As with any industry, medical device manufacturers are governed by industry standards and government regulations. Chief among these standards is ISO 9001—the international standard for quality management systems for companies, businesses, and organizations. ISO first published the standard in 1987. Updated versions were published in 1994, 2000, 2008, with the newest version being ISO 9001:2015. The ISO 9001 quality management standard applies to a wide range of industries, suppliers, and services. A short list includes pharmaceuticals, oil and gas, mining, energy, electronics, steel, banking, health care, hospitality, utilities, biotechnology, and the manufacturing of medical devices. With regard to the latter, many countries rely on ISO standards in regulating medical devices to develop similar quality system requirements internationally. Yet, does the ISO set inspection standards for medical devices with regulatory agencies globally? In the U.S. what role does the FDA play in medical device regulation and compliance? And what exactly is the ISO? And how does ISO 9001 affect the medical device industry? It can be confusing. Read on to answer these and other FAQ’s relating to ISO 9001:
What is the FDA?
The Food and Drug Administration (FDA) is a U.S. government agency responsible for protecting the public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological goods and products, blood products, and medical devices, as well as to ensure the safety of the food supply for people and animals, dietary supplements, cosmetics, and products that emit radiation. It is the regulatory body for the medical device industry.
What is the ISO?
ISO is the International Organization for Standardization. It is an independent, non-governmental international organization with a membership of 162 national standards bodies. It establishes guidelines, requirements and specifications for products, services and systems, to ensure quality, safety and efficiency. It also works to harmonize its standards with those of the regulatory agencies and bodies around the world.
What is ISO 9001?
ISO 9001 is the International Standard that promotes and defines the criteria for the development, implementation, and effectiveness of a quality management system for companies, businesses, and organizations. It is the only standard in the ISO 9000 series of standards of quality management guidelines and tools that is certifiable for companies and organizations. To date, over one million companies and organizations in over 170 countries have been certified to ISO 9001. The standard focuses on seven customer-oriented quality management principles to ensure consistent, quality services and products for customers, that the implementation of will also, in turn, reward businesses with success. The ISO 9001 principles are customer focus, leadership, engagement of people, process approach, improvement, evidence-based decision making, and relationship management. It is important to note that ISO 9001 is not a product standard, but a tool to control your processes and a quality system that your end product should meet. Also, ISO 9001 is not a membership group. A company or organization doesn’t ‘join’ ISO 9001. It must meet the criteria as defined in the certification requirements and pass the ISO audit. Once passed, the ISO registrar issues an ISO 9001 Certificate good for a three year period.
Why was ISO 9001 Developed?
Developing and establishing international standards provides a benchmark for quality management systems to meet. A consequence of bureaucratic regulation is a tendency toward a piecemeal approach to address evolving system requirements. Quite often, an overarching consistency is lacking, along with other inefficiencies, be it the private or public sector. ISO 9001 was developed to avoid such inconsistencies and to achieve a uniformity of objectives for quality management systems.
What is the influence of ISO 9001 on Medical Devices?
The entire scope of ISO 9001 is used by all companies that design, produce, manufacture, process, pack, label, and ship medical devices are required to comply with governmental regulations based either directly or indirectly on the ISO 9000 series. Most medical device manufacturers are ISO 9001 certified, along with other certifications.
Does the Medical Devices Industry Have an ISO?
The medical device sector follows the guidelines and requirements of ISO 13485. It is the international standard for quality management systems that established requirements for the medical device industry. ISO 13485 is designed and intended to function with other management systems around the world, and by doing so, work more efficiently and transparently with each other. The standard functions as a set of supplementary requirements used in conjunction with ISO 9001, which encompasses requirements specific to medical device manufacturers. Recently, the FDA announced its intention to use ISO 13485 as the basis for its quality system legislation.
