Audit time follows the general audit time document Global ACI TECH-3-004 (quality, environmental and OH&S systems) except its EMS and OH&S provisions and its table QMS 1, which Annex D Table D.1 replaces as the starting point for an initial audit (stage 1 plus stage 2). Time depends on the scope, objectives and regulatory requirements to be audited and on the devices' range, risk class and complexity and of the organisation; enough time is allowed for the team to establish conformity with the relevant regulatory requirements, and time for auditing national or regional regulatory requirements and for dossier review is additional and justified so the QMS audit is not shortened. Audit time counts time at the client's physical or virtual premises by on-site, remote or combined methods plus planning, document review, client interaction and reporting, but not reviews of design dossiers, type examinations, audits for pre-market approval and similar work; it is adjusted by the Annex D factors. Where ISO 9001 and ISO 13485 are certified together, the time demonstrably suffices for an effective audit of both; integrated audits with other standards follow TECH-3-008.
The graph holds this control, the 0 it maps to, and the evidence behind each claim, over MCP and REST.