Quality Management
Skill packages tagged with “Quality Management”
Health Canada & MDSAP
Align QMS documentation to MDSAP and Health Canada expectations. Guides users to map procedures and records to MDSAP/ISO 13485, prepare for audits, and use the mdsap_audit_aligner skill when available.
QMS CAPA Tracker
Draft and validate CAPA (Corrective and Preventive Action) reports for medical device quality management systems. Standardizes root cause analysis using 5 Whys or Fishbone (Ishikawa) methods, enforces Effectiveness Check completeness, and validates CAPA structure against ISO 13485 and FDA 21 CFR Part 820 requirements.
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.