Iso 13485 Audit Checklist

Quality Management System

□ Scope of QMS defined for medical devices
□ Quality manual maintained
□ Quality policy appropriate
□ Quality objectives measurable
□ Management commitment demonstrated
□ Customer focus maintained
□ Regulatory requirements identified
□ Risk-based approach implemented
□ Documentation requirements met
□ Software validation performed
□ Process validation completed
□ Effectiveness evaluated

Management Responsibility

□ Management commitment evident
□ Customer/regulatory focus clear
□ Quality policy communicated
□ Planning documented
□ Responsibilities defined
□ Management representative appointed
□ Internal communication effective
□ Management review conducted
□ Review inputs comprehensive
□ Review outputs actionable
□ Improvement actions taken
□ Resources provided

Resource Management

□ Resources determined and provided
□ Human resources competent
□ Training needs identified
□ Training effectiveness evaluated
□ Infrastructure maintained
□ Work environment controlled
□ Contamination control implemented
□ Sterile barrier systems validated
□ Equipment maintained
□ Utilities monitored
□ Information systems validated
□ Supporting services controlled

Product Realization

□ Planning of realization processes
□ Customer requirements determined
□ Regulatory requirements identified
□ Risk management per ISO 14971
□ Design and development planned
□ Design inputs documented
□ Design outputs verified
□ Design reviews conducted
□ Design verification performed
□ Design validation completed
□ Design transfer controlled
□ Design changes managed

Purchasing Controls

□ Purchasing process established
□ Supplier evaluation criteria defined
□ Approved supplier list maintained
□ Purchasing information clear
□ Product specifications defined
□ Verification of purchased product
□ Supplier performance monitored
□ Supplier agreements documented
□ Critical suppliers identified
□ Re-evaluation performed
□ Records maintained
□ Traceability ensured

Production & Service

□ Production planned and controlled
□ Product cleanliness controlled
□ Installation activities validated
□ Servicing activities documented
□ Sterile medical devices validated
□ Validation of processes
□ Identification throughout realization
□ Traceability maintained
□ Customer property controlled
□ Product preservation ensured
□ Monitoring devices calibrated
□ Records maintained

Monitoring & Measurement

□ Customer satisfaction monitored
□ Complaint handling procedure
□ Regulatory reporting performed
□ Internal audits conducted
□ Process monitoring active
□ Product monitoring performed
□ Nonconforming product controlled
□ Advisory notices issued when required
□ Measurement equipment calibrated
□ Statistical techniques applied
□ Data analysis performed
□ Trending conducted

Control of Nonconforming Product

□ Procedure for nonconforming product
□ Identification and segregation
□ Evaluation and disposition
□ Rework procedures validated
□ Concessions documented
□ Regulatory requirements met
□ Investigation of nonconformities
□ Records maintained
□ Re-verification performed
□ Customer notification if required
□ Advisory notices issued
□ Recall procedures ready

Data Analysis & Improvement

□ Data collection planned
□ Analysis techniques appropriate
□ Feedback system established
□ Complaint handling effective
□ Regulatory reporting timely
□ Corrective action system
□ Preventive action process
□ Root cause analysis performed
□ Effectiveness verified
□ Continuous improvement demonstrated
□ Risk management updated
□ Post-market surveillance active

Documentation Requirements

□ Document control procedure
□ Documents approved before use
□ Documents reviewed and updated
□ Changes identified
□ Obsolete documents controlled
□ Documents legible and identifiable
□ External documents controlled
□ Records control procedure
□ Records readily identifiable
□ Records retrievable
□ Retention times defined
□ Records protected

Medical Device Files

□ Device master record complete
□ Device history record maintained
□ Design history file comprehensive
□ Technical documentation complete
□ Risk management file current
□ Clinical evaluation report
□ Regulatory submissions documented
□ Post-market surveillance data
□ Vigilance reporting records
□ Software validation records
□ Process validation records
□ Sterilization validation

Regulatory Compliance

□ Regulatory requirements identified
□ Regulatory strategy defined
□ Submissions timely and accurate
□ Regulatory changes tracked
□ Compliance verified
□ Audit readiness maintained
□ Regulatory training current
□ Communication with authorities
□ Vigilance system active
□ Field safety actions ready
□ Recall procedures tested
□ Market surveillance conducted