Country- Documentation
See our product tour or contact our main ISO 13485:2016 expert who is here to assist you in your implementation.
- Books
PREPARING FOR ISO CERTIFICATION AUDIT: A PLAIN ENGLISH GUIDE
In this book Dejan Kosutic, an author and experienced ISO consultant, is giving away his practical know-how on preparing for ISO certification audits. No matter if you are new or experienced in the field, this book gives you everything you will ever need to learn more about certification audits.
Managing ISO Documentation: A Plain English Guide
In this book Dejan Kosutic, an author and experienced ISO consultant, is giving away his practical know-how on managing documentation. No matter if you are new or experienced in the field, this book gives you everything you will ever need to learn on how to handle ISO documents.
Preparations for the ISO Implementation Project: A Plain English Guide
In this book Dejan Kosutic, an author and experienced ISO consultant, is giving away his practical know-how on preparing for ISO implementation. No matter if you are new or experienced in the field, this book gives you everything you will ever need to learn about preparations for ISO implementation projects.
ISO Internal Audit: A Plain English Guide
In this book Dejan Kosutic, an author and experienced ISO consultant, is giving away his practical know-how on ISO internal audits. No matter if you are new or experienced in the field, this book gives you everything you will ever need to learn and more about internal audits.
Pricing & options for ISO 13485 documentation toolkits
FOR IMPLEMENTATION OF PARTS OF THE STANDARD
FOR IMPLEMENTING A FULL STANDARD
ISO 13485:2016 Internal Audit Toolkit
ISO 13485:2016 Documentation Toolkit
ISO 13485 & ISO 14971 Premium Documentation Toolkit
Price (US$)
US$ 97
US$ 797
US$ 997
Number of documents
5 documents
76 documents
91 documents
All documents required by ISO 13485
Extended set of internal audit documents
Commonly used non-mandatory procedures and forms
Fully compliant with
ISO 13485:2016
ISO 13485:2016
ISO 13485:2016
ISO 14971:2012
ISO 14971:2012
Additional procedures for risk management: Procedure for Risk Management (according to ISO 14971); Procedure for Preliminary Hazard Analysis (PHA); Procedure for FMEA Risk Assessment; Procedure for Hazard and Operability Study (HAZOP); Procedure for Hazard Analysis and Critical Control Points (HACCP)
Additional procedures for sterilization process: Procedure for EtO Sterilization; Procedure for Dry Heat Sterilization; Procedure for Ionizing Radiation Sterilization; Procedure for Filtration Sterilization;
Free access to Conformio compliance platform
3 months
12 months
12 months
FOR IMPLEMENTATION
OF PARTS OF THE STANDARD
ISO 13485:2016 Internal Audit Toolkit
US$ 97
5 documents
Extended set of internal audit documents
Fully compliant with ISO 13485:2016
3 months of free access to Conformio compliance platform
Available product languages
English
English
FOR IMPLEMENTING A FULL STANDARD
ISO 13485:2016 Documentation Toolkit
US$ 797
76 documents
All documents required by ISO 13485
Commonly used non-mandatory procedures and forms
Fully compliant with ISO 13485:2016
12 months of free access to Conformio compliance platform
Available product languages
English
English
FOR IMPLEMENTING A FULL STANDARD
ISO 13485 & ISO 14971 Premium Documentation Toolkit
US$ 997
91 documents
All documents required by ISO 13485
Commonly used non-mandatory procedures and forms
Fully compliant with ISO 13485:2016 &
ISO 14971:2012
Additional procedures for risk management: Procedure for Risk Management (according to ISO 14971); Procedure for Preliminary Hazard Analysis (PHA); Procedure for FMEA Risk Assessment; Procedure for Hazard and Operability Study (HAZOP); Procedure for Hazard Analysis and Critical Control Points (HACCP)
Additional procedures for sterilization process: Procedure for EtO Sterilization; Procedure for Dry Heat Sterilization; Procedure for Ionizing Radiation Sterilization; Procedure for Filtration Sterilization;
12 months of free access to Conformio compliance platform
Available product languages
English
English
ISO 13485 & ISO 14971 Premium
Documentation Toolkit
Documentation Toolkit
Consultant White Label Toolkit
Documentation can be used
for your company only
for your own company + for 10 of your clients
Number of documents
91 documents
91 documents
All required ISO 13485:2016 documents
Additional procedures for risk management
Additional procedures for sterilization process
White label templates
Division of tasks & time plan
Sales presentation
Consulting proposal
Stakeholder mapping
ISO 13485 & ISO 14971 Premium Documentation Toolkit
US$ 997
Documentation can be used for your company only
91 full documents
All required ISO 13485:2016 documents
Additional procedures for risk management
Additional procedures for sterilization process
Consultant White Label Toolkit
Documentation can be used for your own company + for 10 of your clients
91 full documents
All required ISO 13485:2016 documents
Additional procedures for risk management
Additional procedures for sterilization process
White label templates
Division of tasks & time plan
Sales presentation
Consulting proposal
Stakeholder mapping
Click on “Download Free Toolkit Preview”, submit your name and email address, and you’ll have access to a free preview of our ISO 13485 toolkit documents. Before you make a decision to buy, these previews will let you see how the templates look, and how simple they are to complete.
Strahinja Stojanovic
Lead ISO 13485 expert
NOT SURE WHICH IS THE BEST OPTION FOR YOU?
Get free expert help with your ISO 13485 implementation
SCHEDULE FREE CONSULTATIONFAQs: Buying 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.
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.
About 13485Academy
13485Academy is one of the Academies of Advisera.com. 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, 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.
We use Secure Socket Layer (SSL) technology, the industry standard and among the best available today for secure online commerce transactions. All of your personal information, including credit card number, name, and address is encrypted so it cannot be read during transmission. You are protected by your credit card company in the case of a fraudulent transaction with any purchase.
AES-128bit SSL safe Privacy Policy
Online payment services are provided by BlueSnap and 2Checkout.
OUR CLIENTS
OUR PARTNERS
- 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.