ISO 9001:2015 Requirement Auditing. (Clause 10)

Clause 10 in ISO 9001:2015 is titled "Improvement" and focuses on the organization's commitment to continual improvement of its quality management system (QMS). It encompasses the following key areas:

1. Nonconformity and Corrective Action:

The organization is required to establish processes for addressing nonconformities and taking appropriate corrective actions. This involves identifying and documenting nonconformities, determining their root causes, implementing corrective actions, and verifying their effectiveness.

2. Continual Improvement: The organization should actively seek opportunities for improving its QMS and overall performance. This includes setting quality objectives, planning actions to achieve them, and continually monitoring progress toward their achievement.

3. Analysis of Data: The organization should analyze relevant data to identify trends, patterns, and areas for improvement. This can include data related to customer satisfaction, process performance, product conformity, and other performance indicators. The analysis helps in making informed decisions and driving improvement initiatives.

4. Management Review: Top management is required to conduct periodic reviews of the QMS to evaluate its suitability, adequacy, effectiveness, and alignment with the organization's strategic direction. The management review assesses the achievement of quality objectives, the results of audits, data analysis, and other relevant information to identify improvement opportunities.

5. Preventive Action: The organization is encouraged to take a proactive approach by identifying potential risks and opportunities for improvement. This involves implementing preventive actions to eliminate or mitigate potential nonconformities and improve performance before issues arise.

6. Continual Improvement Culture: ISO 9001:2015 emphasizes the importance of fostering a culture of continual improvement within the organization. This involves promoting employee involvement, empowerment, and engagement in identifying improvement opportunities and implementing changes

Here are some examples of evidence you can look for during an audit

(Clause 10):

1. Nonconformity and Corrective Action:

- Nonconformity reports or forms indicating the nature of the nonconformity, its identification, and the actions taken to correct it.

- Documentation of root cause analysis, including techniques used (such as 5 Whys or fishbone diagrams) and identified root causes.

- Corrective action plans outlining the steps taken to address nonconformities, responsible parties, and target completion dates.

- Evidence of verification activities to ensure the effectiveness of corrective actions, such as follow-up audits or rechecks.

2. Continual Improvement:

- Documented quality objectives with measurable targets, action plans, and progress tracking.

- Improvement project documentation, including project charters, timelines, and status updates.

- Employee suggestion or improvement forms indicating employee involvement in identifying improvement opportunities.

- Records of process changes or modifications made to improve efficiency, effectiveness, or customer satisfaction.

- Evidence of training programs or initiatives aimed at enhancing employee skills and knowledge for continual improvement.

3. Analysis of Data:

- Data analysis reports showing trends, patterns, or correlations related to quality objectives, customer satisfaction, process performance, product conformity, or other relevant metrics.

- Statistical analysis results, such as control charts, Pareto charts, or trend analysis, demonstrating the understanding and utilization of data.

- Improvement actions or decisions based on data analysis, with documented rationale and outcomes.

4. Management Review:

- Minutes or meeting records from management review meetings, including attendance, topics discussed, decisions made, and action items assigned.

- Reports or presentations provided to management, summarizing performance data, audit results, customer feedback, and improvement initiatives.

- Evidence of follow-up actions resulting from management review, such as revised policies, updated objectives, or resource allocations.

5. Preventive Action:

- Risk assessment or analysis documentation, including identified risks, potential impacts, and actions taken to prevent or mitigate them.

- Evidence of proactive monitoring activities to identify potential nonconformities or improvement opportunities.

- Documentation of preventive actions implemented, such as process changes, equipment maintenance, or training programs.

Remember, the specific evidence required may vary depending on the organization, its context, and the nature of its processes. It's important to tailor the evidence to demonstrate compliance with Clause 10 and the effectiveness of the organization's improvement efforts.