Iso 9001 2015 Audit Checklist Excel Xls !full!

| Clause | Requirement Summary | Audit Question / Evidence | Objective Evidence (Records/Docs) | Findings / Comments | Conformity (C / NC / OFI) | | :--- | :--- | :--- | :--- | :--- | :--- | | | | | | | | | 4.1 | Understanding org & context | Has the organization determined external and internal issues relevant to its purpose and strategic direction? | | | | | 4.2 | Needs of interested parties | Have the requirements of relevant interested parties (customers, suppliers, regulators) been determined? | | | | | 4.3 | Scope of QMS | Is the scope of the QMS defined and available as documented information? Does it state any exclusions? | | | | | 4.4 | QMS and its processes | Has the organization established, implemented, and maintained a QMS according to requirements? Are process interactions defined? | | | | | 5. Leadership | | | | | | | 5.1.1 | Leadership commitment | Does top management demonstrate accountability and commitment to the QMS? | | | | | 5.1.2 | Customer focus | Does top management ensure customer requirements are determined and met? | | | | | 5.2 | Policy | Is the Quality Policy established, appropriate, and communicated to all levels? | | | | | 5.3 | Roles & Responsibilities | Have authorities and responsibilities been assigned and communicated? | | | | | 6. Planning | | | | | | | 6.1 | Actions to address risks | Has the organization determined risks and opportunities and planned actions to address them? | | | | | 6.2 | Quality Objectives | Are quality objectives established at relevant functions and levels? Are they measurable? | | | | | 6.3 | Planning of changes | Is the QMS planned to meet requirements? When changes are needed, are they carried out in a planned manner? | | | | | 7. Support | | | | | | | 7.1.1 | Resources | Has the organization provided the necessary resources to implement and maintain the QMS? | | | | | 7.1.2 | Competence | Does the organization determine and provide necessary competence for personnel? Are training records maintained? | | | | | 7.1.3 | Awareness | Are people aware of the quality policy and how they contribute to the effectiveness of the QMS? | | | | | 7.1.5 | Documented Information | Does the QMS include required documented information? | | | | | 7.2 | Communication | Is internal and external communication determined (what, when, with whom)? | | | | | 8. Operation | | | | | | | 8.1 | Operational planning | Is planning for operations carried out to meet requirements? | | | | | 8.2 | Requirements for products/services | Are customer requirements defined, reviewed, and agreed upon before commitment? | | | | | 8.3 | Design and Development | Is there a design process? Are inputs, controls, and outputs defined? (If applicable) | | | | | 8.4 | Control of external provision | Are external providers evaluated, selected, and re-evaluated? Is information communicated to them? | | | | | 8.5 | Production/Service provision | Are production processes controlled? Is the release of products/services controlled? Is identification/traceability maintained? | | | | | 8.6 | Release of products/services | Is product/service release not proceeded with until planned arrangements are satisfactorily completed? | | | | | 8.7 | Control of nonconforming outputs | Are nonconforming outputs identified and controlled? | | | | | 9. Performance Evaluation | | | | | | | 9.1.1 | Monitoring & Measurement | Has the organization determined what needs to be monitored? | | | | | 9.1.2 | Customer Satisfaction | Is customer satisfaction monitored? | | | | | 9.2 | Internal Audit | Are internal audits conducted at planned intervals? Are reports maintained? | | | | | 9.3 | Management Review | Is the Management Review conducted at planned intervals? Are inputs and outputs recorded? | | | | | 10. Improvement | | | | | | | 10.1 | General | Does the organization determine and select opportunities for improvement? | | | | | 10.2 | Nonconformity & Corrective Action | Are nonconformities reacted to? Is corrective action taken to eliminate the cause? | | | | | 10.3 | Continual Improvement | Is the suitability, adequacy, and effectiveness of the QMS continually improved? | | | |

You can include a summary sheet at the beginning of the Excel file to summarize the findings from the checklist tab. iso 9001 2015 audit checklist excel xls

Features like conditional formatting can automatically highlight non-conformities. | Clause | Requirement Summary | Audit Question