Template

MDSAP Audit Checklist for FDA Compliance

by Cesar Paredes, from the Community

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.

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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 (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
MDSAP Audit Checklist FDA
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.
by Lisa Behrens, from the Community
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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 9001:2015 Audit Checklist (Sample)
Use this comprehensive ISO 9001:2015 audit checklist to evaluate your Quality Management System for compliance. The checklist guides internal auditors through key ISO clauses, covering organizational context, leadership and policy, planning and risk, support and resources, competence and awareness, documented information control, operational planning and control, design and development, external provider management, production and service provision, identification and traceability, preservation and post‑delivery, change control, release of products and services, and control of nonconforming outputs. It also includes performance evaluation requirements such as monitoring and measurement, internal audits, and management review, as well as improvement through corrective action and continual improvement. Attach evidence where required and complete sign‑off to finalize the assessment.
by Sifiso Selelane, from the Community
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MDSAP Audit Checklist for FDA Compliance

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