ISO 9001 checklist

ISO 9001 checklist include these checklists as follows:

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)

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

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.

Related documents to ISO 9001:

ISO 9001 procedures
ISO 9001 standard

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