Routes to Machinery Directive conformity for ‘hazardous’ presses: EC type-examination vs full quality assurance

Directive 2006/42/EC on machinery sets out the vital worker- and user-safety requirements that machinery must meet before it can be sold in the European Union. In Annex IV, this directive lists various types of machinery that are considered hazardous and details a number of routes by which their manufacturers, or the customers that purchase and use them, can demonstrate their conformity with the directive.

The list of machinery categories considered hazardous features a number of different types of press that, as a result of their design, require manual loading and/or unloading. In particular, certain types of presses and press-brakes for the cold working of metals, as well as rubber-moulding or plastics-moulding machines, be these injection or compression.

As they require some level of manual operation, such presses present risks that must be assessed to ensure the adequate protection of users. Such risks, which include entrapment, impact, abrasion, cuts, electrocution and noise, must be minimised or eliminated through the application of countermeasures or design improvements: reduced power, speed and/or weight of mobile parts; safety distances; fixed, mobile or adjustable guards; and appropriate signage and information regarding the correct use of the machinery.

Article 12 cites three different ways of complying with the health and safety requirements applicable to hazardous machinery, although most manufacturers are only familiar with EC type-examination. In this article, we will look at each of these three options, considering their benefits and drawbacks depending on the type of machinery in question and the type of company manufacturing, selling or using it.

Article 12 points 3 and 4 of the directive detail three options for certification: self-assessment, EC type-examination and total quality assurance.

Self-assessment: a limited and risk-prone system

While self-assessment may on first glance seem the simplest and cheapest option open to manufacturers, it has many limitations and is not risk-free. For a start, it only applies to presses manufactured in line with harmonised standards covering all of the essential health and safety requirements. It therefore requires in-depth regulatory knowledge. Secondly, if there turns out to be any problem with the press or an accident occurs, it will fall to the manufacturer to prove that the machinery meets the standard. This can be quite complex, given that the requirements set out in the standard leave room for interpretation. Some degree of technical competence is therefore required to be able to tell if the given solution is in conformity or not.

EC type-examination: the usual way of ensuring conformity

This procedure requires a Notified Body (NB) to inspect the machinery to assess any risks as well as to review the technical dossier. If the machinery fares well in both stages of this process, the NB will issue an EC type-examination certificate.

  • Benefits: This procedure involves just a single evaluation, with the resulting documentation valid for all machinery of the same model as long as no modifications have been made and the standards in force have not changed.
  • Drawbacks: Any modifications or improvements made to the assessed model may require a new EC type-examination by the NB. If a manufacturer produces various different models, each of these must be certified separately and independently.

This system is a good option for companies manufacturing a limited number of machinery types, without model differentiation. Likewise, it is the logical choice for companies having acquired machinery from a manufacturer without CE marking, who are themselves responsible for undertaking the conformity assessment process. And also for companies that sell machinery manufactured by other companies.

Full quality assurance: a means of ensuring the conformity of multiple models of machinery by way of a single annual audit

Unlike EC type-examination, this procedure does not centre on risk-assessing a specific model of machinery, but instead on assessing a company’s quality systems to ensure that it has the requisite procedures in place and the necessary technical expertise to guarantee that each model of machinery it manufactures complies with the requirements of the directive.

In the case of full quality assurance, the NB carries out an annual audit of the company and its quality system. This audit looks at the company’s procedures for assessing if the machinery it manufactures meets the design and construction requirements in force – in all stages of the process, right from the ordering of parts and materials through risk assessment and documentary review and on to sales and marketing.

The auditors analyse the traceability chain in all of the press-manufacturing stages and processes with a view to ensuring that every model or variant is produced in precisely the same way, without errors, thereby safeguarding the quality of manufacturing.

They also review other, more general, aspects of quality, such as equipment calibration and documentation provided by raw material suppliers. If the company passes this audit, every model it manufactures that falls within the audit’s scope is considered to conform with the Machinery Directive – even if modifications are made. In the event of a change to one of the standards in force, at its next annual audit, the company will be assessed on the understanding that it adapted to that change on the requisite date.

  • Benefits: A company can demonstrate the conformity of its full product range through a single annual audit, without restrictions in terms of future innovations or modifications. In addition, if the company already has a quality management system along the lines of ISO 9001, many of the procedures to be assessed will already be in place.
  • Drawbacks: This system is of limited benefit, from a cost and labour standpoint, to companies manufacturing one or only a few models of machinery since it requires a more extensive audit than EC type-examination and is only valid for a year.

Total quality assurance is the ideal solution for large and medium-sized businesses that already have personnel overseeing quality management and management systems in operation. In such cases, synergies between the two systems will ease the auditing process and will also enable the company to continue to innovate by reducing the cost of conformity when machinery is modified or improved.

Selecting the most appropriate option for each company

As we have seen, each system has its advantages and disadvantages. It is up to the individual company to decide which option is best suited to its current needs, taking into account its future plans.

Applus+ Laboratories is a Notified Body for the Machinery Directive, providing both EC type-examination and total quality assurance services. It is also a NB for a range of other directives and regulations (Construction Products Regulation, Electromagnetic Compatibility Directive, Radio Equipment Directive, etc.). As such, we can provide conformity assessment services needed to achieve compliance and obtain the CE mark. Our experts work with manufacturers to identify the most appropriate route to product conformity. Please get in touch for further information.