##  [ISO 13485:2016 Exclusive Department SOPs](/medical-devices/iso-134852016-exclusive-department-sops) 

# ISO 13485:2016 Exclusive Department SOPs







Freyr’s exclusive departmental SOPs include all the department/function specific SOP which are designed to meet all your ISO 13485:2016 needs. It is tailored specifically to your departmental requirements for your medical device(s), for effective QMS at your organization.

Didn't find the department you were searching for? Worry not. [Connect](javascript:void(0)) with our experts today.

### Key Features

- ![]()
    
    End to end Solution
- ![]()
    
    Customisable Toolkit
- ![]()
    
    Includes 90+ Templates and Procedures
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    Cost Efficient



- [![]() Design &amp; Development](#msc-section1)
- [![]() Engineeering](#msc-section2)
- [![]() HR](#msc-section3)
- [![]() Identification](#msc-section4)
- [![]() Internal audit](#msc-section5)
- [![]() Manufacturing](#msc-section6)
- [![]() Marketing-Sales](#msc-section7)
- [![]() Purchase](#msc-section8)
- [![]() Quality Assurance](#msc-section9)
- [![]() Regulatory](#msc-section10)
- [![]() Risk management](#msc-section11)
- [![]() Store](#msc-section12)
- [![]() Work Environment](#msc-section13)



## ![]() Design &amp; Development

- Design and Development Procedure
    
    Price
    
    $300.00
    
     
    
      Select Templates   Procedure with templates 
    
      Procedure Only 
    
    
    
     
    
    
    
     
    
       Quantity
- Purchase the entire Design &amp; Development Department SoP package
    
     Price
    
    $300.00
    
     
    
     
    
       Quantity
 


 

 



 





## ![]() Engineeering

- Calibration
    
    Price
    
    $140.00
    
     
    
      Select Templates   Procedure with templates 
    
      Procedure Only 
    
    
    
     
    
    
    
     
    
       Quantity
- Purchase the entire Engineering Department SoP package
    
     Price
    
    $140.00
    
     
    
     
    
       Quantity
 


 

 



 





## ![]() HR

- Training, Awareness &amp; Competency Procedure
    
    Price
    
    $220.00
    
     
    
      Select Templates   Procedure with templates 
    
      Procedure Only 
    
    
    
     
    
    
    
     
    
       Quantity
- Purchase the entire HR Department SoP package
    
     Price
    
    $220.00
    
     
    
     
    
       Quantity
 


 

 



 





## ![]() Identification

- Identification and Traceability Procedure
    
    Price
    
    $120.00
    
     
    
      Select Templates   Procedure with templates 
    
      Procedure Only 
    
    
    
     
    
    
    
     
    
       Quantity
- Purchase the entire Environment Department SoP package
    
     Price
    
    $120.00
    
     
    
     
    
       Quantity
 


 

 



 





## ![]() Internal audit

- Internal Audit Procedure
    
    Price
    
    $160.00
    
     
    
      Select Templates   Procedure with templates 
    
    
    
     
    
    
    
     
    
       Quantity
- Purchase the entire Internal audit Department SoP package
    
     Price
    
    $160.00
    
     
    
     
    
       Quantity
 


 

 



 





## ![]() Manufacturing

- Process Validation
    
    Price
    
    $100.00
    
     
    
      Select Templates   Procedure Only 
    
    
    
     
    
    
    
     
    
       Quantity
- Rework Procedure
    
    Price
    
    $140.00
    
     
    
      Select Templates   Procedure with templates 
    
      Procedure Only 
    
    
    
     
    
    
    
     
    
       Quantity
- Control of Non-Conforming Product Procedure
    
    Price
    
    $120.00
    
     
    
      Select Templates   Procedure with templates 
    
      Procedure Only 
    
    
    
     
    
    
    
     
    
       Quantity
- Purchase the entire Manufacturing Department SoP package
    
     Price
    
    $360.00
    
     
    
     
    
       Quantity
 


 

 



 





## ![]() Marketing-Sales

- Feedback Procedure
    
    Price
    
    $140.00
    
     
    
      Select Templates   Procedure with templates 
    
      Procedure Only 
    
    
    
     
    
    
    
     
    
       Quantity
- Complaint Handling Procedure
    
    Price
    
    $160.00
    
     
    
      Select Templates   Procedure with templates 
    
      Procedure Only 
    
    
    
     
    
    
    
     
    
       Quantity
- Purchase the entire Marketing-Sales Department SoP package
    
     Price
    
    $300.00
    
     
    
     
    
       Quantity
 


 

 



 





## ![]() Purchase

- Purchasing Procedure 
    
    Price
    
    $220.00
    
     
    
      Select Templates   Procedure with templates 
    
      Procedure Only 
    
    
    
     
    
    
    
     
    
       Quantity
- Purchase the entire Purchase Department SoP package
    
     Price
    
    $220.00
    
     
    
     
    
       Quantity
 


 

 



 





## ![]() Quality Assurance

- Quality Policy
    
    Price
    
    $40.00
    
     
    
      Select Templates   Procedure Only 
    
    
    
     
    
    
    
     
    
       Quantity
- Quality Manual
    
    Price
    
    $150.00
    
     
    
      Select Templates   Procedure Only 
    
    
    
     
    
    
    
     
    
       Quantity
- Quality Objectives
    
    Price
    
    $20.00
    
     
    
      Select Templates   Procedure Only 
    
    
    
     
    
    
    
     
    
       Quantity
- ​Corrective Action &amp; Preventive Action Procedure
    
    Price
    
    $160.00
    
     
    
      Select Templates   Procedure with templates 
    
      Procedure Only 
    
    
    
     
    
    
    
     
    
       Quantity
- Data Analysis Procedure
    
    Price
    
    $100.00
    
     
    
      Select Templates   Procedure with templates 
    
      Procedure Only 
    
    
    
     
    
    
    
     
    
       Quantity
- Management Review Procedure
    
    Price
    
    $140.00
    
     
    
      Select Templates   Procedure with templates 
    
      Procedure Only 
    
    
    
     
    
    
    
     
    
       Quantity
- Control of Records Procedure
    
    Price
    
    $100.00
    
     
    
      Select Templates   Procedure with templates 
    
      Procedure Only 
    
    
    
     
    
    
    
     
    
       Quantity
- Control of Documents Procedure
    
    Price
    
    $160.00
    
     
    
      Select Templates   Procedure with templates 
    
      Procedure Only 
    
    
    
     
    
    
    
     
    
       Quantity
- Procedure for Software Validation 
    
    Price
    
    $100.00
    
     
    
      Select Templates   Procedure Only 
    
    
    
     
    
    
    
     
    
       Quantity
- Change Control Procedure
    
    Price
    
    $140.00
    
     
    
      Select Templates   Procedure with templates 
    
      Procedure Only 
    
    
    
     
    
    
    
     
    
       Quantity
- Medical Device File Procedure
    
    Price
    
    $100.00
    
     
    
      Select Templates   Procedure with templates 
    
      Procedure Only 
    
    
    
     
    
    
    
     
    
       Quantity
- Purchase the entire Quality Assurance Department SoP package
    
     Price
    
    $1,210.00
    
     
    
     
    
       Quantity
 


 

 



 





## ![]() Regulatory

- ​Issuing Advisory Notice Procedure
    
    Price
    
    $120.00
    
     
    
      Select Templates   Procedure with templates 
    
      Procedure Only 
    
    
    
     
    
    
    
     
    
       Quantity
- Reporting to Regulatory Authorities Procedure as per US FDA
    
    Price
    
    $120.00
    
     
    
      Select Templates   Procedure with templates 
    
      Procedure Only 
    
    
    
     
    
    
    
     
    
       Quantity
- Purchase the entire Regulatory Department SoP package
    
     Price
    
    $240.00
    
     
    
     
    
       Quantity
 


 

 



 





## ![]() Risk management

- Risk Management Procedure
    
    Price
    
    $160.00
    
     
    
      Select Templates   Procedure with templates 
    
      Procedure Only 
    
    
    
     
    
    
    
     
    
       Quantity
- Purchase the entire Risk management Department SoP package
    
     Price
    
    $160.00
    
     
    
     
    
       Quantity
 


 

 



 





## ![]() Store

- Preservation of Products Procedure
    
    Price
    
    $100.00
    
     
    
      Select Templates   Procedure with templates 
    
      Procedure Only 
    
    
    
     
    
    
    
     
    
       Quantity
- All The Departmental Toolkits to Purchase the entire Freyr ISO 13485:2016 toolkit package
    
     Price
    
    $100.00
    
     
    
     
    
       Quantity
 


 

 



 





## ![]() Work Environment

- ​Monitoring &amp; Controlling of Work Environment Procedure 
    
    Price
    
    $120.00
    
     
    
      Select Templates   Procedure with templates 
    
      Procedure Only 
    
    
    
     
    
    
    
     
    
       Quantity
- Purchase the entire Environment Department SoP package
    
     Price
    
    $120.00
    
     
    
     
    
       Quantity
 


 

 



 











- Purchase the entire Freyr ISO 13485:2016 toolkit package
    
     Price
    
    $3,650.00
    
     
    
     
    
       Quantity
 


 

 



 







### Our experts will help you in

- ![]() Product specific procedural requirements
- ![]() Regional/Country specific QMS requirements to be incorporated in the procedures
- ![]() Drafting specific procedure required as per the role taken by your organization
- ![]() Integrating existing QMS with ISO 13485:2016 and vice versa

For more details [Contact us](javascript:void(0)) today!