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Audit checklist EN 62366-1:2015/A1:2020

Audit checklist EN 62366-1:2015/A1:2020

$47.00 USD
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Audit checklist EN 62366-1:2015/A1:2020
  • Audit checklist EN 62366-1:2015/A1:2020
  • Audit checklist EN 62366-1:2015/A1:2020
  • Audit checklist EN 62366-1:2015/A1:2020
  • Audit checklist EN 62366-1:2015/A1:2020
  • Audit checklist EN 62366-1:2015/A1:2020
  • Audit checklist EN 62366-1:2015/A1:2020
Audit checklist EN 62366-1:2015/A1:2020

Audit checklist EN 62366-1:2015/A1:2020

$47.00 USD
Taxes included. Shipping calculated at checkout.

A comprehensive, structured, and immediately usable audit grid to assess the compliance of your usability engineering process according to standard EN 62366-1:2015/A1:2020.

Identify your gaps, track your corrective actions, and visualize your level of compliance with an automatic synthesis and ready-to-use charts.

Ready-to-use structure to save time

Designed by usability experts

Practical Advice and Integrated Examples

Detailed Description

This audit grid was designed to allow you to effectively assess your compliance with the usability engineering process described in standard EN 62366-1:2015/A1:2020.

It includes, clause by clause, all the normative requirements to be checked and offers an operational structure for documenting your evidence, gaps, and action plans.

The grid also includes an automatic synthesis:

  • Compliance rate per clause,
  • Breakdown into compliant / partially compliant / non-compliant,
  • Graphs for internal review or external audit,
  • Overall status for each requirement.

An action tracking tab allows you to organize your remediation plan: priorities, responsible parties, deadlines, comments. This gives you a complete tool to manage your usability compliance.

Designed by specialists who have supported more than 50 manufacturers in their usability processes, this grid combines normative rigor, readability, and pragmatism.

A 15-minute video conference with one of our experts is included for getting started with the model: understanding its structure, color codes, and filling logic.
(This session does not include specific advice or support for the device.)
Template content

This template includes the following sections:

  1. Tutorial
  2. Traceability
  3. Definitions: key definitions from standard EN 62366-1 to avoid any misinterpretation
  4. Documentation: list of mandatory or recommended documents (EN 62366-1 & IEC TR 62366-2)
  5. Audit
  6. Synthesis
  7. Follow-up actions
Why choose this template

  • Save several days of work thanks to a ready-to-use and standard-compliant structure.
  • Identify your gaps quickly, visually, and actionably.
  • Effectively prepare your internal audits or compliance reviews.
  • Get a clear view of your process maturity thanks to automatic synthesis.
  • Structure your corrective action plan with integrated follow-up.
  • Ensure robust traceability and a comprehensive overview of compliance with EN 62366-1 requirements for MDR/IVDR regulations.
  • Benefit from a proven framework, designed by usability experts.
  • Enjoy a 15-minute video conference with an expert to quickly master the logic of the model and gain autonomy.
Technical Specifications

Format
  • XLSX

Number of pages / tabs

8

File size

96 KB

Compatibility
  • Microsoft Excel
  • Google Sheets (advanced Excel features recommended)

Language

English

License Type

Internal use only

Delivery

Immediate download after payment

Updates

Included for 12 months
License and Terms of Use

This template is copyrighted and intended for internal use only. Any reproduction, resale, distribution, or adaptation for commercial purposes is strictly prohibited without prior authorization from Aptenys™.

This template is sold as methodological support but does not alone guarantee regulatory compliance.

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Frequently Asked Questions

Do the templates ensure regulatory compliance?

The templates are designed based on regulatory requirements and expected audit practices.
They provide a solid and structured foundation, to be adapted to your system, risks, and usage context to ensure final compliance.
May I use a template for a client, resell it, or share it?

No. The license only permits internal use. Any use for third parties, external sharing, or resale is prohibited without written agreement.
Can I modify the templates?

Yes. The templates are provided in fully editable formats, so you can freely adjust them to your organization, processes, and systems.
Are templates accepted in an audit?

Yes, when properly adapted and integrated into your documentation.
They reflect the expectations observed during audits and provide a clear methodological framework. As with any regulatory document, their acceptance depends on the overall consistency of your documentation and the regulatory context of your device.
Do you offer additional support?

Yes. Usarea's teams can assist you in addition to the templates, whether it's for your usability approach, design, or user research.

You can contact us at contact@usarea.fr to discuss your needs.