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UNIDOScope 2004
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Laboratory Accreditation in Developing Countries: Tested Once Accepted Everywhere |
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Laboratory Accreditation in Developing Countries
"Tested Once - Accepted Everywhere"
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Globalization and trade liberalization do not offer much to the developing world, especially the Least Developed Countries (LDCs), unless they have competitive exportable products. Having competitive exportable products means not only having the capacity to produce at developed country standards, which is a big enough challenge for any developing country, but it also means having the ability to prove that the products meet those standards.
Technical regulations and product standards may vary from country to country. If regulations are set arbitrarily, they could be used as an excuse for protectionism. The WTO Agreement on Technical Barriers to Trade (TBT) tries to ensure that regulations, standards, testing and certification procedures do not create unnecessary obstacles to trade.
To benefit from the TBT Agreement, exporting countries have to prove that a particular product complies with the prescribed technical regulation, standard or testing and certification procedure. "Proof" is only considered as such if it comes from an institution that has been "accredited" according to the requirements prescribed by the international conformity assessment bodies ILAC (International Laboratory Accreditation Cooperation) and IAF (International Accreditation Forum).
For a country that wishes to export, a basic requirement is at the laboratory level. Tests proving conformity have to be carried out by a laboratory that has been "accredited" to carry out the prescribed tests. To keep costs down and maintain the competitiveness of exports, the accredited laboratories should be local. The next step is to have a local or regional body able to accredit laboratories under the ILAC Mutual Recognition Arrangement. The "ILAC Arrangement" seeks to give global recognition to laboratory accreditation bodies through a single peer evaluation against internationally agreed criteria.
UNIDO has developed a programme in cooperation with ILAC and ISO (the International Organization for Standardization) called the Pre-Peer Evaluation Procedure (PPEP) to assist accreditation bodies to understand the requirements of the Arrangement and therefore make it more likely that they satisfy the formal process for admission.
Laboratory Accreditation in Developing Countries: Tested Once Accepted Everywhere, (view or download) published as part of the UNIDO - ILAC - ISO PPEP project, discusses the reasons for establishing an accreditation body (section II) and what the accreditation body has to be able to do (sections III and IV). It then gives an overview of international and regional organizations involved in conformity assessment and the pathways to participation in the ILAC Arrangement (section V). The role of UNIDO and the process of Pre-Peer Evaluation are discussed in section VI.
While it is straightforward in trumpeting accreditation as "the key to lowering the barriers to international trade" the paper cautions that "establishing an accreditation body is not a step to be taken lightly." Demand is the obvious first criterion: there has to be a significant number of laboratories, certification bodies or inspection bodies that have a chance of achieving accreditation and that wish to be accredited. For starters, "A financially and technically viable accreditation programme requires in excess of one hundred laboratories and perhaps at least ten certification bodies." Other "essential prerequisites" are: "political and governmental support, (not necessarily financial support) on an on-going basis, if international recognition is a consideration"; and "certain technical requirements, even for systems that will never aspire to high levels of technology capability." "Nowhere in the world," the authors say, "with the possible exception of the very large markets such as the USA, is an accreditation body a commercially viable activity unless it has strong support from the government of the home market". Even in large markets, where the accreditation body can be financially self-sufficient, it "relies on government policies, and sometimes legislation, to provide the incentives for potential clients to seek accreditation."
While the publication deals essentially with laboratory accreditation infrastructure, it recommends "for most countries setting out to establish an accreditation body it would be sensible to consider a single accreditation body to offer acceditation for all conformity assessment and management system activities. This could extend to laboratories, quality management certification and product certification bodies and inspection bodies, as well as bodies providing certification of environmental management, and possibly occupational health and safety and food safety."
In discussing the possible structures for an accreditation body there is a further note of caution on the subject of single organizations with: "It has been common for small countries in particular, to centralize some or all of what are called standards related activities into a single organization. Such activities as standards writing, standards of measurement, legal metrology, accreditation and certification, and sometimes testing laboratories, may all be located in the same body. For international recognition such arrangements are fraught with difficulties."
The message of caution also prefaces the "How to do it" section III, with "For some developing countries, the decision should be not to set up an accreditation body, but rather to provide an accreditation service through regional cooperation or by engaging an accreditation body from a foreign country to provide those services on mutually agreeable terms. "
On the subject of regional cooperation, the Southern African Development Committee for Accreditation is introduced as the best-developed under the regional accreditation body (as distinct from sovereign national body) concept. "In this model, some member states will choose to establish an accreditation body while others may not. Each will, however, appoint a national focal point for accreditation activity. Any of the established accreditation bodies within the region may be approached to provide the services in those states where one does not exist. Mutual recoginition arrangements will be such that all accredited laboratories in the region have equal status. ..."; Again a note of caution follows: "For the purposes of international recognition, however, particularly by regulatory authorities, the government of the exporting country must be prepared to stand behind the body providing accreditation services and this has yet to be tested at the regional level."
In addressing the many issues pertinent to the establishment of accreditation bodies, from assessing whether there is a real need for such a body in terms of cost effectiveness and viability, or whether the needs of the economy could be better served by using another recognised natonal accreditation body, to what laboratory has to be able to do before it is entitled to accreditation and what an accreditation body has to be able to assess before it bestows accreditation, the reader is left in no doubt of the seriousness of the endeavour. If after digesting all this, it is decided there is a real need to go ahead with the establishment of an accreditation body, the guidelines that follow, on what is necessary once the decision is taken, could easily inspire second thoughts. At least there will be no doubt that there is a real need for the UNIDO - ILAC - ISO Pre-Peer Evaluation Proceedure.
Laboratory Accreditation in Developing Countries: Tested Once Accepted Everywhere, is also available for download from UNIDO's Trade Capacity Building pages.
Otto Loesener, Tel +43-1-26026 / 3079, Email: O.Loesener@unido.org
Send your comments to the editor: K.Timmins@unido.org