ISO 9001 checklist

1. ISO 9001 General Requirements

Has the organization established, documented, implemented and maintained a
quality management system in accordance with the requirements of ISO 9001?
2. General Documentation Requirements
Does the quality management system documentation include documented
procedures and records required ensuring effective operation and control of its
processes?
3. Quality Manual
Has a quality manual been established and maintained that includes:
4. Control of Documents
Are documents required for the quality management system controlled?
5. Control of Records
Have records been established and maintained to provide evidence of conformity
to requirements and of the effective operation of the quality management system?
6. Management Commitment
How has top management demonstrated commitment to the development and
improvement of the quality management system?
7. Quality Policy
Organization has top management ensured that the quality policy:
8. System Planning
1. Quality Objectives
a. What are the quality objectives that have been established at relevant functions
and levels within the organization?
9. Responsibility, authority and Communication
Responsibility, authority and Communication Audit Checklist
1. Responsibility and authority
10. Resource Management
Resource Management Audit Checklist
1. Provision of resources
11. Planning of Product/Service Realization
Planning of Product/Service Realization Audit Checklist
Is planning of the realization processes consistent with the other requirements of
the organization’s quality management system?
12. Management Review
Management Review Audit Checklist
1. General checklist
a) Does the top management review the quality management system, at planned
intervals, to ensure its continuing suitability, adequacy and effectiveness?
13. Product review
Determination of Requirements Related to the Product (7.2.1)

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14. Design and Development Planning and Design and Development
Inputs
What is the design and development planning methodology described in the
design procedure?
15. Design and Development Outputs Audit
Are the outputs of the design and/or development process documented in a
manner that enables verification against the design and/or development inputs?
16. Design and Development Review Audit
Are systematic reviews of design and/or development conducted at suitable
stages?
17. Design and/or Development Verification
Is design and/or development verification performed to ensure the output meets
the design and/or development inputs?
18. Design and/or Development Validation
Is design and/or development validation performed to confirm that resulting
product is capable of meeting the requirements for the intended use?
19. Control of Design and Development Changes
Are design and/or development changes identified, documented, and controlled?
20. Purchasing Process
Does the organization control its purchasing processes to ensure purchased
product conforms to requirements?
21. Purchasing Information
Do purchasing documents contain information describing the product to be
purchased?
22. Verification of Purchased Product
Have the inspection or other activities necessary for ensuring that purchased
product meets specified purchase requirements been established and
implemented?
23. Control of Production and Service
Are the production and service provision planned and carried out under controlled
conditions including:
24. Validation of Processes for Production and Service Provision
Have processes where deficiencies may become apparent only after the product is
in use or the service has been delivered been validated?
25. Identification and Traceability
Is the product identified by suitable means throughout product realization?
26. Customer Property
How does the organization exercise care with customer property while it is under
the
organization’s control or being used by the organization?
27. Preservation of Product
Is conformity of product preserved during internal processing and delivery to the
intended destination?
28. Audit Checklist of Control of Measuring and Monitoring Devices
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Has the organization determined the monitoring and measurement to be
undertaken and the monitoring and measurement devices needed to provide
evidence of conformity of product to determined requirements?
29. Customer Satisfaction
Are measurement and monitoring activities needed to assure conformity and
achieve improvement been identified and included in the product quality plan?
30. Internal Audit Checklist
Are periodic internal quality audits conducted to determine whether the quality
management system has been effectively implemented and maintained?
31. Monitoring and Measurement of Processes
Are suitable methods applied for monitoring and where applicable, measurement
of the quality management system processes necessary to meet customer
requirements?
32. Monitoring and Measurement of Product
Are product characteristics monitored and measured to verify that product
requirements are met?
33. Control of Nonconforming Product Checklist
Is nonconforming product identified and controlled to prevent unintended use or
delivery?
34. Analysis of Data
Is appropriate data determined, collected and analyzed to demonstrate the
suitability and effectiveness of the quality management system and to evaluate
where continual improvement of the effectiveness of the quality management
system can
be made?
35. Corrective Action
How is corrective action taken to eliminate the cause of nonconformities in order to
prevent recurrence?
36 Continual Improvement
Are processes necessary for the continual Improvement of the quality
management system planned and managed?
37. Preventive Action
Has the organization determined actions to eliminate the causes of potential
nonconformities in order to prevent occurrence?
These checklists also called ISO 9000 audit checklist.