ISO 9001 checklist include these checklists as follows:
Has the organization established, documented, implemented and maintained a quality management system in accordance with the requirements of ISO 9001?
Does the quality management system documentation include documented procedures and records required ensuring effective operation and control of its processes?
Has a quality manual been established and maintained that includes:
Are documents required for the quality management system controlled?
Have records been established and maintained to provide evidence of conformity to requirements and of the effective operation of the quality management system?
How has top management demonstrated commitment to the development and improvement of the quality management system?
Organization has top management ensured that the quality policy:
1. Quality Objectives
a. What are the quality objectives that have been established at relevant functions and levels within the organization?
Responsibility, authority and Communication Audit Checklist
1. Responsibility and authority
Resource Management Audit Checklist
1. Provision of resources
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?
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)
What is the design and development planning methodology described in the design procedure?
Are the outputs of the design and/or development process documented in a manner that enables verification against the design and/or development inputs?
Are systematic reviews of design and/or development conducted at suitable stages?
Is design and/or development verification performed to ensure the output meets the design and/or development inputs?
Is design and/or development validation performed to confirm that resulting product is capable of meeting the requirements for the intended use?
Are design and/or development changes identified, documented, and controlled?
Does the organization control its purchasing processes to ensure purchased product conforms to requirements?
Do purchasing documents contain information describing the product to be purchased?
Have the inspection or other activities necessary for ensuring that purchased product meets specified purchase requirements been established and implemented?
Are the production and service provision planned and carried out under controlled conditions including:
Have processes where deficiencies may become apparent only after the product is in use or the service has been delivered been validated?
Is the product identified by suitable means throughout product realization?
How does the organization exercise care with customer property while it is under the
organization’s control or being used by the organization?
Is conformity of product preserved during internal processing and delivery to the intended destination?
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?
Are measurement and monitoring activities needed to assure conformity and achieve improvement been identified and included in the product quality plan?
Are periodic internal quality audits conducted to determine whether the quality management system has been effectively implemented and maintained?
Are suitable methods applied for monitoring and where applicable, measurement of the quality management system processes necessary to meet customer requirements?
Are product characteristics monitored and measured to verify that product requirements are met?
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
How is corrective action taken to eliminate the cause of nonconformities in order to prevent recurrence?
Are processes necessary for the continual Improvement of the quality management system planned and managed?
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: