Time and again, customers approach us with the question: How do we best organize our CE documentation in order to be prepared in the event of damage and to have the proverbial "good papers" when dealing with a regulatory authority or in a legal dispute??
For us, this is not an easy question to answer, because while every product usually goes through a CE process, the documents required can be highly individual and different. Because "machine is equal to machine" or "device is equal to device" is very rarely true.
Nevertheless, I have tried to find an answer to the question. At the same time, I would be very happy if you share with us and the readers of this blog your experience and perspective on this topic. Simply use the comment function at the bottom of this page to do so.
Scope of technical documentation clearly defined in the CE directives
Whether it's the Machinery Directive, the Low Voltage Directive or the EMC Directive, all directives require the compilation of so-called "technical documentation". These documents are intended to "prove" that the product complies with relevant regulations and standards. Must be able to be presented to market surveillance upon request. Within the EU, these documents must be kept for at least ten years.
Technical documentation includes u. a.:
- General Description
- Designs, production drawings
- Explanations for understanding the drawings and how the product works
- List of applied standards or parts from standards
- Results of the design calculations
- Test reports
- Risk assessment
But simply having these documents is by no means sufficient. It must also be conclusively recognizable how the standards were implemented. This is especially important if, for example, only parts from standards were implemented.
Already at first sight: "Hui!" or "Fie!"
Let's put ourselves in the shoes of officials in the market regulator's office and imagine being presented with a thrown-together hodgepodge of documents:
Documents lie scattered unsystematically in folders with no table of contents, date, or validity; documents, such as the risk assessment, are missing; standards referenced appear outdated ..
Immediately, inspectors become suspicious: does the manufacturer even have a functioning CE process in place? Reason enough to drill deeper.
5 Tips to have your paperwork complete and well sorted at your fingertips
- Implement a clean CE process – from standards research to risk assessment, conformity assessment, technical documentation and product monitoring.
- Set up a functioning standards management system: All relevant standards must be available and all departments in the company must always work with the latest version.
- Keep the technical documentation for your products up to date, and if you modify the products, pull the documentation so that it is 100 percent consistent with your products.
- Also put the risk assessment to the test for safety-related changes to adjust it.
- File all data in a comprehensible organized way, sorted systematically and consistently, labeled in a talking way.
Of course, setting up the CE process first involves some initial effort. I'd be happy to hear about your experience with building a CE process in the comments.