DAMAS: Dental Appliance Manufacturers Audit Scheme
Why DAMAS?
The dental laboratory is a crucial element
of the delivery of quality dental care.
The requirements set forth in DAMAS are based upon the sound quality
system management principles specified in ISO, but are geared specifically for
the dental laboratory setting. The DAMAS specifications provide a clear-cut process
for improving documentation in every facet of laboratory operations including:
dental prescriptions/work authorizations; patient contact materials; subcontractor/supplier
agreements; material and equipment purchases; employee training; maintenance
and calibration of equipment; labeling; customer complaints; and material traceability.
The
standards required by DAMAS closely mirror the U.S. Food and
Drug Administration’s
Quality System/Good Manufacturing Practice (QS/GMP) 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.
Is
DAMAS Right for My Dental
Laboratory?
Dental laboratories vary in size and manufacturing processes, the
DAMAS process addresses overall operations but can also be augmented to encompass
special requirements for laboratories that manufacture sleep apnea and snore
guard devices.
Although no quality
assurance process can guarantee you compliance with the FDA,
DAMAS was developed for dental laboratories by dental laboratory
owners for the specific operations that labs face day to day.
DAMAS, although not free, is significantly less expensive to
implement than other more general quality assurance programs.
Fact and Fiction on
DAMAS
DAMAS does not require monumental
loads of paper; hours of management time; interference from outside bodies;
and the process does not tell you how to run your business.
However, it can be
of great assistance to your dental laboratory by:
• Improving efficiency and productivity
• Integrating good management disciplines
• Improving customer service
needs and customer confidence
• Providing a competitive edge
• Reducing waste of materials
and manpower
• Reducing risk and liability
• Improves ability to increase
profitability
• Provides a formal process to help meet FDA QS/GMP requirements.
How Can I Implement the DAMAS
System 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 to train the laboratory
and its personnel 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.
History and Background
of DAMAS
The DAMAS Standard
was originally introduced in the mid nineties as an alternative
to ISO Certification. Both ISO9001-2000 & 13485 are full-blown
QA systems with ISO13485 being an extended version of the 9000
specifically aimed at medical device manufacturing in a mass
production basis.
It was felt that both were
over prescriptive for the "custom made" laboratory and required excessive
time and costs over and above a specifically laboratory directed system.
Additionally EN46000 (traceability), introduced at this time required a management
system in place as an operating base in respect of Patient Contact Materials.
The UK Dental Laboratories Association developed the standard to provide a specific system for dental laboratories. NADL owns the rights to the DAMAS system in North American and offers the system to the industry for the purpose of providing a pre-packaged quality assurance system to help raise standards within the industry.
Laboratories can purchase the system manuals and specifications directly from NADL. In most cases, it is suggested that laboratories utilize the services of a consultant to help integrate the system. Additionally, laboratories can achieve full certification in the system by completing a third party audit of compliance.
DAMAS Accredited Laboratories
Download the DAMAS Brochure
To Order the DAMAS System, please contact the NADL Fulfillment House at phone: (800) 950-1150 or download the DAMAS Manual Order Form:
DAMAS Manual Order Form
For DAMAS Consulting, contact Lawrence Hall Consulting at
http://www.lawrencehallconsultants.com/
For DAMAS Certification, contact Ray Kirton, Registrar, at 407/306-8193 or by fax at 407/306-8189.
To open and/or download the pdf files as referenced above, you need to have Adobe Acrobat Reader installed on your computer. To download this free software, click on the link below and follow the instructions on screen.
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