Safety and quality are non-negotiables in the medical devices industry. Regulatory requirements are increasingly stringent throughout every step of a product’s life cycle, including service and delivery. More and more, organizations in the industry are expected to demonstrate their quality management processes and ensure best practice in everything they do.
ISO 13485, is an internationally agreed standard that sets out the requirements for a quality management system specific to the medical devices industry. ISO 13485 is designed to be used by organizations involved in the design, production, installation and servicing of medical devices and related services.
Like other ISO management system standards, certification to ISO 13485 is not a requirement of the standard, and organizations can reap many benefits from implementing the standard without undergoing the certification process. However, third-party certification can demonstrate to regulators that you have met the requirements of the standard. ISO does not perform certification. ISO 13485 helps an organization design a quality management system that establishes and maintains the effectiveness of its processes. It reflects a strong commitment to continual improvement and gives customers confidence in its ability to bring safe and effective products to market.
ISO 9001 is designed to be flexible. Organizations that earn this certification must meet specific requirements, but ISO doesn’t dictate how to meet them. That means organizations certified to ISO 9001 may experience improved processes and increased customer satisfaction.
Our quality management system (QMS) consists of the processes we put in place to meet the needs of our customers.
Six Sigma Certified
Six Sigma certification is becoming an expectation in the business world. Our team has a member with black belt certification and a member with a green belt certification. Both of these team members have advanced training in various problem-solving methods and statistical tools.
To implement Six Sigma strategies, a company must deliver top-quality products while improving and streamlining its processes. It trains team members to continually evaluate critical processes. The term Six Sigma refers to a production that is statistically near perfect. To achieve Six Sigma a process must produce no more than 3.4 defects per million.