ISO 9001 Gap Analysis Tool
Evaluate your Quality Management System. Choose
Yes
,
Maybe
, or
No
for each question.
Context of the Organization (Clause 4)
(ISO Guidance)
Have you identified external and internal issues that affect your QMS?
Yes
Maybe
No
Do you understand the needs and expectations of interested parties?
Yes
Maybe
No
Is the scope of your QMS clearly defined and documented?
Yes
Maybe
No
Have you considered how changes in context affect your QMS over time?
Yes
Maybe
No
Are your interested parties' requirements regularly reviewed and updated?
Yes
Maybe
No
Leadership (Clause 5)
(ISO Guidance)
Is top management actively involved and committed to the QMS?
Yes
Maybe
No
Has a clear quality policy been established, communicated, and understood?
Yes
Maybe
No
Are quality objectives set, measurable, and aligned with your strategic direction?
Yes
Maybe
No
Does leadership promote a culture of quality and continuous improvement?
Yes
Maybe
No
Are responsibilities and authorities clearly assigned within your QMS?
Yes
Maybe
No
Planning (Clause 6)
(ISO Guidance)
Have risks and opportunities been identified and appropriately addressed?
Yes
Maybe
No
Are quality objectives measurable and regularly reviewed?
Yes
Maybe
No
Are changes to the QMS planned and controlled?
Yes
Maybe
No
Is there a risk-based approach embedded in planning activities?
Yes
Maybe
No
Are contingency plans in place for critical processes?
Yes
Maybe
No
Support (Clause 7)
(ISO Guidance)
Are resources sufficient and appropriate for the QMS and its processes?
Yes
Maybe
No
Is personnel competence monitored and maintained with regular training?
Yes
Maybe
No
Is documented information properly controlled and available when needed?
Yes
Maybe
No
Is infrastructure and work environment managed to support conformity?
Yes
Maybe
No
Are communication processes effective internally and externally?
Yes
Maybe
No
Operation (Clause 8)
(ISO Guidance)
Are customer requirements clearly defined and reviewed?
Yes
Maybe
No
Is design and development controlled and documented?
Yes
Maybe
No
Are processes for external providers and suppliers controlled?
Yes
Maybe
No
Is production and service provision controlled to meet requirements?
Yes
Maybe
No
Are nonconformities identified, controlled, and documented?
Yes
Maybe
No
Is traceability maintained where applicable?
Yes
Maybe
No
Performance Evaluation (Clause 9)
(ISO Guidance)
Are monitoring and measurement activities planned and executed?
Yes
Maybe
No
Is customer satisfaction regularly measured and analyzed?
Yes
Maybe
No
Are internal audits conducted effectively and regularly?
Yes
Maybe
No
Are audit results reported and acted upon?
Yes
Maybe
No
Is management review conducted to evaluate QMS effectiveness?
Yes
Maybe
No
Improvement (Clause 10)
(ISO Guidance)
Are nonconformities investigated for root cause and corrective action?
Yes
Maybe
No
Is continual improvement a focus of the QMS?
Yes
Maybe
No
Are improvement opportunities identified proactively?
Yes
Maybe
No
Is innovation encouraged to improve quality and processes?
Yes
Maybe
No
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