ISO 13485 Guide
This is a Guide for setting up and using the ISO 13485 Template Pack. We will cover installation, validation, and customisation of these Templates.
Last updated
This is a Guide for setting up and using the ISO 13485 Template Pack. We will cover installation, validation, and customisation of these Templates.
Last updated
The ISO 13485 Template Pack is an invaluable resource for organisations aiming to simplify the complexities of ISO 13485 compliance while ensuring robust quality management practices are in place.
Each template is fully customisable to align with your organisation's specific needs and includes detailed guidance on implementation.
You can view the details of the Template Pack here.
When the pack has been installed in your organisation, create a Tag labelled 'ISO 13485' and label all procedures and SOP's accordingly
This will help you organise your workspace
It might help to organise these further into a Saved View
To open our Copilot, click on the 'AI Co-Pilot' tab on the right hand side.
Enter the following prompt into the chat:
It might be helpful to give the Co-pilot some extra context or information about your organisation, processes, and necessary workflows. If you already have pre-existing Procedures or Documentation, Neil will be able to use this information when validating.
Neil, our AI-copilot will scan through your organisation, and check if your system is missing any necessary documentation or procedures for ISO-13485 compliance.
Sometimes your organisation may need specific Templates which are not in the pack.
This is because it is designed to meet the necessary key points for ISO-13485 compliance, whereas there may be extra section which are 'Optional' or 'Nice-to-have'.
You can look through the rest of our Template Library to see if you can find what you need. The AI Copilot should be able to suggest which are missing.
Otherwise, you may need to create them yourself. You can find our guides here about creating Documents, Steps, and Procedures.
The AI Co-Pilot in the right-hand sidebar is able to offer you guidance on how the structure or SOP's or workflows should look, with detailed field instructions.
Once all templates are created, you will need to personalise them to your organisation's needs.
Our Templates provide a framework for how these 'should' look, but every organisation will be different!
Be sure to constantly ask the Co-Pilot to check and validate compliance, as well as guide you through creating custom workflows. You can chat to the it at any time in the sidebar.
If you are having trouble adding and creating Fields, and Connections, check out our Help Documentation!
Once finished, you can publish and send your documents and workflows to members in your team for Training. This ensures all your personnel are up-to-date on necessary regulations.
Training progress can easily be monitored in the 'Training' tab on the left sidebar.
See Documentation for Training here
Ensure you regularly re-validate your system by consulting the AI Co-Pilot with the same prompt seen in Step 2.
Be sure to constantly review your compliance with ISO 13485. A good thing to do would be to set up Review Dates where your QA Managers can re-validate your system to ensure your organisation stays up-to-date with all updates and new guidelines!
If you want to give us any feedback on how we can improve our Guides or Templates, please feel free to contact us - we would love to hear it!
For more info on Seal, check out our website
To see more Templates, take a look at the Template Library
Document Control
Procedures for creating, approving, distributing, and maintaining controlled documents.
Risk Management
Templates for risk assessment, mitigation, and management throughout the product lifecycle.
Design and Development
Documentation to support compliant product design, verification, and validation processes.
Supplier Management
SOPs and Procedures for qualifying, auditing, and monitoring suppliers and vendors.
Production and Process Control
Guidelines for process validation, production monitoring, and quality assurance.
Non-Conformance and CAPA
Forms and workflows for managing non-conformities, root cause analysis, and corrective and preventive actions.
Complaint Handling and Post-Market Surveillance
Tools for logging, investigating, and resolving complaints, and ensuring effective post-market activities.
Internal Audits
Comprehensive internal audit checklists and reporting templates to assess compliance and identify areas for improvement.
Training and Competency
Documentation to track staff training, qualifications, and competency assessments.
Equipment and Calibration
Procedures for equipment maintenance, calibration, and validation.
Traceability and Labelling
Guidelines for product identification, labelling, and traceability throughout the supply chain.
Emergency Procedures
SOPs and Procedures for handling emergencies, incidents, and recalls.