How Proemion Cut
EN 18031 Documentation
Time by 90% with
Z-CMS

Proemion's EN 18031 Compliance Journey

At the beginning of the year, our engineering teams at Proemion embarked on the challenging task of creating EN 18031 technical documentation for our products. Initially, we relied on an Excel-based template, which required frequent reworking and imposed a significant cognitive load on our engineers. We had to manage implicit dependencies between the Excel sheets while deeply understanding EN 18031 requirements and applying them to our product functionalities.

We soon realized that manually creating the documentation would pose a significant risk to our internal timelines. We knew Z-CMS would be the right solution immediately.

Ultimately, we made the pivotal decision to adopt Z-CMS for our technical documentation needs. This transition enabled us to create entirely new documentation within just 2-3 person-weeks, allowing us to approach the Notified Body assessment with newfound confidence.

What Proemion Loved About Z-CMS

• Intuitive Questionnaire: The structured approach made documentation straightforward and efficient

• Centralized Updates: Changes could be made easily and reflected throughout the documentation, reducing the risk of errors

• Visual Monitoring: The dashboard allowed for real-time tracking of documentation progress and compliance status

Before and After: Manual Approach vs Z-CMS Approach

Documentation in a Questionnaire-Style Approach

Pain Point

Applying the EN 18031 standard and trying to fill out the Excel sheet to provide the right information and justification was both difficult and time consuming. There was always uncertainty about whether the provided information was sufficient, which cells needed to be filled out, under what conditions, and how items linked to others in later pages of the Excel sheet.

Discussing these issues with the team was challenging since everyone needed to be familiar with the standard to participate meaningfully in conversations. Even then, it was hard to be sure if we were on the right track with the information we were trying to document.

Solution

By using the questionnaire format of Z-CMS, we could focus on answering specific questions. While having the EN 18031 standard at hand was still necessary for deeper context, the questionnaire structure of Z-CMS guided us to the exact sections we needed to reference.

Answering one question at a time provided a clearer picture of how information linked together. If we encountered questions we couldn't answer, we could use the questions and relevant snippets from the standard to facilitate discussions with the team, eliminating the need for everyone to know the entire standard.

If we failed to meet a requirement, we had a better understanding of how to address it using the questions and snippets as acceptance criteria. Ultimately, we could generate the documentation for the Notified Body with just the press of a button, producing a format that was accepted without discussion.

Creating Technical Documentation Quickly and Confidently

Pain Point

The manual documentation process was time-consuming and frustrating. The lack of structure, dependency management, and pass/fail overview caused numerous delays that could and should have been avoided. As a result, even after 6 months, our documentation was still incomplete. Even if we had managed to finish it, there would have been ongoing uncertainty regarding the sufficiency and accuracy of the information.

Solution

With Z-CMS, we decided to start our documentation from scratch, entering the information directly into the software. This process took only about 2-3 person-weeks, resulting in a remarkable 90% time savings.

By that point, we had already familiarized ourselves with the EN18031-1 standard. While this knowledge may have expedited the process, the effort required for Z-CMS was still minimal.

With Z-CMS, we gained confidence in the quality of the technical documentation generated. The software made it easy for us to verify that we had answered the questions correctly and that the relationships between relevant EN 18031 items had been accurately mapped. A final review of the automatically generated Excel sheet from Z-CMS confirmed this. The documentation produced by Z-CMS was much more detailed and complete than what we had created manually over those 6 months.

As a result, we experienced significantly fewer problems or discussions when talking with the Notified Body.

Updating the Technical Documentation is Easy

Pain Point

Manually editing an Excel sheet felt like playing with fire. Even with links set up between cells on different pages, the process was prone to errors. It was easy to overlook a section of the document, accidentally edit or delete it, or fail to account for dependencies between sections. During the lab evaluation phase, we frequently received questions that required us to make updates to the Excel sheet as quickly as possible to unblock the process. Making these changes was always a delicate task.

Solution

With Z-CMS, this issue is much better solved. If changes are necessary, we only need to locate them in Z-CMS and adjust them according to the requirements. The tool ensures that these changes are applied consistently throughout the final document. When we export the documentation, all updates are reflected accurately.

High-quality Automatically Generated Justifications

Pain Point

Providing justification was particularly challenging without Z-CMS. It was often unclear what information needed to be provided, and some of it had already been described elsewhere. Additionally, it was uncertain how detailed an answer should have been.

Solution

Z-CMS automatically generates justifications based on the answers we provide, which simplifies the process. While we can overwrite these justifications manually in the tool if necessary, we found the automatically generated justifications to be effective and satisfactory in most cases.

Test Plan Generation

Since we rely on a third-party laboratory to test our products in accordance with EN 18031-1, the test plan document has not received much attention thus far. We typically generated it and provided it to the Notified Body as an “additional document.” However, in situations where we may need to conduct our own internal tests, we have already determined that the test plan provides a solid foundation for conducting a self-assessment. It effectively covers the same points that the current Notified Body utilizes, making it a standard-aligned document for our internal processes.

Extending Z-CMS to Other Products

We plan to continue using Z-CMS and expand its application to more products in the future. Z-CMS includes features for sharing information that has already been created for other products, which saves us even more time.

This capability is expected to facilitate the easy transfer of identical information across all our products, allowing us to scale efficiently. By leveraging Z-CMS, Proemion can ensure consistency in our documentation and testing processes, ultimately enhancing compliance efforts, product quality and customer trust.