What is a Quality Management System and how can it benefit your dental laboratory? Learn why businesses pursue certification and how your Quality Management System should be working for your business.
Quality System management is a multidimensional issue, covering more than just verification that a finished product meets certain expectations. As a component of regulatory standards, quality management requires a system for controlling, monitoring, and verifying any activity or process that could affect product conformance. The Food and Drug Administration requires dental laboratories to develop, implement, and maintain a Quality System. They don’t require certification or registration of that Quality System, however, many business owners go beyond the FDA’s requirements and certify or register their Quality System.
In the dental lab industry there are two recognized certification programs. The Dental Appliance Manufacturers Audit System (DAMAS) is specific to dental laboratories and is offered through the National Association of Dental Laboratories (NADL). The International Organization for Standardization (ISO) is the other.
DAMAS was brought to the U.S. by the NADL to provide a certification for dental laboratories who want to ensure that their Quality System is not only in dental compliance with FDA Quality System requirements, but is effective in improving their business. DAMAS Certification requires an onsite audit in years 1-3 and then in years 4 & 5 submission of documentation showing continued compliance with the DAMAS Specifications. Beginning in year 6, there is an onsite audit that is repeated every 3 years. The years without an onsite audit require submission of the remote document review. This alternation between onsite visits and remote document reviews provides an economical advantage over ISO.
ISO dates back to 1947 when it was founded in Geneva. ISO was born from two organizations – the International Federation of the National Federation of the National Standardizing Associates, established in 1926, and the United Nations Standards Coordinating Committee, established in 1944. In 1946 delegates from 25 countries met at the Institute of Civil Engineers in London and decided to create a new international organization. The objective was to “facilitate the international coordination and unification of industrial standards.” Today ISO is a network of the national standards institutes of 157 countries, one member per country, with a central secretariat in Geneva that coordinates the system. Each country is represented by its own national body. The American National Standards Institute represents the U.S.
In most cases, dental laboratories that want to show that their quality system is audited by an outside auditing firm, choose DAMAS. ISO 13485 is specific to Medical Devices, therefore, some dental labs select that type of registration or certification.
The reasons for certification can include a company’s need to:
- Evidence an effective Quality System to a governmental agency or institution that requires their vendors/suppliers to have a Quality System;
- Comply with applicable state and federal requirements;
- Demonstrate its ability to provide medical devices and related services that consistently meet customer requirements and regulatory requirements applicable to medical devices and related services; and
- Facilitate harmonized medical device regulatory requirements for their quality management systems.
What is a Quality System supposed to provide my business?
Your Quality System should be working for you so whether you are certified or not, here’s what your Quality System should be providing you:
- Aiding in enhancing customer satisfaction and improved customer loyalty thus leading to repeat business
- Increasing revenue and market share obtained through flexible and fast responses to market opportunities
- Integrating and aligning internal processes which will lead to increased productivity and results
- Enhancing business performance and better cost management
- Providing confidence to interested parties as to the consistency, effectiveness and efficiency of the organization
- Increasing credibility and competitiveness in the market
- Consistency in the delivery of your product or service
- Lowering costs and shorter cycle times through effective use of resources
- Improving communication, planning and administration processes
Are you a manufacturer of dental devices? Need Quality System consulting or other services?
Here's what SafeLink Consulting can do for you:
- Quality Management consulting
- Quality Management training online courses
- Quality System Regulation Risk Assessment
- FDA consultants
- 510k consultants
- DIY Quality Systems Lab
- Quality System Manual