Auditoría interna ISO 9001: checklist (capítulos 4–10) con reporte

Internal and external issues relevant to the quality system are identified and reviewed.

Interested parties and their relevant requirements are known and kept up to date.

Scope of the quality management system is documented, including justified exclusions.

Processes, their sequence, interactions, inputs, outputs, owners and measures are defined.

Top management takes part in the quality system and promotes process approach and risk-based thinking.

Quality policy is documented, communicated and understood (ask employees).

Roles, responsibilities and authorities are assigned and communicated.

Risks and opportunities are identified, actions are planned and their effectiveness evaluated.

Quality objectives are measurable, monitored and have plans with owners and dates.

Changes to the quality system are planned and controlled.

Monitoring and measuring equipment is suitable, calibrated, identified and protected.

Organisational knowledge needed for the processes is kept and available.

Competence requirements are defined, training is given and its effectiveness evaluated.

Employees are aware of the policy, objectives and their contribution.

Documented information is controlled: approval, revision, availability, protection and retention.

Operational planning defines criteria, resources and records for products and services.

Customer requirements are reviewed before acceptance of orders and changes.

Design and development has planning, inputs, reviews, verification, validation and change control.

External providers are evaluated, selected and monitored, and requirements are communicated to them.

Production is done under controlled conditions: instructions, equipment, monitoring and qualified people.

Product identification and traceability are maintained where required.

Product is preserved during handling, storage, packaging and delivery.

Product release is done by authorised people after planned checks, with records.

Nonconforming outputs are identified, segregated and dispositioned, with records.

Customer satisfaction is monitored and the results are used.

Data is analysed to evaluate process performance, suppliers and the need for improvement.

Internal audit programme covers all processes, auditors are impartial and findings are followed up.

Management review is held with all required inputs and documented outputs.

Nonconformities are corrected, causes are analysed and corrective actions are checked for effectiveness.

Continual improvement is planned and visible in results.