QMS-FORM-00-4 ISO9001 Gap Assessment Tool

Gap Assessment Tool (Questionnaire Based) QMS-FORM-00-4

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

Gap Assessment Tool (Questionnaire Based) QMS-FORM-00-4 Terms used QMS: Quality Management System AREA/SECTION

SUB-SECTION

ISO9001 REQUIREMENTS

REQS MET? ACTION NEEDED TO MEET REQ

4 Context of the organization 4.1 Understanding the organization and its context

4.2 Understanding the needs and expectations of interested parties

4.3 Determining the scope of the quality management system

4.4 Quality management system and its processes

Have the external and internal issues relevant to the QMS been determined?

Are these issues monitored on a regular basis?

Yes

Have the interested parties and their requirements been identified?

Is information about these interested parties and their requirements monitored and reviewed regularly?

Yes

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?

Yes

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?

Yes

Total:

Yes

Yes

Yes Yes

Yes Yes

Yes

11

5 Leadership 5.1 Leadership and commitment

5.1.1 General

5.1.2 Customer focus

Please Note: not all rows are shown in this sample

Does top management demonstrate leadership and commitment with respect to the QMS? Are clear leadership actions taken by top management such as taking accountability, providing resources, communicating, engaging and supporting others?

Is there a focus on enhancing customer satisfaction?

Are customer and other relevant requirements determined, understood and met?

Are risks and opportunities affecting customer satisfaction addressed?

Yes Yes

Yes Yes Yes

ACTION OWNER

Gap assessment results AREA OF STANDARD 4 Context of the organization 5 Leadership 6 Planning 7 Support 8 Operation 9 Performance evaluation 10 Improvement

REQS IN SECTION 11 10 6 17 28 9 4 Totals 85

NO OF PERCENTAGE REQS MET CONFORMITY 11 100% 10 100% 6 100% 17 100% 28 100% 9 100% 4 100% 85 100%