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ISO 13485 Documentation Toolkit

The easy and cost-effective route to ISO 13485 implementation

With our ISO 13485 Documentation Toolkit, that is compliant with ISO 13485:2016 you can quickly implement the standard all by yourself. The process is easy to understand, and we support you all the way through, allowing you to realize savings of 90% compared to the cost of paying a consultant.


Get all the help and support you need for your project

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+1 (646) 759 9933


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Pricing & options


Ask any question you like, and never be left alone in the implementation. Our guarantee – we will answer all of your questions within 1 business day. You can ask us as many questions as you like – there is no limit, ever.

Included in your purchase of the ISO 13485 Toolkit is a free, one-on-one consultation with one of our resident experts. You’ll speak online in real time via Skype or GoToMeeting, at a time that’s convenient for you. Learn how to start, get your questions answered, and find out what comes next in your project.

After completing three documents yourself, we’ll review them for free and give you our comments on what you need to improve to make them compliant with the standards. In any case, you can always count on us :)

Toolkit Features

Price – US$ 799
Compliant with – ISO 13485:2016 revision
Documentation included – 76 templates 13485:2016 revision
Documentation language – English
Can documents be edited? – Yes. The documents are fully editable – just enter information specific to your company.
Included bonus – List of documents marking each document template as mandatory or optional.
Clear guidelines – Averaging 20 comments per document, templates provide clear direction on what to fill in – and how to do so.
Instant delivery – Toolkit is downloadable immediately upon purchase.
Free consultation – One live web conference with an expert is included, so that you can ask any questions you may have. In addition, you may submit any three completed documents for professional review.
Created for your business – Templates are optimized for small and medium-sized organizations.
Free upgrades – Updates are available for one full year after purchase.

Free preview of ALL documents in the ISO 13485 Documentation Toolkit before you buy

1. Get your free ISO 13485 documentation preview in under a minute.
2. Find out for yourself how clear and simple our documentation can be.
3. Discover the significant cost savings you can achieve by avoiding expensive consultants.
4. FREE BONUS: tips for handling ISO 13485 documentation.

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ISO 13485 Documentation Toolkit: Is it for you?

Designed for Small and Medium Businesses – Each of our ISO 13485 documentation templates is created and optimized specifically for small and medium-sized businesses, and gives you the information and guidance necessary for quick completion. Work for a larger company? Our templates are just as useful for you – you’ll just need a few additional documents. Click here to go to our Contact form, and request more information.
Our quality is international – Our documentation templates are available in a range of common languages. We ensure excellent quality and 100% accuracy of every single document template by utilizing only native speakers AND highly trained quality management experts when translating the documents into other languages.
Appropriate for any industry – Quality management is critical, regardless of the industry you’re in. With our document templates, combined with broad support from the 13485Academy, your business can reap the many benefits of ISO 13485 compliance.

Toolkit Documents

Below is a list of documents you’ll find in the toolkit – feel free to click each category to see which templates are included.

  1. Procedure for Document and Record ControlRead more
  2. List of Internal DocumentsRead more
  3. List of External DocumentsRead more
  4. List of Types of RecordsRead more
  5. Registry of Records for Detention/Central ArchiveRead more
  1. Quality PolicyRead more
  2. Quality ObjectivesRead more
  3. Quality ManualRead more
  1. Procedure for Human ResourcesRead more
  2. Training ProgramRead more
  3. Training RecordRead more
  4. Record of AttendanceRead more
  1. Procedure for Risk ManagementRead more
  2. Risk Management RecordRead more
  1. Sales ProcedureRead more
  2. Product Requirement Review RecordRead more
  1. Procedure for Customer Communication, Feedback and ComplaintsRead more
  2. Customer Feedback ReportRead more
  3. Registry of Customer ComplaintsRead more
  4. Registry of Reports to the AuthoritiesRead more
  1. Procedure for Design and DevelopmentRead more
  2. Design and Development FileRead more
  3. Project Plan and ReviewRead more
  4. Change Review RecordRead more
  5. Design Review MinutesRead more
  6. Design and Development verification and validation plansRead more
  7. Verification ReportRead more
  8. Validation ReportRead more
  9. Design and Development Transfer RecordRead more
  1. Procedure for Purchasing and Evaluation of SuppliersRead more
  2. Checklist for Evaluation of SuppliersRead more
  3. List of Approved SuppliersRead more
  4. Registry of Complaints about SuppliersRead more
  5. Request and Order for PurchasingRead more
  6. Purchasing Verification RecordRead more
  1. Procedure for Production and Service ProvisionRead more
  2. Product SpecificationRead more
  3. Record of Product/Service ConformanceRead more
  4. Quality PlanRead more
  5. Notification to a Customer about Changes on his PropertyRead more
  6. Record of Production Process ValidationRead more
  7. Record of TraceabilityRead more
  8. Record of Medical Device InstallationRead more
  9. Record of Servicing ActivitiesRead more
  1. Record of Warehousing Temperature ControlRead more
  2. Warehousing ProcedureRead more
  1. Procedure for Control of Non-Conforming ProductsRead more
  2. Non-Conforming Product RecordRead more
  3. Registry of Non-ConformitiesRead more
  4. Registry of Recalled / Withdrawn ProductsRead more
  1. Procedure for Equipment Maintenance and Measurement EquipmentRead more
  2. List of EquipmentRead more
  3. Plan for Preventive Maintenance of EquipmentRead more
  4. Maintenance and Calibration RecordRead more
  1. Procedure for Internal AuditRead more
  2. Internal Audit ChecklistRead more
  3. Internal Audit ProgramRead more
  4. Internal Audit ReportRead more
  5. Internal Audit PlanRead more
  1. Procedure for Management ReviewRead more
  2. Matrix of Key Performance IndicatorsRead more
  3. Management Review MinutesRead more
  1. Procedure for Infrastructure and Work EnvironmentRead more
  2. Record of Infrastructure MaintenanceRead more
  1. Procedure for Sterile Medical DevicesRead more
  2. Records for SterilizationRead more
  1. Procedure for Documentation and Validation of Computer SoftwareRead more
  2. Record of Software ValidationRead more
  1. Procedure for Adverse Event Investigation and ReportingRead more
  2. Investigation ReportRead more
  1. Procedure for Corrective and Preventive ActionRead more
  2. Corrective/Preventive Action RequestRead more
  3. Registry and Status of Corrective and Preventive ActionsRead more
  1. Procedure for Data AnalysisRead more
  2. Data Analysis ReportRead more


Features and benefits of
ISO 13485 Documentation Toolkit


Templates for every required document

Our documentation toolkit includes templates for every single document you need to comply with ISO 13485 – all fully acceptable for certification audit.

For a complete list of included documents, please click here.

We’ve done most of the work for you – documents are 90% complete

We have already filled in about 90% of the information for you. For most documents, you’ll just need to enter the particulars for your organization: business name, responsible parties, and any other information unique to your company. Each document guides you through the process, including comments on which elements are required, and which are optional.

We take the guesswork out of ISO 13485 documentation, so you can rest assured you’ve completed everything accurately and with the utmost efficiency.


Created by experts

13485Academy is known for its quality and accuracy, and you can rest easy knowing that each document in our toolkit has been written and double-checked by top ISO 13485 experts. Our templates are designed to make completion quick and easy, taking the frustration out of the implementation process.


Fully editable documents

Every document is available in either MS Word or MS Excel, making them a breeze to customize for your company. Maintain branding by adding company logos and colors, and edit headers and footers to match your preferred style.


Clearly organized, logical steps

Each document is ordered so that you can follow its sequence perfectly. By following each step in order, you make sure nothing is missed, and that no one gets lost in the process. Included flowcharts help employees understand each process to make quality management easier, and processes easier to follow.


Standardized formatting

Each document in the toolkit follows an identical structure and format to help you speed through completion efficiently and accurately. Further, to help you understand relationships between each document, we cross-reference all documents.

Created especially for Small and Medium Businesses

The ISO 13485 Documentation Toolkit was created specifically for Small and Medium Businesses and supplying companies to reduce the costs (in money and time) of implementation. With our toolkit, we don’t make you complete every document that a major multi-national corporation would need. Instead, our toolkit contains only the documents needed for YOUR business.

ISO 13485 Documentation Toolkit

Get all the help and support you need for your project

FAQs: Buying the ISO 13485 Documentation Toolkit

When and how will I get the toolkit?

Immediately after your payment is processed, you’ll receive an email that includes a link to download the templates. It’s quite simple.

What kinds of payment can you accept?

We take all major credit cards, PayPal payment, and we can accept a wire transfer from your bank account.

Are my payment details secure?

We proudly use Secure Socket Layer (SSL) technology, which is the industry standard. This technology encrypts your credit card information, keeping it secure, and sends it directly to the payment processor. We never store – or even see – your payment information.

Which currencies can I use?

We gladly accept more than 50 commonly used currencies, including the US Dollar, the Euro, the British Pound, and the Swiss Franc.

Do you offer a discount if I purchase the toolkit in multiple languages?

Yes! You can purchase a second toolkit in another language at 70% off.

I’m still not sure if this toolkit is right for my business. Can I try it out before I decide to buy?

Please do! Click on the “Free Preview” tab and enter your name and your email address. You can instantly access a free preview of each document template, helping you make up your mind. This is a great chance to see how each document looks, and how easy they are to complete.

Is the toolkit compliant with the newest changes in the ISO standard?

Yes. Also, you are entitled to receive free updates of those toolkits for one year after your purchase date.

Pricing & options for
ISO 13485 Documentation Toolkits

ISO 13485 Toolkit Free Preview
ISO 13485 Documentation Toolkit
Price (US$)
US$ 799
Included documentation
Number of documents
76 (preview)
76 full documents for ISO 13485:2016
All documents required by ISO 13485

(preview only)
Commonly used non-mandatory procedures and forms

(preview only)
Fully compliant with
ISO 13485:2016
ISO 13485:2016
Included support
Live consultation
1 hour
Unlimited support via email
Support via Expert Advice Community
Included review of
3 documents
Applicable for
Small companies (up to 50 employees)
Available product languages
ISO 13485 Toolkit Free Preview
Included documentation
76 (preview)
All documents required by ISO 13485 (preview only)
Commonly used non-mandatory procedures and forms (preview only)
Fully compliant with ISO 13485:2016
Included support
Support via Expert Advice Community
Available product languages
ISO 13485 Documentation Toolkit
US$ 799
Included documentation
76 full documents for ISO 13485:2016
All documents required by ISO 13485
Commonly used non-mandatory procedures and forms
Fully compliant with ISO 13485:2016
Included support
Live consultation 1 hour
Unlimited support via email
Support via Expert Advice Community
Included review of 3 documents
Applicable for
Small companies (up to 50 employees)
Available product languages

About 13485Academy


13485Academy is one of the Academies of Advisera specializes in helping organizations implement top international standards and frameworks such as ISO 27001, ISO 9001, ISO 13485, ISO 14001, OHSAS 18001, IATF 16949, AS9100, ISO 20000 and ITIL. Over the years, Advisera has become a global leader in the provision of web-based training and documentation for ISO 27001 (information security management) and ISO 22301 (business continuity management).

Our products are of best-in-class quality. With a proven performance record of successful implementations in more than 100 countries, our world-class customer support ensures success. Read more about the 13485Academy here.

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