ISO 13485:2016 Certification for Small Business

Everything a small business needs to become ISO 13485 certified


Use our Small Business Package to lead your company to ISO 13485 Certification with confidence!

Our All in One Documentation and Training Package is our most popular product – for good reason: It gives you everything you need to prepare for registration. But if you don’t plan to train your internal auditors, the Small Business Package is tailored especially for you. Some companies don’t need to train their internal auditors because

  • There are trained auditors on staff
  • They will be trained elsewhere
  • An outside consultant will perform the audits, at least for the first year
  • There are not enough employees to perform internal audits (NOTE: ISO 13485 does not allow someone to audit their own work)

With this ISO 13485 Small Business Package your end product will be a quality system that works for you and helps your company continually improve its processes and customer satisfaction.

  • Package has been used by companies across the globe since 2001
  • Has never failed an audit
  • Auditors love the efficient and effective design
  • Major OEM’s and Registrars recommend our product!

Save time:

  • The documented Quality Management System (QMS) is organized for you. You won’t have to face a blank page or figure out what is required. Quality Manual, Procedures & Forms are fully written and ready for you to customize. They contain guidance so you know what to edit and examples are provided.

Save money:

  • No need to hire consultants to develop your system or to train your employees.
  • Our training will teach you the requirements of the standard and how to implement them.
  • Train your employees in house. You can choose to train them yourself like a pro with the PowerPoint training complete with trainer’s guide and detailed speaker’s notes. Or, let your employees self-train with convenient online training.

No worries! Have a question along the way? Ask the experts anytime throughout your project. Use the product that has been successfully used by thousands of companies around the world.

  • All the documentation you need to document your QMS:
    • All documents are in MS Word format for ease of editing and provide text to address each requirement of the ISO 13485 Standard.
    • Required references to the recommended procedures and forms for your Quality Management System
    • Intuitive numbering system for easy Document Control
      • We’ve numbered the sections of the Quality Manual to correspond with the sections of the ISO 13485 Standard. Registrars LOVE this feature!
      • Procedure and Form numbers relate to the section in the Quality Manual.
  • Conveniently train employees in house with PowerPoint Training Presentation or Online Training.
  • Detailed “Understanding the Standard” online training prepares your project manager for implementation.
  • Gap Checklist gets you started on your project plan.
  • Set up your internal audit program with our detailed Internal Audit Checklist. We include both a Microsoft Word version and an Excel version so you can use whichever format is best for you. You will receive BOTH formats for one price. Also includes the Internal Audit Procedure, Forms and PowerPoint – all the tools you need to set up your audit program.
  • This is a downloadable product.

The Small Business Package includes everything else you need for certification:

  • Support Throughout Your Project
  • Complete QMS
    • 26 Procedures to cover every ISO 13485 requirement
    • 45 Forms & Attachments
    • Quality Manual
  • Training
    • Administrator function for online training to assign and track users for record keeping
    • Online Employee Training (10 people)
    • PowerPoint Training Materials
    • Requirement of ISO 13485 PowerPoint Training Package
  • Gap Checklist
  • Internal Audit Checklist
  • ISO 13485 Risk Analysis Worksheet
    • Risk Analysis Exercise
    • PowerPoint outlining the process

13485:2016 QMS Procedures and Forms Matrix

Product Details

Product Type: Digital

Price: $697.00

Compare Products

Which version is right for me?
  • Choose 13485:2016 to create a new 13485 Quality Management System
  • Choose 13485:2003 to 13485:2016 QMS to modify your existing 13485 QMS to meet the 13485:2016 requirements
  • Choose 13485:2016 FDA QMS Upgrade to develop an integrated management system that is 13485 and FDA compliant
  • Choose ISO 9001:2015 to 13485:2016 QMS Upgrade to modify your existing ISO 9001:2015 to meet the 13485:2016 requirements

If you plan to reconfigure your existing quality manual completely by yourself, you can use either of the Upgrade Instructions to create everything on your own. They will tell you where to make the changes but will NOT provide any procedure or form templates for the new requirements.

  Price Each ISO 13485:2016
Small Biz
ISO 13485:2016 FDA Small Biz ISO 13485:2003 to 2016 Small Biz ISO 13485:2016 / ISO 9001:2015 Combined Small Biz
Your Price  
13485:2016 Quality Manual
(not sold separately)
$100.00 N N  N  
13485:2016 / 9001:2015 Combined Quality Manual
(not sold separately)
$299.00       N
ISO 13485:2016 Procedures $400.00 26 27  26 24
ISO 13485:2016 Forms and Attachments $109.00 45 47  45 60
ISO 13485:2016 Flow Charts $109.00 23    23  
ISO 13485:2003 to 2016 Upgrade Instructions $299.00     N  
ISO 13485:2016 to FDA Upgrade Instructions $299.00   N    
ISO 13485:2016 Gap Analysis Checklist $49.00 N   N N
ISO 13485:2016 FDA Gap Analysis Checklist $69.00   N    
ISO 13485:2016 Employee PowerPoint Training $129.00 N N N N
Requirements of ISO 13485:2016 PowerPoint Training $149.00 N N  N N
ISO 13485:2016 Risk Management Exercise $39.00 N N  N N
ISO 13485:2016 Internal Audit Checklist $125.00 N    N N
ISO 13485:2016 FDA Internal Audit Checklist $125.00   N    
Support FREE N N  N N
Total Value   $1078 $1297 $1277  $1003
Package Discount   -381 -$600  -$580 -$306
Your Price