ISO9001 Gap Assessment Tool - Questionnaire
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Terms Used QMS = Quality Management System
Quality management systems - Requirements Area
Section
Sub-section
Question
Response
4 Context of the organization 4.1 Understanding the organization and its context Have the external and internal issues relevant to the QMS been determined? Are these issues monitored on a regular basis? Section Total:
Yes Yes 2
4.2 Understanding the needs and expectations of interested parties Have the interested parties and their requirements been identified? Is information about these interested parties and their requirements monitored and reviewed regularly? Section Total:
Yes Yes
2
4.3 Determining the scope of the quality management system Has the scope of the QMS been determined and documented? Are the boundaries and applicability of the QMS clearly defined and justified? Have the external and internal issues, requirements of interested parties and products and services been considered in determining the scope? Section Total:
Yes Yes Yes
3
4.4 Quality management system and its processes Is a QMS in place and being continually improved? Are the processes needed for the QMS determined? Is each process fully defined in terms of aspects such as inputs, outputs, resources, ownership, risks and improvement? Is adequate documented information maintained about the processes and their operation? Section Total: Area Total:
Yes Yes Yes
Yes
4 11
5 Leadership 5.1 Leadership and commitment Section Total:
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5
Action needed to meet requirement
Action owner