Teel Plastics 06.19.18
Teel Plastics, a Baraboo, Wis.-based plastic processing company, has received its ISO 13485:2016 certification. Teel has served customers in the medical market for over twenty years and the process to add the certification started in 2016. Achieving the certification is part of Teel’s long term plan to expand its offerings in the medical market, such as flexible PVC and co-extrusion, to a wider customer base.
“We have had customers that have worked with us for years and kept auditing us to higher and higher standards, which we always maintained, and we wanted to certify that for new customers,” said Mike Faust, Teel’s director of quality.
ISO 13485:2016 is the most widely accepted global quality standard for manufacturers working in the medical device space. It potentially covers all aspects of the business with a focus on quality and evaluation and control of risk. The auditing process is spread over a week of on-site time to ensure procedures and processes are capable of controlling critical aspects of the business. Teel passed the rigorous auditing process without issue.
The certification covers Teel’s extrusion and injection molding operation at their company headquarters as well as their Laboratory Sampling Products division. Teel has been serving the medical market with a variety of products for over thirty years and has invested considerably in technology, facilities, and equipment in that time.
“We think this demonstrates our commitment to our customers and the medical market,” said Teel’s president, Tom Thompson. “This is an important first step,” he added. “We are excited for future possibilities and the challenge of continuing to improve.”
“We have had customers that have worked with us for years and kept auditing us to higher and higher standards, which we always maintained, and we wanted to certify that for new customers,” said Mike Faust, Teel’s director of quality.
ISO 13485:2016 is the most widely accepted global quality standard for manufacturers working in the medical device space. It potentially covers all aspects of the business with a focus on quality and evaluation and control of risk. The auditing process is spread over a week of on-site time to ensure procedures and processes are capable of controlling critical aspects of the business. Teel passed the rigorous auditing process without issue.
The certification covers Teel’s extrusion and injection molding operation at their company headquarters as well as their Laboratory Sampling Products division. Teel has been serving the medical market with a variety of products for over thirty years and has invested considerably in technology, facilities, and equipment in that time.
“We think this demonstrates our commitment to our customers and the medical market,” said Teel’s president, Tom Thompson. “This is an important first step,” he added. “We are excited for future possibilities and the challenge of continuing to improve.”