5.7 Management When will your management review 8.2.1 Internal audit: internal audit will be review be conducted? reviewed during the management review What is your management review 8.4.1 Continual improvement: continual frequency? improvement will be reviewed during the management review 8.4.2 Corrective action: corrective action(s) will be reviewed during the management review 8.5 Preventive action: preventive action will be reviewed during the management review 6.2.2 Competence, How do you measure the 5.6 Communication: training must be awareness and effectiveness of your training conducted and communicated to relevant training program? internal personnel and external associates How do you ensure that those 8 Monitoring, Analysis and Improvement: associated with regulated field trials training program(s) are monitored, are trained? analyzed and improved effectiveness and How is competency addressed? suitability Do you train external associates? How is training delivered? 6.3 Infrastructure How would you describe your 7.2 Critical control points and procedures: organization’s infrastructure? proper infrastructure must be provided, How are resources provided to established and maintained for the achieve conformance? implementation of critical control points and procedures
5.7 Management review When will your management review be conducted? What is your management review frequency? 8.2.1 Internal audit: internal audit will be reviewed during the management review 8.4.1 Continual improvement: continual improvement will be reviewed during the management review 8.4.2 Corrective action: corrective action(s) will be reviewed during the management review 8.5 Preventive action: preventive action will be reviewed during the management review 6.2.2 Competence, awareness and training How do you measure the effectiveness of your training program? How do you ensure that those associated with regulated field trials are trained? How is competency addressed? Do you train external associates? How is training delivered? 5.6 Communication: training must be conducted and communicated to relevant internal personnel and external associates 8 Monitoring, Analysis and Improvement: training program(s) are monitored, analyzed and improved effectiveness and suitability 6.3 Infrastructure How would you describe your organization’s infrastructure? How are resources provided to achieve conformance? 7.2 Critical control points and procedures: proper infrastructure must be provided, established and maintained for the implementation of critical control points and procedures
1001B_BQMS_Process_Audit_Checklist_V2.0.docx