CALL US +44 1502 449001
CountryCountry

  • Optimized for small and medium-sized companies
  • Costs up to 80% less than using consultants
  • Expert consultations and unlimited email support available
  • Created by Advisera, the leading independent website for ISO standards

ISO 13485:2016 Documentation Toolkit

Implement ISO 13485 yourself, and do it easily and efficiently with our Documentation Toolkit.

TOOLKIT WITH LIVE EXPERT SUPPORT

Features:
  • 76 document templates – all documents required for ISO 13485 certification, plus commonly used non-mandatory documents
  • Unlimited email support
  • Expert review of a document
  • One hour of live one-on-one online consultations with an ISO 13485 expert
  • 12 months of free access to Conformio, the leading online compliance software

US$ 797*

*Note on VAT for customers from the European Union

100% secure online billing
AES-128bit SSL safe

How does expert support work?

  1. Our ISO 13485 expert will meet with you regularly – he will tell you where to start, what the next steps are, and how to resolve any issues you may face. You can meet via Skype, over the telephone, or through any other means at your convenience.
  2. Reach out to us at any time during your implementation project with unlimited email support, and have your questions answered within 24 hours by our experts.
  3. Once you complete your documents, let our experts review them – they’ll provide you with feedback and indicate what needs to be improved.

Here’s your ISO 13485 expert


Strahinja Stojanovic is an expert in Quality Management and ISO 13485. His wealth of experience has helped companies just like yours in their ISO 13485 implementation efforts.

He participated in implementation of this standard in more than 100 SMEs, through creation of documentation and performing in-house trainings for maintaining management system, internal audit and management review.


Strahinja Stojanovic
Lead ISO 13485 expert

Toolkit Features

Toolkit Documents

Look at EVERY template in the ISO 13485:2016 Documentation Toolkit – for free! – before making a purchase decision.

Note: Documents are available individually, or as part of the toolkit.
  1. Procedure for Document and Record Control PreviewDetails & purchase
  2. List of Internal Documents PreviewDetails & purchase
  3. List of External Documents PreviewDetails & purchase
  4. List of Types of Records PreviewDetails & purchase
  5. Registry of Records for Detention/Central Archive PreviewDetails & purchase
  1. Procedure for Human Resources PreviewDetails & purchase
  2. Training Program PreviewDetails & purchase
  3. Training Record PreviewDetails & purchase
  4. Record of Attendance PreviewDetails & purchase
  1. Procedure for Risk Management PreviewDetails & purchase
  2. Risk Management Record PreviewDetails & purchase
  1. Sales Procedure PreviewDetails & purchase
  2. Product Requirement Review Record PreviewDetails & purchase
  1. Procedure for Customer Communication, Feedback and Complaints PreviewDetails & purchase
  2. Customer Feedback Report PreviewDetails & purchase
  3. Registry of Customer Complaints PreviewDetails & purchase
  4. Registry of Reports to the Authorities PreviewDetails & purchase
  1. Procedure for Design and Development PreviewDetails & purchase
  2. Design and Development File PreviewDetails & purchase
  3. Project Plan and Review PreviewDetails & purchase
  4. Change Review Record PreviewDetails & purchase
  5. Design Review Minutes PreviewDetails & purchase
  6. Design and Development verification and validation plans PreviewDetails & purchase
  7. Verification Report PreviewDetails & purchase
  8. Validation Report PreviewDetails & purchase
  9. Design and Development Transfer Record PreviewDetails & purchase
  1. Procedure for Purchasing and Evaluation of Suppliers PreviewDetails & purchase
  2. Checklist for Evaluation of Suppliers PreviewDetails & purchase
  3. List of Approved Suppliers PreviewDetails & purchase
  4. Registry of Complaints about Suppliers PreviewDetails & purchase
  5. Request and Order for Purchasing PreviewDetails & purchase
  6. Purchasing Verification Record PreviewDetails & purchase
  1. Procedure for Production and Service Provision PreviewDetails & purchase
  2. Product Specification PreviewDetails & purchase
  3. Record of Product/Service Conformance PreviewDetails & purchase
  4. Quality Plan PreviewDetails & purchase
  5. Notification to a Customer about Changes on his Property PreviewDetails & purchase
  6. Record of Production Process Validation PreviewDetails & purchase
  7. Record of Traceability PreviewDetails & purchase
  8. Record of Medical Device Installation PreviewDetails & purchase
  9. Record of Servicing Activities PreviewDetails & purchase
  1. Record of Warehousing Temperature Control PreviewDetails & purchase
  2. Warehousing Procedure PreviewDetails & purchase
  1. Procedure for Control of Non-Conforming Products PreviewDetails & purchase
  2. Non-Conforming Product Record PreviewDetails & purchase
  3. Registry of Non-Conformities PreviewDetails & purchase
  4. Registry of Recalled / Withdrawn Products PreviewDetails & purchase
  1. Procedure for Equipment Maintenance and Measurement Equipment PreviewDetails & purchase
  2. List of Equipment PreviewDetails & purchase
  3. Plan for Preventive Maintenance of Equipment PreviewDetails & purchase
  4. Maintenance and Calibration Record PreviewDetails & purchase
  1. Procedure for Infrastructure and Work Environment PreviewDetails & purchase
  2. Record of Infrastructure Maintenance PreviewDetails & purchase
  1. Procedure for Sterile Medical Devices PreviewDetails & purchase
  2. Records for Sterilization PreviewDetails & purchase
  1. Procedure for Documentation and Validation of Computer Software PreviewDetails & purchase
  2. Record of Software Validation PreviewDetails & purchase
  1. Procedure for Adverse Event Investigation and Reporting PreviewDetails & purchase
  2. Investigation Report PreviewDetails & purchase
  1. Procedure for Internal Audit PreviewDetails & purchase
  2. Internal Audit Checklist PreviewDetails & purchase
  3. Internal Audit Program PreviewDetails & purchase
  4. Internal Audit Report PreviewDetails & purchase
  5. Internal Audit Plan PreviewDetails & purchase
  1. Procedure for Corrective and Preventive Action PreviewDetails & purchase
  2. Corrective/Preventive Action Request PreviewDetails & purchase
  3. Registry and Status of Corrective and Preventive Actions PreviewDetails & purchase
  1. Procedure for Data Analysis PreviewDetails & purchase
  2. Data Analysis Report PreviewDetails & purchase
  1. Procedure for Management Review PreviewDetails & purchase
  2. Matrix of Key Performance Indicators PreviewDetails & purchase
  3. Management Review Minutes PreviewDetails & purchase

Step-by-step guidance for your implementation

The toolkit documents are organized to guide you on your implementation path. They’re structured in clearly numbered folders, so that you know where to start, and – after each document is completed – where to go next.

80% complete – guidance for the remaining 20%

We’ve done 80% of the work a consultant would charge you for. Anything that can be prefilled in the documents is already done, and the remaining adaptation you need to do is clearly marked with comments and instructions.

Placeholders guide you where editing is needed

Simply move through the documents, filling in the specifics for your company as instructed. Our experts have even added some instructions on what to enter, to help you move through the implementation as efficiently as possible.

Additional instructions for more specific tasks

Completing some parts of a document might be a challenge for you if you’ve never done this before. In these cases, we’ve added detailed instructions and, where needed, links to articles that will help you understand and complete these sections.

Fully customizable documents

Most companies have a specific design and structure for their official documents. There’s header information, confidentiality level, even prescribed graphic design and fonts. All of our documents are fully customizable, so that you can make them look just the way they should.

All the support you need

ISO 13485 certification is much more than just documentation. The implementation of the standard needs to be appropriate to your company, and you need to deal with your employees, your management, and your existing processes in an appropriate way.

This is why our experts are on hand with live online support to answer any difficult questions – we can set up a call via Skype, over the telephone, or through any other method convenient for you; or, we can answer your questions via email – whatever suits you best.

Highlights and advantages of the ISO 13485:2016 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.

Ready for the certification audit

Companies in more than 100 countries have achieved certification with our documents.

  • Toolkit guides you through the implementation
  • Expert support throughout your project
  • Expert review of some of your completed documents
  • Pre-audit expert meeting to make sure everything is in place

ISO 13485:2016 Documentation Toolkit:

Right for your business?

Are you small or medium-sized company?
Are you looking to minimize time and cost of implementation?
Are you searching for concise and easy-to-use templates?
We understood your needs, found the answers to your questions, and developed ISO 13485:2016 Toolkit especially for your company. Our toolkit doesn’t require completion of every document that a large world-wide corporation needs. Instead, it includes only those documents YOUR business needs.

Download free demo

Need more support?

TOOLKIT WITH
LIVE EXPERT SUPPORT

US$ 797
76 document templates compliant with
ISO 13485:2016
Bonus: Access to Conformio for 12 months
Unlimited email support
1 hour of one-on-one support
with an ISO 13485 expert
Expert review of 1 completed document
 
 

TOOLKIT WITH
EXTENDED SUPPORT

US$ 1297
76 document templates compliant with
ISO 13485:2016
Bonus: Access to Conformio for 12 months
Unlimited email support
5 hours of one-on-one support (a series of online meetings with an ISO 13485 expert)
Expert review of 5 completed documents
 
 

POWER TOOLKIT
 

US$ 2297
76 document templates compliant with
ISO 13485:2016
Bonus: Access to Conformio for 12 months
Unlimited email support
15 hours of one-on-one support (a series of online meetings with an ISO 13485 expert)
Expert review of 15 completed documents
Pre-audit check workshop (1 hour training on audit preparation with leading ISO 13485 expert)

BONUS: 12-months of free access to Conformio, leading online software for ISO implementation (save 797 EUR)

When purchasing the ISO 13485 Documentation Toolkit you’ll gain the access to:

 

  • ISO modules included: Document Management System (DMS), Nonconformities and Corrective Actions.
  • Define all yours project tasks, and easily collaborate with up to 20 members of your ISO 13485 implementation team.

LEARN MORE ABOUT CONFORMIO

Can you really implement ISO 13485 by yourself?

Simple and secure payment and delivery

FAQs: Buying ISO 13485:2016 Documentation Toolkit

When and how will I get the toolkit?

We are delivering this toolkit through our Conformio document management system. After your payment is processed you will receive an e-mail with the access to your Conformio account.

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.

strahinja-iso-expert

Strahinja Stojanovic
Lead ISO 13485 expert

NOT SURE WHICH IS THE BEST OPTION FOR YOU?

Get free expert advice to better grow your business

SCHEDULE FREE CONSULTATION

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.

100% Secure Online Billing

 

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.

cards

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.