ISO 9001
Skill packages tagged with “ISO 9001”
CAPA Report
Corrective and Preventive Action reports for audit non-conformities. Enforces 5 Whys root cause analysis and a future Effectiveness Check date (ISO 9001 / ISO 13485).
QMS Procedure Elaborator
Guided elaboration of QMS procedures, process maps, and quality objectives aligned to ISO 9001 clauses and context of the organization. Verifies required clause topics are addressed and objectives are measurable.