What is a Quality Management System and how can it benefit your dental laboratory? Find out here 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 is now just one recognized certification program - the International Organization for Standardization (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.
Dental laboratories may choose to hire a third party auditing firm for their quality system audits. 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.
Benefits of Implementing a Quality System
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
How to Stay on Top of FDA Dental Regulations
Contact SafeLink Consulting for assistance.
Are you a manufacturer of dental devices? Need Quality System consulting or other services?
Here's what SafeLink Consulting can do for you:
Learn more about what SafeLink Consulting can do to help your business with compliance services, including safety compliance, to meet OSHA training requirements and quality system consulting to meet FDA compliance. SafeLink Consulting assists businesses with workplace safety training, infection control training, HIPAA training online, quality systems, assessments, audits, due diligence, and more.
Industries include:
Dentistry compliance - assisting the dental practice with meeting requirements for OSHA, HIPAA, EPA, and CDC guidelines, patient safety and employee health & safety
Dental Laboratory compliance - assisting the dental lab with meeting requirements for OSHA, FDA, and CDC guidelines, employee health & safety, plus FDA requirements for lab manufacturing custom implant abutment /gmp for medical device manufacturers
Medical Device Manufacturers compliance - assisting with meeting OSHA compliance & FDA requirements, GMP - good manufacturing practices
General Industry compliance - assisting with OSHA compliance and FDA compliance as it pertains to the specific business
Beverage Industry compliance - assisting beverage businesses such as the craft brewery, winery, cidery, distillery, vintner with meeting OSHA compliance, health & safety, FDA requirements / GMP - Good Manufacturing Practices.