David Collier, the Business Development Manager at Pilz Automation Technology, explains why machine builders and end users integrating complex assemblies of machines should consider the benefits of working with an Inspection Body rather than a Notified Body when CE marking machines to the Machinery Directive.
The single European market depends on the setting of common and high standards for safety of specific product types, including machinery. Directives and standards supporting this free market set guidelines, which include the Essential Health and Safety Requirements (EHSRs) laid down in the Machinery Directive 2006/42/EC, and Inspection of Product in the standard ISO/IEC 17020 (EN 17020), General criteria for the operation of various types of bodies performing inspection.
New machinery introduced to the market will generally be CE marked through a process of self-assessment. However, inspection by an accredited body reduces the risk for businesses and their customers.
The conformance of machinery is the responsibility of the manufacturer through the requirements defined in the Machinery Directive. A manufacturer could be an OEM introducing a machine to the market (including for use by the manufacturer), or an end user integrating interlinked machinery in order to create a complex assembly of machines. The manufacturer may use third parties to assist at various or all stages of the safety lifecycle.
Third parties carrying out such work must be competent at the technical and regulatory level. The use of an accredited organisation is a means for clients to manage the associated risks; such accredited organisations include Inspection Bodies and Notified Bodies.
Notified Body versus Inspection Body
A Notified Body is authorised by an EU member state to conduct the certification procedures or perform compliance monitoring on products that are subject to EU directives, or where the conformance procedures for such directives designate a role for a notified body for EC type examination. In relation to machinery, the notified body process applies primarily to Annex IV (particularly dangerous) machines. Notified Bodies point to their worldwide presence, accreditation, test facilities and independence from any remedy or product – yet herein lies a gap in satisfying real market demand. According to the Machinery Directive 2006/42/EC, a Notified body is required "...to maintain its impartiality and independence from all applicants and in no circumstances should it take on the role of authorised representative." This means that a Notified Body is prohibited from offering complete CE marking services; it can indicate where a machine fails to conform to essential health and safety requirements, but it cannot propose a remedy. In today's de-skilled and pressurised work environment, manufacturers are looking for remedies, not just 'tick box pass/fail reports'.
For this reason Pilz Automation Technology has elected and achieved two important accreditations as an alternative to Notified Body status. Firstly, Pilz has achieved DAkkS accreditation as a Type C Inspection Body, which proves the company's international impartiality and objectivity (with Quality Management Systems to ISO/IEC 17020) and permits the continuance of lifecycle service beyond any inspection and test phase to Safety Concept. Secondly, Pilz has TUV accreditation to IEC 61508 for the integration of functional safety, which is vital to the subsequent stages of Safety Design, System Implementation, Validation and CE marking, and provides confidence in the configuration, programming, documentation, structure and test.
If the machine manufacturer needs to CE mark an Annex IV machine and has not used or partially used harmonised standards, then there are two options: have the machine assessed by a Notified Body ('EC type-examination' as per Annex IX of the Machinery Directive); or have the 'full quality assurance' system assessed and approved by the Notified Body (as per Annex X). Both of these options therefore require the involvement of a Notified Body rather than an Inspection Body.
Annex IV machinery and self-assessment
A key change in the new Machinery Directive is the liberalisation of the conformity assessment procedures for machinery listed in Annex IV. Previously, Annex IV machines needed EC-type examination by a Notified Body. However, since the end of 2009, if machinery is designed in accordance with the relevant harmonised standards (generally this means machine-specific C Type standards such as those covering presses, packaging machines, woodworking machines, etc), the new Machinery Directive gives manufacturers the option to self-certify machinery, thereby avoiding the previous Directive's requirement to deposit the technical file with a Notified Body. Nearly all Annex IV machines have an applicable harmonised C Type standard, which means that manufacturers of these types of machine can self-certify or mandate an 'authorised representative' to carry out the conformity assessment, which is usually a more cost-effective route to CE marking without the need for EC-type examination provided by a Notified Body.
The Machinery Directive anticipates that machine builders may need to appoint competent persons to carry out some or all of the administrative and assessment procedures required to CE mark a machine. The current Machinery Directive defines an authorised representative as "...any natural or legal person established in the Community who has received a written mandate from the manufacturer to perform on his behalf all or part of the obligations and formalities connected with this directive..."
The role of the authorised representative is described in the new Machinery Directive 2006/42/EC, Annex II A.
The EC Declaration of Conformity (DoC) produced for each machine must contain the following particulars:
- Business name and full address of the manufacturer and, where appropriate, his authorised representative;
- Name and address of the person authorised to compile the technical file, who must be established in the Community (based/resident in Europe).
When mandated by its customer, Pilz will act as the authorised representative established in the community to perform on that company's behalf all or part of the obligations and formalities connected with the Machinery Directive. As the authorised representative, Pilz becomes the first point of contact for the statutory authorities enforcing the Directive (the HSE in the UK). Pilz would perform a quality assurance on the conformance assessment procedures followed and the Technical Construction File (TCF) prepared by the machine builder. To assure CE marking services are provided in accordance with the defined requirements Pilz would prepare and co-sign the Declaration of Conformity. Pilz would retain the TCF for a period of at least 10 years from the last date of manufacture of the machinery, keep the original EC Declaration of Conformity or Declaration of Incorporation, make the technical files available to the competent authorities, and the Pilz name and address would appear on the CE marking plate as the authorised representative.
Inspection body advantages
There are major advantages for a manufacturer that uses an inspection body as an authorised representative rather than a Notified Body:
- The inspection body is not prohibited from providing comprehensive support throughout the machine safety lifecycle, so it can help the manufacturer identify non-conformities, propose modifications, engineer these modifications, validate them, certify and CE mark the machine.
- It can significantly reduce administration and engineering costs, as well as time to market.
- Inspection bodies such as Pilz work continuously in the field of machine safety and have a wealth of experience across industry sectors (such as in paper, food and beverage, pharmaceuticals, automotive, rail, etc), so these companies are well placed to offer practical guidance on automation which not only improves safety (for which there are moral and regulatory requirements) but also productivity (which is important financially and competitively).
Industry demands service-providers that are competent to tackle machine safety throughout the entire life-cycle, which requires a combination of expertise in safety standards compliance, engineering and automation experience on machinery. Pilz's DAkkS accreditation as a Type C inspection body (in accordance with IEC 17020) guarantees the impartiality of its conformity assessments, while also enabling the company to apply its TUV certification and expertise covering the application of a safety management system to IEC 61508 to integrate functional safety systems. This produces safe machines that are both usable and productive. Contact Pilz to find out more about the services Pilz can provide as an Inspection Body when CE marking machinery.