Study Guide GD211: Guidance on the Content of Quality Management System Audit Reports

Canada, H. (2011). Study Guide GD211: Guidance on the Content of Quality Management System Audit Reports: Guidance on the Content of Quality Management System Audit Reports.

Type

Report

Intellectual base

Grey literature

Year

2011

Link

https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices/quality-systems-13485/study-guide-gd211-guidance-content-quality-management-system-audit-reports.html

Cited by

1 citation across 1 artifact.

Each citation links to the sentence it supports in the citing article.

Mechanisms

• Sample Review Dashboard
  • A regime that samples the wrong moments can show green — full coverage of what it looked at, 100% follow-up — while missing the real condition entirely

    This sourceWarns that audit sampling can miss a real nonconformity because it examines only part of the available evidence.

Verification

This reference passed the adversarial substantiation pipeline: it was checked to exist and to support the claim it is attached to. See how references were verified.

Registry ID ref:7ed1f89980ce · see in the full table