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Glossary of PLM and QMS Terms

A Comprehensive List of PLM and QMS Terms and Definitions

Terms & Definitions

#
A
B
C
D
E
F
G
H
I
J
K
L
M
N
O
P
Q
R
S
T
U
V
W
X
Y
Z

#

510(k)

A

Approved Manufacturer List
Approved Vendor List
Assembly

B

Bill of Materials
Build to Order

C

CE Mark
Change Control Board
Change Management
Child Item
Class I Device
Class II Device
Class III Device
Compliance
Compliance Management
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

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 Management
Engineering Change Notice
Engineering Change Order
Engineering Change Order Form
Engineering Change Process
Engineering Change Request (ECR)
Enterprise Resource Planning
Environmental Compliance
Export Administration Regulations
Export Controls Compliance

F

FDA Compliance
Finished Goods
Form, Fit and Function

G

Good Manufacturing Practice

I

Installation Qualification
ISO
ITAR
ISO 13485
ISO 13485 Compliance
ISO 14971
ISO 9000
ISO 9001 Compliance
ISO Compliance
Issue Management
ITAR Compliance

J

Just in Time Manufacturing

M

Manufacturer
Manufacturing Bill of Materials
Manufacturing Change Process
Manufacturing Deviation
Manufacturing Execution Systems
Manufacturing Work Instructions
Material Disposition Codes
Mechanical CAD Software
Medical Device
Medical Device Single Audit Program
Multilevel BOM

N

New Product Development
New Product Introduction

O

Operational Qualification
Original Design Manufacturer
Original Equipment Manufacturer

P

Parent Item
Part
Part Number
Performance Qualification
Premarket Approval
Premarket Notification
Preventive Action
Product Analytics
Product Data Exchange
Product Data Management
Product Design
Product Development Process
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 Matrix
RoHS
RoHS Compliance

S

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

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
FDA Compliance
Underwriters Laboratory
Unit of Measure

W

WEEE

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