New Scale Technologies, Inc. has achieved ISO 9001:2015 certification for its quality management systems and also ISO 13485:2016 certification for its quality management systems specifically related to the manufacturing of medical devices.
“ISO 9001:2015 certification, which applies to both New Scale Technologies and our New Scale Robotics Division, underscores our ongoing commitment to quality in the design and assembly of micro motion modules and fabrication of parts,” said David Henderson, CEO of New Scale Technologies and New Scale Robotics.
“ISO 13485:2016 certification, which applies to New Scale Technologies, demonstrates our accountability and conformance to industry best practices when making micro modules for use in compact medical instruments and devices,” Henderson continued. “This certification is essential for our customers who will submit their products for regulatory approval to government bodies such as the USA Food and Drug Administration (FDA) or the European Medicines Agency (EMA).”
ISO 9001:2015 and ISO 13485:2016 are the most current versions of the globally-recognized quality management standards developed and published by the International Organization for Standardization (ISO). ISO 9001:2015 provides a model for building effective quality management systems based on core quality management principles. ISO 13485:2016 additionally specifies requirements needed to deliver medical devices and related services that consistently meet customer and applicable regulatory requirements.
New Scale’s certificates were issued following extensive analysis of its quality management systems by independent auditing firm Eagle Registrations, Inc., accredited by the ANSI National Accreditation Board (ANAB). New Scale will undergo ongoing auditing inspections and annual process verification to maintain its certifications.