Manufacturing with ISO Certification 9001:2015 | SYNEO

At SYNEO, we strive to enhance the quality of medical devices by providing integrated solutions in the manufacturing process of catheter punches. Our catheter hole-making punches are manufactured to be very precise, sharp and extremely durable punches for drilling, punching and skiving holes into catheter-based devices. We manufacture our punches to precise tolerances to ensure high quality performance. This mission has led to the achievement of the ISO 9001:2015 certification of our Texas manufacturing facility for the manufacturing and distribution of catheter hole-making punches.

What is an ISO Certification?

ISO 9001 is an internationally recognized standard for Quality Management Systems (QMS) and is the most widely used QMS standard in the world, based on eight quality management principles: strong customer focus, leadership, involvement of people, process approach, system approach to process management, continual improvement, factual approach to decision making, and mutually beneficial supplier relationships. Certified organizations must demonstrate conformance to all requirements of the standard.

What are the benefits of ISO Certification

Companies that are certified to the standard have well-documented, repeatable processes with focus on the quality of products and services they provide, as well as positive customer feedback and high customer satisfaction ratings. Other benefits include a reduction in operating costs and improved risk management. Certification also helps opens doors for an increase in sales due to many procurement specifications requiring certification as a condition to supply.

How SYNEO Achieved this ISO Certification

SYNEO Texas became an ISO certified organization in 2012 after many years of maintaining documented processes. Our organization also maintains a set of processes that show our products, contract services, and quality management system meet the requirements of the standard. Thorough documentation, established and measured quality objectives, and dedicated management and personnel are key contributors to the success of the organization and conformance to the standard.

What Makes SYNEO Different?

This ISO certification is a significant achievement not only for SYNEO, but in the medical device manufacturing industry as a whole. By obtaining this certification, SYNEO has demonstrated the ability to go above and beyond with our commitment to quality, procedures and customer satisfaction. We work closely with each customer to evaluate their needs then determine the best application to achieve their desired manufacturing specifications. At SYNEO, we will determine the optimal cutter material, tip style, shape and coating to ensure the best results are achieved.

To learn more about our catheter hole-making punches, visit We also design and manufacture machines for cutting, feeding, slitting, flaring, grinding, printing and laser micromachining of surgical device applications. Visit our homepage to learn more about or services, or contact us today!


Certified System - ISO 9001 Quality

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