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Assessment Details Standard assessed: Date(s) of assessment: Location of assessment: Assessor: Assessment participants: Purpose of assessment: Scope of assessment:


ISO9001 Gap Assessment Tool - Questionnaire

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Terms Used QMS = Quality Management System

Doc ref: QMS-FORM-00-4

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 Section Total:

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:

Please Note: Not all tabs and rows are shown in this sample.

5

Action needed to meet requirement

Action owner


Summary Results Table

Area 4 Context of the organization 5 Leadership 6 Planning 7 Support 8 Operation 9 Performance evaluation 10 Improvement

Total Number of Questions

Number of Positive Responses

% Positive Responses

11 10 6 17 28 9 4

11 10 6 17 28 9 4

100% 100% 100% 100% 100% 100% 100%


Detailed Results Table

Area 4 Context of the organisation

5. Leadership

6. Planning

7. Support

8. Operation

9. Performance evaluation

10. Improvement

Section 4.1 Understanding the organisation and its context 4.2 Understanding the needs & expectations of interested parties 4.3 Determining the scope of the quality management system 4.4 Quality management system and its processes 5.1 Leadership and commitment 5.2 Policy 5.3 Organisational roles, responsibilities and authorities 6.1 Actions to address risks and opportunities 6.2 Quality objectives and plans to achieve them 6.3 Planning of changes 7.1 Resources 7.2 Competence 7.3 Awareness 7.4 Communication 7.5 Documented information 8.1 Operational planning and control 8.2 Requirements for products and services 8.3 Design and development of products and services 8.4 Control of externally provided processes, products and services 8.5 Production and service provision 8.6 Release of products and services 8.7 Control of nonconforming outputs 9.1 Monitoring, measurement, analysis and evaluation 9.2 Internal audit 9.3 Management review 10.1 General 10.2 Nonconformity and corrective action 10.3 Continual improvement

Total Number of Questions 2 2 3 4 5 3 2 2 3 1 9 2 1 1 4 3 6 6 3 6 2 2 4 2 3 1 2 1

Number of Positive Responses 2 2 3 4 5 3 2 2 3 1 9 2 1 1 4 3 6 6 3 6 2 2 4 2 3 1 2 1

% Positive Responses 100% 100% 100% 100% 100% 100% 100% 100% 100% 100% 100% 100% 100% 100% 100% 100% 100% 100% 100% 100% 100% 100% 100% 100% 100% 100% 100% 100%


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QMS-FORM-00-4 ISO9001 Gap Assessment Tool  

QMS-FORM-00-4 ISO9001 Gap Assessment Tool  

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