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Flex-Cell Precision Gains ISO 13485:2016/9001:2015 Certifications

Flex-Cell Precision, a Lancaster, Pennsylvania-based contract manufacturer of orthopaedic implants and surgical components, has received ISO 13485:2016 and 9001:2015 Certifications.

ISO 13485 is the standard that defines the requirements for quality management systems. ISO 13485:2016 has a greater emphasis on risk management and risk-based decision making. It also reflects changes related to the increased regulatory requirements for organizations in the supply chain. It is a major update from the 2003 standard and is designed to respond to latest quality management system practices, including changes in technology and regulatory requirements and expectations. 

ISO 9001:2015 specifies requirements for a quality management system when an organization: a) needs to demonstrate its ability to consistently provide products and services that meet customer and applicable statutory and regulatory requirements, and b) aims to enhance customer satisfaction through the effective application of the system, including processes for improvement and the assurance of conformity to customer and applicable statutory and regulatory requirements.

Flex-Cell’s capabilities include 5-axis milling (PEEK and titanium), Swiss machining, robotic automation, anodizing, finishing, ultrasonic cleaning, soda blasting and ink marking.

Source: Flex-Cell Precision