When a company trusts a vendor to handle their most complex IoT deployments, it’s absolutely crucial that they fully demonstrate their commitment to quality assurance, standards, and regulatory compliance. IoT managed services providers can do this through strict adherence to processes set by non-governmental organizations that establish, maintain, and promote industry-leading standards. One of the most reputable global standards bodies is the International Organization for Standardization, or ISO. ISO has established and published 23,301 international standards covering almost all aspects of technology and manufacturing.
ISO 9001 sets the criteria for a quality management system and is the only standard of its kind with an associated certification. According to ISO, “this standard is based on a number of quality management principles including a strong customer focus, the motivation and implication of top management, the process approach, and continual improvement.” ISO 9001:2015 is the certification that a company can receive and ensures consistent delivery of high-quality products and services.
From a regulatory compliance standpoint, ISO 9001:2015 certification is not required. However, it does demonstrate an IoT managed services provider’s commitment to process rigor and quality management. ISO 9001:2015 certification proves, as verified by a third-party audit, that the necessary processes and quality systems are in place and adhered to in order to ensure consistent and timely delivery of services. When it comes to IoT managed services, no company can afford the errors that can result from a lack of quality management.
ISO 13485 sets standards for organizations that design, produce, install, and service medical devices, specifically. While this certification is not required from a regulatory compliance standpoint, similar to ISO 9001, it is the leading method of proving a company’s commitment to compliance among regulators. ISO 13485:2016 certification demonstrates not only an ability to routinely meet customer requirements but also a strict adherence to medical device regulation.
The latest version of ISO 13485 standards “has a greater emphasis on risk management and risk-based decision making, as well as changes related to the increased regulatory requirements for organizations in the supply chain.” This means that vendors with this certification who provide IoT managed services for connected health — and handle medical devices in doing so — are using the most up-to-date best practices based on changing technology and regulatory guidelines.
Similar to ISO 9001, there is no regulation that requires companies who serve the connected health industry to be ISO 13485:2016 certified in order to handle medical devices. It’s important to consider, however, the risk of trusting a company to provide IoT managed services without such a quality management system certification. Without demonstrating its ability to provide medical device services that consistently meet customer and regulatory requirements, the company risks improper handling, incorrect/non-compliant packaging and labeling, and operational inefficiency that could result in costly delays.
Selecting an IoT managed services provider with a demonstrable commitment to process rigor and quality assurance is critical to successfully deploy, manage, and scale a company’s IoT initiatives. KORE has maintained ISO 9001:2015 and ISO 13484:2016 certification since 2012, enabling the IoT vision of enterprises across the globe with seamless execution and a constant focus on maximizing the return on your IoT investments.
Download the eBook by James Brehm & Associates, “Internet of Things (IoT) Managed Services,” to learn more about how managed services enable successful deployments and business results.
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