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    FDA Guidelines - MDSAP

    Uploaded by

    Lawrence

    Copyright:

    © All Rights Reserved
    Download as XLSX, PDF, TXT or read online from Scribd

    FDA Guidelines - MDSAP

    Uploaded by

    Lawrence
    35 views9 pages

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    © © All Rights Reserved

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    Copyright:

    © All Rights Reserved
    Download as XLSX, PDF, TXT or read online from Scribd
    Download as xlsx, pdf, or txt
    35 views9 pages

    FDA Guidelines - MDSAP

    Uploaded by

    Lawrence

    Copyright:

    © All Rights Reserved
    Download as XLSX, PDF, TXT or read online from Scribd
    Download as xlsx, pdf, or txt
    of 9

    FDA Guidelines (Medical Device Single Audit Program) based on ISO 13485:2016 Standard

    (Ref.: MDSAP AU P0002.008; 2023-04-01)

    Task Task Description


    CHAPTER 1 - MANAGEMENT

    TASK 1 QMS PLANNING, IMPLEMENTATION, CHANGES AND QUALITY MANUAL

    TASK 2 MANAGEMENT REPRESENTATIVE

    TASK 3 QUALITY POLICY AND QUALITY OBJECTIVES

    TASK 4 ORGANIZATIONAL STRUCTURE, RESPONSIBILITY, AUTHORITY, RESOURCES

    TASK 5 EXTENT OF OUTSOURCING

    TASK 6 PERSONNEL COMPETENCY AND TRAINING

    TASK 7 RISK MANAGEMENT PLANNING AND REVIEW

    TASK 8 DOCUMENT AND RECORD CONTROLS

    TASK 9 MANAGEMENT REVIEWS

    TASK 10 DISTRIBUTION OF DEVICES WITH APPROPRIATE MARKETING AUTHORIZATION

    TASK 11 TOP MANAGEMENT COMMITMENT TO QUALITY

    CHAPTER 2 - DEVICE MARKETING AUTHORIZATION AND FACILITY REGISTRATION

    TASK 1 SUBMISSION FOR DEVICE MARKETING AUTHORIZATION AND FACILITY REGISTRATION

    TASK 2 EVIDENCE OF MARKETING CLEARANCE OR APPROVAL

    TASK 3 NOTIFICATION OF CHANGES TO MARKETED DEVICES OR TO THE QMS

    CHAPTER 3 - MEASUREMENT, ANALYSIS AND IMPROVEMENT


    PROCEDURES FOR MEASUREMENT, ANALYSIS, AND IMPROVEMENT OF QMS
    TASK 1
    EFFECTIVENESS AND PRODUCT CONFORMITY

    TASK 2 SOURCES OF QUALITY DATA

    TASK 3 INVESTIGATION OF NONCONFORMITY

    TASK 4 INVESTIGATION OF POTENTIAL NONCONFORMITY

    TASK 5 CORRECTION, CORRECTIVE ACTION, AND PREVENTIVE ACTION

    ASSESSMENT OF DESIGN CHANGE RESULTING FROM CORRECTIVE OR PREVENTIVE


    TASK 6
    ACTION
    ASSESSMENT OF PROCESS CHANGE RESULTING FROM CORRECTIVE OR PREVENTIVE
    TASK 7
    ACTION

    TASK 8 IDENTIFICATION AND CONTROL OF NONCONFORMING PRODUCT

    TASK 9 ACTION REGARDING NONCONFORMING PRODUCT DETECTED AFTER DELIVERY

    TASK 10 INTERNAL AUDIT

    TASK 11 INFORMATION SUPPLIED FOR MANAGEMENT REVIEW

    EVALUATION OF INFORMATION FROM POST-PRODUCTION PHASE, INCLUDING


    TASK 12
    COMPLAINTS

    TASK 13 COMMUNICATIONS WITH EXTERNAL PARTIES INVOLVED ON COMPLAINTS

    TASK 14 EVALUATION OF COMPLAINTS FOR ADVERSE EVENT REPORTING


    TASK 15 EVALUATION OF QUALITY PROBLEMS FOR ADVISORY NOTICES

    TOP MANAGEMENT COMMITMENT TO MEASUREMENT, ANALYSIS, AND IMPROVEMENT


    TASK 16
    PROCESS
    CHAPTER 4 - MEDICAL DEVICE ADVERSE EVENTS AND ADVISORY NOTICES REPORTING
    TASK 1 NOTIFICATION OF ADVERSE EVENTS
    TASK 2 NOTIFICATION OF ADVISORY NOTICES
    CHAPTER 5 - DESIGN AND DEVELOPMENT
    IDENTIFICATION OF DEVICES SUBJECT TO DESIGN AND DEVELOPMENT PROCEDURES;
    TASK 1
    TECHNICAL DOCUMENTATION
    TASK 2 SELECTION OF A COMPLETED DESIGN AND DEVELOPMENT PROJECT
    TASK 3 DESIGN AND DEVELOPMENT PLANNING
    TASK 4 IMPLEMENTATION OF THE DESIGN AND DEVELOPMENT PROCESS
    TASK 5 DESIGN AND DEVELOPMENT INPUT
    COMPLETENESS, COHERENCE, AND UNAMBIGUITY OF DESIGN AND DEVELOPMENT
    TASK 6
    INPUT
    TASK 7 DESIGN AND DEVELOPMENT OUTPUT AND DESIGN VERIFICATION
    RISK MANAGEMENT ACTIVITIES APPLIED THROUGHOUT THE DESIGN AND
    TASK 8
    DEVELOPMENT PROJECT
    DESIGN VERIFICATION OR DESIGN VALIDATION TO CONFIRM EFFECTIVENESS OF RISK
    TASK 9
    CONTROL MEASURES
    TASK 10 DESIGN VALIDATION
    CLINICAL EVALUATION AND/OR EVALUATION OF MEDICAL DEVICE SAFETY AND
    TASK 11
    PERFORMANCE
    TASK 12 SOFTWARE DESIGN AND DEVELOPMENT
    TASK 13 DESIGN AND DEVELOPMENT CHANGE
    TASK 14 DESIGN REVIEW
    IMPACT REVIEW OF DESIGN AND DEVELOPMENT CHANGES ON PREVIOUSLY MADE AND
    TASK 15
    DISTRIBUTED DEVICES
    TASK 16 DESIGN TRANSFER
    TASK 17 TOP MANAGEMENT COMMITMENT TO DESIGN AND DEVELOPMENT PROCESS
    CHAPTER 6 - PRODUCTION AND SERVICE CONTROLS

    TASK 1 PLANNING OF PRODUCTION AND SERVICE PROCESS

    TASK 2 SELECTION OF PRODUCTION AND SERVICE PROCESS(ES)

    CONTROLS FOR THE IMPLEMENTATION OF SELECTED PRODUCTION AND SERVICE


    TASK 3
    PROCESS(ES)

    TASK 4 CONTROL OF PRODUCT CLEANLINESS

    TASK 5 INFRASTRUCTURE
    TASK 6 WORK ENVIRONMENT

    TASK 7 IDENTIFICATION OF PROCESSES SUBJECT TO VALIDATION

    TASK 8 PROCESS VALIDATION

    TASK 9 VALIDATION OF STERILIZATION PROCESS


    TASK 10 MONITORING AND MEASUREMENT OF PRODUCT CONFORMITY
    CONTROL, OPERATION, AND MONITORING OF THE PRODUCTION AND SERVICE
    TASK 11
    PROCESS; RISK CONTROLS
    TASK 12 COMPETENCE OF PERSONNEL
    TASK 13 CONTROL OF MONITORING AND MEASURING DEVICE
    IMPACT ANALYSIS OF MONITORING AND MEASURING DEVICE FOUND OUT OF
    TASK 14
    SPECIFICATIONS
    VALIDATION OF SOFTWARE USED FOR THE CONTROL OF THE PRODUCTION AND
    TASK 15
    SERVICE PROCESS
    TASK 16 DEVICE MASTER FILE
    TASK 17 PRODUCTION RECORD; EVIDENCE OF COMPLIANCE OF RELEASED DEVICES
    TRACEABILITY APPLIED TO IMPLANTABLE, LIFE-SUPPORTING OR LIFE-SUSTAINING
    TASK 18
    MEDICAL DEVICES
    TASK 19 IDENTIFICATION OF PRODUCT STATUS
    TASK 20 CUSTOMER PROPERTY
    TASK 21 ACCEPTANCE ACTIVITIES
    TASK 22 IDENTIFICATION, CONTROL, AND DISPOSITION OF NONCONFORMING PRODUCTS
    TASK 23 REWORK OF NONCONFORMING PRODUCTS
    TASK 24 PRESERVATION OF THE PRODUCT
    TASK 25 REVIEW OF CUSTOMER REQUIREMENTS, DISTRIBUTION RECORDS
    TASK 26 INSTALLATION ACTIVITIES
    TASK 27 SERVICING ACTIVITIES
    TASK 28 RISK CONTROLS APPLIED TO TRANSPORT, INSTALLATION, AND SERVICING
    TASK 29 TOP MANAGEMENT COMMITMENT TO THE PRODUCTION AND SERVICE PROCESS
    CHAPTER 7 - PURCHASING
    PLANNING ACTIVITIES REGARDING PURCHASED PRODUCTS AND OUTSOURCED
    TASK 1
    PROCESSES
    TASK 2 SELECTION OF SUPPLIER FILE TO AUDIT
    PROCEDURE FOR THE CONTROL OF PURCHASED PRODUCTS AND OUTSOURCED
    TASK 3
    PROCESSES
    EXTENT OF CONTROLS APPLIED TO THE SUPPLIER AND THE PURCHASED PRODUCT;
    TASK 4
    CRITERIA FOR SELECTION, EVALUATION, AND RE-EVALUATION OF THE SUPPLIER
    SELECTION OF SUPPLIER BASED ON ABILITY OF THE SUPPLIER TO SATISFY THE SPECIFIED
    TASK 5
    PURCHASE REQUIREMENTS
    TASK 6 RECORDS OF SUPPLIER EVALUATION
    TASK 7 EFFECTIVE CONTROLS OVER SUPPLIER AND PRODUCTS
    VERIFICATION OF THE ADEQUACY OF PURCHASING INFORMATION, SPECIFIED
    TASK 8 PURCHASE REQUIREMENTS, AND WRITTEN AGREEMENT TO NOTIFY CHANGES, BEFORE
    THEIR COMMUNICATION TO THE SUPPLIER

    TASK 9 DOCUMENTED PURCHASING INFORMATION AND SPECIFIED PURCHASE REQUIREMENTS

    TASK 10 VERIFICATION OF PURCHASED PRODUCTS


    PURCHASING CONTROL ACTIVITIES AS SOURCE OF QUALITY DATA FOR THE
    TASK 11
    MEASUREMENT, ANALYSIS, AND IMPROVEMENT PROCESS
    TASK 12 TOP MANAGEMENT COMMITMENT TO THE PURCHASING PROCESS
    Audit Program) based on ISO 13485:2016 Standard
    AU P0002.008; 2023-04-01)

    Document/ Record Remarks

    Quality Manual
    Quality Plan
    MR Appointment Letter
    MR Job Description
    Quality Policy
    Quality Objectives
    Organogram
    Job Descriptions
    CV's
    Employee List with Designations
    List of Critical Suppliers

    Competency Skill Matrix


    Training Matrix / TNA
    Training Completion Form
    Training Evaluation
    Training Feedback
    Training Certificates

    Risk and Opportunity register


    Risk Management Policy (policy for determining
    criteria for risk acceptability)
    Master list of Documents
    Master list of Records

    MRM Invites
    MRM Presentation
    MRM Report
    MRM Minutes
    MRM Attendance Record

    Company Branding/ Labelling on Products


    Procedure for proper registration,
    Logo/ Trademark Registration
    listing, licensing, notification and
    List of Marketing Authorizations
    approval from regulatory
    Distribution Agreements
    authorities
    Marketing Materials

    Communication of Quality Policy & Quality


    Objectives
    Display of Quality Policy

    Application for Trade Name Registration / License


    Application for Product Registration/ Marketing
    Authorizations
    Application for ISO 13485:2016 Certification/ Audit

    Trade Name Registration / License


    Product Registration/ Marketing Authorizations
    from Regulatory Authorities
    ISO 13485:2016 Certificate

    Change in Critical suppliers,


    CR's
    software's, materials, process
    Product Re-registration/ Marketing Authorizations
    design, specifications, composition,
    from Regulatory Authorities
    packaging & labels
    NCR's
    CAPA's
    Customer Feedback
    Customer Survey

    Internal Audit Reports


    External Audit Reports
    Concessions
    Supplier Monitoring Log
    Customer Complaints
    Quality Statistics Report
    Service/ Product Records
    Inspection / QC Records
    Customer Survey Analysis
    MRM Report
    Product Reject Reports
    Product Recall Reports

    NCR's
    CAPA's
    NCR's
    CAPA's
    NCR's
    CAPA's
    CAPA's
    Design Change Validations
    CAPA's
    CR's
    NCR's
    CAPA's
    Concession's
    Supplier Monitoring Log

    NCR's
    CAPA's
    Customer Complaints

    Internal Audit Plan


    Internal Audit Schedule
    Internal Audit Report
    Internal Audit NCR Log
    Internal Audit Communication
    NCR's
    Internal Auditor Certificate

    MRM Presentation
    MRM Report
    Quality Statistics

    Customer Complaints Log


    Customer Complaints Summary
    CAPA's
    Customer Feedback
    Customer Survey
    Post Market Surveillance
    Warranty Claim
    Clinical Trials

    Customer Complaints Communication


    Customer Complaints
    NCR's
    Advise and supplementary
    information in the use of a medical
    device other than information
    Advisory Notices represented in the Instructions for
    Use, of a modification of a medical
    device, return and/or destruction
    instructions.

    MRM Minutes
    MRM Attendance Record

    Record for ADVERSE EVENTS


    Record for ADVISORY NOTICES

    Quality Plan
    Inspection Test Plan
    Quality Objectives
    Quality Plan
    Quality Objectives
    Product Work Instructions
    Product Manuals
    Product Procedures
    Pest Control Program
    Housekeeping Schedules
    Waste Management
    Facility
    List of Equipment's/ Machinery
    Equipment/ Machinery Maintenance Plan
    Controlled Condition (Humidity & Temperature)
    PPE
    Housekeeping
    Contamination Control
    Training Records (special environment conditions)

    Procedure for Process Validation


    (clinical testing)
    Supplier Monitoring
    Supplier NCR's

    Procedure for Process Validation (clinical testing)


    Records of Process Validation
    Inspection Test Plan
    Supplier Monitoring
    Supplier NCR's
    Equipment's Calibration List
    Equipment's Calibration Certificates
    Equipment's Maintenance Plan
    Equipment's Maintenance Record
    Sampling Plan (test samples)
    Competency Skill Matrix (Process Operators)
    Product/ Process NCR's

    Calibration Master List

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