ISO 13485 certification, what is it and why should it impact my buying decision?
Navigating any specific facet of the medical industry means understanding a lot of jargon. While it may seem overwhelming, keeping up with the latest acronyms and terminology is critical to consistent management decision making, with the ultimate goal of improving quality patient care.
The same is true for manufacturers of medical equipment and devices, such as Reina Imaging. In fact, we believe that quality flows downstream.
Like yours, our world is driven by our dedication to meeting or exceeding the highest recognized principles in our work processes.
The internationally recognized standard for medical device manufacturers is referred to as “ISO 13485 certification.”
ISO is in acronym for International Standardization of Organization, an independent, non-governmental international organization with a membership of the national standards bodies of 162 nations (as of January, 2016.)
According to its website, through its members, ISO “brings together experts to share knowledge and develop voluntary, consensus-based, market-relevant International Standards that support innovation and provide solutions to global challenges. ISO has published more than 21,000 International Standards and related documents covering almost every industry, from technology to food safety, to agriculture and healthcare.”
So ISOs are sets of standards, written by top experts from around the world, voluntarily adhered to by some companies and their employees.
They are not laws, or regulations. They are voluntary standards, used to indicate dedication to the highest ideals in an industry. In many countries, however, importers are required to prove that their foreign suppliers are certified to the ISO 13485 standard. Many of the largest OEM’s in our industry will not source parts from suppliers unless they can prove compliance to the ISO standard.
ISO 13485 pertains to medical devices, ranging from Band-Aids to sophisticated, software-controlled devices like CT scanners and MRI machines. According to the ISO group, this standard is designed to be used by manufacturers and end-users throughout the life cycle of a medical device, from initial conception to production and post-production, including final decommission and disposal.
It covers aspects such as storage, distribution, installation and servicing, and the provision of associated services like complaints, corrective action responses, and risk management. In addition, this standard helps an organization design a Quality Management System that establishes and maintains the effectiveness of its processes. According to ISO, the standard reflects a “strong commitment to continual improvement and gives customers confidence in its ability to bring safe and effective products to market.”
To be ISO 13485 certified, like Reina Imaging, a dynamic Quality Management System must also be in place, to help “streamline and reinforce internal processes and procedures while carrying out the changes and evolutions affecting the market,” states the standard.
What this means, bottom line, is that Reina Imaging commits itself to the highest standards of internationally recognized quality manufacturing because although this comes as a high business expense, we believe that our customers recognize and appreciate the value we create with our designs, products, and services. We are constantly seeking to improve our processes and systems, to bring you the very best the industry has to offer in radiological imaging accessories. Our ISO certification is one of the ways we demonstrate our commitment to our trade, the patients, and all the stakeholders. It sets us apart from our competition and makes us a preferred supplier to the largest OEMs in our industry.
The international standard was written by ISO to support medical device manufacturers in designing quality management systems that establish and maintain the effectiveness of their processes. It ensures the “consistent design, development, production, installation, and delivery of medical devices that are safe for their intended purpose.”
ISO 13485 is based on the process-model concepts of “Plan, Do, Check, Act,” and is designed for regulatory compliance. It is prescriptive in nature, and requires a thorough documentation of all aspects of manufacture.
If you look, you’ll see this designation on Reina product literature. It’s your way to know that our products live up to the highest internationally established standards for medical device manufacturing.
Not all manufacturers work at this level. To be absolutely sure your practice is providing the highest quality radiological imaging, be sure to ask if equipment is being produced by ISO 13485 Certified medical manufacturers.
Earlier I suggested that quality flows downstream. Although our primary niche is accessories, we understand the importance of quality in the devices and parts we supply, as it relates to both patient safety and OEM reputation.
After all, what good is a car if the wheels won’t spin or if they blow out after the first pothole they encounter? What will patients think of the car manufacturer based on the quality of the wheels? This is why it is important to work only with medical device manufacturers and parts suppliers that adhere to the same quality standard as the largest international players in our industry – ISO 13485.