Except for auditors working solely under Table A.1.7, auditors have knowledge equivalent to post-secondary education, typically four years, or equivalent work experience in fields such as biology, chemistry, software, engineering, physiology, medicine, pharmacy or physics; they have four years or more of full-time working experience in medical devices or a related sector, with advanced degrees able to replace up to two years, and any exception is shown equivalent and the justification recorded; parts and services auditors meet ISO/IEC 17021-1 and 17021-3 instead. Competence follows Annex B. Each auditor undertakes at least 8 hours of continuing professional development a year for Table A.1.7 work and at least 16 hours for Tables A.1.1 to A.1.6, keeping abreast of regulatory change and emerging technology, and the body maintains auditors' knowledge through timely training; advanced training in risk management, process validation, sterilisation, electronics, plastics, software and hardware validation and specific devices is recommended.
The graph holds this control, the 0 it maps to, and the evidence behind each claim, over MCP and REST.