OUR QUALITY SYSTEMS
m2m Imaging (Australia) is certified to both ISO9001 and ISO13485 standards.
About our certification standards:
ISO 9001:2008 specifies requirements for a Quality Management System overseeing the production of a product or service. This international quality standard is used to assess the ability of our business to meet customer and applicable regulatory requirements and thereby address customer satisfaction. ISO9001 is the International Standardisation Organisation's (ISO) standard for quality management systems.
ISO 13485:2003 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 requirements and regulatory requirements applicable to medical devices and related services. The primary objective of ISO 13485:2003 is to facilitate harmonized medical device regulatory requirements for quality management systems.
Preclinical products are manufactured within our ISO9001 framework. Clinical research products are manufactured within our ISO13485 framework.