What is ISO 13485 & why do I need it?
ISO 13485:2003 lists the International Standards Organization requirements for quality management systems for medical devices. Like many of ISO's 17,500 different standards, ISO 13485 takes the core quality management concepts of ISO 9001:2008 and adapts them to the medical device industry.
The ISO technical committee for this standard took input from the Global Harmonization Taskforce and from food and drug agencies around the world, to ensure that those who pursued 13485 certification would be well-positioned to meet the requirements of a variety of medical device regulatory bodies – a true benefit to those designing, manufacturing and marketing anything to the medical device industry.
If you have ISO 9001 certification it’s a relatively small leap to this more advanced set of requirements – and like ISO 9001, if a specific area doesn’t apply to the activities that occur at your company, you can identify it as not applicable within your QMS.
If you design, manufacture, or distribute medical devices or their components this standard is worth your consideration and attention.