Growing Medical Business Propels ISO 13485 Certification Progress at Allegheny Performance Plastics
To meet the growing demand for high-performance thermoplastics in healthcare applications, we’re proud to share that our medical business continues to grow. To meet the industry regulations and standards demanded by this industry, we are enhancing our current clean room manufacturing capabilities to include strategic compliance with the highest standards of quality and compliance. We have recently taken two critical steps toward ISO 13485 certification; a globally recognized quality management system (QMS) standard specifically designed for medical device manufacturing.
Step 1: Lead Auditor Training
A foundational component of any ISO-compliant quality management system is the ability to conduct rigorous internal audits. That’s why our Quality Team has recently completed Lead Auditor Training for ISO 13485 certification. This advanced training allows us to assess compliance, identify process risks, and drive continuous improvement from within. This capability strengthens our internal quality controls and prepares us for both certification audits and the demands of our medical customers.
Step 2: Gap Analysis
The second major milestone we’ve completed is a comprehensive gap analysis. This process involves evaluating our existing QMS against the ISO 13485 standard to identify areas that require modification, enhancement, or validation. We are now aware of where our systems already meet the standard and where adjustments are necessary.
Quality Manager Todd Fleming states, “Having a QMS already aligned with ISO 9001, AS 9100, and IATF 16949 reduces the potential gaps and puts us in an excellent position to move forward with integrating ISO 13485 into our systems.”
Path to ISO 13485 Certification
We anticipate that our journey toward ISO 13485 certification will be complete by the end of this year.
“As we progress on current expansion plans, achieving ISO 13485 is key to our business strategy. The addition of this certification will bolster our overall QMS and align us with our customer requirements while enabling us to meet the demands of this growing industry segment,” said Robert Stutzman, CEO.
We look forward to being your trusted injection-molding partner for all your medical device needs. Explore our work in the healthcare industry here.
