Precision Group of San Antonio today announced the company’s quality management system received its ISO 13485:2016 certification which will allow the plastics and tooling manufacturer to enter the medical device production market. The ISO 13485:2016 quality program specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements.
“This certification was new for us and was a major step forward for our company because it opens up a new avenue of business for us,” said Precision Group Quality Manager Anna Wulfe. “We have been working with San Antonio’s KCI-Medical over the last several years, but this quality certification will allow us to provide a wider array of services to them, and open some doors to the broader medical device market.”
Wulfe explained that company went through a thorough three-day audit of its operations to secure the certification. They hired Perry Johnson Registrars, a world leader in quality assessments, to conduct their review. The analysis included a complete inspection of the procedures Precision Group developed for its business to ensure that all steps were being followed as described.
“This is an A to Z inspection. Businesses we work with will know for certain that we have been vetted for delivering the highest quality standards. This gives our clients a level of confidence we think they deserve.”
“We were pleased to be able to work with a company with the international stature Perry Johnson has earned over the years,” Wulfe noted. “They looked at every aspect of our processes to include who our suppliers are, how we receive inventory, how we check against purchase orders to ensure we are accepting exactly what was ordered, how we label inventory and a host of other procedural steps like those. Then they examined our production processes and quality controls we implement there. This is an A to Z inspection so that businesses we work with will know for certain that we have been vetted for delivering the highest quality standards, which gives our clients a level of confidence we think they deserve.”
By earning the ISO 13485:2016 certification, Precision Group will now need be open to unannounced inspections by the U.S. Food and Drug Administration. Wulfe said that those types of “without warning” inspections will be welcomed because it will be another level of quality assurance they can provide to current and future customers.
“At the end the certification process, the company being inspected gets a full report and a listing of major and minor findings. In other words, the audit team will explain where they found flaws in the system,” Wulfe said. “We were pretty excited to learn that this audit team found no flaws in our procedures. We were told that this was the first time their team did not have any findings to report. Essentially, we were the first company to ever ace that particular inspection.”
This quality assurance certification is valid for three years. However, the company will undergo annual inspections over that term to ensure compliance. At the end of the three years, another full examination must be performed in order for Precision Group to be re-certified for the ISO 13485:2016 approval. Requirements of ISO 13485:2016 are applicable to organizations regardless of their size or type, and can apply to medical devices or services supplied by the organization.