Our Blog

ISO 13485:2016 Certification Achieved

We are delighted and proud to announce Spectra-Tech Manufacturing, Inc. received ISO 13485:2016 certification for Medical Devices and Quality Management Systems!

In conjunction with this outstanding accomplishment, Spectra-Tech also attained its ISO 9001:2015 Quality Management Systems renewal.

ISO 13485:2016 is a global quality standard where companies that achieve the certification must meet stringent product quality requirements of the International Organization of Standards (ISO) and must demonstrate the highest level of quality controls in meeting customer and regulatory requirements throughout all stages of a product’s lifecycle: from prototype through manufacturing.

This achievement signifies Spectra-Tech’s commitment to delivering the highest level of quality and consistency in its products and services to its customers. It is another example of our focus on continual improvement and strive for excellence.

When asked his thoughts Phil Sexton, Director of Quality & Manufacturing had this to say. “This is a significant milestone for our company, and it is very exciting to have accomplished our goal of the ISO 13485:2016 certification. To establish our Quality Management System to be fully aligned with both ISO quality standards serves as our persistent dedication to producing world-class, high-quality products. We knew we wanted to set ourselves apart in the EMS Industry of electronic circuit board assemblies. The route we chose is an unwavering commitment to quality in everything we do and earning this certification honors that dedication.”

The benefits to our customers go beyond just having a certificate because it assures them our company has a strong, solid, & dependable Quality Management System. As goals focus on the customer, the organization spends less time focusing on individual goals of departments and more time working together to meet customer needs. It is not just words to be spoken but rather a way of life in how we do business.

As it is stated in our quality policy, it is our commitment to continual improvement and achieving customer satisfaction in all aspects of our business activities. Congratulations to our outstanding team of employees!

“We are proud to be awarded the internationally recognized ISO 13485:2016 certification. At Spectra-Tech, we integrate the mindset of quality in our daily work and constantly challenge ourselves to improve the quality management system to provide products and services that meet or exceed the expectations of our customers. The accreditation demonstrates our commitment to providing our customers with independent assurance that our dedication to quality permeates everything we do.” said Scott Reilman, President of Spectra-Tech Manufacturing, Inc.

Click the thumbnail below to view the certificate: