17 May, 2022

Body of evidence

27 October, 2011

When it comes to safety conformance, machine manufacturers and their end users should consider the benefits of working with an inspection body rather than a notified body, writes David Collier, business development manager at Pilz Automation Technology.

The single European market depends on the setting of common and high standards for safety of specific products, including machinery. Directives and standards supporting this free market set guidelines, which include the ‘Essential Health and Safety Requirements’ found in the Machinery Directive 2006/42/EC, and ‘Inspection of Product’ in the standard EN ISO 17020. New machinery introduced to the market will have CE marking applied through 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, or an end user integrating interlinked machinery in order to create an 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 any EU member state to conduct the certification procedures or to 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 laboratory capabilities and independence from any solution 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 solutions throughout the CE marking process; it can indicate where a machine fails to conform to essential health and safety requirements (EHSRs), but it cannot propose a remedy or solution. In today’s de-skilled and pressurised work environment manufacturers are looking for remedies and solutions, not just tick box pass/fail reports.
For this reason, Pilz Automation Technology has elected and achieved two important accreditations as an alternative to a Notified Body. Firstly, Pilz has achieved DAkkS accreditation as a ‘Type C’ inspection body, which proves Pilz’s international impartiality and objectivity (with Quality Management Systems to IEC17020) and permits the continuance of lifecycle service beyond any inspection and test phase to Safety Concept. Secondly, Pilz has TÜV 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 engineered solution.
Annex IV machinery, the new Machinery Directive 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 (particularly dangerous machinery). 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 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’ standard, which means that manufacturers of these types of machine can self-certify or mandate an ‘authorised representative’  to carry out the conformity assessment, usually a more cost effective route to CE certification without the need for assessment by a Notified Body.
What is an authorised representative and what can it do?
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 authorised representative is described under the new Machinery Directive EC 2006/42 - Annex II A. The EC declaration of conformity produced for each machine must contain the following particulars:
1. Business name and full address of the manufacturer and, where appropriate, his authorised representative.
2. 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 authorised representative established in the community to perform on that company’s behalf all or part of the obligations and formalities connected with this Directive.
As authorised representative Pilz becomes the first point of contact for the statutory authorities (The HSE in the UK) enforcing the Directive. 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 Conformance. 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 incorporation, make the technical files available to the competent authorities, and the Pilz name and address would appear on the CE marking plate as authorised representative.
When can an Inspection Body not act as authorised representative?
If the machine manufacturer wants to CE mark Annex IV machines and they have not used or partially used harmonised standards, then they are faced with two options: either to contact a Notified Body to have the machine assessed by them (EC type-examination, Annex IX) or to have their ‘full quality assurance’ system (Annex X) reviewed by them. Either way, both these options require the involvement of a Notified Body.
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-conformity, propose solutions, engineer these solutions, 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 & beverage, pharmaceutical, 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 solution-providers who are competent to tackle machine safety throughout the entire life cycle, which requires a combination of expertise in both safety standards compliance, sound 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, whilst also allowing them to apply their 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.

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