Template

ISO 9001 Internal Audit: Context of the Organisation

by James Tononcelli, from the Community

10+

This ISO 9001 internal audit checklist covers section 4, Context of the organisation. Use it to review internal and external issues, verify management review inputs, assess interested parties and their requirements, confirm the scope of the QMS, and check that processes are maintained. Auditors can capture evidence of conformity and nonconformity, assign actions to responsible managers, and sign off completion. Intended as a starting point for quality audits in engineering and manufacturing environments.

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Confirm accountability and compliance with a digital log

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This community page makes available free workplace checklists and templates created by other users within the SafetyCulture community. SafetyCulture has re-published this content and where possible, has credited the original author. SafetyCulture has not verified the accuracy, reliability or suitability of any community content. You agree that your use of any of this content is in accordance with SafetyCulture’s Terms and Conditions.

Template
Context of the Organisation Clause 4 Audit Checklist
This ISO 9001 Clause 4 internal audit checklist helps evaluate the context of the organisation, including external and internal issues, interested parties, and the scope and applicability of the quality management system. It guides auditors through mandatory checks, evidence capture, opportunities for improvement and observations, and recording nonconformances with links to audit trackers. Use it to maintain and continually improve a QMS and document audit completion details.
by Shaun Collins, from the Community
Downloads: 20+
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Template
ISO 9001 Section 4: Context of the Organisation
This ISO 9001 Section 4 checklist helps organizations assess the context of the organization and establish an effective QMS. It covers 4.1 to 4.4: identifying internal and external issues, understanding interested parties, defining QMS scope, and managing processes. Prompts include reviewing previous audits and NCRs, determining inputs and outputs, sequence and interaction of processes, criteria and methods for control, resource needs, roles and responsibilities, risks and opportunities, performance evaluation, improvement, and maintaining documented information.
by Jamie Kerrigan, from the Community
Downloads: 10+
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Template
Internal Audit 6 - ISO 9001 Planning Checklist
Use this ISO 9001 internal audit planning checklist to review clause 6 requirements in the context of your quality management system. Assess risks and opportunities, confirm quality objectives are measurable and aligned to policy, and evaluate the effectiveness of change management procedures. Capture evidence for conformity and nonconformity, document findings, and allocate corrective actions to responsible managers. Includes fields for site details, auditor, traceability, and sign off to complete the audit.
by James Tononcelli, from the Community
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Template
ISO 9001 Context of the Organization Audit
Use this internal audit checklist to assess ISO 9001:2015 clause 4.0 Context of the Organization. Review strategic direction, internal and external issues, interested parties, scope of the management system, and key process interactions. Capture evidence for SWOT inputs, risk and opportunity, policy alignment, documented information, and control of outsourced processes. Record opportunities for improvement and nonconformances, and reference meeting records, surveys, and registers. Ideal for manufacturing operations like Tricel Weston seeking robust QMS governance.
by Internal Audit, from the Community
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ISO 9001 Internal Audit: Context of the Organisation

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