Winco Mfg., LLC is pleased to announce that it has received ISO 13485:2016 Medical devices certification. According to BSI, the global standards company that certified Winco, ISO 13485:2016 expands greatly on ISO 9001 and is stricter in nature demanding a more thoroughly documented quality management system as required by medical device markets. Randy Landry, Quality and Regulatory Manager at Winco commented that “Winco’s upgrade to this specific 2016 standard is directly in line with FDA Medical Device requirements”.
According to the standard, ISO 13485:2016 was written 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 applicable for their intended purpose.
As outlined, and as widely understood, there are multiple benefits of ISO 13485:2016 certification. With it, an organization can increase access to more markets worldwide, improve processes across the organization, increase efficiency, cut costs and effectively monitor supply chain performance. Landry also noted that “Winco’s goal is to manufacture compliant and safe medical devices meeting regulatory requirements and exceeding customer expectations, achieving and maintaining this certification is our means to insure this goal is met.”
“We are delighted to position our company, our customers and our employees for solid future growth” says Tom Lorick, President of Winco. Tom adds that “this certification is only a part of that larger strategy to enhance our organization’s development and provide our customers with the ongoing level of excellence that they have come to know from Winco Medical Furnishings and TransMotion Medical branded products”, and that “the company is committed to raising the bar on the ever-increasing needs of the overall healthcare market”.