Finding Competitive Edges
Inside Dental Technology delivers updates on digital workflows, materials, lab techniques, and innovation in dental technology through expert articles and videos.
February 1, 2013
Volume 4, Issue 2, February 2013
Page(s):
All dental technicians are confident about their skills and know they provide excellent service to their clients while also assuring compliance with the law. But how can they make both existing and potential customers aware of the many benefits they have to offer?
The dental laboratory is the glue for the delivery of quality dental care. Without the skillset of the dental technicians in the laboratory, where would dentistry be today? The requirements set forth in the Dental Appliance Manufacturer Audit System (DAMAS) are based upon the sound quality system management principles specified in ISO (International Organization for Standardization), but they are geared specifically for the dental laboratory setting.1
Becoming a DAMAS-certified laboratory will give your customers peace of mind and can be the crucial deciding factor for those choosing a laboratory. The DAMAS specifications can be a great asset to your laboratory by:
Improving workflow and efficiency
Improving customer service and management disciplines
Providing a competitive edge (less than 1% of laboratories in North America are DAMAS certified)
Reducing labor inefficiencies and material waste
Reducing risk and liability
Provide traceability throughout the whole manufacturing process
Most importantly, improving the ability to increase profitability and save time
The standards required by DAMAS closely mirror the FDA’s Quality System/Good Manufacturing Practice (QS/GMP) specifications, which are required of all dental laboratories conducting business in the United States. By complying with the DAMAS requirements, you demonstrate that you can manufacture patient-specific dental appliances in compliance with the US Code of Federal Regulations.1
The following management system requirements are aimed at achieving dental client satisfaction by preventing nonconformity at all stages of dental appliance manufacture. It is also aimed at providing sources of objective evidence that will allow a third party to assess the dental laboratory’s conformity with the specification requirements.
Any person who designs, manufactures, fabricates, assembles, or processes any medical device that is suitable for use or capable of functioning—whether it is packaged, labeled, or sterilized—should comply, by defining, documenting (in writing or electronically), and implementing a Quality Management
System (QMs).
There is obviously some work for the laboratory to undertake, but this will be minimal and generally consist of gathering information, for example, on suppliers and subcontractors.
A laboratory can hire a DAMAS-approved trainer/consultant to train the laboratory and its personnel on how to fully integrate the system into your daily 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.1
If you are looking to improve your laboratory’s efficiency, reduce waste, improve customer service, provide a competitive edge, reduce risk, increase profitability, and—most importantly—provide a formal process to help meet FDA QS/GMP requirements, you are encouraged to go through DAMAS-compliance requirements. Certification of your quality system proves to your existing customers that you are meeting a recognized standard, and DAMAS certification can certainly be used to attract new ones.
