Internal quality mgmt system audit checklist (iso 9000 2000)


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Internal quality mgmt system audit checklist (iso 9000 2000)

  1. 1. Internal Quality Management System Audit Checklist (ISO 9000:2000)Q# ISO 9001:2000 Clause Text Audit Question Objective Evidence 4 Quality management system 4 Quality management system 4.1 General requirements 4.1 General requirements4.1q1 The organization shall establish, document, Has Organization established, documented, implement and maintain a quality implemented and maintained a QMS and management system and continually continually improved its effectiveness in improve its effectiveness in accordance with accordance with ISO 9001:2000? the requirements of this International (Questions in section 4.1 are verified Standard. throughout the audit)4.1q2a The organization shall a) identify the Where has Organization identified the processes needed for the quality processes needed for the QMS and their management system and their application application throughout the organization? throughout the organization (see 1.2), (see 4.2.2)4.1q2b The organization shall b) determine the Were has organization determined the sequence and interaction of these sequence and interaction of QMS processes, processes? (see 4.2.2)4.1q2c The organization shall c) determine criteria What are the criteria and methods and methods needed to ensure that both organization uses to ensure that the the operation and control of these operation and control of QMS processes processes are effective, are effective?4.1q2d The organization shall d) ensure the Has organization provided resources and availability of resources and information information needed to support the operation necessary to support the operation and and monitoring of QMS processes? (see monitoring of these processes, section 6)4.1q2e The organization shall e) monitor, measure How does organization monitor, measure and analyse these processes, and and analyze QMS processes?4.1q2f The organization shall f) implement actions How has organization implemented actions necessary to achieve planned results and necessary to achieve planned results and continual improvement of these processes. continual improvement of processes needed for the QMS?4.1q3 These processes shall be managed by the Are processes needed for the QMS organization in accordance with the managed by the organization in accordance requirements of this International Standard. with the requirements of ISO 9001:2000?4.1q4 Where an organization chooses to When organization outsources any process outsource any process that affects product that affects product conformity with conformity with requirements, the requirements, how is control ensured over organization shall ensure control over such such processes? processes.4.1q5 Control of such outsourced processes shall Where is the control of outsourced be identified within the quality management processes that affect product conformity system. with requirements identified within the QMS? NOTE Processes needed for the quality management system referred to above should include processes for management activities, provision of resources, product realization and measurement. 4.2 Documentation requirements 4.2 Documentation requirements Page 1 of 26