ISO 13485 Documentation Toolkit


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Vendor: ucstoolkitSKU: UCSTK13485documentsN/A
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What's Included in Our Toolkit?

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  • Ready to use documents.
  • All the required policies, manual, procedures and templates as per the requirements of ISO 13485:2019 Medical Devices - Quality Management System Standard.
  • 50+ template documents – including policies, procedures, manual, templates, and presentations.
  • ISO 13485:2019 standard.
  • Instructions to use.

Product Description


Product Type: Digital

File Type: MS Word File and MS Excel File

Number of documents: +50


UCS toolkit store offers readymade documents that covers the requirements of ISO standards, the documents are ready to be used by any organization by following the instructions of use. The documents are designed and created by professional consultants.

The documents do not require any further customization or edition, it is as per the ISO standards requirements and best practices in respect of design and process.

We provide continuous online support to all our clients and customers.


ISO 13485:2016 Documentation toolkit covers the following manual, policies, procedures, and templates:

  • QMS Manual
  • QMS Policy
  • Control Of Documents
  • Control Of Records
  • Management Review
  • Competence, Awareness & Training
  • Purchasing
  • Customer Satisfaction
  • Internal Auditing
  • Control Of Non-Conforming Product/Services
  • Corrective Action
  • Customer Related Process
  • Design & Development
  • Production And Service Provision
  • Control Of Monitoring & Measurement
  • Complaint Handling
  • Analysis Of Data
  • List Of Quality System Procedures
  • Complaints and Feedback
  • Human Resource
  • Internal Audit
  • Management Representative
  • Management Review Meeting
  • Purchase


Simply click “Buy now” to start the process. Once you have completed your payment, the toolkit will be available to download.

Please ensure to use a valid email address.

Custom Product Request

We can create any ISO documentation toolkit or training material as per your request from our expert team. Contact us and share your inquiry details. Our team will get in touch with you within 24 hours.

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ISO 13485 Documentation Toolkit