Audit Report Summary

Audit Overview
ISO 9001 Compliance Audit

Date: 2023-10-15

Auditor: John Doe

Status: Completed

Key Metrics
Total Questions 50
Passed 45 (90%)
Failed 5 (10%)
Non-Conformities 3
Clause 4: Context of the Organization
Understanding internal and external factors affecting quality management.
  • 4.1: The organization has determined internal and external issues affecting its QMS.
  • 4.2: The needs and expectations of interested parties are identified.
  • 4.3: The scope of the QMS is documented and maintained.
  • 4.4: QMS processes are defined, documented, and implemented.
Recommendations:
  • Regularly review and update the context of the organization to reflect changes in internal and external issues.
Clause 5: Leadership
Top management commitment to the QMS.
  • 5.1: Top management demonstrates leadership and commitment to the QMS.
  • 5.2: A quality policy is established, communicated, and understood.
  • 5.3: Responsibilities and authorities for the QMS are assigned and communicated.
Recommendations:
  • Conduct regular leadership reviews to ensure continued commitment to the QMS.
Clause 6: Planning
Identifying and addressing risks and opportunities.
  • 6.1: Risks and opportunities are identified and addressed.
  • 6.2: Quality objectives are established and measurable.
  • 6.3: There is a process for planning changes to the QMS.
Recommendations:
  • Enhance the risk management process to include more proactive identification of risks and opportunities.
Clause 7: Support
Providing adequate resources for the QMS.
  • 7.1: Adequate resources are provided for the QMS.
  • 7.2: Employees are competent and trained for their roles.
  • 7.3: Documented information is properly controlled (created, updated, stored).
Recommendations:
  • Implement a more robust training program to ensure all employees are fully competent in their roles.
Clause 8: Operation
Ensuring operational control to meet requirements.
  • 8.1: Operational controls are in place to meet customer and regulatory requirements.
  • 8.2: Customer communication and contract review processes are effective.
  • 8.3: External providers and suppliers are evaluated for compliance.
  • 8.4: Controls are in place to prevent nonconforming product or service delivery.
Recommendations:
  • Strengthen supplier evaluation processes to ensure consistent compliance.
Clause 9: Performance Evaluation
Monitoring and measuring QMS effectiveness.
  • 9.1: There is a process for monitoring and measuring QMS effectiveness.
  • 9.2: Customer satisfaction levels are monitored.
  • 9.3: Internal audits are conducted at planned intervals.
Recommendations:
  • Enhance customer satisfaction monitoring to include more detailed feedback mechanisms.
Clause 10: Improvement
Identifying nonconformities and taking corrective action.
  • 10.1: Nonconformities are identified and corrective actions are taken.
  • 10.2: There is a process for continual improvement of the QMS.
Recommendations:
  • Implement a more proactive approach to identifying and addressing nonconformities.