Quality Management (QMS) 13 items
ISO 9001:2015 Transition & Gap Assessment Checklist
A gap-assessment checklist to evaluate an existing QMS against the ISO 9001:2015 high-level structure (Annex SL Clauses 4-10) and plan corrective actions before certification or surveillance audit.
ISO 9001:2015
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Context & Leadership (Clauses 4-5)
- Have external and internal issues relevant to the QMS purpose and strategic direction been determined and monitored? *
- Have interested parties and their relevant requirements been identified and reviewed? *
- Is the scope of the QMS documented, including justification for any non-applicable requirements? *
- Has top management demonstrated leadership and commitment, including establishing a customer-focused quality policy? *
Planning & Risk-Based Thinking (Clause 6)
- Have risks and opportunities been determined and actions planned to address them? *
- Are quality objectives established at relevant functions, measurable, and supported by plans (what, resources, who, when, evaluation)? *
- Are changes to the QMS carried out in a planned manner? *
Support & Operation (Clauses 7-8)
- Have resources, competence, awareness, communication, and documented information requirements been met? *
- Has the mandatory 'quality manual' been re-evaluated (no longer required) and documented information restructured accordingly? *
- Are operational processes, design and development, external providers, and production controls aligned to Clause 8? *
Evaluation, Improvement & Action Plan (Clauses 9-10)
- Are monitoring, measurement, analysis, internal audit, and management review processes established? *
- Has the preventive-action concept been replaced by risk-based thinking and evidenced in the QMS? *
- Record each identified gap with clause reference, owner, and target completion date
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