This article was originally published on INSTRKTIV.com
Are you writing user manuals, are you importing products into the EU or are you in any other way involved in placing products in the European market? There is a good chance that you will have to deal with a declaration of conformity, the last step in the process towards CE-Marking.
Today, I am going to show you how to draw up a fully compliant Declaration of Conformity.
And… after reading this post, you will be able to do this all by yourself.
Just follow the steps of my Declaration-of-Conformity-Template-Method and use the templates and examples I have provided in this post.
Caution! This method does by no means replace the process of CE-Marking. It only supports in the last step of this process: drawing up the declaration of conformity. Always consult our CE-Expert for full guidance.
Drawing up a Declaration of Conformity
Whether you are importing or manufacturing products, exporting to the EU, are working on the R & D department of any company or are an entrepreneur, safety expert, technical writer, QA manager, translator, the chances are good that you will have to deal with a declaration of conformity (DoC).
These legal documents need to be integrated into the user manual, or need to be included with the product you (or your company) sell, or in the technical file.
Someone has to draw up the declaration of conformity. And if there is no official safety expert, the company often relies on the technical author or product engineer. And if there is no technical writer or product engineer you might be responsible for it yourself!
Do you struggle with drawing up a compliant declaration of conformity? Read on to learn how to create a compliant declaration of conformity for your specific product.
Origin of the Declaration-of-Conformity-Template-Method
Having an Industrial Design Engineering background and being involved in both product development and technical writing, I have always been interested in CE-marking. That’s why I got more and more involved in the CE-marking process, risk analysis, technical files and compiling declaration of conformities.
Before I used the method that I describe in this post, I spent ages on the internet, finding the right information on what to include and what not. And at the end I still wasn’t sure!
That’s why I structured this way of working and ‘developed’ the Declaration-of-Conformity-Template-Method.
By using the method
It is very clear what information should be included in the EU-Declaration of Conformity for a certain product.
I always have a good example of a declaration of conformity for my product group.
And the best part? You can do exactly the same! The only thing you need to do is to follow the steps as described below. It is a method that includes good examples and templates for each product group that requires a declaration of conformity. So if you want to draw up compliant declaration of conformities, keep on reading!
Let’s break it down into actionable steps.
Just 4 steps bring you to a compliant declaration of conformity!
There are just 4 steps that make up the Declaration-of-Conformity-Template-Method.
Go to the EU site. Select your product group(s).
Find all the information about the declaration of conformity in the directive you need
Download the correct template(s) and draw up your declaration of conformity
Check if you have met all the requirements
Caution! This method does by no means replace the process of CE-Marking. It only supports in the last step of this process: drawing up the declaration of conformity. Always consult our CE-Expert for full guidance.There are 25 product groups that require CE-marking and thus a Declaration of Conformity*.
If you have a product that fits into one of those product groups, then you have to draw up a declaration of conformity.
Many products need to comply with more than one directive. If this is the case for your product, all steps described below need to be performed for each applicable directive.
The requirements for the contents of the declaration of conformity can mostly also be found in the applicable directive. Most directives have their own specifications regarding the declaration of conformity and very few directives have exactly the same requirements.
Sometimes you will not find any requirements in a directive (e.g. the Directive 90/385/EEC on Active Implantable Medical Devices does not give any requirements). For those directives the harmonised standard EN-ISO/IEC 17050-1:2014 Supplier’s declaration of conformity — Part 1: General requirementscan be used. Because, above all, compliance with harmonised standards provides a presumption of conformity with the directive.
But if a directive has its own specific requirements, like the Machinery Directive or the Radio Equipment Directive, the EN-ISO/IEC 17050-1:2014 can be used as a basis, but it should be enhanced or modified according to the additional requirements as set out in the directive.
Another thing to be aware of is that directives change now and again. And if they change, there is a big chance that the requirements of the declaration of conformity change as well.
Now don’t be afraid! I have done all the hard work for you. But because it is your product you’re dealing with (and legally you are liable for it), I would like you to also have a close look yourself. This will be done in step 2.
To find the directives that apply to your product:
- Go to the website of the European Commission.
- From the drop-down menu choose the product group that applies to your product.
– Information about the product group is displayed below.
- Click on the link to open the directive.
– A page with links to the different languages and formats of the directive opens.|
- Select your language and format (e.g. English and pdf).
– The directive opens
To find all requirements and other relevant information:
- Press ctrl+f and type declaration of conformity
-> the number of hits is shown.
Note: for construction products you should type declaration of performance. For partly completed machinery you should type declaration of incorporation.
- Create a table with two columns in a document or spreadsheet.
- Copy/paste in the left column the number of the article and in the right column the text which contains “declaration of conformity”. Read the text carefully. Copy/paste all other hits to the table.
|DIRECTIVE 2014/28/EU – explosives for civil uses|
|24||To ensure effective access to information for market surveillance purposes, the information required to identify all applicable Union acts should be available in a single EU declaration of conformity. In order to reduce the administrative burden on economic operators, that single EU declaration of conformity may be a dossier made up of relevant individual declarations of conformity.|
|Article 5.2||Where compliance of an explosive with the applicable requirements has been demonstrated by that procedure, manufacturers shall draw up an EU declaration of conformity and affix the CE-marking.|
You have now created an overview of all relevant information regarding the declaration of conformity. Next to the specific requirements on the content, this can also be information about the requirements whether to translate the declaration of conformity or not, to deliver the declaration of conformity with the product, or to draw up a single declaration of conformity for all applicable directives.Now you are aware of the requirements, it’s time to draw up the declaration of conformity for your
In order to do so:
- Scroll down to the bottom of this page.
- Download the correct template(s).
- Draw up your own declaration of conformity, based on the template provided
Now you have created your declaration of conformity that meets all content requirements, it is time to check the other requirements. For this, the document you created in step #2 can be used as a checklist.
Check the document for other important information about translating the declaration of conformity, the medium to be used et cetera.