ISO 9001 Quality Management System Audit Checklist - Intermediate Level
Free ISO 9001 Quality Management System Audit Checklist - Intermediate Level checklist for logistics, manufacturing, service companies. Structured / Systematic implementation level. Management Systems category. Includes 30 questions covering Basic information, Organizational Context and Stakeholder Awareness, Leadership and Top Management Commitment. Typical completion time: 120 minutes.
This checklist template is designed for logistics, manufacturing, service companies and focuses on Basic information, Organizational Context and Stakeholder Awareness, Leadership and Top Management Commitment.
What This Template Covers
Use this template to review Basic information, Organizational Context and Stakeholder Awareness, Leadership and Top Management Commitment with a structured format that supports consistent follow-up and faster decision-making.
- Basic information
- Organizational Context and Stakeholder Awareness
- Leadership and Top Management Commitment
Why This Version Is Different
Unlike generic templates, this version is tailored to the management systems category, the Structured / Systematic implementation maturity level, and the workflow of logistics, manufacturing, service companies.
Template Questions
Showing first 15 rows
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Basic information |
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Audit date |
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Name of the auditors |
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Audited department |
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Names of the interviewed employees |
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SECTION 1 - Organizational Context & Stakeholder Awareness |
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1. Has the organization identified and documented the internal and external issues that can affect its ability to meet quality objectives?
Clauses:
(clause 4.1). Internal issues include company culture, employee competence, organizational structure, and available resources. External issues include regulatory requirements, customer expectations, market competition, and technological developments. At this maturity level, documentation may be basic but should exist.
Recommendations:
The organization should have a documented process for identifying and analyzing internal and external issues. This could include tools like SWOT analysis, PESTLE analysis, or regular environmental scanning. Evidence may include documented analyses, meeting minutes, or records of actions taken to address identified issues.
If nothing exists, conduct a structured context analysis using tools like SWOT or PESTLE. If partially done, formalize the review and schedule it for annual updates.
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2. Has the organization identified relevant interested parties and documented their quality-related requirements?
Clauses:
(clause 4.2). Interested parties include customers, suppliers, employees, regulators, and owners. Requirements may relate to product quality, timely delivery, compliance, or communication.
Recommendations:
The organization should maintain a documented list of relevant interested parties along with their needs and expectations. This may be evidenced by stakeholder registers, meeting minutes, or records of communications.
If not identified, create a stakeholder register listing all relevant parties. If partially done, clarify each partys expectations and link them to your processes.
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3. Is the scope of the QMS clearly defined, justified, documented, and communicated?
Clauses:
(clause 4.3). The scope defines the boundaries of your QMS — which products, services, locations, and processes are included — and specifies any justified exclusions. It should be documented and communicated to relevant parties.
Recommendations:
The organization should have a documented scope statement for the QMS that is justified and communicated to relevant parties. Evidence may include the scope statement itself, records of communication, or references to the scope in procedures and work instructions.
If missing, write a formal scope statement. If partially done, review it, ensure it covers all relevant areas, justify exclusions, and communicate to employees.
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4. Have the core and support processes been identified and documented, including process inputs, outputs, and interactions?
Clauses:
(clause 4.4.1). Processes include sales, design, purchasing, production/service delivery, and support. At this level, simple diagrams or flowcharts suffice.
Recommendations:
The organization should have a documented process map or flowchart that identifies core and support processes, their inputs, outputs, and interactions. This may be evidenced by process maps, flowcharts, or descriptions in procedures.
If nothing exists, list all main processes and create a simple process map. If partially done, include inputs/outputs, responsibilities, and basic interactions.
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5. Are responsibilities and authorities for processes defined and communicated?
Clauses:
(clause 5.3). Employees should understand who is accountable for tasks, approvals, and process outcomes.
Recommendations:
The organization should have documented roles and responsibilities for QMS-related activities, and these should be communicated to relevant personnel. Evidence may include organizational charts, job descriptions, or records of communication.
If not defined, document responsibilities in job descriptions or organizational chart. If partially done, clarify accountability for process performance indicators and communicate them to staff.
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SECTION 2 - Leadership & Top Management Commitment |
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6. Does management demonstrate commitment to the QMS by allocating resources and supporting implementation?
Clauses:
(clause 5.1.1). Commitment includes participating in reviews, approving documents, and providing personnel or infrastructure.
Recommendations:
The organization should have evidence of management involvement in QMS activities, such as attending meetings, reviewing performance data, or participating in improvement initiatives.
If absent, schedule management involvement on relevant meetings and document support actions. If partial, formalize evidence of commitment in meeting minutes or internal memos.
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7. Does management ensure customer requirements are determined and consistently fulfilled?
Clauses:
(clause 5.2). This means orders are reviewed, customer needs are understood, and products/services meet expectations.
Recommendations:
The organization should have evidence that management ensures customer requirements are determined and fulfilled, which may include records of order reviews, customer feedback, or performance reports related to customer satisfaction.
If not evident, implement a formal order review process and document customer requirements. If partially done, ensure all orders are reviewed and customer feedback is systematically collected and addressed.
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8. Is a quality policy established, communicated, and understood by staff?
Clauses:
(clause 5.2). The policy should reflect managements intent and be relevant to company objectives.
Recommendations:
The organization should have a documented quality policy that is communicated and understood by employees. Evidence may include the policy document itself, records of communication, or employee surveys. If missing, create a short policy statement aligned with objectives. If partially done, communicate clearly through meetings or internal channels.
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30 total questions
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