Internal Audit of Quality Management System

Steps in Internal Audit of Quality Management System

Conducting an internal audit of a Quality Management System (QMS) involves a systematic and structured approach to assess compliance with established procedures, standards, and regulations by its own personnel. Internal audit of a quality management system aims to assess compliance, identify areas for improvement, and ensure effectiveness in achieving the objectives while adhering to established standards, policies, and procedures. Here are the critical steps involved in performing an internal audit of a quality management system:

• Planning:

• Define the audit scope, objectives, and criteria based on the requirements of the ISO 9001 standard and the organization's goals.
• Select qualified auditors and assemble an audit team.
• Develop an audit plan detailing the schedule, areas to be audited, resources needed, and evaluation methods.

• Documentation Review:

• Examine documented processes, procedures, quality manuals, and records related to the QMS.
• Verify that documented procedures align with actual practices and meet the requirements of ISO 9001.

• On-Site Assessment:

• Conduct interviews and discussions with personnel involved in various processes to understand their roles and responsibilities.
• Observe processes and activities to ensure they comply with documented procedures and standards.

• Evaluate Compliance:

• Use checklists or audit tools to systematically assess each area of the QMS against ISO 9001 requirements.
• Collect evidence and data to support findings, including records of non-conformities and areas for improvement.

• Reporting and Analysis:

• Prepare an audit report summarizing audit findings, observations, identified non-conformities, and opportunities for improvement.
• Differentiate between minor non-conformities and critical issues requiring immediate attention.

• Corrective Actions and Follow-Up:

• Collaborate with relevant stakeholders to develop corrective action plans to address identified non-conformities.
• Monitor and verify the implementation and effectiveness of corrective actions taken.

• Closure and Continuous Improvement:

• Close the audit process by verifying the resolution of identified issues.
• Use audit findings to initiate improvements in the QMS, fostering a culture of continuous improvement.

By following these steps, organizations can effectively conduct internal audits of their QMS, ensuring compliance with ISO 9001 standards and driving ongoing enhancements in quality and performance.