ISO 9001 Quality Management System Audit Checklist - Foundation Level
Free ISO 9001:2015 Quality Management System (QMS) internal audit checklist for beginners. Perfect for companies starting their QMS implementation. Covers basic documentation, processes, and compliance requirements. Import this comprehensive checklist to assess your current QMS maturity level and identify improvement areas. Includes 60+ audit questions across Context, Leadership, Planning, and Support clauses.
This checklist template is designed for logistics, manufacturing, service companies and focuses on Basic information, Context of the Organization, Leadership.
What This Template Covers
Use this template to review Basic information, Context of the Organization, Leadership with a structured format that supports consistent follow-up and faster decision-making.
- Basic information
- Context of the Organization
- Leadership
Why This Version Is Different
Unlike generic templates, this version is tailored to the management systems category, the Foundation / Initiation 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 - Context of the Organization (Clause 4) |
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1. Has the organization systematically identified internal and external issues that can affect its ability to achieve intended quality results?
Clauses:
(clause 4.1). This refers to understanding business environment factors such as market conditions, regulatory changes, technology shifts, organizational culture, or economic risks.
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.
1 - Conduct a structured workshop (e.g., SWOT or PESTLE analysis) involving leadership to formally document relevant internal and external factors.
2 - Ensure issues are reviewed at least annually and linked to risk assessment and strategic planning.
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2. Have relevant interested parties and their expectations been identified and documented? (4.2)
Clauses:
(clause 4.2) Interested parties may include customers, regulators, employees, suppliers, shareholders, or local communities.
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.
0 - Create a stakeholder register identifying their expectations and compliance obligations.
1 - Define how requirements from key stakeholders are monitored and reviewed periodically.
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3. Is the scope of the Quality Management System clearly defined and documented?
Clauses:
(clause 4.3) The scope should define what products, services, locations, and processes are covered.
Recommendations:
The organization should have a documented scope statement for the QMS that is communicated to relevant parties. Evidence may include the scope statement itself, records of communication, or references to the scope in procedures and work instructions.
0 - Define formal scope including boundaries and justification for any exclusions.
1 - Communicate scope internally and ensure it aligns with operational activities.
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4. Are QMS processes identified including their sequence and interaction?
Clauses:
(clause 4.4.1) Processes should not exist in isolation; their inputs, outputs, and interactions must be understood.
Recommendations:
The organization should have a documented process map or flowchart that identifies key QMS processes, their sequence, and interactions. This may be evidenced by process maps, flowcharts, or descriptions in procedures.
0 - Create a high-level process map showing core and support processes.
1 - Define process owners and describe inputs/outputs for each process.
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SECTION 2 - Leadership (Clause 5) |
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5. Has top management established and approved a quality policy aligned with organizational strategy?
Clauses:
(clause 5.2.1)The policy should reflect commitment to quality, customer satisfaction, and continual improvement.
Recommendations:
The organization should have a documented quality policy that is approved by top management and aligned with the organizations strategic direction. Evidence may include the quality policy document, records of approval, and communication materials.
0 - Draft and formally approve a quality policy.
1 - Ensure policy reflects strategic direction and business goals.
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6. Is the quality policy communicated, understood, and applied within the organization?
Clauses:
(clause 5.2.2) Employees should understand how their work supports the policy.
Recommendations:
The organization should have evidence that the quality policy is communicated and understood by employees. This may include training records, internal communications, or employee surveys.
0 - Conduct communication sessions and make policy visible in workplace.
1 - Verify understanding through employee interviews or surveys.
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7. Are roles, responsibilities, and authorities clearly defined and communicated?
Clauses:
(clause 5.3) People must know what they are accountable for in the QMS.
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.
0 - Document responsibilities in job descriptions or organizational chart.
1 - Clarify accountability for process performance indicators.
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8. Does leadership demonstrate active commitment to the QMS?
Clauses:
(clause 5.1.1) Commitment means visible involvement, not only formal approval.
Recommendations:
The organization should have evidence of leadership involvement in QMS activities, such as attending meetings, reviewing performance data, or participating in improvement initiatives.
0 - Include QMS performance as standing item in management meetings.
1 - Define leadership KPIs related to quality performance.
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30 total questions
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