ISO 13485 Certified Custom Sewing Services

TPI is an ISO 13485 certified provider of custom sewing services that is committed to product quality and reliability. As a 13485 company, TPI’s certification confirms that our custom sewing services have the controls in place to ensure repeatability and a high level of quality for the products we produce. ISO 13485:2016 also relates to custom sewing of medical device products, which may include carry cases, CPAP components, monitor cases, vests, belts, and other related sewn goods.

Dedicated Quality personnel inspect incoming raw materials and finished goods for both domestic and imported goods. All products are inspected throughout each stage of production. Products undergo test procedures that align with how the product will be used in the field. TPI performs 1st article, in-process, and final inspections of all produced products. All subcomponent materials and final products are traceable and manufacturing documentation is maintained for future reference.

The TPI Management Team defines the overall quality policy and promotes a culture of conformance to requirements, customer satisfaction, and continuous improvement.

TPI’s goal is to meet and exceed customer and regulatory requirements and provide high quality products and services. We seek to continually improve and maintain the effectiveness of our quality management system and processes to maintain our certification as a 13485 provider of custom sewing services.

our goal