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Document management

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

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

  • The Risk Assessment in accordance with EN ISO 12100
  • The Declaration of Conformity (DoC) or Declaration of Incorporation (DoI) or exclusion document in accordance with the applicable directive or regulation.
  • The Machine ID plate and CE marking ,
  • The Operating Instructions in accordance with EN ISO 20607:2019

CERTAIN's mission is to simplify this process for you as far as possible by automatically integrating your product, company, team, risk, and standards research information into finished, rendered documents, requiring no further editing or formating. Your Company logo and product images are also automatically embedded.

1. Click on CE Documentation​

Retrieve the product to be worked on from the product list. On the right side you can see the progess bar. The final step in the process is the preparation of the final CE documentation.

2. The CERTAIN document manager​

This summary screen lists the available CE Documents and information regarding their usage, readiness, revision and status.

With a single click you may preview or download individual documents to check them and make data adjustments if necessary. You can rerender them and create a new revision at any time.

💡 Document control & revisions​

Any time you create or update your product information, including documents or research, and wish to reissue your documentation, then you need to regenerate or "re-render" a new controlled revision of your full portfolio. CERTAIN takes care of this for you automatically in the document manager.

3. Create a new set of documentation - a new revision​

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

This may take a 30 seconds to complete as all the data is compiled. A success message is displayed top right in the screen and the button turns dark blue on completion.

All currently available documents will have been generated with a new revision number and rendered as a finished pdf document.

4. To preview any document click on PDF preview​

5. PDF preview screen​

From this preview you can check content, download and print draft examples for proof reading in paper form if required.

If you identify changes to be made, simply return to the applicable process step and revise the information accordingly. Here for example the risk assessment.

6. Preview your documents​

Review your documentation in detail making sure important contacts and company designations are correct. Remember, these are legally binding declarations.

7. 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.

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 of the CE marking itself are detailed in Annex I section 1.7.3 Machinery Directive. The label should be placed visibly on the machine's exterior, avoiding placement behind or beneath any machinery components. Considering the machine's size, the characters utilized should be sufficiently large for easy readability. The method employed for marking should guarantee that it remains intact throughout the machine's lifespan, considering foreseeable usage conditions. If the label is on a plate, it ought to be securely attached to the machinery, preferably through welding, riveting, or bonding.

8. Download your final documents​

On the left hand side select the documents you wish to download.

9. Download the selected documents​

The documents are extracted in a zip file containing two subdirectories. One for internal use with the risk assessment and machine plate, and one for external use containing the declaration of conformity. (In future also the operating instructions).

Save the extracted files to any location of your choice as required by your internal processes.

10. Process completion​

With your key documentation, 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 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 risks that may be associated with your equipment throughout its lifecycle. For each of these risks, 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, rendered and downloaded final versions of your Risk Assessment, Declaration of Conformity and machine ID and CE-Marking plate.
  • You have produced your supporting operating manual in accordance with EN ISO 20607:2019 (Currently not included in CERTAIN - Coming soon - See tip below)
  • You now have all your CE-Marking documentation together and have successfully completed the CE-Marking Process.
  • You are authorised to affix the CE-Marking plate to your machine and place

(v0.0.3)

💡 Coming Soon - Your Operation Instructions​

Currently the CERTAIN Team is working on an additional process tool step to assist you with the creation of your operations instructions. In line with EN ISO 20607:2019 and integrated seemlesly into the CERTAIN application, it will intelligently structure and prepare your operating manual contents based on your filtered product information, standards choices, risk assessment and detailed user instructions.

We hope to release this additional functionality very soon and will be informing all CERTAIN users when we're ready.