ISO 13485 The Best Way to Gauge the Quality of Medical Devices

Isots 16949 certification

For any industry, it is critical for its processes to be efficient, safe, and reliable. This is especially true for the health care industry, which includes physicians offices, hospitals, clinics, and all medical facilities. They must house the best equipment and methods in order to offer the highest quality care.

One way to do this is to invest in ISO certification for medical devices in these facilities. This certification comes from the International Organization for Standardization (ISO), a body that employs numerous global representatives that create international standards for a number of practices, products, and services. ISO certification for medical devices, food safety certification, environmental health and safety certification, construction quality management certification, and overall quality management certification are just some of the credentials the ISO awards qualified candidates.

One of the advantages of seeking ISO certification 13485, the specific code for medical devices, is a higher quality product. For most hospitals, their machines and medical devices are essential to delivering the care patients need. To obtain an ISO certification, a third party auditor evaluates these devices, how they are manufactured, and if they meet international standards. This includes ensuring that every part of design, production and distribution follow particular regulations. The result is an increase in the quality of these devices, which translates into higher level of medical care.

Another advantage is the transparency it gives medical facilities. In other words, patients can trust that their hospital is doing its best to provide them with the best care by using medical devices that are safely manufactured. This also holds manufacturers accountable for their products, and forces them to create superior devices for doctors, nurses, and medical professionals to use. A hospital may also be more likely to do business with a medical device manufacturer that has an ISO certification, as it will be able to trust the manufacturer’s merchandise.

Additionally, ISO 13485 creates a standard by which all medical devices can be measured for quality assurance. This means that regardless of the country a patient is in, he or she can be sure that devices certified by the ISO are reliable. This also opens the doors to more global participation in health care, and can even facilitate trade and idea exchanging between countries to share their best equipment. Ultimately, this will benefit patients all over the world.

Consequently, obtaining an ISO certification for medical devices would be worth any manufacturer’s time. It will make their business look more credible, boost their visibility, and could eventually lead to higher profits on an international scale.