Auditing Improvement (Clause 10 of ISO 9001:2015) focuses on ensuring the organization continually improves the effectiveness of its quality management system (QMS). It includes three sub-clauses that address nonconformity and corrective actions, continual improvement, and the use of results from audits, data analysis, and customer feedback to drive improvement.

Understanding Clause 10 Requirements

Clause 10 is divided into three main sections:

General Requirements for Improvement (Clause 10.1)

Nonconformity and Corrective Action (Clause 10.2)

Continual Improvement (Clause 10.3)

The clause emphasizes the need for organizations to address issues proactively and reactively, using data and analysis to identify areas for improvement and implementing actions to enhance processes, products, and services.

Pre-Audit Preparation

Before conducting an audit of Clause 10, the auditor should:

• Review previous audit reports: Look at past audits, both internal and external, for nonconformities and corrective actions taken.
• Analyze improvement records: Look at documented evidence of continual improvement efforts, including records of corrective actions, preventive actions, and outcomes of risk-based thinking.
• Understand key performance indicators (KPIs): Identify the KPIs used by the organization to measure improvement in areas such as customer satisfaction, defect rates, and process efficiency.

1. General Requirements for Improvement (Clause 10.1)

This sub-clause outlines that organizations must identify and select opportunities for improvement and take necessary actions to meet customer requirements and enhance customer satisfaction.

a. Identifying Improvement Opportunities

Audit Checklist Questions:

Audit Objective: Confirm that the organization has mechanisms in place for identifying opportunities for improvement. These mechanisms could include data analysis (e.g., product quality, process performance), customer feedback, internal audits, and risk assessments.

b. Documented Evidence of Improvement

Audit Checklist Questions:

Audit Objective: Ensure that the organization keeps records of improvement actions and assesses their effectiveness in meeting organizational objectives.

2. Nonconformity and Corrective Action (Clause 10.2)

This sub-clause requires the organization to react to nonconformities by taking corrective action and eliminating the causes of nonconformity to prevent recurrence.

a. Managing Nonconformities

Audit Checklist Questions:

Audit Objective: Verify that the organization has a documented process for managing nonconformities. The process should ensure that nonconformities are identified, recorded, investigated, and resolved.

b. Root Cause Analysis

Audit Checklist Questions:

Audit Objective: Confirm that the organization performs a root cause analysis to identify why the nonconformity occurred and to prevent recurrence. This analysis should be thorough and methodical.

c. Corrective Action Implementation

Audit Checklist Questions:

Audit Objective: Ensure that corrective actions are implemented in response to identified nonconformities and that their effectiveness is reviewed over time. Corrective actions should be monitored to ensure that they are effective in preventing recurrence.

d. Preventive Actions

Audit Checklist Questions:

Audit Objective: Verify that the organization applies preventive measures and risk-based thinking to prevent issues from occurring. Preventive actions should be documented and monitored for effectiveness.

e. Documentation of Nonconformities and Corrective Actions

Audit Checklist Questions:

Audit Objective: Confirm that the organization maintains documented information on nonconformities, corrective actions, and their outcomes. The records should be complete, organized, and available for review during the audit.

3. Continual Improvement (Clause 10.3)

This sub-clause requires organizations to continually improve the suitability, adequacy, and effectiveness of their QMS.

a. Commitment to Continual Improvement

Audit Checklist Questions:

Audit Objective: Confirm that the organization is actively working to improve its QMS. This can be demonstrated through specific initiatives, projects, or objectives aimed at improving processes, reducing waste, enhancing efficiency, or increasing customer satisfaction.

b. Use of Data and Analysis for Improvement

Audit Checklist Questions:

Audit Objective: Verify that the organization uses data and analysis to inform its improvement efforts. Data should be collected and analyzed to identify trends, risks, and opportunities for enhancing quality and performance.

c. Monitoring and Reviewing Improvement Actions

Audit Checklist Questions:

Audit Objective: Confirm that improvement actions are monitored over time and reviewed to ensure they deliver the desired outcomes. The organization should track the progress of improvement projects and share lessons learned across teams to encourage a culture of continuous improvement.

d. Use of Audits, Feedback, and Other Inputs for Improvement

Audit Checklist Questions:

Audit Objective: Ensure that the organization actively uses the results from internal and external audits, customer complaints, and performance reviews to drive improvement. These inputs should be reviewed and incorporated into planning future improvement initiatives.

4. Risk-Based Approach to Improvement

A key part of continual improvement is the use of risk-based thinking, which is central to ISO 9001:2015.

a. Identifying and Managing Risks

Audit Checklist Questions:

Audit Objective: Verify that the organization applies a risk-based approach to its improvement efforts. This means identifying and addressing risks before they become significant problems, thereby preventing potential nonconformities and improving processes.

5. Documentation of Improvement

The organization should maintain documented information as evidence of continual improvement efforts.

a. Documenting Improvement Initiatives

Audit Checklist Questions:

Audit Objective: Confirm that the organization documents its improvement efforts, including the actions taken, the results achieved, and any adjustments made based on the outcomes. Documentation should be available for review during the audit.