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Document management

This step in the process involves the creation, management, translation and downloading of your product documentation.

The revision controlled documents that CERTAIN automatically generates for you are as follows:

External documents

  • Declaration of Conformity (DoC) or Declaration of Incorporation (DoI)
  • Operating Instructions in accordance with EN ISO 20607:2019
  • Machine ID nameplate and CE marking ,

Internal documents

  • Risk Assessment in accordance with EN ISO 12100
  • Exclusion Statement - if applicable
  • List of selected relevant directives and/or regulations
  • List of selected relevant standards

CERTAIN's mission is to optimise the CE process for you as far as possible by automatically integrating all available project information into finished, rendered documents, requiring no further editing or formating.

1. Click on CE Documentation​

First, choose the product you want to work on from the product list.

Once in the project, on the right-hand side you can see the progress bar. The final step in the process is the preparation of the CE documentation.

2. The CERTAIN document manager​

This summary screen lists all available CE documents for the project, including revision and language translation information. The list remains empty until a complete set of documentation has been created for the project for the first time.

To select and review previous revisions, click the drop-down menu at the top and select the required revision from the list.

To open and review a specific document, click on the relevant document.

💡 Document control & revisions​

Whenever you update your product information, researched standards, risk assessment or operating instructions and wish to reissue your documentation, you need to regenerate, or “re-render”, a new controlled revision of your complete documentation portfolio. CERTAIN takes care of this automatically for you in the Document Manager.

3. Create a new revision of all documents​

To create a new set of documents click on "Create complete document revision set".

4. Document creation menu​

A preliminary menu will appear, listing the documents available for rendering and offering two options at the top.

Dry Run

If you wish to only review the documents to check their content and validity and to proof read them without creating a new official revision, click "Dry Run".

or

Official Document Revision

If you have reviewed all the documentation and wish to generate a new official revision, click "Official document revision".

Year of manufacture - To be displayed on the declaration (DoC)? Yes or no?

You can use this checkbox to indicate whether or not the date of manufacture/placing on the market should be included in the Declaration of Conformity (DoC).

Choosing the list of relevant harmonized standards for the declaration (Doc)

You can choose to list either all of your identified relevant harmonised standards or only the ones you consider to be the most important. Deselect any from the list that you wish to be omitted from the declaration.

If you've chosen Dry Run - click on " Create Documents " to continue.

5. Name the Revison​

If instead you've chosen "Official document revision" then enter your chosen revision number and add a description in the comments section.

The revision name may only contain letters, numbers, and the following characters:

  • Underline _
  • Quotation marks "
  • Full stop .
  • Colon :

No spaces are allowed in the revision name.

6. Choose the languages and standards to be listed.​

Select the additional languages into which you wish to translate your documentation. In this example:

  • Original language – English
  • Additional languages – French and Italian

Year of manufacture - To be displayed on the declaration (DoC)? Yes or no?

You can use this checkbox to indicate whether or not the date of manufacture/placing on the market should be included in the Declaration of Conformity (DoC).

Choosing the list of relevant harmonized standards for the declaration (Doc)

You can choose to list either all of your identified relevant harmonised standards or only the ones you consider to be the most important. Deselect any from the list that you wish to be omitted from the declaration.

When you are ready, click " Create Documents" .

💡 Information on multi-language operation​

For more detailed information about CERTAIN's multilingual functionality and capabilities, click on this additional WiKi link.

[https://dubble.so/guides/05060-multi-language-operation-v005-pcmwq88mlbxoy31bp09n](Multi-language operation)

7. The rendering process​

While rendering, the progress is displayed to provide an indication that the process is ongoing. Depending on the quantity of documentation and the number of selected languages, this may take a few minutes.

8. Document list​

Once rendering is complete, the list of documents are displayed with the revision name at the top. On the right the number of files and languages can be seen.

9. View or download the documents.​

By clicking on the arrow to the right of each listed document, the list of translation versions will open.

  • Click on the eye to view a preview the specific pdf document.
  • Click on the download button to download it directly.

10. Document Preview​

Depending on your browser and PDF viewer, the documents can be viewed, downloaded and, if necessary, printed.

If you identify any changes that need to be made, simply return to the relevant process step and revise the information accordingly. The example shown here is a Declaration of Conformity translated into Italian.

Review your documentation carefully and make sure that all important contact details, company information and designations are correct. Remember that these are legally binding declarations.

11. Your CE-marking and machine ID plate​

The preformatted machine ID plate with your CE-Marking , containing all the required information is now also ready for you to download from the document list.

Preview the plate it for completeness and accuracy too.

The resulting pdf can be used for final machine plate manufacture and printing.

And finally once the evaluation is complete and the mitigation measures implemented, the all important CE marking can be afixed to the machine.

💡 Affixing your CE Marking​

The requirements for the CE marking are set out in Articles 23 and 24 of the Machinery Regulation (EU) 2023/1230 and are subject to the general principles established in Article 30 of Regulation (EC) No 765/2008.

The CE marking must be affixed visibly, legibly and indelibly to the machinery or related product. It should therefore be positioned in a clearly visible location and should not be obscured by other machine components. Its size and positioning should ensure that it can be easily identified and read.

Where the CE marking and machine identification information are applied to a machine identification plate, the plate should be permanently and securely attached to the machinery. The method of attachment should be suitable for the machine and its foreseeable conditions of use and should ensure that the identification remains in place throughout the expected lifetime of the machine.

12. Exporting your final set of revised documents​

To export your final set of documentation click on "Download all documents"

13. Preparing ZIP Archive​

All documents will be compressed into a single ZIP file containing two subfolders.

The ZIP file must first be unpacke d before the documents can be viewed or used. The exact method for unpacking ZIP files depends on your operating system.

14. Extracting the zip file and saving the documents.​

In Windows, first locate your local Downloads folder and find the ZIP file. Right-click the file and select Extract All .

Once extracted, two folders will be displayed: one containing the internal documents and the other containing the external documents .

Copy, cut and paste, or move these documents to their final storage location. If necessary, rename the files to comply with your internal documentation requirements and processes.

15. Process completion​

With your key internal documentation, risk assessment, declarations and CE marking ready, you have completed the CERTAIN process steps.

You may revisit your products and projects at any time in the future. You can ammend any information, identify new risks and subsequent mitigating measures, check for newly ammended or released harmonized standards and regenerate a new set up updated documentation as and when you wish.

You may also replicate and ammend this project in future for subsequent similar machines or products.

Your product data and information remains accessible and safe at all times in the AWS cloud.

💡 Recap on your completed work..​

Lets briefly reflect on the steps you have taken and their importance for your machine CE Marking.

  • You have captured the key project stakeholder information including the legal company representative and logo, the authorised documentation representative, and the key project team members and their roles.
  • You have named your machine, understand its purpose, have summarized its key information and data including its intended application, forseeable misuse and have provided a graphic illustration of what the equipment looks like.
  • You understand and have documented the various boundaries and limits that apply to your product throughout its life including those physical, environmental and performance related.
  • You have validated through research that the Machinery Directive 2006-42 EG is infact applicable to your product and it requires a CE Marking.
  • You understand fully whether you are authorized to conduct a complete internal self assessment and issue the CE-Marking without external support from an official notified body, or if additional measures are infact required by legislation.
  • You have researched using the EU-Lex database which current harmonized standards may be relevant and have considered and applied them in the final design of your product.
  • You have carefully documented the possible hazards that may be associated with your equipment throughout its lifecycle. For each of these, you have evaluated the hazard potential and incorporated mitigating measures to reduce them to a level you deem acceptable. You have also documented any risidual risks in your product documentation.
  • Based on your risk assessment results, you have revalidated your legislation research and if needed you have updated your applicable standards list and applied them to your product.
  • You have produced your supporting operating manual in accordance with EN ISO 20607:2019
  • You have produced, rendered and downloaded final versions of your Risk Assessment, Declaration of Conformity and machine ID and CE-Marking plate.
  • You now have all your CE-Marking documentation together and have successfully completed the CE-Marking Process.

(v0.0.5)