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