Quality Management and Documentation
Core concepts
Understand ISO 9001 structure: process approach, PDCA cycle, risk-based thinking, and the seven quality principles. Know the difference between Qualitätskontrolle (inspection), Qualitätssicherung (process assurance) and Qualitätsmanagement (system). Familiarise yourself with Prüfprotokolle, Abnahmeprotokolle, Messprotokolle and their retention periods. Understand Korrekturmaßnahmen vs. Vorbeugemaßnahmen and how a Reklamationsprozess is documented.
Traps
Exams confuse correction (fixing the defect) with corrective action (removing the cause). Another trap: assuming ISO 9001 certifies product quality - it certifies the management system. Watch for confusion between Audit (system check) and Inspektion (product check).
Worked example
A recurring fault appears in three installations. Rule of thumb: correction = repair each installation; corrective action = root-cause analysis (e.g., supplier change) and process update. Document both in the CAPA record. Answer: the exam asks for the corrective action, not the repair.
Documentation practice
Every measurement must record instrument, calibration status, date, value and signature.