MDSAP Audit Checklist

Use this MDSAP Audit Checklist to assess compliance with medical device regulations across multiple countries, ensuring readiness for MDSAP inspections.

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MDSAP Audit Checklist



Management Process (Primary Process)

1. Has top management defined, planned, and implemented the MDSAP QMS (Quality Management System)?


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2. Has the established quality policy been communicated and understood throughout the organization?


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3. Does top management ensure that customer and regulatory requirements are determined and met?


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4. Are responsibilities and authorities for QMS functions clearly defined and communicated?


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5. Does the management review procedure include proper inputs and outputs, ensuring the QMS is effective?


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6. Are all QMS documents and records properly controlled and managed according to defined procedures?


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7. Is there objective evidence that the organization has adequate infrastructure and resources needed to implement and maintain the QMS?


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8. Is internal communication effective between various levels and functions regarding the QMS processes?


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Device Marketing Authorization And Facility Registration (Supporting Process)

1. Is an up-to-date inventory of regulatory licenses, approvals, and facility registrations maintained for all applicable jurisdictions?


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2. Is there evidence of marketing clearance or approval for all marketed devices in each relevant country?


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3. Is the notification process for changes to marketed devices or the QMS clearly defined and compliant with regulatory requirements?


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4. Is the facility's Declaration of Conformity up to date and readily available?


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Measurement, Analysis, And Improvement Process (Primary Process)

1. Are quality objectives established, and is there evidence of using them to improve the QMS's effectiveness?


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2. Are internal audits conducted according to established procedures by trained individuals?


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3. Is the output of internal audits used as an input to the management review?


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4. Is there an effective process for handling complaints and conducting root cause analysis?


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5. Are Corrective and Preventive Actions (CAPA) tracked, implemented, and verified for effectiveness?


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6. Are non-conforming outputs identified, controlled, and managed to prevent unintended use or delivery?


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7. Are QMS processes regularly monitored and analyzed to support continuous improvement efforts?


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Medical Device Adverse Events And Advisory Notices Reporting (Supporting Process)

1. Are the procedures for notifying adverse events and advisory notices clearly defined and followed?


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2. Does the organization ensure that reporting incidents complies with the regulatory requirements of all participating jurisdictions (e.g., specific timelines)?


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3. Are records maintained for any advisory notices or field safety corrective actions?


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Design And Development Process (Primary Process)

1. Are design controls clearly defined and documented, from planning through design transfer?


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2. Are design input, output, verification, and validation activities fully documented and complete?


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3. Are change control processes defined and implemented for design modifications?


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4. Is a complete Design History File (DHF) maintained that reflects the entire development journey?


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5. Are risk management processes defined and connected to verification and validation activities?


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Production And Service Controls Process (Primary Process)

1. Are production processes validated and controlled to ensure product quality?


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2. Are work environments and infrastructure adequate and monitored to prevent adverse effects on product quality?


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3. Are operators trained and qualified for their assigned tasks, and is the effectiveness of this training evaluated?


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4. Is there a documented system for the identification and traceability of products and components?


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5. Are product preservation and storage conditions controlled to maintain product integrity?


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6. Is there adequate control and segregation of non-conforming product within the production area?


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7. Are servicing and installation activities (if applicable) controlled and documented?


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Purchasing Process (Supporting Process)

1. Are there defined procedures for purchasing and outsourcing activities?


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2. Are critical suppliers and outsourced services formally selected, evaluated, and included on the approved supplier list?


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3. Is supplier monitoring and auditing performed based on risk, and are records maintained?


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4. Are there written agreements with critical suppliers that define responsibilities, especially for components or services supplied?


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5. Is the verification of purchased products documented?


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Checklist by GoAudits.com – Please note that this checklist is intended as an example. We do not guarantee compliance with the laws applicable to your territory or industry. You should seek professional advice to determine how this checklist should be adapted to your workplace or jurisdiction.

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