Safety conformance: inspection body or notified body?
04 October 2011
When it comes to safety conformance, David Collier says that machine manufacturers and their end users should consider the benefits of working with an inspection body rather than a notified body.
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 versus inspection
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 system 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 it's 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 making a complete offering 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 a complete service, not just tick box pass/fail reports.
The 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?
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:
- 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).
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 to problems, engineer them, validate them, then certify and CE mark the machine.
- It can significantly reduce administration and engineering costs as well as time-to-market.
- Inspection bodies work continuously in the field of machine safety and have a wealth of experience across industry sectors, 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 full service 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 machinery automation experience. This produces safe machines that are both usable and productive.
David Collier is business development manager at Pilz Automation Technology
Pilz: the role and responsibilities of an ‘authorised representative’
Pilz Automation Technology has achieved two important accreditations as an alternative to a notified body. Firstly, it has achieved German accreditation body, Deutsche Akkreditierungsstelle (DakkS) accreditation as a ‘Type C’ inspection body, which proves its 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, the company 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, providing confidence in the engineered system.
When mandated by a client, Pilz will act as an 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. And as authorised representative, it becomes the first point of contact for the statutory authorities (HSE in the UK), enforcing the Directive by performing 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, retain the TCF for a period of at least ten years from the last date of manufacture of the machinery, keep the original EC declaration of conformity or incorporation, and make the technical files available to the competent authorities (the Pilz name and address would appear on the CE marking plate as authorised representative).
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