Auditing ISO 9001:2015 Clause 10 Improvement
by Walt Prystaj
Auditing Clause 10 of ISO 9001:2015, which focuses on "Improvement," requires assessing whether the organization effectively identifies opportunities for continual improvement, manages nonconformities, and implements corrective actions. Below is a detailed guide for auditing Clause 10, including audit objectives and sample questions.
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Objectives for Auditing Clause 10
1. Verify the Organization’s Commitment to Continual Improvement: Ensure that the organization has established mechanisms to identify and act upon opportunities for improving the effectiveness of the Quality Management System (QMS).
2. Assess the Nonconformity and Corrective Action Process: Confirm that nonconformities are managed appropriately and that corrective actions are implemented and verified for effectiveness.
3. Evaluate the Organization’s Approach to Preventive Actions: Determine if preventive actions and risk management activities are effective in preventing potential nonconformities.
4. Check the Use of Data and Evidence for Improvement: Ensure that the organization uses data, such as audit results, performance metrics, and customer feedback, to drive continual improvement efforts.
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Detailed Audit Plan for Clause 10
1. 10.1 General: Continual Improvement
• Objective: Assess if the organization has an established process to continually improve the QMS.
• Sample Questions:
o How does the organization identify opportunities for continual improvement?
o What methods are used to evaluate the effectiveness of improvement initiatives?
o Can you provide examples of recent improvements made to the QMS and the rationale behind them?
o How are lessons learned from previous improvements applied to future initiatives?
What to Look For:
• Evidence of a structured approach to improvement activities, such as projects or Kaizen events.
• Records showing how improvement opportunities are prioritized and implemented.
• Examples of successful process improvements and how they have positively impacted the QMS.
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2. 10.2 Nonconformity and Corrective Action
• Objective: Verify that nonconformities are identified, documented, and addressed effectively, with appropriate corrective actions to prevent recurrence.
• Sample Questions:
o How are nonconformities identified, and who is responsible for documenting them?
o Describe the process for conducting root cause analysis. How do you ensure that the root cause is accurately identified?
o How are corrective actions determined, and what criteria are used to ensure they are effective?
o Can you show records of nonconformities, root cause analysis, and corrective actions taken in the past year?
o How does the organization verify the effectiveness of corrective actions?
o How is communication about nonconformities and corrective actions managed across departments?
What to Look For:
• Nonconformity reports with clear documentation of the issue, analysis, and corrective actions.
• Evidence that corrective actions are implemented and monitored for effectiveness.
• Records showing that the organization has learned from past nonconformities and made adjustments to prevent future occurrences.
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3. 10.3 Continual Improvement
• Objective: Check that the organization has mechanisms in place to ensure continuous improvement of the QMS and that these improvements are based on data-driven analysis.
• Sample Questions:
o What data sources (e.g., internal audits, customer feedback, performance metrics) are used to identify improvement opportunities?
o How does the organization ensure that continual improvement is embedded in its culture and processes?
o Can you provide examples of improvement initiatives that were data-driven? What metrics were used to measure success?
o How does the organization ensure that improvements are communicated and sustained over time?
o What preventive measures are in place to address potential risks before they become nonconformities?
What to Look For:
• Evidence of data-driven decision-making for process improvements.
• Records of management review meetings where improvement initiatives are discussed.
• Examples of how the organization has proactively improved processes and minimized risks.
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Practical Tips for Auditing Clause 10
1. Prepare in Advance: Review relevant documents such as nonconformity logs, corrective action reports, and management review minutes before the audit.
2. Engage with Different Departments: Speak to personnel involved in various processes to understand how improvement initiatives are implemented and communicated.
3. Observe Processes: Where possible, observe how nonconformities are identified and how corrective actions are carried out to ensure they align with documented procedures.
4. Check for Consistency: Ensure that the organization’s approach to continual improvement and corrective actions is consistent across different areas of the QMS.
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Example Evidence to Collect
• Improvement plans and records of implemented projects.
• Nonconformity and corrective action reports, including root cause analysis documentation.
• Meeting minutes from management reviews that discuss improvement initiatives.
• Performance metrics showing improvements over time.
• Training records that indicate personnel are aware of and understand the importance of continual improvement.