ISO 9001:2008 Standards Check List

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 checklist.
Read more on ISO 9001:2008 Standard at http://www.iso9001store.com