Internal Quality Management System Audit Checklist (ISO9001:2015) Division/Department: Process: Auditee: Auditor: Date/Time: Objective: Classification of Audit: Regular Special Q# ISO 9001:2015 Clause Audit Question Category Audit Evidence C OFI Minor NC Major NC.
Whether you're undergoing an external audit for certification, or simply improving your management system's internal audit regime, the ISO 9001 internal audit checklists help deliver meaningful results by promoting effective audit planning, reporting and problem-solving.
The ISO 9001 internal audit checklist, supplier audit checklist and process audit template are fully editable, supplied in .docx and .xlsx formats. Easily amend the text, and tailor the templates to suit your business's audit requirements.
Developed to align with the concepts, guidelines, and terminology fromISO 19011:2018 Guidelines for Auditing Management Systems, the audit checklists reduce the risk of nonconformities during crucial internal audits for implementation and certification purposes.
If you're looking for ISO 9001:2015, 14001:2015 and 45001:2018 integrated management system templates, please click here for more information. ISO 14001 and ISO 45001 internal audit checklists are available here.
The purpose of internal audit checklist is to help monitor and evaluate the conformance of an organization’s quality management system and the effectiveness of its processes. By using the internal audit checklist to compare business activities to broad system requirements, you can ensure that each clause or requirement has been assessed.
Once your quality management system has matured, businesses should develop a process approach to their internal auditing programme. You can cross-refer the clause references in the process audit template to the questions in the filtered internal audit checklist.
Use the FREEprocess audit template, which replicates the turtle diagram from the Internal Audit Procedure, to encourage the auditors to review the inputs, outputs, risks, controls, activities, equipment, materials, personnel and methods of measurement for each process.
The fully editable internal audit checklists comprise the certifiable requirements from ISO 9001:2015, phrased as question, to help ensure that each clause is assessed and that your processes are delivering the expected outputs. To see examples of the internal audit checklists and procedures, click the orange coloured links in the table below.
What's included with the internal audit checklists? | IAC02 | IAC04 |
The Excel-based internal audit checklist focuses on the quality management system requirements to help ensure each clause is effectively implemented: | ✓ | ✓ |
» Use the ISO audit checklist to capture management system conformance | ✓ | ✓ |
» Filter the checklist to select specific clauses to create process audit checklists | ✓ | ✓ |
» Generate charts to summarize and communicate audit findings | ✓ | ✓ |
» Use the FREEprocess audit template to capture process performance | ✓ | ✓ |
» FREE 9-page off-site supplier self-assessment questionnaire | ✓ | ✓ |
» FREE 21-page on-sitesupplier audit checklist template | ✓ | ✓ |
The 2 procedures each include a turtle diagram to define process inputs, activities, and outputs, as well as process maps to define the sequence of operation: | ✓ | ✓ |
» Internal Audit Procedure | ✓ | ✓ |
» Nonconformity and Corrective Action Procedure | ✓ | ✓ |
4 Essential report and form templates in .docx and .xlsx format to communicate internal audit outputs and corrective actions to demonstrate effective operation: | ✓ | ✓ |
» Internal Audit Report | ✓ | ✓ |
» Internal Audit Feedback Form | ✓ | ✓ |
» Corrective Action Report (includes 5-Whys root-cause analysis method) | ✓ | ✓ |
» Corrective Action Log | ✓ | ✓ |
Use the internal audit programme template to schedule your internal audits and meet the requirements of ISO 9001:2015, Clause 9.2.2a, includes: | x | ✓ |
» 2-year, short range, detailed internal audit programme | x | ✓ |
» 10-year, long range, overview internal audit programme | x | ✓ |
» Process application matrix to link ISO 9001 clauses to your processes | x | ✓ |
With plenty of practical examples, the guidance documents describe the requirements for internal auditing and corrective action: | x | ✓ |
» 68-pageinterpretation and guidance for each ISO 9001:2015 requirement | x | ✓ |
» 17-pageguide on conducting internal audits, gap analysis, and process audits | x | ✓ |
» 18-page problem solving and implementing corrective action guide | x | ✓ |
» ISO 9001:2015 v ISO 9001:2008 correlation matrix and change summary | x | ✓ |
FREEGap analysis checklist, 14-page transition planning guide with a 9-step ISO 9001:2015 implementation plan with 7 transition checklists | ✓ | ✓ |
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IAC02 | IAC04 | ||
ISO 9001:2015internal audit, gap analysis, supplier audit, checklists, and process audit worksheet ~ €56.00 Euros, $67.00 USD, $87.00 AUD | IAC01 + Internal audit and non-conformity & corrective action procedures, with 4 reports and forms ~ €110.00 EUR, $132.00 USD, $175.00 AUD | IAC02 + Internal audit programme with 2-year and 10-year internal audit plan, and process matrix worksheets ~ €169.00 EUR, $201.00 USD, $265.00 AUD | IAC03 + Internal audit guidance, and root-cause analysis and corrective action guidance documents ~ €226.00 EUR, $268.00 USD, $353.00 AUD |
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Download examples of our internal audit and process audit templates in .pdf format and see how they could help you save time and money!
Internal Audit Checklist Demo | Supplier Self-Assessment |
10-Year Audit Programme | Internal Audit Procedure |
Process Audit Checklist Template | RCA & Corrective Action Guidance |
The editable internal audit checklist, gap analysis and process audit checklist templates are supplied in .docx and .xlsx formats, while the guidance documents are supplied .pdf format. They are compatible with Microsoft Office and Adobe Acrobat for Windows or MAC and are compatible with SharePoint, Microsoft Office 365, and all proprietary digital storage solutions. The ISO templates are supplied as .zip files for fast download (3.9 to 9.2Mb) | extracted .docx and .pdf file sizes are between 1.5 and 8.5Mb
The gap analysis will likely be your first ISO 9001:2015 audit as it provides a valuable baseline for the implementation process as a whole. The Gap Analysis Checklist summarizes the requirements contained in ISO 9001:2015 and will help to determine the differences, or gaps, between your existing quality management system and the requirements.
System audits are commonly referred to as a ‘first-party audit’ and are conducted by organizations to determine conformance to a set of audit criteria arising from standards like ISO 9001:2015, often in preparation for certification. The Internal Audit Checklist focuses on the quality management system requirements to ensure that each clause has been implemented. The internal audit checklist may be used for requirement audits initially and then filtered for ongoing process audits.
The adoption of the ‘process approach’ is mandated by ISO 9001:2015 and is one of the most important concepts relating to your quality management system. You can use the Process Audit Checklist Template for conducting an in-depth analysis to verify that individual processes; comprising the management system, are performing and producing outputs in accordance with your planned outcomes.
When evaluating and selecting suppliers, supplier audits are often conducted to verify that the potential supplier has an adequate management system that can ensure consistent performance in delivering conforming products, parts or services. Use the off-site Supplier Self-assessment Form to initially gather this information. Based on risk and other priorities, use the on-site Supplier Audit Checklist to undertake a more detailed, 2nd party, follow-up supplier audit.
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ISO Navigator™ is our FREE online training tool that shows you how to apply the principles of PDCA to your operations. We also offer many helpful templates that get you on the road to documenting your management system, please visit the download page.