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PPM Earns ISO 13485:2016 Certification
ISO 13485:2016 Certification Earned By Pittsburgh Plastics Manufacturing
Butler, PA - SRI Quality System Registrar is pleased to announce that it has recently awarded an ISO 13485:2016 Management System certificate to Pittsburgh Plastics Manufacturing, located in Butler, PA for the design and manufacture of advanced polymer devices for medical, foot care, safety, athletic and industrial markets.
According to Edward L. Maschmeier, Associate Vice President, Certification:
“We are pleased to acknowledge that Pittsburgh Plastics Manufacturing has demonstrated effective implementation of a management system. ISO 13485:2016 certification provides evidence to customers, suppliers, employees, and their community of their commitment to producing a quality product (service) and providing customer satisfaction.”
ISO 13485:2016 is process-based; certification recognizes organizations that can link business objectives with operating effectiveness. Companies that achieve Management System certification to ISO 13485:2016 have demonstrated effective implementation of documentation and records management, top management’s commitment to their customers, establishment of clear policy, good planning and implementation, good resource management, efficient process control, and measurement and analysis.
Pittsburgh Plastics Vice President, Casey Carr, noted:
"The ISO 13485:2016 certification validates the commitment to quality that PPM has had throughout the years. We are excited about the new opportunities that this certification will allow us in the development and manufacturing of medical devices."
Pittsburgh Plastics Mfg., Inc. is a contract manufacturer of custom cushioning solutions for the foot care, medical, safety, industrial and athletic markets. PPM utilizes a variety of proprietary materials including PPM’s exclusive polyurethane IsoGel®, IsoFoam® and GELoam®, TPE’s, silicones and hydrogels.
SRI Quality System Registrar is an internationally accredited registrar for management systems standards, such as ISO 9001, AS9100, IATF 16949, OHSAS 18001, ISO 13485, ISO 20000-1, ISO 27001, ISO/FSSC 22000 and environmental management systems standards such as ISO 14001, RC14001, and RCMS. SRI also provides public training for auditing, implementing, and maintaining these standards.
