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What Is The ISO 13485:2003 Specification?

June 6th, 2012

ISO 13485:2003 is an ISO standard, that is an "International Organization for Standardization". An ISO is simply a body that has representatives from various organizations around the world to help companies adhere to standards.

The ISO 13485 standard is one that is meant to help designers and manufacturers of medical devices create instruments to a better standard. This allows them to be made of a higher quality with less cost.

There have been other standard for the medical industry - some of these were EN 45001 and EN 46002 in 1997, but the newer ISO 13485 supercedes these. SIO 13485 was published in 2003 (there was a previous version of it in 1996 but the newer ISO 13845 also supercedes that).

This is a completely stand-alone document, however it pretty much jives with ISO 9001. One big difference is that ISO 9001 requires organizations to keep improving, while with ISO 13485 the only requirement is to follow the standards of quality and maintain it.

There are many specific thigns that an organization needs to do to comply with an ISO 13485 audit. Most companies have an ISO 13485 internal audit checklist in place to be able to make sure they have everything covered and can quickly refer back to it.

There are many specific things that the specification requires. One of these is have some controls in the work environment to make sure that product safety is high. There's also a focus on risk management and design control during the time of product development, as this is a critical phase. There are certain requirement to make sure that the organization is taking preventative and corrective actions.

There's much more to ISO 13485 and being compliant with it, but this is just a general overview. More to come on it and how to do internal audits including checklists in the future!