Most clinical applications of medical devices are safe and effective, but occasionally there are adverse incidents, mostly resulting from human error or technological imperfections. In fact, a review of operating theatre adverse events, published in a study in the Journal of Medical Engineering and Technology found that over a fifth of medical-device-related incidents was equipment-related. This only goes to underscore the importance of quality control and checks when it comes to the purchase of medical equipment, especially imaging equipment.
And that’s why it is important that the equipment you procure adheres to the most stringent quality standards. One of the ways to do that is by ensuring ISO certifications are met.
ISO certification means that a third party has independently validated that an organisation conforms to standards established by the International Organization for Standardization (ISO). A company that meets the ISO requirements is awarded the certification for three years, which means organisations must continually improve to qualify for the recertification process.
ISO compliance may sound like it means the same as ISO certified, but it does not. ISO compliance is a form of self-assessment that a company may do. It only means that the company adheres to the requirements of ISO standards but without the formal certification processes.
Compliance being more like a self-assessment, means that although a company may still implement a complete quality management system, it doesn’t hire a third-party certification body to conduct the certification audit.
Before choosing a medical imaging equipment provider, it is important to understand if they are ISO certified or ISO compliant. If the company uses phrases such as “recognise ISO standards” or “follow ISO standards”, then most likely they are only compliant and not certified. It could also mean that they were ISO certified at one time and lost the certification. So it is important to double-check the terms before procurement.
For example, ISO 13485 compliance would mean that the company has consistent processes that meet the standard of a quality management system but the company does not actually have the certification for it.
To receive an ISO 13485 certification the company would have had to perform a series of audits for validation, verification, measuring, monitoring, measurement, inspection, handling, distribution and traceability. Today, several regulatory bodies worldwide are including ISO 13485 into their requirements making the product suitable for companies to market internationally, especially since it lays emphasis on risk-based approaches for quality and safety.
ISO certifications for medical devices guarantee that the systems have all the requirements for standardisation, quality assurance, and consistency. ISO standards for medical devices help in the improvement of product efficiency.
ISO certification is a commitment to quality. It improves accountability. It eliminates delays. It promises continuous improvement. It is for these reasons that many countries follow stringent regulations that require hospitals to purchase medical equipment only from ISO-certified providers.
ISO 13485, for instance, which requires medical equipment providers to focus on risk management can help hospitals reduce liability risks. So, why go with an equipment provider such as Blue Star, which is ISO certified? Patient safety and your peace of mind.
Blue Star Engineering & Electronics’ processes adhere to ISO 13485 standards, which assures efficient turnaround times, less wastage, and greater reliability. We have a dedicated team of sales and service engineers to help with identification, installation, and commissioning of refurbished diagnostic imaging systems tailormade to suit your requirements. We also offer 24×7 service support. And yes, we are ISO certified! Contact us today.