Which processes must be lived in a company in order for all relevant departments to follow the conformity process efficiently? What legal and technical agreements must be made with suppliers in order to achieve conformity of your own products? How can the CE conformity process be meaningfully established in the PEPs?
Not only these but also many other questions are frequently asked by our customers. We at IQZ support you in managing the entire CE coordination process. With the initial recording of the current status, many questions are often already clarified and the current status with regard to CE becomes transparent. Subsequently, we clarify together with you how CE conformity can be achieved. If necessary and desired, we will work with you to develop the appropriate processes so that your team has a guideline for CE activities. We can also take over the corresponding coaching of the employees in order to consolidate the procedure with our own competencies. And if your capacities just show a bottleneck, we provide a certified CE coordinator who brings the processes in your company to life and leads you with certainty to your goal.
For machine manufacturers
- Assistance in establishing the CE conformity process in the product development process (PDP)
- Support in the formulation of CE conformity requirements in the specifications for purchased parts / systems from suppliers
- Advice on the formulation of requirements for the interfaces between your own product and the supplied components
- Taking over the role of CE coordinator
For operators of machines
- Support in the preparation of a safety specification sheet
- Identification of the actual state of your machinery from the point of view of machine safety
- Analysis and development of CE coordination in your company
- Taking over the role of CE coordinator
- Support in negotiations with suppliers or OEMs
- Development of SIL-compliant systems
- Establishment of CE conformity in the PEPs
- CE coordination after a successful analysis of the actual state at a German automotive OEM
- Recording of the actual state of an international steel processing company at a location in Germany
- Assessment of the conformity of machines in Sweden, China and the USA
- ACTUAL status assessment of the production equipment for a location from the point of view of machine safety. Development of a plan to achieve CE conformity within a horizon of four years.
- Negotiation with suppliers regarding product safety requirements under public law for the supplied subsystem.
- Assumption of the role of the CE coordinator in a medium-sized company.
The following methods are used by us in CE coordination:
- Identification of the ACTUAL state
- Analysis and structure of CE coordination
- Preparation of expert opinions in accordance with the MRL 2006/42/EC
- SIL-compliant system development according to IEC 61508
- Functional safety concepts according to ISO 13849
OnePager Machine safety
The initial focus of the topic “CE” usually lies on the conformity process. Immediately all thoughts are assigned directly to the directly confronting process. However, the conformity process is not the core topic of CE coordination, but the result. The goal is the conformity of your product with the legislative regulations of your target market. For the European market, this defines the “CE coordination”.
If you want to successfully create a CE conformity process, it is initially irrelevant whether you do this in a small, medium-sized, family-run company or in a globally active listed company with several locations in Europe. The initial generic process is initially identical for both scenarios.
First, an ACTUAL state must be recorded. In the case of a machine operator, the first question is: What percentage of the machinery is safety-compliant? Then the question arises as to where conformity has been impaired by changes, interlinkages, or acquisitions in the course of product changes or changes in the order situation? As a machine manufacturer, the question is not addressed to production, but to development and the PDP. Here, too, questions arise again: Is work on conformity carried out across departments in accordance with a common concept along the PDP? How is it documented? How are errors or weaknesses detected?
Once the actual state is known, the process of designing a pragmatic conformity process can be started. The first focus is to get over the hurdle of the legal minimum requirements as quickly as possible in order to be clearly positioned in the case of liability (“mandatory”). Especially in the area of liability and subsequent criminal prosecution, which only natural persons know, this point should be pursued with care and emphasis by all parties involved.
According to this, CE conformity can support product development. The availability of plants can be increased, weak points decimated and quality increased (“freestyle”). In addition, in the event of damage, it is even easier to prove that the necessary safety activities have been carried out by the company itself.
Identification of the actual state
Without valid CE conformity there is no operating permit for machines in Germany and Europe. The condition of the machinery under product law is therefore directly dependent on the CE conformity of the machines! Unfortunately, it often happens that a valid CE conformity is invalidated when the machine is purchased, due to significant changes, conversions, performance optimizations or a product change. Possible damage to these machines may then not be covered by the current insurance status. Even if damage is rare, the question quickly arises as to who is actually liable in the company in the event of damage?
On the other hand, there are of course the issues of time and costs. What has to be done when and where to invest in order to be on the safe side in all these questions? But what does the safe side mean? Liability in general cannot be excluded. However, it is important not to get into “debt liability”, but to be in the insured area of “strict liability”!
All these questions will be answered with the results of this study.
Analysis and structure of CE coordination
With the results of the identification of the actual state, a first plan regarding CE coordination can be developed. For example, you can counteract a shutdown of your machines by market supervisors and other authorities (if something has already happened) as well as the personal liability of your executives. To achieve these goals, we will work with you to adapt your processes to achieve legally and technically compliant development, production and operation of your machinery.
Taking on the role of CE Coordinator
A lot has already happened in our own company with the basic framework from the analysis and development of CE coordination. Now the new processes have to be put into practice. As a rule, this happens with many uncertainties in the company as well as a certain degree of rejection of the new.
At this point you need a committed person who can easily communicate complex issues and work with objective determination towards achieving the goals, who conducts negotiations and declarations with suppliers, department heads and corresponding employees. Experience has shown that an external coordinator can sometimes work wonders. So have a try!
Get in touch with us!
You’ve got questions about the CE Coordination?
Feel free to contact Thomas Prokopowicz!
Telefon: +49 (0)202 – 515 616 90