Bio-AMD to Implement ISO 9001 and ISO 13485 Quality Standards

Bio-AMD Inc. (OTCMKTS:BIAD) and its majority owned subsidiary Bio Alternative Medical Devices Ltd, announced that is will formalize the implementation of the International Organisation for Standardization quality standards ISO 9001:2008 and ISO 13485:2012.

As quoted in the press release:

The Company, which already works to the requirements of these standards, has engaged a specialist ISO quality standard consultancy to provide support for this implementation as we move through our technology commercialization process.

ISO 9001 is the world’s most popular quality management system framework. More than a million organisations in over 175 countries are certified to its requirements. The standard’s focus is on the use of planning to drive success through improved customer satisfaction, motivation of personnel and continual improvement.

ISO 13485 is the preferred management system for the quality control of medical devices. The standard “tunes” the fundamental requirements of ISO 9001 to provide a management framework for the design and production of medical devices and in-vitro diagnostic devices. ISO 13485 is an essential requirement for the mandatory CE conformity marking of medical devices manufactured in or designed to be sold in the European Economic Area.

Nasr Djennati, managing director of Bio Alternative Medical Devices, commented:

ISO 9001 and ISO 13485 are the primary international quality standards applicable to med-tech companies. Registration will provide our partners and customers assurance that our products have been through a rigorous quality process that will continue well beyond a product launch. We are confident that we will achieve registration to both ISO standards, which will further enhance our reputation in the healthcare sector.

Click here to read the full Bio-AMD Inc. (OTCMKTS:BIAD) press release.