ISO 9001:2015 (Quality Management) Controls Checklist

The processes needed for the QMS and their interactions are determined, with inputs, outputs, sequence, criteria and responsibilities.

Evidence: SOP Hub process map and SOP inventory with owners.

Top management demonstrates leadership and commitment to the QMS and to customer focus.

Evidence: Management review minutes; quality objectives with executive sign-off.

A quality policy is established, communicated, understood and applied within the organisation.

Evidence: Policy Hub policy version with acknowledgment completion report.

Risks and opportunities that could affect conformity of products and services and customer satisfaction are determined and addressed.

Evidence: Compliance Hub risk register with linked inspection findings.

Measurable quality objectives consistent with the policy are set, monitored, communicated and updated.

Evidence: Objectives document; Inspections quality-check analytics against targets.

Equipment used to verify conformity is suitable, maintained, and calibrated or verified at specified intervals.

Evidence: Asset maintenance / calibration records with due dates.

Persons doing work that affects quality performance are competent, and competence is evidenced.

Evidence: Training completion and certification records per role.

Documented information is created, updated and controlled — identification, format, review, approval, distribution, retention.

Evidence: SOP Hub / Policy Hub version histories with approvals.

Requirements for products and services — including applicable statutory and regulatory requirements — are determined.

Evidence: Compliance Hub legal register entries tagged industry / contractual.

External providers are evaluated, selected, monitored and re-evaluated against defined criteria.

Evidence: Vendor certification records and supplier evaluation results.

Production and service provision are carried out under controlled conditions — documented procedures, monitoring, competent people, suitable infrastructure.

Evidence: Inspections quality-check records with scores; SOP completion logs.

Changes to production or service provision are reviewed and controlled to ensure continuing conformity.

Evidence: Change records with review and authorisation; updated SOP versions.

Outputs that do not conform to requirements are identified and controlled to prevent unintended use or delivery.

Evidence: Failed inspection items with corrective actions and dispositions.

Customer perceptions of the degree to which their needs and expectations are met are monitored.

Evidence: Survey results; complaint log with resolution times.

Data from monitoring and measurement is analysed to evaluate conformity, satisfaction, QMS performance, and supplier performance.

Evidence: Inspections and CAPA analytics; quarterly quality report.

Internal audits at planned intervals determine whether the QMS conforms to requirements and is effectively implemented.

Evidence: Inspections audit records with scoring and corrective actions.

Top management reviews the QMS at planned intervals — audit results, customer feedback, process performance, nonconformities, supplier performance, risks.

Evidence: Management review minutes and the dashboards / exports presented.

Nonconformities are reacted to, their causes evaluated, corrective action taken, and effectiveness reviewed.

Evidence: The unified CAPA register with verification stamps.

The suitability, adequacy and effectiveness of the QMS are continually improved.

Evidence: Trend of quality metrics; closed improvement actions.