ISO 13485:2016 Section 6 (Resource Management) incorporated via §820.10. ELEMENTS: (6.1) PROVISION OF RESOURCES - determine + provide resources needed for the QMS + product realization; (6.2) HUMAN RESOURCES - competence + training + awareness; personnel performing work affecting product quality must be competent on the basis of education + training + skills + experience; documented procedures for establishing competence + training needs + providing training + evaluating effectiveness of actions; awareness records; (6.3) INFRASTRUCTURE - buildings + workspace + utilities + process equipment + supporting services; maintenance activities to prevent product / process risks; (6.4) WORK ENVIRONMENT + CONTAMINATION CONTROL - work environment requirements documented per product / process; planned controls for environment-sensitive products; contamination control including personnel cleanliness + clothing + handling procedures; pest control + cleaning programmes. FDA QMSR-specific note: §820.15 clarifies that 'work environment' includes COMPUTER SYSTEM environment - computer system validation under Part 11 + cybersecurity controls.
The graph holds this control, the 0 it maps to, and the evidence behind each claim, over MCP and REST.