09 March 2011
Newcomers to the field â€“ and sometimes even those who have been involved for some time â€“ often find it difficult to distinguish the roles of the various European and international bodies involved in standards writing and certification. In this article, based on my presentation at Februaryâ€™s HazardEx Conference, I attempt to show the interaction between the various involved bodies and to answer some basic questions.
Standards Writing Bodies
IEC – International Electrotechnical Commission – based in Geneva (founded 1906)
The majority of developed countries throughout the world are members and contribute to the process of writing standards in the electro-technical field through their National Committees, who each have one vote in the process. Specific hazardous area standards are handled in Technical Committee 31. IEC standards have a number in the 60000 series.
ISO – International Standards Organisation – based in Geneva (founded 1926)
Committee system is similar to IEC, but working other than in the electrotechnical field. ISO standards do not have a particular numbering pattern, but some standards are a joint publication with IEC and these are numbered in the 80000 series.
Cenelec – European Committee for Electrical Standardisation – based in Brussels
The European “shadow” of IEC. Unlike IEC, Cenelec works on a basis of weighted voting, so that the largest countries (UK, France and Germany) have more power than the smaller countries (e.g. Malta and Belgium). Europe is defined geographically, rather than politically, but Cenelec has a special relationship with the European Commission and a mandate to write standards in support of specific EU directives such as EMC, LVD and ATEX.
CEN – European Committee for Standardisation – based in Brussels
The European “shadow” of ISO. Works with ISO in the same way that Cenelec works with IEC, but the numbering sequences do not follow a rigid pattern. CEN and Cenelec share administration resources from the same address in Brussels. Similar relationship with the European Commission, with responsibility for non-electrical standards in the ATEX field, mainly through committee TC305.
European Commission – particularly, DG Enterprise based in Brussels
Although not a standards writing body as such, the Commission directly influences standards through its mandates given to Cenelec and CEN to provide “flesh and technical detail” on the bare bones of the Essential Health and Safety Requirements (EHSRs) of the various directives.
BSi – British Standards Institution – based in Chiswick, London
BSi is one of the oldest National Standards Bodies in the world and still a major world player in terms of standards publication. Because the English language version of Cenelec standards is the most popular, BSi has supplied standards through much of Europe as well as many other parts of the world.
BSi Committee GEL/31 shadows both Cenelec TC31 and IEC TC31 for the electrical standards. BSi Committee FSH/23 shadows both CEN TC305 and IEC SC31M (see below) for the non-electrical standards. GEL/31 and FSH/23 have a common BSi secretary and a significant overlap in membership to try to ensure that responses are coordinated.
Uniquely, IEC TC 31 has a sub-committee SC 31M, which has an ISO secretariat and its standards will be published in the ISO/IEC 80079 series. This was done in order to gain better coherence in the development of both the electrical and non-electrical standards at the international level.
SC 31M is just about to publish its first standard, ISO/IEC 80079-34, the new document for QA in the Ex field which will replace both EN 13980 and IECEx OD 005. Coming next are 80079 -36 and -37 which, together, will provide the international versions of EN 13463-1, -5, -6 and -8 for the majority of non-electrical equipment. Publication, possibly towards the end of 2012, will enable international certification for such equipment.
Although there are still “local” conformity assessment schemes in most countries or regions of the world, the various schemes within the IECEx international system are gaining significant sway and (with the minor exception of some North American requirements) can form the input to the local schemes, particularly ATEX in Europe, or are fully accepted in their own right.
Last year, the United Nations Economic Commission for Europe (UNECE), formally adopted the IECEx methodology as a recommendation for any developing country seeking to put in place regulations concerning conformity assessment of Ex Equipment. Although developed within UNECE, this is now worldwide policy within the UN and is intended to guide countries changing their regulations as well as countries developing new ones.
ATEX 94/9/EC – The “Product Directive” is a legal construction based on the need to avoid concerns over safety being a barrier to trade. It allows many different levels of conformity assessment, none of which equate to what most people understand by “Product Certification”.
ATEX 1999/92/EC – The “User Directive” is about minimum levels of safety on plants where hazardous atmospheres may be present.
DSEAR – The Dangerous Substances and Explosive Atmospheres Regulations is the UK implementation of 1999/92/EC, together with some requirements of the Chemical Agents Directive. It is not a direct repetition of the two directives but interprets the requirements to fit the UK way of working.
DSEAR and 1999/92/EC both allow on site risk assessment and evaluation of existing plant, or second-hand plant. Only new equipment must comply with 94/9/EC.
The IECEx Certification System comprises three distinct Certification Schemes, all voluntary and managed by a committee comprising delegates from the member countries:
IECEx Product Certification – The original scheme and still the one most people think of when IECEx is mentioned. Over 6000 certificates have now been issued with worldwide recognition, a number currently growing at about 1500 new certificates per year.
IECEx Service Facility Certification – The second scheme to be developed, covering service facilities and repair workshops working to IEC 60079-19.
IEC Certification of Personnel Competence – The newest scheme, which complements the other two, to look after the safety of Ex Equipment and Installations throughout installation, inspection and maintenance.
Management and appointment of certification bodies
The top level body of ATEX 94/9/EC is the ATEX Standing Committee and its Working Group. National Governments are members, together with a few selected observers (including myself as chair of Cenelec TC31) who have no right of vote. The European Ex Notified Bodies Group (ExNB) is a separate committee with observer status at the Standing Committee.
The next level down comprises the individual member states in the EU and EFTA who are responsible for monitoring the directive and appointing “Notified Bodies”. A Notified Body is a certification body that has been “notified” by a national government to the Commission in respect of certain activities under certain directives.
For much ATEX Equipment, there need be no involvement of a Notified Body and the manufacturer drafts his top level document (the Declaration of Conformity) based entirely on his own view of compliance. Where a Notified Body is involved, its formal role is only to endorse the reports already prepared by the manufacturer. In practice, most Notified Bodies go beyond this and actually prepare the documentation (Technical File) in conjunction with the manufacturer. Where a Notified Body is involved in the production phase, this is not necessarily properly coordinated with the type examination phase, and there is no cross-reference on the EC-Type Examination Certificate, which exists formally as a paper-only document.
IECEx has a clearly-defined hierarchical structure closely monitored by the IECEx Secretariat. Certification Bodies must be nominated by their National Committee (in UK, L/6/10) but are subject to a rigorous system of validation and peer review, involving assessors from three different member countries.
Although the manufacturer can make an input, certification must be based entirely on the ExTR (an Ex Test Report produced by an IECEx Testing Laboratory). There is no conception of merely validating the manufacturer’s own results.
The top-level document in the original scheme is the IECEx Product Certificate which can be inspected on the IECEx web site and is based on the ExTR plus relevant input (in the form of a QAR – Quality Assessment Report) covering production methods. This certificate is updated in real time on the web site to reflect any change in status of manufacturing capability.
In both other schemes, the certificate is also based on a report and continued surveillance, to ensure that only currently valid certificates are displayed on the IECEx web site.
All the European Certification Bodies within IECEx are also Notified Bodies for the ATEX Directive 94/9/EC, but there are many Notified Bodies that are not within IECEx.
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