Quality Audit (ISO 9001 · ISO 13485)

Quality · ISO 9001 · ISO 13485 · IATF 16949

Internal quality audit
without a separate QMS tool

ISO 9001 quality management, ISO 13485 medical devices, IATF 16949 automotive, AS9100 aerospace. CAPA workflow, nonconformance register, internal audit programme — all on the audit-execution cascade your internal audit team already uses.

Internal audit programme

  • Annual audit plan with rotation across departments
  • ISO 19011 procedure templates
  • Lead auditor + audit team assignment
  • Management review pack auto-assembly

Nonconformance + CAPA

  • Nonconformance register with severity rating
  • CAPA workflow with root-cause analysis
  • Effectiveness verification tracking
  • Repeat-finding analytics across processes

Process audits

  • Process owner + RACI capture
  • Walkthrough + control testing
  • Customer-complaint trend integration
  • Supplier audit module (ISO 9001 cl. 8.4)

Standards covered

  • ISO 9001:2015 (general QMS)
  • ISO 13485:2016 (medical devices)
  • IATF 16949:2016 (automotive)
  • AS9100D / AS9110 (aerospace)
  • ISO 14001 (environmental)
  • ISO 45001 (OH&S)

Run quality audits on a modern QMS-grade platform

ISO 9001 / 13485 / IATF / AS9100 seed packs on the GRC Enterprise tier.