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Damas PDF

The document discusses DAMAS, a quality assurance process for dental laboratories. It can be implemented by following published guidelines and training from an approved consultant. Laboratories must then undergo a third-party audit to verify compliance with DAMAS standards. DAMAS is based on ISO quality principles tailored for dental labs and mirrors FDA QS/GMP requirements. It aims to improve documentation, efficiency, customer service and meet regulatory standards for quality assurance.
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0% found this document useful (0 votes)
165 views2 pages

Damas PDF

The document discusses DAMAS, a quality assurance process for dental laboratories. It can be implemented by following published guidelines and training from an approved consultant. Laboratories must then undergo a third-party audit to verify compliance with DAMAS standards. DAMAS is based on ISO quality principles tailored for dental labs and mirrors FDA QS/GMP requirements. It aims to improve documentation, efficiency, customer service and meet regulatory standards for quality assurance.
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF, TXT or read online on Scribd
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How Can I Implement Do You Have

Tallahassee, FL
Permit # 801
US Postage
First Class
the DAMAS System Peace of Mind?
in My Dental Laboratory?

A laboratory can incorporate DAMAS


by following the published guidelines to
improve quality assurance.
A laboratory can utilize the services of
a DAMAS approved trainer/consultant DAMAS FOR NORTH AMERICA
to train the laboratory and its personnel DENTAL APPLIANCE MANUFACTURERS AUDIT SYSTEM
FDA COMPLIANCE & QUALITY MANAGEMENT SYSTEM
on how to fully integrate the system
into day-to-day operations. Once your
laboratory has integrated the processes,
the laboratory must go through a third
party audit to ensure compliance with
the DAMAS specification standards. This
gives your laboratory outside verification
that the business is doing what it intends
to do relative to quality assurance.
For more information on DAMAS, contact
the National Association of Dental
Laboratories today at 800/950-1150 to
order the DAMAS Information Packet and
Standard.
325 John Knox Road, L103

Good Business Practices


Quality Assurance for
Tallahassee, FL 32303

Dental Laboratories!

Improved Efficiency
Product Quality

DAMAS: A process for all A Quality Assurance


www.nadl.org

size dental laboratories Process for Dental


Laboratories Developed by
Visit www.nadl.org for a full list of DAMAS
certified labs and approved DAMAS Auditors. Dental Laboratories
Why DAMAS? Is DAMAS Right for DAMAS Fact and Fiction
The dental laboratory is a crucial element of the My Dental Laboratory? DAMAS does not require monumental loads of
delivery of quality dental care. The requirements set paper; hours of management time; interference from
Dental laboratories vary in size and manufacturing outside bodies; and the process does not tell you
forth in DAMAS are based upon the sound quality
processes, the DAMAS process addresses how to run your business.
system management principles specified in ISO, but
overall operations but can also be augmented to
are geared specifically for the dental laboratory
encompass special requirements for laboratories that However, it can be of great assistance to your
setting. The DAMAS specifications provide a clear-
manufacture sleep apnea and snore guard devices. dental laboratory by:
cut process for improving documentation in every
facet of laboratory operations including: dental • Improving efficiency and productivity
Although no quality assurance process can • Integrating good management disciplines
prescriptions/work authorizations; patient contact
guarantee you compliance with the FDA, DAMAS • Improving customer service needs and customer
materials; subcontractor/supplier agreements; material
was developed for dental laboratories by dental confidence
and equipment purchases; employee training;
laboratory owners for the specific operations that • Providing a competitive edge
maintenance and calibration of equipment; labeling;
labs face day to day. DAMAS, although not free, is • Reducing waste of materials and manpower
customer complaints; and material traceability.
significantly less expensive to implement than other • Reducing risk and liability
more general quality assurance programs. • Improves ability to increase profitability
The standards required by DAMAS closely mirror
the U.S. Food and Drug Administration’s Quality • Provides a formal process to help meet FDA
System/Good Manufacturing Practice (QS/GMP) QS/GMP requirements
specifications, which are required of all dental
laboratories conducting business in the United States.

To ensure product quality and foster a professional


industry relative to quality assurance, NADL offers this
system as a resource to dental laboratories.
DAMAS FOR NORTH AMERICA

System/Good Manufacturing Practices


DENTAL APPLIANCE MANUFACTURERS AUDIT SYSTEM
Peace of M
FDA Quality ind fo
r Dent
FDA COMPLIANCE & QUALITY MANAGEMENT SYSTEM
al Client
s Ensurin
g Qualit
y of Dental Restorations

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