MDSAP QMS Procedures and Forms

These MDSAP Regulatory Authority Quality Management System (QMS) procedures provide a transparent overview on how participating regulatory authorities are working together to ensure a quality program. However, the MDSAP regulatory authorities may update these QMS procedures without notice, and the documents on this page may not reflect the latest version of the procedures.  If you have any questions, please send an email to mdsap@fda.hhs.gov.

MDSAP QMS Implementation Plan

• MDSAP QMS Implementation Plan
• MDSAP QMS RA’s Functions and List of Representatives (available in Box only)

More MDSAP QMS Documents

Back to Available Documents

MDSAP QMS P0001

• MDSAP QMS P0001: Quality System Manual
• MDSAP QMS F0001.1 QMS Policy and Objectives

MDSAP QMS P0002

• MDSAP QMS P0002.006: Document Control Approval Procedure
• MDSAP QMS F0002.2.003 New Document Proposal (NDP) Template and Guidelines

MDSAP QMS P0004

• MDSAP QMS P0004: Risk Management Procedure
• MDSAP QMS F0004.1.001: Risk Management Flowchart
• MDSAP QMS F0004.2.001: Identifying and Analyzing Risks Form (optional)
• MDSAP QMS F0004.3.001: Risk Treatment Action Plan (optional)

MDSAP QMS P0005

• MDSAP QMS P0005: Management Responsibility and Management Review Procedure
• MDSAP QMS F0005.1.002: Management Review Report Form
• MDSAP QMS F0005.2.002: Management Review Agenda Form

MDSAP QMS P0007

• MDSAP QMS P0007: Control of Quality Records Procedure

MDSAP QMS P0008

• MDSAP QMS P0008.005: Internal Assessment Procedure
• MDSAP QMS F0008.1.003: Internal Assessment Report Form
• MDSAP QMS F0008.2: Internal Assessment Checklist
• MDSAP QMS F0008.3: Internal Assessment Qualification / Training Form
• MDSAP QMS F0008.4: Internal Assessment Schedule Instruction Form

MDSAP QMS P0009

• MDSAP QMS P0009: Nonconformity and Corrective Action Procedure

MDSAP QMS P0011

• MDSAP QMS P0011: Complaints and/or Customer Feedback Procedure