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      • DESIGN SYSTEM
      • BASE PLUS SYSTEM
      • BASE SYSTEM
      • ISO 13485 Quality Management System Manual
    • ISO 13485 PROCEDURE BUNDLES >
      • ISO 13485 Document Control Procedure Bundle
      • Design Control Procedures Bundle
      • Risk Management Procedures Bundle
      • ISO 13485 Process Validation Procedure Bundle
      • Medical Device Sterilization Procedure Bundle
      • Medical Device Labeling Bundle
      • Medical Device Software Procedure Bundle
      • Clinical Evaluation Procedure Bundle
      • Cleanroom Procedure Bundle
      • Complaint Handling Procedures Bundle
    • ISO 13485 QUALITY SYSTEM PROCEDURES >
      • ISO 13485 DOCUMENTATION REQUIREMENTS PROCEDURES >
        • Engineering Change Notice Procedure
        • Document Control Procedure
        • Record Retention Procedure
      • ISO 13485 MANAGEMENT RESPONSIBILITIES PROCEDURES >
        • Management Review Procedure
      • ISO 13485 RESOURCE MANAGEMENT PROCEDURES >
        • Training Procedure
        • Facility Inspection Procedure
        • Respiratory Protection Procedure
        • Biohazard Procedure
        • Lockout - Tagout Procedure
        • Preventive Maintenance Procedure
      • ISO 13485 PRODUCT REALIZATION PROCEDURES >
        • ISO 13485 DESIGN - DEVELOPMENT PROCEDURES >
          • Design Control Procedure
          • Customer Requirements Validation
          • Human Factors - Usability Engineering Procedure
          • Design Review Procedure
          • Risk Management Procedure
          • Design Transfer Procedure
          • Shelf Life Procedure
          • Technology Transfer Procedure
          • Design Verification - Validation Procedure
          • Design Risk Management Procedure
          • Design Analysis Procedure
          • Biocompatibility - Toxicity Testing Procedure
          • ISO 13485 Label Review and Approval Procedure
          • Unique Device Identification Procedure
          • Software Development Procedure
          • Software Clinical Evaluation Procedure
          • Clinical Evaluation Procedure
          • Clinical Investigation Procedure
          • Product Performance Specification Procedure
          • CE Marking Procedure
        • ISO 13485 PURCHASING PROCEDURES >
          • Supplier Management Procedure
          • Purchase Order Procedure
        • ISO 13485 PRODUCTION - SERVICE PROVISION PROCEDURES >
          • Cleanroom Design and Validation Procedure
          • Environmental Controls Procedure
          • Controlled Environment Cleaning Procedure
          • Sterile Load Preparation - Release Procedure
          • Gamma Irradiation Sterilization Validation Procedure
          • Ethylene Oxide EO Sterilization Validation Procedure
          • Software Validation Procedure
          • Installation Qualification (IQ) Procedure
          • Medical Device Process Validation
          • Validation Protocols - Reports Procedure
          • Process Risk Management Procedure
          • Device History Record
          • Identification Procedure
          • Lot Inspection Procedure
          • First Article Inspection Procedure
          • Line Clearance Procedure
          • ISO 13485 Contract Review Procedure
        • ISO 13485 CONTROL MONITORING MEASUREMENT DEVICES PROCEDURES >
          • Calibration System Procedure
      • ISO 13485 MEASUREMENT ANALYSIS IMPROVEMENT >
        • Complaint Handling Procedure
        • Complaint Trending Procedure
        • Nonconforming Material Procedure
        • Corrective - Preventive Action Procedure
        • Internal Audit Procedure
        • Medical Device Report MDR Procedure
        • Product Hold Procedure
        • Remedial Action - Recall Procedure
        • Statistical Techniques Procedure
        • Post Market Surveillance Procedure
        • Post Market Clinical Follow Up Plan
        • Post Market Clinical Follow Up Evaluation Report
        • Periodic Safety Update Report (PSUR) Procedure
        • Vigilance Procedure
        • Failure Investigation Procedure
    • VALIDATION PROTOCOLS >
      • Clinical Investigation Report
      • Clinical Investigation Plan
      • Ethylene Oxide (EO) Product Adoption
      • Accelerated Aging Study
      • Injection Mold Validation Procedure
      • Medical Device Software Development Plan
      • Final Cleaning Orthopedic Implants
      • Bar Sealer Operational Qualification OQ Protocol
      • Bar Sealer Performance Qualification PQ Protocol
      • Bar Sealer Qualification Protocol Bundle OQ - PQ
      • Tray Sealer Operational Qualification OQ Protocol
      • Tray Sealer Performance Qualification PQ Protocol
      • Tray Sealer Qualification Protocol Bundle OQ - PQ
      • 4 Sided Sealer Operational Qualification OQ Protocol
      • 4 Sided Sealer 4SS Performance Qualification PQ Protocol
      • 4 Sided Sealer Qualification Protocol Bundle OQ - PQ
    • CONTRACTS - AGREEMENTS >
      • Medical Device Quality Agreement | US
      • Medical Device Quality Agreement | EU
      • Master Consulting Agreement
  • CONSULTING
    • QUALITY SYSTEM INSTALLATION - TRAINING
    • FDA QSIT AUDIT PREPARATION
    • DESIGN - PROCESS VALIDATION
  • FDA US AGENTS
    • US AGENTS
    • FACILITY REGISTRATION SERVICES
    • FDA FURLS DATABASE DATA ENTRY SERVICES
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Medical Device Quality Management Systems | ISO 13485 and FDA QSR Compliant

Our customers have different QMS needs, so we try and provide a variety of QMS configurations that allow our customers to select the best possible solution for gaining ISO 13485:2016, MDR 2017/745, and FDA QSR compliance. Listed below are our BASE, DESIGN, and MANUFACTURING systems along with a content comparison table to help you make an informed decision as to which product is best aligned with your QMS needs.

BASE PLUS QMS PRODUCT

Our BASE PLUS QMS product is a starter package configured to provide customers who develop and manufacture medical devices with ISO 13485:2016 and FDA QSR compliant procedures that address common areas of need.
medical device quality management system base plus
The BASE PLUS System is a stand alone quality management system configured for companies engaged in the design and manufacture of medical devices who need only the minimum required QMS content  to obtain ISO 13485:2016 certification and FDA QSR compliance.
  • Quality Management System Manual​
  • ​38 Standard Operating Procedures
  • Includes Detailed Forms
  • MS Word and Excel Format​
  • ​Content Audited to ISO 13485:2016 and 21 CFR Part 820 (Multiple Audits)
  • ​ISO 13485:2016, MDR 2017/745 and FDA QSR Compliant
  • ​Digital Content - Instant Download
read more

DESIGN PLUS QMS PRODUCT

Our DESIGN PLUS QMS product are configured to help customer's  engaged in medical device design who need a complete system to obtain ISO 13485:2016 and FDA compliance.
medical device quality management system design plus
The DESIGN PLUS Quality Management System product is a stand alone quality management system configured to provide medical device design companies with the required procedures needed for ISO 13485:2016 certification and FDA QSR compliance.
  • ​Quality Management System Manual​
  • ​46 Standard Operating Procedures
  • Includes Detailed Forms
  • MS Word and Excel Format​
  • ​Content Audited to ISO 13485:2016 and 21 CFR Part 820 (Multiple Audits)
  • ​ISO 13485:2016, MDR 2017/745 and FDA QSR Compliant
  • ​Digital Content- Instant Download
read more

DESIGN & MANUFACTURING COMBO QMS PRODUCT

Our MANUFACTURING PLUS QMS product is  deep in content and configured for customer's engaged in both the design and manufacture of medical devices who are seeking ISO 13485:2016 certification and FDA QSR compliance.
medical device quality management system manufacturing plus
The MANUFACTURING PLUS System is our "top line" QMS product configured for companies engaged in the design and manufacture of medical devices, including Software as a Medical Device, seeking ISO 13485:2016 certification and FDA QSR compliance.
  • Quality Management System Manual​
  • ​72 Standard Operating Procedures
  • Includes Detailed Forms
  • MS Word and Excel Format​
  • Content Audited to ISO 13485:2016 and 21 CFR Part 820 (Multiple Audits)
  • ​ISO 13485:2016, MDR 2017/745 and FDA QSR Compliant
  • ​Digital Content - Instant Download
read more

Medical Device Quality Management System Content and Product Comparison Table

Listed below is the content included with each QMS package. An "O" in the applicable cell means the procedure is included.
​ID
PROCEDURE DESCRIPTION
BASE  SYSTEM
BASE PLUS
DESIGN SYSTEM
DESIGN PLUS
MFG
​SYSTEM
MFG PLUS
QMSM
QUALITY SYSTEM MANUAL
O
O
O
O
O
O
4-001
ENGINEERING CHANGE NOTICE PROCEDURE
O
O
O
O
O
O
4-002
DOCUMENT CONTROL PROCEDURE
O
O
O
O
O
O
4-003
RECORD RETENTION PROCEDURE
 
O
  
O
O
O
4-004
EXTERNAL STANDARDS PROCEDURE
 
O
  
O
O
O
4-005
DOCUMENTATION PRACTICES
 
O
  
O
O
O
4-006
SPECIFICATION FORMAT PROCEDURE
 
O
  
O
O
O
4-007
DEVICE MASTER RECORD PROCEDURE
 
O
  
O
O
O
5-001
MANAGEMENT REVIEW PROCEDURE
O
O
O
O
O
O
5-002
ORGANIZATION RESPONSIBILITIES AND AUTHORITY
 
O
 
O
O
O
6-001
TRAINING PROCEDURE
O
O
O
O
O
O
6-002
RESPIRATORY PROTECTION
 
 
  
  
  
O
6-003
BIOHAZARD PROCEDURE
 
 
  
  
 
O
6-004
LOCKOUT / TAGOUT PROCEDURE
 
 
  
  
 
O
6-005
GOWNING PROCEDURE
 
O
  
  
O
O
7-001
DESIGN CONTROL PROCEDURE
O
O
O
O
O
O
7-002
DESIGN REVIEW PROCEDURE
O
O
O
O
O
O
7-003
RISK MANAGEMENT PROCEDURE
O
O
O
O
O
O
7-004
CONTRACT REVIEW PROCEDURE
 
 
 
 
O
O
7-005
PURCHASE ORDER PROCEDURE
 
 
  
 
O
O
7-006
SUPPLIER MANAGEMENT
O
O
  
O
O
O
7-007
IDENTIFICATION PROCEDURE
 
O
  
 
O
O
7-008
RECEIVING PROCEDURE
 
 
  
 
O
O
7-009
CALIBRATION PROCEDURE
O
O
 
O
O
O
7-010
FINISHED GOODS SHIPPING
 
 
 
 
O
O
7-011
LOT INSPECTION PROCEDURE
O
O
  
 
O
O
7-012
PROCESS VALIDATION
O
O
O
O
O
O
7-013
ENVIRONMENTAL CONTROLS
 
O
 
  
O
O
7-014
INSTALLATION QUALIFICATION
O
O
  
O
O
O
7-015
PROTOCOLS AND REPORTS
  
 
O
O
O
O
7-016
PREVENTIVE MAINTENANCE
O
O
  
O
O
O
7-017
FIRST ARTICLE INSPECTION
  
 
  
O
O
O
7-018
CONTROLLED ENVIRONMENT CLEANING
  
O
  
 
O
O
7-019
DEVICE HISTORY RECORDS
O
O
  
  
O
O
7-020
LINE CLEARANCE PROCEDURE
  
 
  
  
O
O
7-021
DESIGN TRANSFER PROCEDURE
O
O
O
O
O
O
7-022
DESIGN CHANGE PROCEDURE
O
O
O
O
O
O
7-023
STERILE LOAD PREP AND RELEASE
  
O
 
  
O
O
7-024
TECHNOLOGY TRANSFER
  
 
 
  
 
O
7-025
RETURNED GOODS PROCEDURE
  
 
 
  
O
O
7-026
SHELF LIFE PROCEDURE
 
 
O
O
O
O
7-027
LABEL REVIEW AND APPROVAL
  
O
O
O
O
O
7-028
PRODUCT PERFORMANCE SPECIFICATIONS
  
 
O
O
O
O
7-029
DESIGN VERIFICATION AND VALIDATION
O
O
O
O
O
O
7-030
DESIGN RISK MANAGEMENT
  
 
O
O
O
O
7-031
PRODUCTION RISK MANAGEMENT
 
O
O
O
O
O
7-032
DESIGN ANALYSIS PROCEDURE
O 
O
O
O
O
O
7-033
SOFTWARE VALIDATION
  
O
 
O
O
O
7-034
BIOCOMPATIBILITY PROCEDURE
  
 
O
O
O
O
7-035
EO STERILIZATION VALIDATION
  
O
 
  
O
O
7-036
GAMMA STERILIZATION VALIDATION
  
O
 
  
O
O
7-037
UNIQUE DEVICE IDENTIFICATION
  
 
O
O
O
O
7-038
CLINICAL EVALUATION
  
 
O
O
 
O
7-039
CLINICAL INVESTIGATION
 
 
O
O
  
O
7-040
CE MARKING PROCEDURE
  
 
O
O
O
O
7-041
INJECTION MOLD VALIDATION 
  
 
 
O
  
O
7-042
USABILITY ENGINEERING
  
 
O
O
 
O
7-043
SOFTWARE AS A MEDICAL DEVICE
  
 
 
O
 
O
7-044
SOFTWARE CLINICAL EVALUATION 
  
 
 
O
  
O
7-045
CLEANROOM DESIGN AND VALIDATION 
  
 
 
  
  
O
7-046
CUSTOMER REQUIREMENTS VALIDATION
  
 
O
O
O
O
8-001
COMPLAINT HANDLING
O
O
 
O
O
O
8-002
COMPLAINT TRENDING
O
O
 
O
O
O
8-003
REMEDIAL ACTION / RECALL
 
 
 
 
O
O
8-004
CORRECTIVE AND PREVENTIVE ACTION
O
O
 
O
O
O
8-005
INTERNAL AUDIT PROCEDURE
 
O
 
 
O
O
8-006
MEDICAL DEVICE REPORT (MDR)
  
  
 
 
O
O
8-007
STATISTICAL TECHNIQUES
O
O
O
O
O
O
8-008
NONCONFORMING MATERIALS
O
O
 
 
O
O
8-009
VIGILANCE PROCEDURE
  
 
 
 
 
O
8-010
PRODUCT HOLD PROCEDURE
  
 
 
  
O
O
8-012
POST MARKET SURVEILLANCE
 
  
 
 
O
O
8-013
PERIODIC SAFETY UPDATE REPORT
  
 
 
  
 
O
8-014
FAILURE INVESTIGATION
  
  
  
O
O
O
 
TOTAL NUMBER OF PROCEDURES
23
38
27
46
60
72

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  • HOME
  • STORE
    • ISO 13485 QUALITY SYSTEMS >
      • MANUFACTURING PLUS
      • MANUFACTURING SYSTEM
      • DESIGN PLUS SYSTEM
      • DESIGN SYSTEM
      • BASE PLUS SYSTEM
      • BASE SYSTEM
      • ISO 13485 Quality Management System Manual
    • ISO 13485 PROCEDURE BUNDLES >
      • ISO 13485 Document Control Procedure Bundle
      • Design Control Procedures Bundle
      • Risk Management Procedures Bundle
      • ISO 13485 Process Validation Procedure Bundle
      • Medical Device Sterilization Procedure Bundle
      • Medical Device Labeling Bundle
      • Medical Device Software Procedure Bundle
      • Clinical Evaluation Procedure Bundle
      • Cleanroom Procedure Bundle
      • Complaint Handling Procedures Bundle
    • ISO 13485 QUALITY SYSTEM PROCEDURES >
      • ISO 13485 DOCUMENTATION REQUIREMENTS PROCEDURES >
        • Engineering Change Notice Procedure
        • Document Control Procedure
        • Record Retention Procedure
      • ISO 13485 MANAGEMENT RESPONSIBILITIES PROCEDURES >
        • Management Review Procedure
      • ISO 13485 RESOURCE MANAGEMENT PROCEDURES >
        • Training Procedure
        • Facility Inspection Procedure
        • Respiratory Protection Procedure
        • Biohazard Procedure
        • Lockout - Tagout Procedure
        • Preventive Maintenance Procedure
      • ISO 13485 PRODUCT REALIZATION PROCEDURES >
        • ISO 13485 DESIGN - DEVELOPMENT PROCEDURES >
          • Design Control Procedure
          • Customer Requirements Validation
          • Human Factors - Usability Engineering Procedure
          • Design Review Procedure
          • Risk Management Procedure
          • Design Transfer Procedure
          • Shelf Life Procedure
          • Technology Transfer Procedure
          • Design Verification - Validation Procedure
          • Design Risk Management Procedure
          • Design Analysis Procedure
          • Biocompatibility - Toxicity Testing Procedure
          • ISO 13485 Label Review and Approval Procedure
          • Unique Device Identification Procedure
          • Software Development Procedure
          • Software Clinical Evaluation Procedure
          • Clinical Evaluation Procedure
          • Clinical Investigation Procedure
          • Product Performance Specification Procedure
          • CE Marking Procedure
        • ISO 13485 PURCHASING PROCEDURES >
          • Supplier Management Procedure
          • Purchase Order Procedure
        • ISO 13485 PRODUCTION - SERVICE PROVISION PROCEDURES >
          • Cleanroom Design and Validation Procedure
          • Environmental Controls Procedure
          • Controlled Environment Cleaning Procedure
          • Sterile Load Preparation - Release Procedure
          • Gamma Irradiation Sterilization Validation Procedure
          • Ethylene Oxide EO Sterilization Validation Procedure
          • Software Validation Procedure
          • Installation Qualification (IQ) Procedure
          • Medical Device Process Validation
          • Validation Protocols - Reports Procedure
          • Process Risk Management Procedure
          • Device History Record
          • Identification Procedure
          • Lot Inspection Procedure
          • First Article Inspection Procedure
          • Line Clearance Procedure
          • ISO 13485 Contract Review Procedure
        • ISO 13485 CONTROL MONITORING MEASUREMENT DEVICES PROCEDURES >
          • Calibration System Procedure
      • ISO 13485 MEASUREMENT ANALYSIS IMPROVEMENT >
        • Complaint Handling Procedure
        • Complaint Trending Procedure
        • Nonconforming Material Procedure
        • Corrective - Preventive Action Procedure
        • Internal Audit Procedure
        • Medical Device Report MDR Procedure
        • Product Hold Procedure
        • Remedial Action - Recall Procedure
        • Statistical Techniques Procedure
        • Post Market Surveillance Procedure
        • Post Market Clinical Follow Up Plan
        • Post Market Clinical Follow Up Evaluation Report
        • Periodic Safety Update Report (PSUR) Procedure
        • Vigilance Procedure
        • Failure Investigation Procedure
    • VALIDATION PROTOCOLS >
      • Clinical Investigation Report
      • Clinical Investigation Plan
      • Ethylene Oxide (EO) Product Adoption
      • Accelerated Aging Study
      • Injection Mold Validation Procedure
      • Medical Device Software Development Plan
      • Final Cleaning Orthopedic Implants
      • Bar Sealer Operational Qualification OQ Protocol
      • Bar Sealer Performance Qualification PQ Protocol
      • Bar Sealer Qualification Protocol Bundle OQ - PQ
      • Tray Sealer Operational Qualification OQ Protocol
      • Tray Sealer Performance Qualification PQ Protocol
      • Tray Sealer Qualification Protocol Bundle OQ - PQ
      • 4 Sided Sealer Operational Qualification OQ Protocol
      • 4 Sided Sealer 4SS Performance Qualification PQ Protocol
      • 4 Sided Sealer Qualification Protocol Bundle OQ - PQ
    • CONTRACTS - AGREEMENTS >
      • Medical Device Quality Agreement | US
      • Medical Device Quality Agreement | EU
      • Master Consulting Agreement
  • CONSULTING
    • QUALITY SYSTEM INSTALLATION - TRAINING
    • FDA QSIT AUDIT PREPARATION
    • DESIGN - PROCESS VALIDATION
  • FDA US AGENTS
    • US AGENTS
    • FACILITY REGISTRATION SERVICES
    • FDA FURLS DATABASE DATA ENTRY SERVICES
  • ABOUT
  • CONTACT