We are proud to announce that Stress Engineering Services, Inc. (SES), Mason, OH location has received recertifications for ISO 9001:2015 and ISO 13485:2016 with design for our quality management system (QMS). These global certifications affirm our commitment to excellence in engineering design, analysis, and testing to ensure products meet the stringent regulatory requirements for medical devices and consumer products.
Renewing these certifications confirms our team’s dedication to maintaining the strict standards necessary to provide customers and partners with the highest level of service possible, ensuring our QMS is appropriate and effective and we continually identify and implement improvements. ISO 13485:2016 Certified shows our commitment to the safety and reliability of medical devices for the patient and support to the manufacturer throughout the design, development, and rigorous approval process. Building on the ISO 9001:2015, the complex ISO 13485:2016 process-based model ensures our design, development, testing, and risk evaluation are documented throughout the process.
We partnered with Smithers Quality Assessments, www.smithers.com, an accredited quality and environmental management systems certification body, to achieve our certification.
Approval Certificate Number: 11.354.1
Approval Certificate Number: 11.354.2
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