Delivering Quality – The ISO 13485 Certification

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The medical device industry is one of the most highly regulated verticals worldwide. Devices and quality systems must satisfy stringent requirements before they can be marketed and sold in the U.S. and worldwide.

The ISO 13485 standard specifies requirements for a quality management system (QMS) for an organization to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements. By certifying your QMS, you can better market your products, and improve your organization’s level of efficiency.

The standard requires that the certified organization can demonstrate that their QMS is implemented effectively and that it is maintained. You do this through documentation that proves you not only have processes in place but that you also follow them.

Why Seek ISO 13485 Certification?

Achieving an ISO 13485 certification has significant benefits to your company, whether a large organization or a startup. It systematizes processes that may already be in place for quality assurance, mitigates risk by ensuring your product is safe for its intended use, and can accelerate speed to market within a stringent quality and regulatory framework.

Fundamentally, certification establishes a strong foundation before venturing into the highly regulated medical device approval process.  Going through certification ensures a focus on risk management and design control activities during the product development stage. It creates monitors and controls in the work environment to ensure product safety.

ISO 13485 is considered the most common path to meeting requirements to market and sell your device worldwide. For example, compliance with this standard is considered to be the first step in achieving compliance with European regulatory requirements.

Who Needs ISO 13485 Certification?

Medical device manufacturers and anyone who intends to market and sell their products globally can benefit from ISO 13485 certification. However, even companies who provide services to device manufacturers can benefit.

Goddard, for example, sought ISO 13485 certification to better align to our client’s needs and formalize our rigorous product development process.

Whether your company is focused on production, design and development, installation, or servicing of medical devices, ISO 13485:2016 is relevant to your business.

Benefits for Startups and Small Organizations

Achieving ISO 13485 certification can be an arduous process. If you’re managing a startup speed to market matters, and a well-functioning QMS can be a catalyst rather than a burden.

Product design becomes more efficient when definitions of product requirements and quality processes are standardized. Well executed, ISO 13485 should reduce design, and create safer more effective products.

If you need guidance with the certification process, Goddard can help. Our quality assurance and regulatory affairs team has already gone through it, and can assist in setting up quality processes per the ISO 13485 standard. Or, your organization can leverage Goddard’s quality system to speed product development until the time is right to transition to an in-house certified QMS.

Some countries require ISO 13485 certification to support regulatory approval, so depending on the markets where you intend to sell, this should be an early consideration.

For Large Organizations with an Established QMS

If your company already has a quality system in place, there are benefits to working with a product design firm that is ISO 13485 certified. First, Goddard is able to interface with your organization’s existing QMS. More importantly, having a second, outside set of eyes is useful for identifying opportunities for improvement in your QMS. By spotting any non-conforming areas, you can minimize the associated risks before they become a problem.

In large medical device organizations, an ISO 13485-certified QMS is likely already in place. It’s an important part of defining and controlling operations and product development.

When engaging external technical teams, a quality certification indicates an understanding of regulatory requirements and experience operating in a controlled system. Likewise, an external QA/RA team is often able to identify opportunities for improvement within a QMS

ISO 13485 Certification Can Help Avoid Device Recalls

According to the FDA, the number one benefit of achieving and applying ISO 13485 certification lies in avoiding recalls. The FDA also reports that between 40-50% of all medical device recalls are related to flaws in product development.

Unfortunately, 2018 saw a spike in medical device recalls.  While the root causes vary, risk management is consistently linked to QMS structure and compliance.  A functioning system supports the definition of user inputs and product requirements, controls on supplier processes, and appropriate overall management of the product development process. Of course, a QMS does not eliminate risk of recalls, but it plays a significant role in reducing that risk, and producing high quality, safe products.

Improving Business Performance through ISO 13485 Certification

Going through the certification process pushed the Goddard team to thoughtfully assess business performance and critical contributing factors.  Part of our 13485 quality metrics include measuring company growth, employee satisfaction, and success in addressing customer needs.

We implemented a rigorous approach to measuring client and partner satisfaction, leveraging both surveys and periodic, less formal check-ins.  Analysis of structured and unstructured datasets established an impartial representation of key stakeholder opinions and led to actionable results.

The certification process also includes tracking employee development, advancement and satisfaction. Again, a data-centric and controlled approach led to new learnings in accelerating team development, and early identification of issues.

In concert with end-to-end product development services, Goddard is well positioned to address challenges in the regulatory and quality space, and support the establishment of effective ISO 13485-compliant quality management systems.