Context of the Organization

□ Internal/external issues determined
□ Interested parties identified
□ Their requirements understood
□ Scope of QMS defined
□ QMS processes determined
□ Process interactions defined
□ Process criteria established
□ Resources determined
□ Responsibilities assigned
□ Risks and opportunities addressed
□ Process monitoring planned
□ Improvement opportunities identified

Leadership

□ Leadership commitment demonstrated
□ Customer focus maintained
□ Quality policy established
□ Policy communicated/understood
□ Organizational roles assigned
□ Responsibilities defined
□ Authorities communicated
□ Management review conducted
□ Customer requirements determined
□ Regulatory requirements identified
□ Customer satisfaction monitored
□ Continual improvement promoted

Planning

□ Risks and opportunities identified
□ Actions planned and integrated
□ Effectiveness evaluated
□ Quality objectives established
□ Objectives measurable/monitored
□ Planning to achieve objectives
□ Changes planned systematically
□ Resources considered
□ Responsibilities assigned
□ Timeframes established
□ Evaluation methods defined
□ Results documented

Support

□ Resources determined/provided
□ People competent/available
□ Infrastructure maintained
□ Environment suitable
□ Monitoring resources calibrated
□ Organizational knowledge managed
□ Competence requirements defined
□ Training effective
□ Awareness ensured
□ Communication planned
□ Documented information controlled
□ External provider controlled

Operation

□ Operational planning conducted
□ Customer requirements determined
□ Design and development controlled
□ External provision controlled
□ Production/service controlled
□ Product/service release controlled
□ Nonconforming outputs controlled
□ Customer communication effective
□ Contingency plans prepared
□ Post-delivery activities managed
□ Changes controlled
□ Requirements preserved

Performance Evaluation

□ Monitoring/measurement planned
□ Customer satisfaction measured
□ Analysis and evaluation performed
□ Internal audits conducted
□ Audit program implemented
□ Audit results reported
□ Management review scheduled
□ Review inputs comprehensive
□ Review outputs actionable
□ Evidence of improvement
□ Effectiveness evaluated
□ Trends analyzed

Improvement

□ Improvement opportunities identified
□ Nonconformities addressed
□ Corrective actions taken
□ Root causes analyzed
□ Action effectiveness reviewed
□ Preventive actions considered
□ Continual improvement demonstrated
□ Customer complaints resolved
□ Process improvements implemented
□ Innovation encouraged
□ Best practices shared
□ Lessons learned captured

Document Control

□ Document control procedure exists
□ Documents approved before use
□ Documents reviewed/updated
□ Changes identified
□ Current versions available
□ Documents legible/identifiable
□ External documents controlled
□ Obsolete documents prevented
□ Records controlled
□ Retention times defined
□ Records protected/retrievable
□ Electronic media controlled

Customer Focus

□ Customer requirements determined
□ Regulatory requirements identified
□ Product requirements defined
□ Contract review conducted
□ Changes communicated
□ Customer property controlled
□ Customer feedback obtained
□ Satisfaction measured
□ Complaints handled effectively
□ Customer needs anticipated
□ Relationships managed
□ Future needs considered

Process Approach

□ Processes identified
□ Sequence/interaction determined
□ Criteria/methods defined
□ Resources available
□ Responsibilities assigned
□ Risks addressed
□ Monitoring implemented
□ Measurements analyzed
□ Improvements made
□ Process documentation adequate
□ Process performance evaluated
□ Process objectives achieved

Risk-Based Thinking

□ Risk assessment conducted
□ Opportunities identified
□ Risk criteria established
□ Risk treatment planned
□ Controls implemented
□ Effectiveness monitored
□ Risk register maintained
□ Risk communication effective
□ Risk review scheduled
□ Lessons learned applied
□ Risk culture promoted
□ Integration achieved

Measurement & Analysis

□ KPIs established
□ Data collection systematic
□ Statistical techniques used
□ Trends analyzed
□ Benchmarking performed
□ Root cause analysis conducted
□ Data integrity ensured
□ Reporting effective
□ Decision-making informed
□ Performance gaps identified
□ Improvement actions taken
□ Success measured