Medical devices are critical to the health and well-being to both the sick and the healthy. These devices support doctors, nurses, and specialists in the medical field to provide accurate diagnoses and prescribe the appropriate treatment for any illnesses. This is why there are stringent policies and rigid standards to be followed when manufacturing such devices. Quality standards are essential to the manufacturing of such products, which impact the lives of millions of people every day. ISO 13485 is the global standard for the comprehensive quality management system for the design and manufacture of medical devices. It was published in 1996 and since then has provided businesses who actively manufacture medical devices and their components with global standard guidelines on safety, effectivity, and accuracy. ISO 13485 often goes hand in hand with ISO 9001, which is a standard that guarantees continued improvement of products and services to maintain quality.

As a business involved in the manufacturing of such medical devices, your company may be interested in getting certified, and with good reason. There are several benefits of getting certification for ISO 13845, as outlined in the next section.

ISO 13485 as a Global Standard of Quality and Reliability

Management systems certifications are often put in place to serve several benefits to one’s business. While several management systems such as ISO 9001 Quality Management Systems serve specific manufacturing purposes, so does ISO 13485. This standard is in fact derived from the ISO 9000 quality management standard series and adapts the ISO 9000 process-based model for a regulated medical device manufacturing environment. The primary goal of ISO 13485 is to provide support to medical device manufacturers and businesses in the medical device field to design quality management systems (QMS) that define and maintain the effectiveness and efficiency of their business processes. According to BSI, this standard also ensures consistency when it comes to the design, development, production, installation, and delivery of medical devices to guarantee their safety, quality, and reliability. Here are some of the benefits of getting an ISO 13485 certification.

Quicker, more efficient cycle times

As a medical device manufacturer, you’re often encumbered by meeting delivery schedules on time and keeping clients satisfied by providing them what they need when they need it. Part of the ISO 13485 compliance process is identifying your cycles and processes and identifying bottlenecks and areas of improvement so you can address these and create a more efficient, streamlined process. Because the ISO 13485 certification process forces you to review your cycle, you can alleviate problem areas and eliminate delays in the system.

Decreased or eliminated waste of time and costs

When you revamp your manufacturing processes to comply with ISO 13485, you effectively remove bottlenecks and areas that produce waste, whether its cost, time, or effort. Providing solutions to these problem areas will not only increase efficiency but decrease overall waste.

Increased customer satisfaction and brand loyalty

Cutting costs also means that you can provide clients with a more competitive price versus the next provider, without sacrificing quality. This competitive offer, when delivered consistently to clients, will increase customer satisfaction and boost customer retention. The best part? Your loyal customers can also act as a marketing tool. After all, positive testimonials are one of the best ways to market your products and services.

Greater access to a wider market globally

The ISO 13485 certification, as with other ISO certifications, bring about a sense of credibility and reliability to your brand. The rigorous process of getting certified may prove challenging, which is why it is recommended to team up with ISO certification specialists, but companies like yours must see it as an investment for your business to remain competitive in a rapidly changing global market.

Companies who have ISO 9001 Quality Management Systems and ISO 13485 certifications in place experience these and many other benefits. If your business is looking to get certified to ISO 13485, ISO 9001, or ISO 45001, partner with an ISO certification specialist like ICS Consulting, which offers professional assistance and quality service when it comes to transitioning, integrating, or applying for ISO certifications. Backed by years of experience in supporting businesses to achieve ISO certification status, ICS Consulting provides gap assessment audits and action reports to help you determine gaps in your process and address these problem areas appropriately. They even provide ISO internal audits to review your business system to ensure it is working as efficiently as possible before it is assessed by the ISO certification body. These review processes are an opportunity for your company to revamp and overhaul any faulty processes before the ISO certifying body can do their own evaluation. Experience the full benefits of having an ISO certification today with ICS Consulting.