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 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 QMS PRODUCTS

Our BASE QMS products are configured to provide our customers with ISO 13485 and FDA QSR compliant procedures that address common areas of need.

BASE SYSTEM
The BASE System contains  QMS procedures that serve as the foundation for your QMS needs. ISO 13485 and FDA QSR compliant.
  • ​23 Procedures
  • MS Word and Excel Format
  • ​Includes Related Forms
  • ​Instant Download

BASE PLUS
The BASE PLUS System builds on  the BASE system adding more content to round out your QMS. ISO 13485 and FDA QSR compliant.
  • ​38 Procedures
  • MS Word and Excel Format
  • ​Includes Related Forms
  • ​Instant Download

DESIGN QMS PRODUCTS

Our DESIGN QMS products are configured to help customer's who need to add design control to an existing system, or for those customer's engaged in medical device design who need a complete system to obtain ISO 13485 and FDA compliance.

DESIGN SYSTEM
The DESIGN System is configured for companies needing procedures to govern medical device design and design controls. ISO 13485 and FDA QSR compliant.
  • ​27 Procedures
  • MS Word and Excel Format
  • ​Includes Related Forms
  • ​Instant Download

DESIGN PLUS
The DESIGN PLUS System builds on  the DESIGN system and is configured for companies seeking ISO 13485 certification and FDA QSR compliance.
  • ​46 Procedures
  • MS Word and Excel Format
  • ​Includes Related Forms
  • ​Instant Download

DESIGN and MANUFACTURE QMS PRODUCTS

Our DESIGN and MANUFACTURING QMS products are configured for our customer's who are engaged in both the design and manufacture of medical devices who are seeking ISO 13485 certification and FDA QSR compliance.

MANUFACTURING SYSTEM
The MANUFACTURING System is for companies engaged in the design and manufacture of medical devices who seek ISO 13485 and FDA compliance.
  • ​60 Procedures
  • MS Word and Excel Format
  • ​Includes Related Forms
  • ​Instant Download

MANUFACTURING PLUS SYSTEM
The MANUFACTURING PLUS System is our ultimate QMS package configured for ISO 13485 certification and FDA QSR compliance.
  • ​72 Procedures
  • MS Word and Excel Format
  • ​Includes Related Forms
  • ​Instant Download

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 SYSTEM
DESIGN SYSTEM
DESIGN PLUS SYSTEM
MFG
​SYSTEM
MFG PLUS SYSTEM
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
 
PRODUCT
BASE SYSTEM
BASE PLUS SYSTEM
DESIGN SYSTEM
DESIGN PLUS SYSTEM
MFG
​SYSTEM
MFG PLUS SYSTEM
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