ISO 9001 Audit Checklist

What is an ISO 9001 Audit Checklist?

An ISO 9001 Audit Checklist is used to assess the effectiveness of an organization’s Quality Management System (QMS). The audit helps organizations identify and address issues, and discover potential improvements they can make with their QMS to ensure best practice processes are in place as preparation for a third-party ISO 9001:2015 certification audit.

Types of ISO 9001 Audit

An ISO Audit is an official assessment sanctioned by the International Organization for Standardization (ISO) to determine if a company fulfills set criteria, usually for developing a product or rendering a service. An ISO certification gives merit to companies and protects consumers by ensuring that international safety, reliability, and quality standards are met. An ISO 9001 audit is conducted in two methods:

Internal Audit

An internal audit is conducted by an organization member to compare the existing QMS with industry regulations and standards, such as ISO 9001. It helps prepare for certification by identifying non-conformances, evaluating progress, ensuring regulatory compliance, finding improvement areas, and reviewing QMS processes for certification readiness.

External Audit

An external audit is conducted before obtaining ISO certification. An external auditor assesses the organization’s documentation to ensure it meets ISO 9001 requirements. After the audit, the auditor will recommend either granting certification or requiring corrective actions. If certified, the organization must renew the certification every three years by undergoing the same external audit.

ISO 9001: 2008 vs 2015 comparison

ISO 9001:2015 intends to focus on the PDCA (Plan, Do, Check, Act) management method so the updated ISO 9001 template follows this structure. Refer to the table below to identify the key differences between the ISO 9001:2008 and ISO 9001:2015 structures.

Furthermore, ISO 9001:2015 focuses on risk-based thinking rather than preventative measures. Therefore, the most recent ISO 9001 checklist reflects this by focusing on analyzing situations that are specific to your organization and deciding individual actions based on that risk analysis.

Step-by-Step Guide for Creating an ISO 9001 Audit Checklist

The key requirements to successfully integrating ISO 9001 into your organization are:

1. Understand the context of the organization – Determining the external and internal factors that affect the organization’s ability to achieve desired results.

2. Ensure top management commitment – Management must demonstrate leadership by taking responsibility for the effectiveness of the QMS and ensuring the integration of QMS requirements into the organization’s processes.

3. Focus on the customer – The organization must understand the needs of its customers by continuously monitoring customer perceptions about the quality of products and services.

4. Provide adequate resources – Determine and provide the necessary resources (people, infrastructure, environment, monitoring and measuring resources, organizational knowledge) to implement and maintain the QMS.

5. Verify employee competence – Ensure employees are competent based on, training, skills, and experience.

6. Execute quality planning – Plan and control the processes needed to meet product and service requirements.

7. Design of products and services effectively – Involves systematic planning and control of the design process to avoid errors and ensure the final output aligns with the intended purpose.

8. Manage customer complaints – Organizations must ensure that they have a system in place to receive customer complaints, document them, and identify their root cause to resolve them.

9. Implement Corrective actions – Address nonconformities, take corrective actions to eliminate the cause, and prevent recurrence.

10. Drive continuous improvement  – Continuously improve the suitability, adequacy, and effectiveness of the QMS.

What should be Included in a ISO 9001 Internal Audit Checklist

Below is an example of what a typical ISO 9001 audit checklist might look like. Using this format helps you on how to prepare for an ISO 9001 audit and adhere with ISO 9001 standards:

Clause 4: Context of the Organization

• Understanding the organization and its context

• Understanding the needs and expectations of interested parties

• Determining the scope of the QMS

• The Quality Management System and its processes

Example questions:

• Have all external and internal issues that are relevant to your organization’s purpose and the achievement of customer satisfaction and the organization’s strategic direction been determined?

• Are these issues reviewed and monitored on a regular basis?

• Have the needs and expectations of interested parties that are relevant to the QMS been determined?

Clause 5: Leadership

• Leadership and commitmentQuality policy

• Organizational roles, responsibilities, and authorities

Example questions:

• Has top management taken accountability for the effectiveness of the QMS?

• Have the policy and objectives for the QMS, which are compatible with the strategic direction of the organization, been established and communicated?

• Have the objectives been established at relevant departmental and individual levels with the business?

Clause 6: Planning

• Actions to address risks and opportunities

• Quality objectives

• Planning of changes

Example questions:

• Have the risks and opportunities that need to be addressed to give assurance that the QMS can achieve its intended result(s) been established?

• Has the organization planned actions to address these risks and opportunities and integrated them into the system processes?

• Is there a defined process for the determining the need for changes to the QMS and managing their implementation?

Clause 7: Support

• Resources (general, people, infrastructures, environment for the operation of processes, monitoring and measuring resources, and organization knowledge)

• Competence

• Awareness

• Communication

• Documented information

Example questions:

• Has the organization determined and provided the resources needed for the establishment, implementation, maintenance and continual improvement of the QMS?

• Is monitoring or measuring is used for evidence of conformity of products and services to specified requirements?

• Has the organization determined the resources needed to ensure valid and reliable monitoring and measuring of results?

Clause 8: Operation

• Operational planning and control

• Determination of requirements for products and services (market needs and interactions with customers)

• Design and development of goods and services

• Control of externally provided goods and services

• Production of goods and provision of services

• Release of goods and services

• Control of nonconforming process outputs, products, and services

Example questions:

• Is there a defined process for the provision of products and services that meet the requirements defined by the customer?

• Are there any changes planned?

• Are any outsourced processes managed and controlled?

Clause 9: Performance Evaluation

• Monitoring, measurement, analysis, and evaluation

• Internal audit

• Management review

• ISO 9001 Clause 10: Improvement

• Continual improvement

• Nonconformity and corrective action

Example questions:

• Has the organisation determined what needs to be monitored and measured and the methods for monitoring, measurement, analysis and evaluation, to ensure valid results?

• Has it established when the results from monitoring and measurement shall be analyzed and evaluated?

• Have methods of monitoring customer perceptions of the provision of products and services been established?

ISO 9001 Audit Checklist Example PDF

Here is an example of an ISO 9001 PDF in the context of a QMS gap analysis. This internal audit checklist PDF for ISO 9001 lets users visualize the report of an already answered audit for an organization’s QMS.

ISO 9001 PDF Free Download | SafetyCulture