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.
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.
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.
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.