Friday, 17 May 2013

Using The New CE Marking App In PLM 360

This week I'm covering a new app in the PLM 360 App Store, the CE Marking App. The purpose of this app is to manage the approval stages needed for the affixing of the CE marking on your products. With this app you can also create the EC Declaration Of Conformity and get an automatically generated document ready to print and sign for the official bodies to approve.

Background to CE Marking..

CE marking does not indicate that a product was made in the EEA, but merely states that the product is assessed before being placed on the market and thus satisfies the legislative requirements (e.g. a harmonised level of safety) to be sold there. It means that the manufacturer has verified that the product complies with all relevant essential requirements (, health, environmental protection requirements) of the applicable directive(s) – or, if stipulated in the directive(s), has had it examined by a notified conformity assessment body.

Using the CE Marking App
A visual indicator will tell you if you have completed all the sections and your product is approved

Stage 1: Identify the applicable Directive(s)
Stage 1: Identify the applicable Directive(s)
The first step is to identify whether the product needs to bear CE marking or not. Not all products are required to bear CE marking, only the products that fall within the scope of at least one of the sectoral directives requiring CE marking. There are more than 20 sectoral product directives requiring CE marking covering, but not limited to, products such as electrical equipment, machines, medical devices, toys, pressure equipment, PPE, wireless devices and construction products.

Stage 2: Identify the applicable requirements of the Directive(s)
Stage 2: Identify the applicable requirements of the Directive(s)

Each Directive has slightly different methods of demonstrating conformity depending on the classification of the product and its intended use. Every Directive has a number of ‘essential requirements’ that the product has to meet before being placed on the market.

Stage 3: Identify an appropriate route to conformity
Stage 3: Identify an appropriate route to conformity

Although the process is always a self-declaration process, there are various routes to conformity depending on the directive and classification of the product. Some products (such as invasive medical devices, or fire alarm and extinguisher systems) may, to some extent, have a mandatory requirement for the involvement of an authorised third party or "notified body".

Stage 4: Assessment of the product's conformity
Stage 4: Assessment of the product's conformity
When all of the requirements have been established, the conformity of the product to the essential requirements of the Directive(s)needs to be assessed. This usually involves assessment and/or testing, and may include an evaluation of the conformity of the product to the harmonised standard(s) identified in step 2.

Stage 5: Compile the technical documentation
Stage 5: Compile the technical documentation

Technical documentation, usually referred to as the technical file, relating to the product or range of products needs to be compiled. This information should cover every aspect relating to conformity and is likely to include details of the design, development and manufacture of the product.

Technical documentation will usually include:

  • Technical description
  • Drawings, circuit diagrams and photos
  • Bill of materials
  • Specification and, where applicable, Declarations of Conformity for the critical components and materials used
  • Details of any design calculations
  • Test reports and/or assessments
  • Instructions
  • EC Declaration of Conformity

Technical documentation can be made available in any format (i.e. paper or electronic) and must be held for a period of up to 10 years after the manufacture of the last unit, and in most cases reside in the European Economic Area (EEA). Using this App you have a permanent record to keep.

Stage 6: Make a Declaration and affix the CE marking
Stage 6: Make a Declaration and affix the CE marking
When the you are satisfied that your product conforms to the applicable Directives, an EC Declaration of Conformity must be completed.

Declaration of Incorporation.
The requirements for the Declaration vary slightly, but will at least include:
  • Name and address of the manufacturer
  • Details of the product (model, description and the serial number where applicable)
  • List of applicable sectoral Directives and standards that have been applied
  • A statement declaring that the product complies with all of the relevant requirements
  • Signature, name and position of the responsible person
  • The date that the Declaration was signed
  • Details of the authorised representative within the EEA (where applicable)
  • Additional Directive/standard specific requirements

Once completed you can approve the Declaration of Conformity using the workflow below:
Approval Proces for the Declaration of  Conformity

Using the Advanced Print views in PLM 360 your Declaration of Conformity will automatically be created for you
A PLM 360 Print view is automatically created 

The whole process is tracked using the CE approved 1 to 6 stage workflow process.
CE approved 1 to 6 stage workflow process.

Once a Declaration of Conformity has been completed, the final step is to affix the CE marking to the product. When this has been done, the CE marking requirements have been met.

I hope you find this CE Marking PLM 360 App useful,  I'd be interested to know what Innovative products have been managed  using this App!

Thanks for reading....Mike

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