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Product Tour: ISO 13485 Documentation Toolkits

ISO 13485 Documentation Toolkit

Our best-selling toolkit ensures you are able to conform to the leading Quality Management System standard for medical device industry: ISO 13485.

The toolkit combines documentation templates and checklists that demonstrate how to implement this standard through a step-by-step process. In addition, you can access help from our experts to keep you on the right path, ensuring a straight-forward journey to ISO 13485 certification.

If yours is a small company looking to implement a Quality Management System by applying the mandatory documents required by ISO 13485 requirements, as well as documenting the common non-mandatory procedures, then this is the perfect toolkit.

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ISO 13485 & ISO 14971 Premium Documentation Toolkit

Our leading toolkit provides you with everything necessary to implement ISO 13485 according to the newest 2016 revision, including documentation templates, comprehensive risk management and sterilization process documentation, and unlimited support from our experts.

Within this toolkit you have access to all the tools you need to comply with the requirements of the Quality Management System standard: ISO 13485:2016. Along with the essential documents of ISO 13485:2016, the Premium toolkit includes additional commonly used non-mandatory procedures as well as more in-depth procedure for risk management according to ISO 14971 and procedures for different risk assessment methodologies, such as PHA, HAZOP, FMEA and HACCP.

Also included in this toolkit is documentation specific to different sterilization processes. This covers additional sterilization procedures for a variety of sterilization methodologies, such as EtO, steam, dry heat, ionization and filtration sterilization methodology.

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This internal audit toolkit will help you conduct an internal audit of your Quality Management System according to the requirements established in the latest version of ISO 13485.

The toolkit contains all mandatory documents needed for the internal audit according to ISO 13485:2016, together with the internal audit procedure, internal audit checklist, and internal audit plan. With everything you need to guide you step by step through the internal audit process, you will be able to conduct an internal audit without hiring external expertise.

This toolkit is perfect for you if you want to focus on internal auditing only, and if you already have other Quality Management System documentation in place.

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You know well how it works. Developing new policies and procedures for each of your clients from scratch is time consuming. And the more work you need to do, the greater the possibility of missing something. Why not use well-structured templates of all the required documentation, developed by the experts, and focus on helping your clients to overcome their real problems with your experience?

Use unbranded ISO 13485 & ISO 14971 templates for your own clients
Use additional documents that will help you sell your consulting service
Expert support included – always provide the right answer to your client
No additional costs involved

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FAQs on buying the ISO 13485 Documentation Toolkits

When and how will I get the toolkit?

Immediately after the transaction is processed, you will receive an email with a download link. It could not be quicker or simpler.

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.

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 “DOWNLOAD FREE DEMO” button 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 13485 standard?

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

About 13485Academy

13485Academy is one of the Academies of Advisera specializes in helping organizations implement top international standards and frameworks such as EU GDPR, ISO 27001, ISO 9001, ISO 13485, ISO 14001, ISO 45001, IATF 16949, ISO/IEC 17025, AS9100, ISO 20000 and ITIL. Over the years, Advisera has become a global leader in the provision of web-based training and documentation developed by the leading experts.

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.



  • Advisera is Exemplar Global Certified TPECS Provider for the IS, QM, EM, TL and AU Competency Units.
  • ITIL® is a registered trade mark of AXELOS Limited. Used under licence of AXELOS Limited. All rights reserved.
  • DNV GL Business Assurance is one of the leading providers of accredited management systems certification.