Results

  • Passed certification audit for 13485:2016
  • Updated Quality Manual and Procedures
  • Improved overall quality of the process
  • Trained employees on internal auditing
  • Allowed Mastel to grow business not only in US but in other countries as well

Testimonial

“MTS has been extremely valuable to the Mastel team. Brad Fischer is always ready to help. I know he has the best interests of our company in mind.”

About

Mastel Precision is a Rapid City-based manufacturer with top-notch employees specializing in diamond scalpels for corneal and cataract surgery. While they concentrate on manufacturing, repairing and evaluating diamond scalpels; they also provide services for repairing, cleaning and servicing other eye instruments. The family-owned business prides themselves on the quality and dependability of their products and services. With 16 employees, Mastel Precision has created an exceptional, reliable reputation for manufacturing quality ophthalmic instruments for eye surgeons all around the world.

Challenge

Quality is not only important to Mastel, but vital to their survival—which means they don’t take their quality standards lightly. Going off the philosophy that more heads are better than one, Mastel decided to bring in outside help to continue to uphold their quality standards.

Solution

Friends of the company introduced Mastel to South Dakota Manufacturing & Technology Solutions. Brad Fischer, an MTS business advisor and expert in ISO regulations, helped Mastel transition from ISO 13485:2003 to ISO 13484:2016. He worked with the company to reduce rework and update their policy procedures. The Plan-Do-Check-Act methodology helped identify deficiencies and create a solid plan of attack for the team.

Doug Mastel, founder and owner of Mastel Precision, found MTS’ help extremely beneficial and professional. It was fun on a personal level too, because both graduated from SDSM&T as metallurgical engineers and have family ties.

The work MTS provided was necessary to keep the business moving forward in the United States and expanding into other countries. Mastel may be small in numbers, but they are mighty when it comes to producing quality ophthalmic surgical instrumentation.

The VSM provided opportunities and tactics for the group to work together to remove waste and increase efficiencies in their process and introduced the company to concepts like 5S and set-up time reduction. Three Midstates employees are now bronze-certified in Lean and multiple employees have taken Lean 101 to help drive the concept throughout the company. Pair that with three other employees participating in MTS’ newest offering known as Lean Leadership for Supervisors, and the company is well into its journey for continuous improvement on all levels.

Results

  • Passed certification audit for 13485:2016
  • Updated Quality Manual and Procedures
  • Improved overall quality of the process
  • Trained employees on internal auditing
  • Allowed Mastel to grow business not only in US but in other countries as well

Contact us for help with your quality standards.