ISO 13485:2016

Winco Mfg., LLC has been independently assessed by NQA against internationally recognized standards showing our commitment to quality and assurance.

We have been certified to ISO 13485:2016 the International Quality Management Systems for Medical Devices.

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.

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. 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 by Winco. Winco Mfg., LLC is committed to raising the bar on the ever-increasing needs of the overall healthcare market.

ISO13485 Certification