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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.

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BONUS FEATURES

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, and CD copies are also available.
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 9001Academy, 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 Control [ISO 13485:2016]Read more
  2. List of Internal Documents [ISO 13485:2016]Read more
  3. List of External Documents [ISO 13485:2016]Read more
  4. List of Types of Records [ISO 13485:2016]Read more
  5. Registry of Records for Detention/Central Archive [ISO 13485:2016]Read more
  1. Quality Policy [ISO 13485:2016]Read more
  2. Quality Objectives [ISO 13485:2016]Read more
  3. Quality Manual [ISO 13485:2016]Read more
  1. Procedure for Human Resources [ISO 13485:2016]Read more
  2. Training Program [ISO 13485:2016]Read more
  3. Training Record [ISO 13485:2016]Read more
  4. Record of Attendance [ISO 13485:2016]Read more
  1. Procedure for Risk Management [ISO 13485:2016]Read more
  2. Risk Management Record [ISO 13485:2016]Read more
  1. Sales Procedure [ISO 13485:2016]Read more
  2. Product Requirement Review Record [ISO 13485:2016]Read more
  1. Procedure for Customer Communication, Feedback and Complaints [ISO 13485:2016]Read more
  2. Customer Feedback Report [ISO 13485:2016]Read more
  3. Registry of Customer Complaints [ISO 13485:2016]Read more
  4. Registry of Reports to the Authorities [ISO 13485:2016]Read more
  1. Procedure for Design and Development [ISO 13485:2016]Read more
  2. Design and Development File [ISO 13485:2016]Read more
  3. Project Plan and Review [ISO 13485:2016]Read more
  4. Change Review Record [ISO 13485:2016]Read more
  5. Design Review Minutes [ISO 13485:2016]Read more
  6. Design and Development verification and validation plans [ISO 13485:2016]Read more
  7. Verification Report [ISO 13485:2016]Read more
  8. Validation Report [ISO 13485:2016]Read more
  9. Design and Development Transfer Record [ISO 13485:2016]Read more
  1. Procedure for Purchasing and Evaluation of Suppliers [ISO 13485:2016]Read more
  2. Checklist for Evaluation of Suppliers [ISO 13485:2016]Read more
  3. List of Approved Suppliers [ISO 13485:2016]Read more
  4. Registry of Complaints about Suppliers [ISO 13485:2016]Read more
  5. Request and Order for Purchasing [ISO 13485:2016]Read more
  6. Purchasing Verification Record [ISO 13485:2016]Read more
  1. Procedure for Production and Service Provision [ISO 13485:2016]Read more
  2. Product Specification [ISO 13485:2016]Read more
  3. Record of Product/Service Conformance [ISO 13485:2016]Read more
  4. Quality Plan [ISO 13485:2016]Read more
  5. Notification to a Customer about Changes on his Property [ISO 13485:2016]Read more
  6. Record of Production Process Validation [ISO 13485:2016]Read more
  7. Record of Traceability [ISO 13485:2016]Read more
  8. Record of Medical Device Installation [ISO 13485:2016]Read more
  9. Record of Servicing Activities [ISO 13485:2016]Read more
  1. Record of Warehousing Temperature Control [ISO 13485:2016]Read more
  2. Warehousing Procedure [ISO 13485:2016]Read more
  1. Procedure for Control of Non-Conforming Products [ISO 13485:2016]Read more
  2. Non-Conforming Product Record [ISO 13485:2016]Read more
  3. Registry of Non-Conformities [ISO 13485:2016]Read more
  4. Registry of Recalled / Withdrawn Products [ISO 13485:2016]Read more
  1. Procedure for Equipment Maintenance and Measurement Equipment [ISO 13485:2016]Read more
  2. List of Equipment [ISO 13485:2016]Read more
  3. Plan for Preventive Maintenance of Equipment [ISO 13485:2016]Read more
  4. Maintenance and Calibration Record [ISO 13485:2016]Read more
  1. Procedure for Internal Audit [ISO 13485:2016]Read more
  2. Internal Audit Checklist [ISO 13485:2016]Read more
  3. Internal Audit Program [ISO 13485:2016]Read more
  4. Internal Audit Report [ISO 13485:2016]Read more
  5. Internal Audit Plan [ISO 13485:2016]Read more
  1. Procedure for Management Review [ISO 13485:2016]Read more
  2. Matrix of Key Performance Indicators [ISO 13485:2016]Read more
  3. Management Review Minutes [ISO 13485:2016]Read more
  1. Procedure for Infrastructure and Work Environment [ISO 13485:2016]Read more
  2. Record of Infrastructure Maintenance [ISO 13485:2016]Read more
  1. Procedure for Sterile Medical Devices [ISO 13485:2016]Read more
  2. Records for Sterilization [ISO 13485:2016]Read more
  1. Procedure for Documentation and Validation of Computer Software [ISO 13485:2016]Read more
  2. Record of Software Validation [ISO 13485:2016]Read more
  1. Procedure for Adverse Event Investigation and Reporting [ISO 13485:2016]Read more
  2. Investigation Report [ISO 13485:2016]Read more
  1. Procedure for Corrective and Preventive Action [ISO 13485:2016]Read more
  2. Corrective/Preventive Action Request [ISO 13485:2016]Read more
  3. Registry and Status of Corrective and Preventive Actions [ISO 13485:2016]Read more
  1. Procedure for Data Analysis [ISO 13485:2016]Read more
  2. Data Analysis Report [ISO 13485:2016]Read more

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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

9001Academy 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-sized businesses 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
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English, German, Spanish
English, German, Spanish, French, Italian, Chinese, Japanese
English, German, Spanish, French, Dutch, Italian, Chinese, Japanese, Serbian, Croatian, Portuguese (Brazilian)
English, German, Spanish, Italian
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All required ISO 9001 documents (preview only)
All required ISO 14001 documents (preview only)
Set of basic mandatory documents (preview only)
Extended set of internal audit documents (preview only)
Complete set of risk management documents (preview only)
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Additional production procedures for following industries: construction, food, manufacturing, software development, transportation, chemical, electrical and optical, machinery and equipment, metals, rubber and plastics, wholesale and retail (preview only)
FMEA risk assessment method (preview only)
Fully compliant with ISO 9001:2015 & ISO 14001:2015
Included support
Live consultation 30 minutes
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Available product languages
English, German, Spanish, French, Dutch, Italian, Chinese, Japanese, Serbian, Croatian, Portuguese (Brazilian)
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Startup plan
(For 12 months)
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4 full documents for ISO 9001:2015
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Access to Conformio platform
Startup plan
(For 12 months)
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Startup plan
(For 12 months)
Included support
Live consultation 30 minutes
Unlimited support via email
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Access to 1 documentation tutorial
Applicable for
Very small companies (up to 10 employees)
Available product languages
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Advanced plan
(For 12 months)
Included support
Live consultation 1 hour
Unlimited support via email
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Included review of 3 documents
Access to 12 documentation tutorials
Applicable for
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Fully compliant with ISO 9001:2015
ISO Compliance tool
Access to Conformio platform
Advanced plan
(For 12 months)
Included support
Live consultation 1 hour
Unlimited support via email
Support via Expert Advice Community
Included review of 3 documents
Access to 15 documentation tutorials
Applicable for
Small companies (up to 50 employees)
Available product languages
English, German, Spanish, French, Dutch, Italian, Chinese, Japanese, Serbian, Croatian, Portuguese (Brazilian)
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ISO 9001 Premium Documentation Toolkit
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SAVE 47%
Included documentation
76 full documents for ISO 9001:2015
All required ISO 9001 documents
Set of basic mandatory documents
Extended set of internal audit documents
Complete set of risk management documents
Commonly used non-mandatory procedures and forms
Additional production procedures for following industries: construction, food, manufacturing, software development, transportation, chemical, electrical and optical, machinery and equipment, metals, rubber and plastics, wholesale and retail
FMEA risk assessment method
Fully compliant with ISO 9001:2015
ISO Compliance tool
Access to Conformio platform
Advanced plan
(For 12 months)
Included support
Live consultation 2 hours
Unlimited support via email
Support via Expert Advice Community
Included review of 5 documents
Access to 15 documentation tutorials
Applicable for
Small and medium companies. Specially designed for certain industries.
Available product languages
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100 full documents for ISO 9001:2015 and ISO 14001:2015
All required ISO 9001 documents
All required ISO 14001 documents
Set of basic mandatory documents
Extended set of internal audit documents
Complete set of risk management documents
Commonly used non-mandatory procedures and forms
Additional production procedures for following industries: construction, food, manufacturing, software development, transportation, chemical, electrical and optical, machinery and equipment, metals, rubber and plastics, wholesale and retail
FMEA risk assessment method
Fully compliant with ISO 9001:2015 & ISO 14001:2015
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Access to Conformio platform
Professional plan
(For 12 months)
Included support
Live consultation 5 hours
Unlimited support via email
Support via Expert Advice Community
Included review of 15 documents
Access to 28 documentation tutorials
Applicable for
Small and medium companies. Specially designed for certain industries.
Available product languages
English, German, Spanish
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ISO 13485 Toolkit Free Preview
ISO 13485 Documentation Toolkit
Price (US$)
Free
US$ 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
English
English
ISO 13485 Toolkit Free Preview
Free
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
English
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
English
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Purpose
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Included documentation
Documentation can be used for your own company only
Number of documents 76
All required ISO 9001:2015 documents
Included support & training
Live consultation 2 hours
Unlimited support via email
Support via Expert Advice Community
Included review of 5 documents (total)
Consultant White Label Toolkit
Purpose
Implement ISO 9001 at your clients
Included documentation
Documentation can be used for your own company + for 10 of your clients
Number of documents 76
All required ISO 9001:2015 documents
White label templates
Division of tasks & time plan
Training presentation for ISO 9001
Sales presentation
Consulting proposal
Stakeholder mapping
Included support & training
Live consultation 6 hours (1 hour per month)
Unlimited support via email
Support via Expert Advice Community
Included review of 5 documents per month (for 6 months)
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Purpose
Sell your value-added services together with 9001Academy toolkits
Included documentation
Access to template previews only
Division of tasks & time plan
Training presentation for ISO 9001
Sales presentation
Consulting proposal
Stakeholder mapping
Included support & training
Live consultation 6 hours (1 hour per month)
Unlimited support via email
Support via Expert Advice Community
Included review of 5 documents per each client
Access to internal 9001Academy ISO 9001 Knowledgebase (free for first 6 months)
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