What Is An ISO Certification & Why Is It Important?
It is well-known that the healthcare systems and their caregivers, due to the nature of high risks and sensitive information, are held to strict standards to ensure patient privacy and safety. Healthcare Technology Management (HTM) providers are expected to hold themselves accountable, so they can positively impact the efforts of maintaining those standards. However, they are not required to be held to a specific, regulated standard. This doesn’t mean that one does not exist. Within the HTM and medical equipment space, there are two main standards that providers can choose to pursue to solidify their commitment to high standards and quality.
What Is ISO?
ISO, or the International Organization for Standardization, creates and updates the medical equipment industry standards. They are an independent, non-governmental organization that develops and publishes sets of standards for multiple industries ranging from health to transportation and more. ISO provides a framework, tailored to the industry, for organizations to ensure consistent quality, efficiency, and safety. Within the medical equipment space, there are two sets of standards that those in the industry are concerned with. The lower of the two is ISO 9001. This standard focuses on general quality management principles when providing a service. Organizations that are ISO 9001 certified follow specific guidelines for resolving customer complaints, have strong quality control processes in place and conduct regular audits, among other standards. On the other hand, there is ISO 13485, which is the quality management standard specifically for medical devices. The requirements for this standard ensure that the organization, who is responsible for one or more stages in the life-cycle of medical devices, provide medical device services that consistently meet customer and applicable regulatory requirements.
Importance Of ISO To Healthcare Facilities
Choosing an organization that is ISO-certified holds many benefits for healthcare facilities. There are four major advantages, in particular. First and foremost, these organizations are well-equipped to help facilities meet regulatory compliance requirements. By being ISO certified, it demonstrates a commitment to compliance that can be applied to relevant patient care regulations. This commitment also extends to medical device regulations, to ensure patient safety, which is the second advantage of an ISO-certified organization. Through strongly adhering to these regulations and following rigorous quality processes involving proper maintenance of the devices, the chance of risks and adverse events is reduced, increasing patient outcomes and safety. Coming in third is the improvement of operational efficiency. ISO standards regulate asset management, equipment procurement, and maintenance, thus allowing the service provider to optimize the facility’s resource utilization and reduce costs, in turn, leading to higher efficiency. Last but not least, choosing an ISO-certified provider boosts the facility's reputation and trust. It showcases the facility’s dedication to adhering to continuous improvement and fosters trust and confidence in the quality of the care provided.
As an HTM provider, who covers multiple aspects of the medical device lifecycle for our clients, we strongly believe in bringing the best quality in everything we do. That is why we’ve been ISO certified for 10 years, starting with ISO 9001 certified, and now ISO 1348 certified. We always bring the best, and our ISO certification is evidence of that.