Mdsap audit checklist (fda)

Template Questions

• MDSAP Quality Manual -Section 1
• 1.1 Quality Management System – Scope
• PROCEDURE MDSAP QMS P0002 – Document Control and Approval ProcedurePROCEDURE MDSAP QMS P0007 – Contro
• 1.2 Quality Management System Documented information
• 1.2.2 Has each site implemented the MDSAP QMS P0002 in the following aspects:
• 1.2.3 Has the established MDSAP Quality Manual been implemented, including:
• 1.2.5 Has each site implemented the MDSAP QMS P0007 in the following aspects:
• MDSAP Quality Manual – Section 5.1 Leadership and Commitment
• 2.1.1 Has the RAC demonstrated commitment to the QMS development and improvement by:
• 2.1 –Leadership and Commitment
• MDSAP Quality Manual – Leadership - Section 5.1.2 Customer Focus
• 2.2 Leadership - Customer Focus
• MDSAP Quality Manual – Leadership- Section 5.2 PolicyMDSAP QMS F0001.1 QMS Policy and Objectives
• 2.3 Leadership - Policy
• MDSAP Quality Manual – Leadership - Section 5.3 Organizational roles, responsibilities and authoritie
• 2.4 Leadership - Responsibility and Authority
• MDSAP Quality Manual – Section 6. PlanningMDSAP QMS F0001.1 QMS Policy and Objectives
• 3.1 Planning - Strategic and Quality Planning
• PROCEDURE MDSAP QMS P0014 – TrainingMDSAP Quality Manual – Support – Section 7.1 Resources, Section 7
• 4.1 Support – Resources, Competence and Awareness
• MDSAP Quality Manual – Support - Section7.4 Communication
• 4.2 Support – Internal Communication
• 5.1 Operation – Operational planning and control
• MDSAP Quality Manual – Operation, Section 8.6 Release of products and servicesMDSAP Audit Procedures
• 5.2 Operation – Release of Product and Services
• PROCEDURE MDSAP QMS P0009 – Nonconformity and Corrective ActionMDSAP Quality Manual – Operation, Sect
• 5.3 Operation – Control of Non-conforming outputs
• 5.3.2 Has each MDSAP site implemented the MDSAP QMS P0009 in the following aspects:
• MDSAP Quality Manual – Performance Evaluation, Section 9.1.1 GeneralPROCEDURE MDSAP QMS P0004 – Risk
• 6.1 Performance Evaluation and Improvement – General
• PROCEDURE MDSAP QMS P0011 – Complaints and/or Customer FeedbackPROCEDURE MDSAP QMS P0004 – Risk Manag
• 6.2 Performance Evaluation and Improvement – Monitoring, measurement, analysis and evaluation - Customer Satisfaction - Complaints & Feedback
• 6.2.3 Has each MDSAP site implemented the MDSAP QMS P0011 in the following aspects:
• MDSAP Quality Manual – Performance Evaluation, Section 9.1.3 Analysis and EvaluationPROCEDURE MDSAP Q
• 6.3 Performance Evaluation and Improvement – Analysis and Evaluation
• PROCEDURE MDSAP QMS P0008 – Internal AssessmentPROCEDURE MDSAP QMS P0013 – Continual ImprovementPROCE
• 6.4 Performance Evaluation and Improvement - Monitoring, measurement, analysis and evaluation - Internal Assessment/Audit and Continual Improvement
• 6.4.2 Has each MDSAP site implemented the MDSAP QMS P0008 in the following aspects:
• PROCEDURE MDSAP QMS P0005 – Management Responsibility and Management ReviewPROCEDURE MDSAP QMS P0013
• 6.5 Performance Evaluation and Improvement - Management Review
• 6.5.2 Do management reviews include at a minimum:
• 6.5.4 Are management reviews recorded to include:
• PROCEDURE MDSAP QMS P0009 – Nonconformity and Corrective ActionPROCEDURE MDSAP QMS P0013 – Continual
• 6.6 Performance Evaluation and Improvement - Improvement – Nonconformity and Corrective Action
• 6.6.2 Has each MDSAP site implemented the MDSAP QMS P0009 in the following aspects:
• 6.7 Performance Evaluation and Improvement - Improvement - Continual Improvement
• 6.7.3 How are data analyzed to provide information and identify opportunities for improvement on:
• 6.7.6 How is continual improvement of the quality management system facilitated through use of:
• Comments/Recommendations
• Name and signature