As a maker of quality medical equipment who wishes to offer safe and effective products, having in place an ironclad quality management system (QMS) that adheres to approved regulatory standards is very necessary. Ever since its inception and approval by the global harmonization task force (GHTF), ISO 13485 has rapidly evolved into the gold standard in the healthcare equipment industry. Below are some of the most notable benefits of being ISO 13485 certified, you should know.
Benefits of being ISO 13485 certified
Unlimited access to lucrative global markets
The ISO 13485 standard is universally recognized by virtually all main medical equipment markets globally. This, of course, includes the US, Europe, Australia and Japan. As you may probably be aware, most governmental regulatory agencies in this industry have stringent regulations.
One of this is requiring private companies who make healthcare devices to possess a 3rd party audited and certified QMS set up. Therefore, investing in this certification will allow you to gain entry into such markets with just a single audit. It will, additionally, expedite market entry in those nations, which don’t have any such guidelines. ISO 13485 certification will also imply that your QMS concurs with the FDA’s QSR standards.
Significantly minimized costs of sales
Secondly, this certification will go a long way in underscoring your company’s credibility and utmost commitment to quality. As the overall task of proving the efficiency of your QMS will be very straightforward, it will take lesser time in fostering trust and confidence in your brand. This along with the improved capability of actually responding to your clients’ needs, will permit you to reduce greatly the costs of selling your products.
Highly enhanced business performance
Finally, another of the most important benefits of being ISO 13485 certified is, without a doubt, facilitating for an improved business performance. Successfully obtaining this all-important certification, will significantly assist in enhancing your products and business processes. All of which will be totally based on a uniform and widely acknowledged process control system. This, in its turn, will help you improve your relationships with your suppliers, business associates, and more to the point, clients. This unparalleled efficiency in your business affairs can, in the long run, give you an invaluable edge over your competition in the marketplace.
Even if you are in a relatively unconventional business such as operating an anal bleaching salon, ensuring that you utilize ISO 13485 certified products, can prove to be an incredibly wise decision. Mainly due to the undeniable fact that this certification guarantees effective risk management and efficiently meeting the clients’ expectations at all points.