ISO 9001 2015 Internal Audit Checklist

An ISO 9001 internal audit is a systematic inspection designed to gauge your company’s compliance with the ISO 9001 standard. By using our 2015 internal audit checklist, you can conduct rigorous and systematic internal inspections.

This comprehensive audit checklist covers clauses 4-10 of ISO 9001. It includes questions for inspecting processes, equipment, records and assessing opportunities for improvement.

Process Definitions

Process audits are used to assess various processes within an organization for effectiveness and performance against ISO 9001 requirements. The checklist used is similar to that used for supplier audits, featuring questions on context, leadership, planning and quality management systems as well as support structures and operations of an organisation.

Questions should focus on whether the QMS meets customer, regulatory and statutory needs effectively. A final audit report should detail findings and suggestions, including any necessary areas for improvement. This serves as part of the feedback loop ensuring compliance with ISO 9001 compliance obligations by providing feedback that keeps companies current.

Conducting compliance audits for ISO can seem intimidating, but using the appropriate tools makes this task simpler and more efficient. Our RiskOptics ROAR platform, for example, automates evidence collection across multiple frameworks allowing auditors to focus on what matters while simultaneously reducing workload and workload burdens; furthermore it allows auditors to identify common issues/risks more quickly which helps make understanding what standards require easier.

Process Resources

Process audits involve auditors carefully reviewing processes by asking probing questions about each step, who is involved, resources utilized, equipment/material requirements, performance metrics and more. This aims to assess whether the process is working as intended and take preventative steps should issues arise.

This approach differs from risk assessment templates in that its focus lies with processes that create products and services and how they meet customer and regulatory requirements. Instead, in this instance it examines them holistically to ensure customer and regulatory satisfaction.

Conducting a gap analysis is an integral step to compliance with ISO 9001. By comparing your existing quality management system with that outlined by ISO, this analysis helps companies pinpoint any policy or procedure gaps they might be missing, then plan and execute remediation work to address those deficits. Furthermore, gap analyses serve as a fantastic way for businesses to strengthen their commitment to ISO.

Process Controls

The Process Controls Checklist covers questions on ensuring the processes within a company are under control. This could involve documenting them or making sure training programs and records of this are kept.

This section also explores how processes are planned, implemented, inspected and handled during changes. Finally, communication of audit findings is covered as well.

This checklist follows a similar template as its counterpart, using compliant, opportunities for improvement, minor non-conformance and major non-conformance as scoring criteria. However, this version of the ISO 9001 internal audit checklist has been enhanced to use PDCA management method, in order to help organizations better utilize their time by focusing on key parts of their processes – this allows companies to be more effective with how they conduct audits and their results.

Training

Although an internal audit checklist isn’t mandatory under ISO standards, it can be an invaluable way of verifying that your Quality Management System is running effectively. A checklist ensures all aspects of process are being examined and documented – providing invaluable preparation for third-party audits.

One of the key aspects of this checklist is assessing whether employees are receiving adequate training. This may require reviewing employee records, verifying qualifications, and reviewing training manuals. Other areas to be investigated may include CTQ characteristics, quality plan implementation and documentation processes are properly documented.

Auditor can tailor their checklist to their own requirements, as well as use it as a way of comparing their Quality Management System against ISO requirements, which will help identify any gaps that need filling before third-party auditors assess your process and check its compliance.