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 13485 vs. ISO 9001, we have to understand that both standards are part of the ISO QMS, and must meet general requirements. These general requirements merely state that “the organization shall establish, document, implement and maintain a quality management system and maintain its effectiveness in accordance with the requirements of this International Standard”.
ISO 13485 flows from ISO 9001. While ISO 9001 is a general standard for third party assessment, ISO 13485 is that part of this standard that is specific to the medical devices industry.
The crux of ISO 13485 vs. ISO 9001 lies in the application. ISO 13485 includes some specific requirements for medical devices and excludes those requirements of ISO 9001 that are not appropriate for regulatory requirements. So, although similar on the surface, these two standards work in tandem, but are yet exclusive to each other in many respects. Organizations which claim that their medical devices meet ISO 13485 requirements cannot claim that their organization automatically meet ISO 9001 as well.
The ISO wanted to make the 13485 specific to the medical devices industry. It wanted to remove the complexity associated with the 9001 and make a standard that was usable by organizations of varying sizes, was easily comprehended, was compatible with management systems such as ISO 14001, and had a direct relationship with the activities that went into running a business. The ISO 13485 standard has achieved all this, and thus is a continuum of the ISO 9001 standard with the necessary refinements.
Difference in terms of operation
ISO 13485 must define document retention times based on organizational and regulatory requirements, while 9001 must record retention times based on organizational and regulatory requirements.
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