CE – SMM

CE

What is CE?

CE logo

CE is the abbreviation of the french phrase “Conformité Européenne”, which could translate to “European conformity”. The CE sign is used in the european community (EU, EFTA) and ensures, that a certain product is produced in accordance to strict rules and regulations regarding safety, health, environmental protection, adequate quality of products and proceedures, … Not all products on the european market have to comply to these standards, but a vast majority of home appliances, equipment, toys and all industrial and medical appliances, machines and equipment has to be certified. Products, manufactured outside Europe, also have to be certified. Since the manufacturing process is certified from raw material to the finished product, that sometimes includes certification of foreign subcontractors.

Legally, the CE sign is not a quality mark. But considering all the regulations and rules (depending on the product, CE certification defines used materials, manufacturing processes, all risks during manufacturing, usability, safety of the end-user, …), it can factually be considered a quality mark. The CE branding on our machines represents a very high standard of material and build quality and more than the necessary safety and health precautions. We conduct all procedures defined in the 2006/42/EU guidelines, which strictly define the criteria for industrial machines. The certification procedure includes several modules:

  • Module A1 – Internal production control
  • Module A2 – Intervention of a Notified Body
  • Module B – EC type-examination
  • Module C – Conformity to type
  • Module D – Production quality assurance
  • Module E – Product quality assurance
  • Module F – Product verification
  • Module G – Unit verification
  • Module H – Full quality assurance

Definition of machines and machine systems by CE

The 2006/42/EU guidelines include:

  • Machines (Assembly of linked parts or devices of which at least one is moveable. The assembly must include controllers and power circuits and must serve a certain purpose.)
  • Replaceable equipment (An interchangeable device (not a tool!), which will be removed from or attatched to the machine by an operator to change the machine’s functions.)
  • Safety clutches
  • Lifting devices
  • Chains, ropes, belts
  • Detachable driveshafts
  • Dependant machines (Those machines may have a machine’s structure, but does not serve a direct function in the production process (e.g. propulsion systems). It is intended as a part of the machine system and must complie the guidelines)

Items marked red are frequent in our production program or are frequent parts of our projects.

Who is obliged by CE?

CE rules and guidelines are mandatory for the manufacturers (SMM) as well as the clients (employers). The manufacturer’s obligation is to analyze the risk according to the standards (EN ISO 12100-1 and 2, EN 14121-1) with the goal of minimizing risk to an acceptable level and providing adequate warning about potentional hazards. At SMM, we complie to these standards by designing our constructions to be safe, implementing technical safety precautions and extensive information about safe use.

EU – based clients also have to take the strict regulations of some standards (ISO 14001, OHSAS 18001) into account. Also, certain guidelines have to be followed: For example, the guideline 89/391/EWG requires the emplyer to

  • choose adequate working machines,
  • provide safe working conditions and processes,
  • provide personal safety equipment,
  • train and educate the employees.

In Slovenia, those rules and regulations are strained even further by:

  • Law about safety and health at work (U.l. 56/99)
  • Regulations on health and safety during the use of work equipment (U.l. 101/04)
  • Law about environmental protection (U.l. 41/04)
  • etc.

CE at SMM

In our company, the verification procedures for CE compliance are conducted routinely by following these steps:

PLANNING is the first step, which begins long before the assemply.At this stage, we asses the feasibility by taking the safety standards into account and draft a safety concept with risk analysis during all stages. Furthermore, we prepare the documentation for building, assemply, testing, use, disassembly and recycling.

RISK ASSESSMENT is a key step for the prevention of injuries and health hazards, because we consider risks, dangers and hazards of all kinds. This way, we can ensure safe use of the products, if the instructions are followed. We also compose a security manual for all risks which may not have been eliminated (acceptable risks by the FMEA method – Failure Mode and Effects Analysis).

RISK REDUCTION is pictured. All the risks are eliminated or reduced, until the remaining risks are acceptable.

ITERATIVE METHOD is a three-step process, which serves for systematic searching of possible risks and allows their elimination or reduction.

FABRICATION must be performed in accordance with the guidelines and plans, since this is the only way all safety precautions are taken into account. Also, safety demands of the products are checked regularly. After fabrication, the entire system is probationary assembled, tested and set up. This way, we can assure safe operation of the machine within the framework of safety demands. After the succesfull test-assembly, the technical documentation is prepared.

HANDOVER / DELIVERY is the last step of machine building. At the HANDOVER/DELIVERY, the certificate of accordance is issued and the CE badge installed. We present the machine and the safety concept to the client and determine the suitability of the machine and the enclosed spare parts. Also, all necessary documentation (operation instructions, specification of usage in accordance with the intent, safety warnings and precautions, list of allowed and prohibited changes and supplements) is included. We also issue safety warnings for all remainig risks and place them (if necessary in the client’s native language) onto the machine.

 

The QM SMM book of procedures includes:

QP7-02 CE certification
QN7-05 Safety concept
QN7-04 Issuing the operation instructions
PR7-21 Declaration of accordcance with CE
PR7-22 Declaration of the CE producer
PR7-23 CE badge
PR7-24 Risk analysis
PR7-38 Composing the instructions
PR7-39 Sample of instructions
PR7-70 DIN EN ISO 12100-1
PR7-71 DIN EN ISO 12100-2
PR7-72 Review of the regulations