMS Terms

A Comprehensive List of PLM and QMS Terms and Definitions

Terms & Definitions

#

A

C

  • CE Mark
  • Change Control Board
  • Change Management
  • Class I Device
  • Class II Device
  • Class III Device
  • Compliance
  • Compliance Management
  • Compliance Mark
  • Components
  • Computer-Aided Design
  • Conflict Minerals
  • Contract Manufacturer
  • Corrective Action
  • Corrective Action Request
  • Corrective and Preventive Action

D

  • Design History File
  • Device History Record
  • Device Master Record
  • Document Change Request
  • Document Control
  • Document Management

E

  • EAR Compliance
  • Electrical CAD
  • Electronic Design Automation Software
  • Electronic Manufacturing Services
  • Engineer to Order
  • Engineering Bill of Materials
  • Engineering Change Control
  • Engineering Change Control
  • Engineering Change Management
  • Engineering Change Notice
  • Engineering Change Notice
  • Engineering Change Order
  • Engineering Change Order
  • Engineering Change Order Form
  • Engineering Change Process
  • Engineering Change Process
  • Engineering Change Proposal
  • Engineering Change Request
  • Engineering Change Request (ECR)
  • Enterprise Resource Planning
  • Environmental Compliance
  • Export Administration Regulations
  • Export Controls Compliance

F

  • FFR
  • Finished Goods
  • Form, Fit and Function

G

  • Good Manufacturing Practice

H

I

  • Inspection
  • Installation Qualification
  • ISO
  • ITAR
  • ISO 13485
  • ISO 13485 Compliance
  • ISO 14000
  • ISO 14971
  • ISO 9000
  • ISO 9001 Compliance
  • ISO Compliance
  • Issue Management
  • ITAR Compliance
  • Item Master

J

  • Just in Time

K

L

M

  • Made-to-Spec
  • Manufacturer
  • Manufacturing Bill of Materials
  • Manufacturing Change Control
  • Manufacturing Change Management
  • Manufacturing Change Notice
  • Manufacturing Change Order
  • Manufacturing Change Process
  • Manufacturing Change Proposal
  • Manufacturing Change Request
  • Manufacturing Deviation
  • Manufacturing Execution Systems
  • Manufacturing Work Instructions
  • Material Disposition Codes
  • Materials
  • Mechanical CAD Software
  • Medical Device
  • Medical Device Single Audit Program
  • Multilevel BOM

N

O

  • Off-the-Shelf
  • Operational Qualification
  • Original Design Manufacturer
  • Original Equipment Manufacturer

P

  • Packaging
  • Parent Item
  • Part
  • Part Name
  • Part Number
  • Performance Qualification
  • Premarket Approval
  • Premarket Notification
  • Prepackaging
  • Preventive Action
  • Procurement Type
  • Product Analytics
  • Product Data Exchange
  • Product Data Management
  • Product Design
  • Product Label
  • Product Lifecycle
  • Product Lifecycle Management
  • Product Management
  • Product Record
  • Project Management
  • Prototype

Q

  • Quality Management
  • Quality Management System
  • Quality System Regulation

R

  • Re-Assembly
  • REACH
  • REACH Compliance
  • Redline
  • Reference Designator
  • Requirement
  • Requirements Management
  • Restriction of Hazardous Substances
  • Return Material Authorization
  • Revision Control
  • Rework
  • Risk Assessment
  • Risk Management
  • Risk Matrix
  • RoHS
  • RoHS Compliance

S

  • Scrubbing
  • Single-Level BOM
  • SKU
  • Software Validation
  • Standard Operating Procedure
  • Supplier
  • Supplier Corrective Action Request
  • Supply Chain
  • Supply Chain Collaboration

T

  • Testing
  • 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
  • FDA Compliance
  • Underwriters Laboratory
  • Unit of Measure

V

  • Vendor

W

  • WEEE

X

Y

Z