The quality manager as CE coordinator

Figure 1: Relationships between CE and QM systems¹

Quality management and CE marking

The aim of quality management systems, in particular those based on ISO 9001, is to improve a company's overall performance through continuous process improvement. These systems are able to ensure consistent fulfilment of customer requirements while also monitoring compliance with legal requirements. In the context of CE marking, the use of a QMS is particularly valuable because it provides a structured approach to conformity assessment and risk assessment. The quality manager is thus faced with the task of applying the principles of quality management to the specific requirements of CE marking, thereby bridging the gap between product quality and product safety.

Speaking of management systems and standards: ISO 37301 provides a framework for compliance management that goes beyond mere product conformity, for example, to include the acceptance of gifts, bribery, etc. In many organisations, compliance management and quality management are considered separately, although the two systems have considerable overlap, as a comparison of ISO 37301 and ISO 9001 also shows. Since this technical article is about product compliance, we will only mention ISO 37301 in passing. An integrated approach, in which the quality manager also acts as the compliance manager, can exploit synergies by ensuring that all requirements – from product safety to compliance with environmental standards – are systematically met.

Figure 2: Company performance in relation to CE¹

Lean management as a tool for increasing efficiency in CE processes

The goal of avoiding waste (Japanese: Muda) and maximising value creation means that all processes that do not directly add value to the final product must be critically scrutinised and, if necessary, eliminated. In the CE context, these can be redundant testing, duplicative documentation or unnecessary administrative tasks. By applying lean principles to CE processes, the quality manager can ensure that these processes remain lean and efficient while also meeting all regulatory requirements. A common example of Muda in practice is the inability to find knowledge regarding safety solutions from old projects. Not every project is completely new; in almost every project, there are some aspects where proven solutions can be drawn upon. If this knowledge cannot be found, however, avoidable additional costs and inefficiencies arise.

To pick up on a second Japanese term alongside Muda, ‘Saiton’ should be mentioned. This term, which is familiar from production optimisation (from the 5S scheme), suggests that all the necessary tools should always be to hand. In safety-related design, harmonised standards often serve as tools. For example, process effectiveness can be increased at this point if designers are given easy access to the current and relevant standards. However, people in technical implementation are often confronted with the fact that, on the one hand, there is only very limited knowledge regarding the work with standards and, on the other hand, there are no tools and processes in place for how to use the right standard in a targeted manner. Due to the cumbersome nature of the process, more and more loops with internal or external experts are then required, which in turn can be named as a waste of valuable resources (Muda) in the CE context.

Figure 3: Stakeholder management¹

Stakeholder management and compliance in the CE process

According to ISO 9001 and ISO 37301, the requirements and expectations of interested parties, such as customers, employees, suppliers and state authorities, must be systematically identified and integrated into the processes. For the CE coordinator, this means ensuring that all stakeholders – from internal departments to external partners – are included in the CE marking process. This includes clearly communicating requirements, monitoring compliance and regularly reviewing processes to ensure that all parties involved understand and fulfil their role in the CE process. In particular, this begins with the first contact between a customer and the technical sales department. Due to a lack of processes, sales engineers sometimes make offers that do not adequately take into account product compliance costs, or they overestimate them. In the first case, the consequence may be a lower margin or, in the worst case, even a negative margin. In the second case, the order is not placed. In most cases, the realistic consideration of compliance costs is not a problem of know-how in the company, but is based on non-existent or non-existent processes that also integrate the technically responsible department for compliance costs in the offer phase.

The successful implementation of CE processes depends to a large extent on the commitment of the company management. Without clear support from management, the CE coordinator will be unable to adequately fulfil their tasks. Good governance, as described in ISO 37301, requires that the compliance function can operate independently within the organisation and has direct access to senior management. This ensures that all necessary resources are provided and that the CE coordinator has the authority to carry out their duties effectively. In practice, organisational structures that are fully compliant with the recommendations of ISO 37301 (and also ISO 9001) are emerging, in which CE coordinators have the backing of the relevant managers and can thus ensure a consistent and effective process landscape.

Unfortunately, however, there are still companies where product compliance officers are seen as pure cost factors. This is unfortunate in that field reports show that safety technology can be used to generate considerable sales. This is the case, for example, when customers want more than is required by law. Thanks to their precise knowledge of the legal requirements and the associated billable additional services, plant engineering companies report significant sales increases in the double-digit percentage range for each unit sold.