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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 requirements
4.1q1    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

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Internal quality mgmt system audit checklist (iso 9000 2000)

  • 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 requirements 4.1q1 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