One of the key requirements of the ISO 9001 quality management system standard is conducting regular internal audits. These audits examine an organization’s QMS and processes to identify any gaps or nonconformities with the ISO 9001 requirements. Beyond just verifying compliance, audits provide tremendous opportunities for driving continual improvement.
Let’s walk through the critical steps involved in planning, carrying out, and following up on an effective ISO 9001 internal audit.
Planning a Structured Audit Approach
First, determine the scope and objectives of the audit. Will you audit the entire QMS or focus on certain processes or departments? Scheduling audits of isolated systems over time can make the workload more manageable.
Identify competent auditors. ISO 9001 requires auditors to be impartial and objective. Leverage internal personnel with strong audit experience or invest in external quality auditor training to develop capabilities. You may also consider third-party auditing firms.
Next, create a schedule of audit activities including:
- Dates for conducting audits of each process/area
- Interviews, observations, and document reviews
- Meetings to communicate results and follow up on actions
Allow enough time to perform a thorough assessment. Define metrics and rating criteria you will use to evaluate the conformity of audit evidence/findings.
Preparing for a Successful Audit
Once scheduled, communicate details of the audit plan across the organization. Give advance notice of which areas will be audited and when. Provide an overview of the goals, scope, and schedule to managers.
Gather key documentation relevant to the audit such as quality manual, procedures, process maps, previous audits, performance data, and quality records. Reviewing this information will help auditors comprehend the systems being assessed.
Develop customized audit checklists with criteria tailored to each process being audited based on ISO 9001 requirements. This guides auditors on what specifically to assess and helps ensure consistency.
Conducting the Audit Objectively
Begin with an opening meeting with auditees explaining the purpose and scope of the audit. Then move through the planned agenda of audit activities including:
- Interviewing personnel on their procedures and responsibilities
- Observing processes first-hand and reviewing documents/records
- Compiling evidence of conformity and nonconformity
Take detailed notes on issues found and grade them on severity (minor vs. major nonconformity for example). Be sure to not just focus on gaps but also document positive findings and best practices. Remain objective and open-minded.
Documenting Audit Results
The evidence gathered during the audit must be documented in detail. This includes:
- Completed audit checklists
- Notes from interviews and observations
- Copies of documents reviewed
- Detailed descriptions of non-conformities
- Grades on the significance of findings
This documentation serves as the foundation for the final audit report.
Concluding the Audit
Schedule a closing meeting with management and process owners to summarize major audit findings, both good and bad. Provide an overview of notable gaps, risks, rating of nonconformities, and positives identified. Solicit feedback and discuss the next steps.
Following up After the Audit
Develop a formal audit report showcasing results. Communicate findings to leadership and request corrective actions for major nonconformities. Track completion of corrective and preventive actions.
Verify completion through follow-up audits when necessary. Use findings during management review meetings to make data-driven QMS improvements.
Leveraging Audits to Improve
While the audit itself provides valuable insight, executing the findings where the rubber meets the road. Continually refine your audit process based on lessons learned. Expand the scope and frequency of audits to cover more areas.
Make audits an engaging process focused on improvement, not just compliance. By investing in robust ISO 9001 internal auditing, organizations can confidently verify their QMS effectiveness while uncovering improvement opportunities.