By Steven Lutz
ISO certification is a valuable asset for many companies. It is a way to prove to customers that you place a strong emphasis on customer satisfaction. The ISO 13485 certification intended for medical device suppliers also ensures that your quality management system (QMS) conforms to and exceeds regulatory requirements such as the FDA 21 CFR 820.
ISO certification can sometimes look like a daunting process, but the idea of ISO is simple. Document and standardize what your company does, then ensure that you follow your documentation and standard operating procedures. When you find areas where the processes don’t conform to the documentation, you find ways to make the documentation and the processes align. In other words, you write what you do, do what you write, and verify that the actions match the documentation.
ISO certification ensures that your company properly tracks and documents every aspect that could impact product quality and customer satisfaction. This certification involves external factors such as supplier quality and performance and internal factors such as quality inspection and documentation of defective products received from either a supplier or internal upstream process. It includes addressing infrastructure needs to provide employees with the tools required to perform their duties properly. This certification also requires the support of management to address concerns and ensure that our quality objectives align with industry and customer expectations. This is critical given that our business is repairing and servicing life-saving medical equipment. A failure on our part to ensure product conformance can result in the loss of human life.
One of the essential aspects of ISO 13485 certification is risk-based analysis and decision-making. As someone who loves numbers, I find data critical to a proper risk evaluation. Our QMS requires that we document both internal and external complaints and take appropriate actions to resolve the issues. Ensuring that we track these complaints allows our company to quickly sort and identify recurring problems, whether these issues are a product issue coming from a supplier or a missed process coming from a department within our organization. This allows us to focus our corrective efforts on the most significant impact on our company and helps us increase efficiency and effectiveness. This streamlining process enables us to offer our customers faster turnaround times, more efficient paperwork and increased transparency.
ISO also emphasizes training employees to make each team member an expert in the processes they’re involved in. ISO helps management empower the technicians to become process owners and subject matter experts. It allows each employee to understand better their role in the company and how their work impacts product quality, customer satisfaction and, most importantly, the effectiveness of the life-saving equipment we provide.
Partnering with an ISO 13485 certified equipment service company gives hospital and EMS purchasing agents peace of mind. It ensures a high level of quality repairs, service and company relations. This ISO 13485 certification verifies the company’s commitment to the quality of its work, constant self-evaluation, and striving for excellence.
Steven Lutz is an analytics manager with ReNew Biomedical.
For more information, go to ReNewBiomedical.com.
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