MDSAP Assessment Procedures and Forms

Overview of the Assessment Program Flowchart

MDSAP AS P0005

• MDSAP AS P0005.002: Assessment Program Procedure
• MDSAP AS F0005.1.001: Assessment Program Flowchart
• MDSAP AS F0005.2.001: AO Assessment Program Management File
• MDSAP AS F0005.3.001: AO Assessment Program Approval Form
• MDSAP AS F0005.5.001: Notice of Change

MDSAP AS P0010

• MDSAP AS P0010.004 Auditing Organization (AO) Application For Recognition Procedure
• MDSAP AS F0010.1.001: AO Application for Recognition Form
• MDSAP AS F0010.2.001 AO Application for Recognition Flowchart
• MDSAP AS F0010.3.001: AO Application Review Checklist
• MDSAP AS F0010.4.001: Supplemental AO Application Matrix - IMDRF N4
• MDSAP AS F0010.5.001: AO Recognition application Additional Information Sheet
• MDSAP AS F0010.6.004: AO Application Matrix
• MDSAP AS F0010.7.001: AO Critical Location Information Form
• MDSAP AS F0010.8.002: Auditor and Tech Support Expert Competency Summary
• MDSAP AS G0010.1.001: Auditor Training

MDSAP AS P0012

• MDSAP AS P0012.003: Witnessed Audit Procedure
• MDSAP AS F0012.1.001: Witnessed Audit Flowchart
• MDSAP AS F0012.2.002: Witnessed Audit Manufacturer Profile Form
• MDSAP AS F0012.3.005: Witnessed Audit Report

MDSAP AS P0013

• MDSAP AS P0013.005: Conducting Stage 1 Assessment Procedure
• MDSAP AS F0013.1.001: Stage 1 Assessment Flowchart
• MDSAP AS F0013.2.005: Stage 1 Assessment Report
• MDSAP AS F0013.3.002 Key Activities Matrix

MDSAP AS P0014

• MDSAP AS P0014.003: Special Remote Assessment
• MDSAP AS F0014.1.001: Special Documentary Assessment Flowchart
• MDSAP AS F0014.2.005: Special Documentary Assessment Report

MDSAP AS P0015

• MDSAP AS F0015.1.001: AO Nonconformity Flowchart
• MDSAP AS F0015.2.006: AO Nonconformity Report Form

MDSAP AS P0016

• MDSAP AS P0016.006: Assessment Audit (Stage 2, Surveillance, Re-Recognition, Critical Locations)
• MDSAP AS F0016.1.001: On-Site Assessment-Audit Process Flowchart
• MDSAP AS F0016.3.006: On-Site Assessment Plan Form
• MDSAP AS F0016.5.004: On-Site Assessment-Audit Report Form
• MDSAP AS F0016.6.001: On Site Attendance Form

MDSAP AS P0017

• MDSAP AS P0017.004 Technical Review and Recognition Decision Procedure
• MDSAP AS F0017.1.003 Technical Review and Recognition Decision Flowchart (PDF)
• MDSAP AS F0017.2.004 Technical Review and Recognition Decision Form
• MDSAP AS F0017.3.003 Letter of Authorization Template
• MDSAP AS F0017.4 Letter of Recognition Template
• MDSAP AS F0017.5.004 Technical Review Form

MDSAP AS P0020

• MDSAP AS P0020.002: Special On Site Assessment Procedure
• MDSAP AS F0020.1.001: Special On-Site Assessment Flowchart

MDSAP AS P0021

• MDSAP AS P0021.003: Appeals Procedure
• MDSAP AS F0021.1.001: Appeals Flowchart
• MDSAP AS F0021.2.002: Appeals Request and Review Form

MDSAP AS P0034

• MDSAP AS P0034.002: Guidance for Regulatory Authority Assessors on the Method of Assessment for MDSAP Auditing Organizations