"ISO Certified" and "FDA Compliant" are popular advertised features in the trade magazines. What is the significance of the designations?
ISO (International Organization for Standardization) is located in Switzerland. The guidelines, authored in 1947, can apply to any type of organization. They are oriented toward companies who do business internationally. ISO does not certify the quality of products or services. It is a process standard and many countries have adopted it because it is believed to control quality by standardizing management.
For firms who choose to implement the ISO quality management system, the designation insures that the processes the company are using follows specific guidelines. Quality management by way of ISO dictates how records are stored, the way information is transferred, rules for engineering changes and iterations, record keeping procedures, the customer communications process, etc. In any case, these companies operate under a strict regulatory structure with the associated fixed costs and overhead.
We designed this portable (about nine pounds) oxygen concentrator for Inogen, Inc., a start-up company. Our flexibility allows us to meet all of our customers’ management and quality needs (ISO and others) without being certified ourselves.
Compliance with ISO is not necessarily a predictor of a well-run company.
For a design firm, the rigid rules could easily become a complicated hindrance, and add extra layers of bureaucracy. As an example, when the documentation process itself needs to be documented, a likely result is a slower product development cycle. It's reasonable to speculate that some companies use ISO as an excuse for why projects are behind and things are not getting done.
Regardless of whether ISO guidelines are followed, the FDA mandates their set of rules, the Quality Systems Regulations (QSRs), to be implemented when developing medical devices in the U.S. The ten elements of Design Control (plus Risk Analysis) are the foundation for the development of medical devices in general. The QSRs assure consistency with quality systems worldwide and allow for the correction of potential problems early in the product design process. Every medical device manufacturer is responsible for maintaining records which demonstrate QSR compliance as it applies to the research and feasibility stages of product development.
Our clients have unique design control systems.
With the exception of some small start-up firms (who are in their initial planning stages), all of our clients have unique design control systems. Our challenge is to mesh the design control system our clients have chosen with ours and comply with the FDA regulations. Our Regulatory and Design Control group has implemented a quality system that follows the model of the ISO guidelines and the FDA Quality Systems Requirements (QSRs). The system describes the general process of activity within the company during the project development cycle.
Since we are not ISO Certified and control our own management policies, we have the flexibility to accommodate almost everyone.
Omnica is a close-knit horizontal organization with a focus on medical device development. The checks and balances we have in place insure our continued effectiveness without the burden of having to work within a rigid process structure.