ISO 9001 2015 Audit Checklist XLS

An internal audit checklist is an effective way of verifying that your management system meets ISO 9001 standards, and highlighting any areas where practices do not match requirements or where there could be room for improvement.

Each question will be worded as an ISO 9001 requirement, allowing you to mark them off using an “x.” A formula then calculates a score for each area.

Process Approach

As your quality management system has been operating for some time, transition to using a process approach for audits to ensure you don’t overlook key parts. Clause-by-clause auditing may be effective at initial internal audits such as gap analyses. However, as time progresses it should no longer be the primary form of inspection.

The ISO 9001 standard describes processes that convert inputs to outputs that meet customer requirements, thus producing products and services which your business must demonstrate conform to these processes.

To do this, it’s necessary to identify your processes and the inputs and outputs they generate, using a flow diagram as a visual aid to represent this.

Our ISO 9001 audit checklist xls makes auditing simple! Use your PC or mobile device to conduct an audit on each’shall’ requirement by phrased as questions that elicit responses that can be represented as an “x”. Various formulae use these responses to track progress and generate visual outputs that you can use in reports and presentations.

Audit Questions

An auditor will ask your organization a series of questions designed to determine whether your Quality Management System complies with ISO 9001 standards, taking notes and noting any compliance issues that arise.

Have you got a quality policy in place and how is it communicated to employees and managers? An auditor will want to see whether this policy demonstrates management’s dedication to meeting requirements of standards.

Does top management ensure that responsibilities and authorities for processes are assigned and communicated throughout the organization? An auditor will want to observe how top management assigns responsibility and allocates resources in order to reach quality objectives.

Have you considered how the processes of external providers could impede your ability to meet customer, regulatory and statutory obligations? How are these external providers assessed, selected and monitored?

An auditor will scrutinize how you identify interested parties. An interested party is defined as any individual or group who could directly impact customer perception of product/service quality.

Error Tracking

Under the Process Audit section of an ISO 9001 internal audit checklist, inspectors will look for materials usage and interfaces between departments as well as documenting and implementing procedures correctly.

This may be one of the more challenging sections to complete, yet also one of the most crucial. This section can help your company identify any issues which are leading to noncompliance with ISO 9001 standards, and prepare for an external audit.

SafetyCulture’s free internal audit templates enable you to assess the quality management system (QMS) at your company, identify areas for improvement and create appropriate corrective actions immediately. Our library includes SOC 2 Type II and PCI DSS certificates as well as compliance with FERPA, CCPA, and GDPR regulations that you can download free via app or website and edit easily to include images, hyperlinks or any other elements to make inspection more meaningful and impactful.

Summary

An audit checklist xls allows you to document your company’s adherence to ISO standards, giving an indication of its performance and helping make informed strategic decisions.

The initial section of an audit checklist focuses on activities planning and broad system requirements. Questions in this section cover subjects like records, training, communication and participation as well as methods for determining qualifications, certification and training programs.

The last section of an audit checklist focuses on non-conformances and opportunities for improvement (OFI). This section examines processes that do not meet standards, current practices that are weak, cumbersome or complex and whether ISO 9001 has been applied within your organization’s documented scope, including any clause exclusions justified; an area is provided to record risk assessments on each OFI to help prioritize areas in need of improvement and move you toward certification. This step in your ISO journey should not be skipped!