Template

MDSAP Audit Checklist FDA

by Lisa Behrens, from the Community

This MDSAP audit checklist helps medical device manufacturers assess alignment of their quality management system with FDA MDSAP requirements. It covers QMS scope, documented information, leadership and commitment, planning, support and competence, internal communication, operations, release of products and services, control of nonconforming outputs, performance evaluation, customer feedback and complaints, internal audits, corrective action and continual improvement, and management review. Use it to structure internal assessments, gather objective evidence, track CAPA, and drive QMS improvements ahead of external audits.

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Digitize any process, procedure or policy

Eliminate mistakes made by paper-based processes

Create and share professional reports instantly

Confirm accountability and compliance with a digital log

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This community page makes available free workplace checklists and templates created by other users within the SafetyCulture community. SafetyCulture has re-published this content and where possible, has credited the original author. SafetyCulture has not verified the accuracy, reliability or suitability of any community content. You agree that your use of any of this content is in accordance with SafetyCulture’s Terms and Conditions.

Template
MDSAP Audit Checklist for FDA Compliance
This FDA based MDSAP audit checklist helps medical device manufacturers assess the alignment of their quality management system with MDSAP requirements. The template guides reviewers through QMS scope and documentation, leadership and policy, planning, resources and competence, operational planning and control, product and service release, control of nonconforming outputs, performance evaluation, customer feedback and complaints, internal audits, management review, corrective and preventive actions, and continual improvement. Use it to prepare for audits and strengthen compliance.
by Cesar Paredes, from the Community
Downloads: 0
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Template
MDSAP Audit Checklist (FDA)
Use this MDSAP audit checklist to assess how aligned is the company's QMS with that of MDSAP. This digitized MDSAP template is based on the US FDA's MDSAP QMS Internal Assessment Checklist.
by SafetyCulture
Downloads: 800+
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Template
ISO 9001:2015 QMS Compliance Audit Checklist
This ISO 9001:2015 QMS compliance audit checklist helps organizations evaluate their quality management system across departments. It covers context of the organization, leadership and policy, roles and responsibilities, risk and opportunity management, quality objectives, change management, control of documented information, performance measurement, internal audits, and management review. Operational areas include sales and customer communication, procurement and supplier evaluation, planning and operations control, identification and traceability, preservation, change control, and release of outputs. Quality control topics include calibration and verification of monitoring and measuring resources, control of nonconforming outputs, and corrective action. The template also captures detected nonconformities, evidence, and closing notes for continual improvement.
by Graeme Brown, from the Community
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Template
ISO 9001 Internal Audit Checklist (QMS)
This ISO 9001 internal audit checklist helps auditors evaluate a Quality Management System against ISO 9001:2015. It covers context, leadership, planning, support, operations, performance evaluation, and improvement, including areas like customer focus, quality policy, objectives, documented information, competence and awareness, operational control, production and service provision, supplier control, measurement traceability, internal audit, management review, nonconformity, and corrective action. Use it to verify conformity, capture findings and evidence, assess risks and opportunities, and guide continual improvement across your QMS.
by Jason Curee, from the Community
Downloads: 10+
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MDSAP Audit Checklist FDA

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