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What is the definition of a "campus" in the context of multi-site QMS audits?
In the context of MDSAP, a "campus" can be defined in two ways:
Proximity-based: A group of sites located within a 1-kilometer radius of each other.
Regulatory-based: A group of geographically close sites (within a 60-minute drive) where no more than one site would require a facility-specific certificate from an RA (e.g., a GMP Certificate or Registration Certificate).
In both cases, the sites within the campus must operate under a single QMS, and their activities must contribute to the production of the finished medical devices covered by the certification.
Important Notes:
Sites sharing the same street address are considered a single facility, not a campus.
A campus may include multiple sites with RA-issued facility identifiers (e.g., FEI issued by the FDA).
A participating RA may use a different definition of "campus" in the context of their own regulatory processes, including audits or inspections.