Quality Management Systems and Standards
What the exam tests
This domain is about the architecture of ISO 9001:2015, how sector schemes (IATF 16949, AS9100D, ISO 13485, ISO 14001) layer on top of it, and the certification lifecycle. Questions are usually clause-mapping, PDCA placement, or definitions of documented information.
Clause map and PDCA
- Clauses 4-10 hold requirements; 1-3 are informative. Plan = 4 (context), 5 (leadership), 6 (planning); Do = 7 (support), 8 (operation); Check = 9 (performance evaluation); Act = 10 (improvement).
- "Maintain documented information" means a procedure-like document must exist; "retain" means records as evidence of results. A quality manual is no longer mandatory but is still permitted.
- Risk-based thinking appears in 6.1 and replaces the old preventive-action clause; 10.2 still requires corrective action, and 8.5.6 covers control of changes.
Certification lifecycle
An accreditation body (ANAB, UKAS, DAkkS) accredits certification bodies; the certification body audits the organization. A two-stage initial audit (Stage 1 readiness, Stage 2 implementation) leads to a three-year certificate, with surveillance audits at least once every 12 months and a recertification audit before expiry. Major nonconformities must normally be closed before the certificate is issued; minors are closed within an agreed timeframe.
Worked example
An auditor finds a torque wrench on a safety-critical joint with an expired calibration sticker, and the recall list has no owner. Mapping: the requirement is 7.1.5.2 (measurement traceability); the missing recall ownership is a system breakdown handled under 10.2 (corrective action); if a customer complaint triggered the visit, 9.1.2 also applies. Reasoning order matters: cite the requirement, then the objective evidence, then the systemic clause.
Traps that cost marks
"Documented procedure" was removed as terminology in 2015. Risk-based thinking does not mandate FMEA. A correction (rework the part) is not a corrective action (remove the cause). Certification proves the QMS conforms, not that every product conforms. Design (8.3) can be excluded only with justification recorded under 4.3. "Shall" is auditable; "should" is guidance.