Document No.

: Page: 1 of 6
MDSAP QMS F0014.1.002
Version Date: Effective Date:
Responsible Office/Division 2015-10-07 2013-07-15
Title: Project Manager:
MDSAP QMS Training Review Liliane Brown, USFDA
Checklist

MDSAP
Title of MDSAP
Procedure/Policy/ Reviewed
Procedure/Policy/Guidance
Guidance Number
MDSAP Functional Statement MDSAP P0001 ☐Yes ☐ No
MDSAP Audit Model MDSAP P0002 ☐Yes ☐ No
MDSAP Regulatory Authority Council and MDSAP P0003 ☐Yes ☐ No
Lead Project Manager Authorities,
Responsibilities, and Governing Rules
MDSAP Assessment Program Procedure MDSAP AS P0005 ☐Yes ☐ No
MDSAP Audit Time Calculation Procedure MDSAP AU P0008 ☐Yes ☐ No
MDSAP Regulatory Authority Council (RAC) MDSAP P0009 ☐Yes ☐ No
Appointment
MDSAP AO Application for Recognition MDSAP AS P0010 ☐Yes ☐ No
Procedure
MDSAP Witnessed Audit Procedure MDSAP AS P0012 ☐Yes ☐ No
MDSAP Conducting Stage 1 Assessment MDSAP AS P0013 ☐Yes ☐ No
Procedure
MDSAP Special Documentary Assessment MDSAP AS P0014 ☐Yes ☐ No
Procedure
MDSAP AO Nonconformities Procedure MDSAP AS P0015 ☐Yes ☐ No
On Site Assessment /Audit Procedure(Stage MDSAP AS P0016 ☐Yes ☐ No
2, Surveillance, Re-cognition, Critical
Locations)
MDSAP Technical Reviews & Recognition MDSAP AS P0017 ☐Yes ☐ No
Decision Making Procedure
MDSAP QMS Audit Report Policy MDSAP AU P0019 ☐Yes ☐ No
MDSAP Special Assessment Audit MDSAP AS P0020 ☐Yes ☐ No
Procedure
Appeals Procedure MDSAP AS P0021 ☐Yes ☐ No
Implementing Suspension or Revocation of MDSAP AS P0022 ☐Yes ☐ No
Recognition
Flagging/Collection and Review of AO Audit MDSAP AS P0023 ☐Yes ☐ No
Reports
Type or Organization Eligible for Audit and MDSAP AU P0024 ☐Yes ☐ No
Excluded from Participating

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 Document No.: Page 2 of 6
MDSAP QMS Training Document
MDSAP QMS F0014.1.002
Review Checklist Form

MDSAP Document
MDSAP Templates and Forms Reviewed
Number
MDSAP Project Team Work Item (PTWI) MDSAP F0003.1 ☐Yes ☐ No
Proposal/Approval Form
MDSAP Assessment Program Flowchart MDSAP AS F0005.1 ☐Yes ☐ No
MDSAP AO Assessment Program MDSAP AS F0005.2 ☐Yes ☐ No
Management File
MDSAP AO Assessment Program Approval MDSAP AS F0005.3 ☐Yes ☐ No
Form
MDSAP Notice of Change MDSAP AS F0005.5 ☐Yes ☐ No
Auditor Training Working Instruction MDSAP AU WI0006.1 ☐Yes ☐ No
MDSAP AO Application for Recognition MDSAP AS F0010.1 ☐Yes ☐ No
Form
MDSAP AO Application for Recognition MDSAP AS F0010.2 ☐Yes ☐ No
Flowchart
MDSAP AO Scorecard Form MDSAP AS F0010.3 ☐Yes ☐ No
MDSAP AO Participant Agreement MDSAP AS F0010.4 ☐Yes ☐ No
AO Recognition Application Additional MDSAP AS F0010.5 ☐Yes ☐ No
Information Sheet
AO Application Matrix MDSAP AS F0010.6 ☐Yes ☐ No
AO Critical Location Information Form MDSAP AS F0010.7 ☐Yes ☐ No
Auditor and Tech Expert Competency MDSAP AS F0010.8 ☐Yes ☐ No
Summary
Witnessed Audit Flowchart MDSAP AS F0012.1 ☐Yes ☐ No
Witnessed Audit Manufacturer Profile Form MDSAP AS F0012.2 ☐Yes ☐ No
Witnessed Audit Report MDSAP AS F0012.3 ☐Yes ☐ No
Witnessed Audit Assessment MDSAP AS F0012.4 ☐Yes ☐ No
Checklist/Performance Checks
Stage 1 Assessment Flowchart MDSAP AS F0013.1 ☐Yes ☐ No
Stage 1 Assessment Consolidated Report MDSAP AS F0013.2 ☐Yes ☐ No
Special Documentary Assessment Flowchart MDSAP AS F0014.1 ☐Yes ☐ No
Special Documentary Assessment Report MDSAP AS F0014.2 ☐Yes ☐ No
Form
AO Nonconformity Flowchart MDSAP AS F0015.1 ☐Yes ☐ No
AO Nonconformity Report Form MDSAP AS F0015.2 ☐Yes ☐ No
On-Site Assessment-Audit Process MDSAP AS F0016.1 ☐Yes ☐ No
Flowchart
Assessment-Audit Announcement Letter MDSAP AS F0016.2 ☐Yes ☐ No
Template
Assessment Audit Plan Form MDSAP AS F0016.3 ☐Yes ☐ No
On-Site Assessment-Audit Report Form MDSAP AS F0016.5 ☐Yes ☐ No
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MDSAP QMS Training Document
MDSAP QMS F0014.1.002
Review Checklist Form

Technical Reviews & Recognition Decision MDSAP AS F0017.1 ☐Yes ☐ No

Flowchart
AO Recognition Decision Form MDSAP AS F0017.2 ☐Yes ☐ No
AO Recognition Decision Making Calculation MDSAP AS F0017.3 ☐Yes ☐ No
Sheet
Letter of Recognition Template MDSAP AS F0017.4 ☐Yes ☐ No
Audit Report Letter to AOs MDSAP AS F0017.5 ☐Yes ☐ No
Audit Report Template for AO Audit MDSAP AU F0019.1 ☐Yes ☐ No
Manufacturer
Special Assessment-Audit Flowchart MDSAP AS F0020.1 ☐Yes ☐ No
Special Assessment-Audit Report MDSAP AS F0020.2 ☐Yes ☐ No
Appeals Flowchart MDSAP AS F0021.1 ☐Yes ☐ No
Appeal Request and Processing Form MDSAP AS F0021.2 ☐Yes ☐ No
Implementing Suspension or Revocation of MDSAP AS F0022.1 ☐Yes ☐ No
Recognition
Collection and Review of AO Audit Reports MDSAP AU F0023.1 ☐Yes ☐ No
Flowchart Overview
Internal FDA Processing of AO Audit MDSAP AU F0024.2 ☐Yes ☐ No
Reports Flowchart
MDSAP QMS
MDSAP QMS Title of Procedure Reviewed
Procedure Number
MDSAP QMS Quality Manual QMS P0001 ☐Yes ☐ No
MDSAP QMS Document Control and QMS P0002 ☐Yes ☐ No
Approval Procedure
MDSAP QMS Quality Policy (refer to the N/A ☐Yes ☐ No
Quality Manual - Section 5)
MDSAP QMS Quality Risk Management QMS P0004 ☐Yes ☐ No
Procedure
MDSAP QMS Management Responsibility QMS P0005 ☐Yes ☐ No
and Management Review Procedure
MDSAP QMS Control of Nonconforming QMS P0006 ☐Yes ☐ No
Processes or Services Procedure
MDSAP QMS Control of Quality Record QMS P0007 ☐Yes ☐ No
Procedure
MDSAP QMS Internal Assessment QMS P0008 ☐Yes ☐ No
Procedure
MDSAP QMS Corrective Action Procedure QMS P0009 ☐Yes ☐ No
MDSAP QMS Preventive Action Procedure QMS P0010 ☐Yes ☐ No
MDSAP QMS Complaints and/or Customer QMS P0011 ☐Yes ☐ No
Feedback Procedure
MDSAP QMS Audit Report Processing QMS P0012 ☐Yes ☐ No
Procedure

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MDSAP QMS Training Document
MDSAP QMS F0014.1.002
Review Checklist Form

MDSAP QMS Continual Improvement QMS P0013 ☐Yes ☐ No

Procedure
MDSAP QMS Training Procedure QMS P0014 ☐Yes ☐ No
MDSAP QMS
MDSAP QMS Templates and Forms Reviewed
Document Number
MDSAP QMS New Document QMS F0002.1 ☐Yes ☐ No
Proposal/Change Request (NDP/CR) Form
MDSAP QMS New Document Proposal QMS F0002.2 ☐Yes ☐ No
(NDP) Form
MDSAP QMS Risk Management QMS F0004.1 ☐Yes ☐ No
Governance Structure
MDSAP QMS Risk Management Process QMS G0004.2 ☐Yes ☐ No
Steps
MDSAP QMS Risk Management Flowchart QMS F0004.3 ☐Yes ☐ No
MDSAP QMS RM Identifying and Analyzing QMS F0004.4 ☐Yes ☐ No
Risks Form
MDSAP QMS Risk Treatment Action Plan QMS F0004.5 ☐Yes ☐ No
MDSAP QMS Management Review Report QMS F0005.1 ☐Yes ☐ No
Form
MDSAP QMS Management Review Agenda QMS F0005.2 ☐Yes ☐ No
Form
MDSAP QMS Nonconformity Report (NCR) QMS F0006.1 ☐Yes ☐ No
Form
MDSAP QMS Control of Quality Records QMS F0007.1 ☐Yes ☐ No
Flowchart
MDSAP QMS Internal Assessment QMS F0008.1 ☐Yes ☐ No
Summary Report Form
MDSAP QMS Internal Assessment Checklist QMS F0008.2 ☐Yes ☐ No
MDSAP QMS Internal Assessment QMS F0008.3 ☐Yes ☐ No
Qualification/Training Form
MDSAP QMS Internal Schedule- Instruction QMS F0008.4 ☐Yes ☐ No
Form
MDSAP QMS Internal Audit/Self Resolution QMS F0008.5 ☐Yes ☐ No
of Findings Form
MDSAP QMS Corrective Action/Problem QMS F0009.1 ☐Yes ☐ No
(CAPR) Form
MDSAP QMS Corrective Action/Problem QMS F0009.2 ☐Yes ☐ No
(CAPR) Flowchart
MDSAP QMS Complaint and Customer QMS F0011.1 ☐Yes ☐ No
Feedback (CF) Form
MDSAP QMS Training Review Checklist QMS F0014.1 ☐Yes ☐ No
Form
MDSAP QMS Training Evaluation Form QMS F0014.2 ☐Yes ☐ No
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MDSAP QMS Training Document
MDSAP QMS F0014.1.002
Review Checklist Form

International Standards Standard Number Reviewed

Quality Management Systems – ISO 9000 ☐Yes ☐ No
Fundamentals and Vocabulary
Conformity Assessment – Vocabulary and ISO/IEC 17000 ☐Yes ☐ No
General Principles
Medical Devices – Quality Management ANSI/AAMI/ISO 13485 ☐Yes ☐ No
Systems – Requirements for regulatory
purposes
Quality Management Systems – ISO 9001 ☐Yes ☐ No
Requirements
Conformity Assessment – General ISO/IEC 17011 ☐Yes ☐ No
Requirements for Accreditation Bodies
Accrediting Conformity Assessment Bodies
Conformity Assessment – Requirements for ISO/IEC 17021 ☐Yes ☐ No
Bodies Providing Audit and Certification of
Management Systems
Medical Devices – Application of Risk BS EN ISO 14971 ☐Yes ☐ No
Management to Medical Devices
Regulatory Authority Guidance
Documents, Regulations and Other Guidance Doc. No. Reviewed
Materials
AUSTRALIA
Australian Regulatory Guidelines for Medical N/A ☐Yes ☐ No
Devices (ARGMD)
Uniform Recall Procedure for Therapeutic N/A ☐Yes ☐ No
Goods (Australia)
BRAZIL
Brazilian Medical Devices Good RDC 16/2013 ☐Yes ☐ No
Manufacturing Practices Resolution
CANADA
Quality Management System Audits GD210: ISO 13485 ☐Yes ☐ No
Performed by Health Canada Recognized
Registrars
JAPAN
Japanese QMS Ordinance MHLW MO169 ☐Yes ☐ No
UNITED STATES
Guidance Document - Medical Device N/A ☐Yes ☐ No
Reporting for Manufacturers
Compliance Program Guidance Manual – 7382.845 ☐Yes ☐ No
Inspection of Medical Device Manufacturers
Guidance Document – Design Control N/A ☐Yes ☐ No
Guidance for Medical Device Manufacturers
Investigations Operations Manual (IOM) N/A ☐Yes ☐ No
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MDSAP QMS Training Document
MDSAP QMS F0014.1.002
Review Checklist Form

(OPTIONAL)
Regulatory Procedures Manual (RPM) N/A ☐Yes ☐ No
Guide To Inspections of Quality Systems – N/A ☐Yes ☐ No
QSIT (OPTIONAL)

IMDRF DOCUMENTS
Requirements for Medical Device Auditing IMDRF/MDSAP/ ☐Yes ☐ No
Organizations for Regulatory Authority WG/N3
Recognition
Competence and Training Requirements for IMDRF/MDSAP/ ☐Yes ☐ No
Auditing Organizations WG/N4
Regulatory Authority Assessment Method for IMDRF/MDSAP/ ☐Yes ☐ No
the Recognition and Monitoring of Medical WG/N5
Device Auditing Organizations
Regulatory Authority Assessor Competence IMDRF/MDSAP/ ☐Yes ☐ No
and Training Requirements WG/N6
Grading Nonconformities Issued to Auditing IMDRF/MDSAP/ ☐Yes ☐ No
Organizations by Recognizing Regulatory WG/N11
Authorities; and Decision-Making Principles
and Criteria for the Recognition of Auditing
Organization

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