ISO 9001’s Process Approach to Quality Management

ISO 9001 came into being exclusively as a means of incorporating a process approach to quality management systems. Both ISO 9000 and ISO 9004 underwent an amendment in 2000 to put this approach into place. It is all about process Where this approach differs from the previous standard is that it improves upon it by […]

The ISO 13485:2003 Standard has quality management systems at its heart

The ISO 13485:2003 Standard has quality management systems at its heart. The ISO 13485:2003 Standard relates to quality management systems in the field of Medical Devices. Its requirements ISO 13485:2003 specifically relate to organizations that are in the business of medical devices, no matter what its size or type. At its core, ISO 13485:2003 is […]

ISO 13485 vs. ISO 9001

ISO 13485 vs. ISO 9001 One of the most commonly countered questions in the medical device industry is: ISO 13485 vs. ISO 9001. They are often confused for each other. But they are never the same, although they have many common requirements. ISO 13485 is part of ISO 9001 family of regulations When understanding ISO […]