Due to the increasingly global nature of the world economy, there has been tremendous worldwide growth in the use of quality management systems. With the increase in outsourcing, both domestically and internationally, you may be relying on the quality of the products and services of another organization. Not only do you need to develop a quality system in your laboratory, but also a need has been created for you to ensure as a consumer and business that the organizations producing products for you have a management system that will ensure conformity to your customer’s requirements. 

In recent years, the U.S. Food and Drug Administration has caused dental laboratories to review their quality systems and ensure that they are meeting FDA’s quality system regulation. This regulation is available at the FDA Web site at the following address:
www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm?CFRPart=820. 

I want to encourage you to go beyond compliance requirements to develop and implement a quality system that is an integral part of all business decisions. The benefits of a quality system are far beyond written manuals and procedures. Certification of your quality system provides even more as far as being able to market to your customers that you are meeting a recognized standard. DAMAS certification can certainly set that standard for you.

Why Become Certified?

Those of you who are CDTs or have your laboratory certified as a CDL can probably answer that question better than I.  Certification is:

• Documentation: Confirmation that some fact or statement is true through the use of documentary evidence.
• Certificate: A document attesting to the truth of certain stated facts.
• Authentication: Validating the authenticity of something or someone 
(wordnetweb.princeton.edu/perl/webwn).
• Certification refers to the confirmation of certain characteristics of an object, person, or organization. This confirmation is often, but not always, provided by some form of external review, education, or assessment.
(en.wikipedia.org/wiki/Certification)
• Professional certification, trade certification or professional designation, often called simply certification or qualification, is a designation earned by a person to assure qualification to perform a job or task
(en.wikipedia.org/wiki/Certification_(software_engineering))

A number of my clients are DAMAS certified and when I asked them the benefits, here’s what they said:

• Forced review of remakes, cleaning logs, vendor complaints and customer complaints leads to trend analysis.
• Reduction of remake percentage. One client reported seeing a 1 percent drop in remakes.
• Cost of equipment tracking means making better decisions on retirement of assets.
• Focus on higher quality so that everyone more in tune on what needs to happen to make the lab a success.
• Marketing advantage in that it proves the laboratory meets a standard. 

How?

DAMAS certification requires that your compliance with the DAMAS specifications be verified by a certifying body. NADL has appointed the North American certifying bodies and accepts their confirmation for the issuance of DAMAS certification to dental laboratories that have satisfactorily met the requirements. Here’s how the process works:

• The dental laboratory owner must contact NADL to register their interest in becoming DAMAS certified. A fee is due with this registration. 
• Upon receipt of the appropriate fee, NADL will send the DAMAS specifications to you along with information for the development of your quality system.
• You develop and document your quality system according to the DAMAS specifications and the FDA quality system regulations.
• After you have been operating under your quality system as documented, then you perform an internal audit or have an outside consultant perform the audit.  The purpose of this is to ensure that you’re doing what your documents say you’re doing so you will be best prepared for the certification audit.
• When you are ready for the onsite certification audit, you will select your NADL-approved certifying company and arrange your onsite visit with them. The certifying body will inform you of the fees involved for this visit.
• The on-site certification audit is performed initially and then in years two and three.
• In years four and five, you will undergo a remote documentation review. This is similar to the requirements for a CDL re-certification.
• In year six, you will undergo an onsite audit and then in years seven and eight the cycle begins again for remote documentation review and then an on-site visit in year nine.
• This new schedule of onsite certification audits and remote documentation reviews apply in North America only to the best of my knowledge.  

After the initial onsite certification, NADL provides you with a certificate and also the DAMAS logo to use according to the guidelines. You should use this certification to demonstrate to your dental clients and to any other customers that you have a quality system in place that protects not only your liability for compliance with regulatory standards, but also aids in the liability of your customers. You can go to the NADL Web site (www.nadl.org) to learn more about DAMAS certification. Also, speaking with laboratory owners who have made this wise decision will help you determine if this is the path you should take to better your business.

About the author:Borg is the co-founder and president of SafeLink Consulting Inc. Since 1991, she has actively participated as a presenter and on-site instructor to audiences of dentists, dental hygienists, dental assistants, and dental laboratory technicians throughout the US. Prior to founding SafeLink Consulting , Borg held senior level management positions in mortgage banking, banking and the family entertainment business. Her positions included responsibility for facilities management, human resources, risk management, crisis and disaster recovery and health and safety.