Following issues regarding specified organic feed products, The Committee on Organic Production (COP) the Commission and EU Member States has introduced increased control and reporting measures are necessary for certain imported organic products. Port Health Authorities will take and send samples to an accredited laboratory for analysis for the presence of pesticide residues.
Laboratory accreditation provides confidence in the compliance of samples with Regulation 889/2008. Further information is available here.
The European Union has finalized the negotiations for an agreement with Japan to facilitate trade and enable European companies to get an easier access Japan’s large market.
This Economic Partnership Agreement will create new opportunities for exporting European goods and services. The EU-Japan agreement is expected to bring concrete benefits to European exporters and consumers alike.
This agreement provides strong guarantees for protecting EU standards, it also intends to ensure that technical regulations, standards and conformity assessment procedures do not create unnecessary obstacles to trade.
In this regard, the Economic Partnership Agreement includes also provisions on conformity assessment and specifies that the EU and Japan shall use accreditation with authority derived from government or performed by government as a means to demonstrate technical competence to qualify Conformity Assessment Bodies (CABs).
Further details are available on the European Commission website.
The efficiency of freight transport is key for the competitiveness of EU transport, economy and the functioning of the internal market. This is all the more so since freight transport increased in the EU by almost 25 % over the last 20 years and, according to the European Commission, is projected to increase by 50 % by 2050. Freight movement is accompanied by a large amount of information, which is still exchanged in paper format and represents a significant burden for businesses, transport operators and public authorities.
The EU Commission has therefore adopted a proposal for a Regulation on electronic freight transport information. This proposed regulation includes provisions about the accredited certification of eFTI platforms and service providers.
Further information is available on the EU Commission website.
The development of robust quality management systems and the provision for accreditation are essential for laboratories around the world. Laboratories performing official diagnostics for regulated pests (insects, diseases etc.) need to achieve high quality standards because of the impact of their diagnosis on international trade, on the agricultural sector, and on the environment.
Many laboratories within the EPPO region are already accredited and there is an increase in applications for accreditation among plant pest diagnostic laboratories. It should be also mentioned that the Regulation EU 2017/625 stipulates that official control laboratories in the area of protection and protective measures against pests of plants have until the 29th of April 2022 to become accredited. Accreditation of plant pest diagnostic laboratories is based on ISO/IEC 17025 General requirements for the competence of testing and calibration laboratories with additional guidance being provided in EPPO Standard PM 7/98 Specific requirements for laboratories preparing accreditation for a plant pest diagnostic activity. Accreditation is given by national accreditation bodies.
One of the principals aims of the European Co-operation for Accreditation (EA) consists of defining, harmonizing and building consistency in accreditation as a service in Europe by ensuring common interpretation of the standards used by its members notably ISO/IEC 17025.
The European and Mediterranean Plant Protection Organization (EPPO) is an intergovernmental organization responsible for European cooperation in plant protection in the European and Mediterranean region. Under the International Plant Protection Convention (IPPC), EPPO is the regional plant protection organization (RPPO) for Europe. One of EPPO’s fundamental roles is to encourage harmonization in all areas of official plant protection action. In this framework, since 1998, EPPO has established a work programme in the area of diagnostics which aims to harmonize procedures across the region by development of Standards. These are developed by involving many national experts and they are approved through a rigorous review and consultation process. These diagnostic Standards include pest-specific protocols for regulated pests as well as more general diagnostic Standards covering topics including quality assurance, accreditation, Interlaboratory comparison etc.
Further information available here
The Global Innovation Index (GII) provides detailed metrics about the innovation performance of 127 countries and economies around the world. The index is the result of a collaboration between Cornell University, INSEAD, and the World Intellectual Property Organization (WIPO). The GII has gained international recognition, establishing itself as both a leading reference on innovation and a ‘tool for action’ for decision makers. It recognises the link between innovation as an engine for economic and social growth in an increasingly knowledge-based global economy.
One of the 81 indicators used to measure a country’s innovation performance is the number of accredited certificates to the quality management system standard, ISO 9001.
The 2017 report can be accessed from the Global Innovation Index website.
Source: Cornell University, INSEAD, and WIPO (2017): The Global Innovation Index 2017: Innovation Feeding the World, Ithaca, Fontainebleau, and Geneva.
The World Health Organisation’s International Health Regulations have been developed to prevent, protect against, control and provide a public health response to the international spread of disease in ways that are commensurate with and restricted to public health risks, and which avoid unnecessary interference with international traffic and trade. Economies are required to develop certain minimum core public health capacities. Access to accredited laboratories provides clear evidence of an economy’s sustainable ability to respond.
Further information is available on the WHO website.
The European Parliament, the Council and the Commission has proposed a major overhaul of the EU type-approval framework for motor vehicles following the Volkswagen revelations in September 2015. The Commission concluded on the need to prevent cases of non-compliance by proposing a new regulation to make vehicle testing more independent and reliable and increase surveillance of cars already in circulation.
The main building blocks of the new rules are:
- Raise the quality level and independence of type-approval and testing before a car is placed on the market
- Increase checks of cars that are already on the EU market:
- Carry out market checks independently from Member States to initiate EU-wide recalls
- Recognition of the Accreditation of Technical Services in accordance with Regulation (EC)765/2008 as an alternative to peer evaluations by Type Approval Authorities.
Accreditation demonstrates impartiality and the technical competence of Conformity Assessment Bodies. By relying on accredited Inspection Bodies and Technical Services, regulators and governments limit cost and resources, avoiding the use of their own personnel and the duplication of audits, obtaining conformity assessment based on technical competence and impartiality providing objective results to support sound decisions in regulation, public procurement or delivery of products or services onto the market.
Further information can be found on the EU Commission website.
European Regulation (EC) No 2017/625 relies on accreditation to support food security in Europe. It requires that all analytical results from laboratories that carry out Official controls must be accredited in accordance with ISO/IEC 17025. It also extends to the whole food chain, with more specific rules for dealing with fraud, including the obligation of Member States to carry out regular, unscheduled checks to ensure integrity and authenticity throughout the food chain.
The requirements for accredited laboratories are reflected in article 37, which directs the laboratory to include every one of the methods of analysis necessary for the realisation of Controls that are required, for example by operators.
Further information is available in the Regulation.
The legal framework for the type-approval of automotive products covers three categories of vehicles: motor vehicles and their trailers, motorcycles, and tractors. The objective of this framework is to facilitate the free movement of motor vehicles and trailers in the internal market by laying down harmonised requirements designed to achieve common environmental and safety objectives.
Following the emissions scandal involving a German car manufacturers, the Commission announced that it would reinforce the type-approval system, in particular by ensuring adequate supervisory mechanisms to ensure a correct and harmonised application of the type-approval procedures. It is proposed that this is achieved through the use of appropriate accredited conformity assessment.
Further information is available on the Commission website.
Switzerland and the European Union have updated the agreement on mutual recognition of conformity assessment (Mutual Recognition Agreement, MRA). The update was required to reflect where technical regulations had been revised. It now allows for friction-free trade and the removal of technical barriers between Switzerland and the EU in the areas of:
- Simple pressure vessels
- medical devices
- Radio equipment and telecommunication terminal equipment
- Equipment and Protective systems intended for use in potentially explosive atmosphere
- Electrical equipment and Electromagnetic compatibility
- Measuring instruments
- Medicinal products
- GMP inspection and batch certification
- Explosives for civil use
A copy of the agreement is available here.
The Canada and EU Comprehensive Economic and Trade Agreement (CETA) is an agreement that reinforces Canada’s trading relationship with the European Union (EU). The CETA agreement covers all aspects of Canada’s broad trading relationship with the EU, including goods, services, investment, government procurement and regulatory cooperation. It will provide Canada’s access to the world’s largest market with more than 500 million people in 28 countries, and a combined GDP of $20 trillion.
The bilateral cooperation agreement (BCA) just signed by the European Cooperation for Accreditation (EA) and the Standards Council of Canada (SCC) will enable the implementation of the Conformity Assessment Protocol provided for in the CETA agreement, allowing for the mutual acceptance by Canada and the EU of test results and product certifications delivered by each other’s recognized bodies. This will help facilitate trade and open doors for EU and Canadian companies.
A market survey covering North America and Europe conducted jointly by the International Federation of Inspection Agencies (IFIA) and the International Confederation of Inspection and Certification Organisations (CEOC) found that 17% of various electrical home appliances verified through self-declaration of conformity (SDoC) showed safety-critical failures, resulting in a high risk of shock or fire. This compares to less than 1% for products with third-party accredited certification.
EU Ship Recycling Regulation states that Independent Verifiers should be accredited as Inspection Bodies to ISO/IEC 17020. The objective of the Regulation is to reduce the negative impacts linked to the recycling of ships flying the flag of Member States of the Union. The use of competent organisations to carry out the verification provides confidence to the regulator that the work is being carried out effectively. Further information on the Regulation is available from the EU Commission website.
Producers of paraffinic fuel recognized the need for a new specification in the context of increasing market demand for cleaner fuels. The new European Standard EN 15940:2016 demonstrates the effective cooperation between fuel producers, automotive vehicle manufacturers and other European stakeholders in reaching a consensus on a specification for a new generation of cleaner transport diesel fuel. Paraffinic diesel fuel can lead to improvements in local air quality without having to introduce changes in the existing fuel infrastructure. It can be used as a blend component in conventional diesel or as a 100% finished fuel, which is already the case in several European markets.
Paraffinic diesel fuels are liquid fuels that can be synthetically created from feedstocks such as natural gas (GTL), biomass (BTL) or coal (CTL); or through hydro-treatment of vegetable oils or animal fats (HVO). These high-quality fuels burn cleaner than conventional crude-oil based diesel fuels and are thus able to reduce local harmful emissions such as nitrogen oxides and particulate matter (i.e. less visible black smoke).
The new European Standard on ‘Automotive fuels – Paraffinic diesel fuel from synthesis or hydrotreatment – Requirements and test methods’ (EN 15940:2016) was developed by CEN’s Technical Committee on ‘Gaseous and liquid fuels, lubricants and related products of petroleum, synthetic and biological origin’ (CEN/TC 19).
The support for increased use of renewable fuels is a long term trend in Europe. A significant change was introduced in the European Standard EN 228:2012 on ‘ Automotive fuels – Unleaded petrol – Requirements and test methods’ to allow increased blending limits of 10 vol-% and 22 vol-% for ethanol and esters in petrol, respectively.
Further information is available on the CEN website.
European Accreditation (EA) has played a key role with the European Commission Initiative on Breast Cancer (ECIBC) for the development of a European quality assurance (QA) scheme for breast cancer services (BCS) coordinated by the EC Joint Research Centre (JRC).
This voluntary scheme, based on revised European Guidelines for Breast Cancer Screening and Diagnosis, is to be underpinned by accreditation in accordance with Regulation (EC) 765/2008. All aspects of BCS including diagnosis, surgery, treatment, nursing care and palliative care will be covered by the QA scheme; the main focus will be the quality of care and experience of the patient. The QA scheme for BCS needs to be very flexible in order to ensure inclusivity for the many different healthcare systems, ranging from rudimentary to mature, throughout Europe. To operate effectively, the scheme needs to make use of different standards, tools and techniques.
EA’s mission is to provide comprehensive guidance for the scheme’s different stakeholders, i.e. national authorities, professional bodies, national accreditation bodies (NABs) and conformity assessment bodies (CABs). Managing a well-established process for the production and publication of application, technical advisory and guidance documents, EA will provide generic publications describing the accreditation framework, toolkit, processes and procedures for accreditation.
EU Construction Products Regulation CPR (305/2011) means that CE marking is mandatory for many construction products. CPR stands for Construction Products Regulation. Construction products must also have a declaration of performance to be sold. This is provided that they are covered by a harmonized standard or has an European Technical approval, ETA. More information about the regulations concerning construction products are available from the National Board of Housing, Building and Planning.
In most cases, the Construction Products Regulation require that a notified body should be involved before the CE marking. Swedac is responsible for assessing competence through accreditation and the notification to the European Commission of notified bodies. Swedac is also responsible for assessment of Technical Approval Bodies, TAB. The National Board of Housing, Building and Planning is responsible to notify them to the European Commission.
Swedac process for the assessment and notification is described on the European Commission website.
What the notified bodies are and what their notification covers is shown by the EU Commission database Nando. The TABs are also listed.
Further information is available from the Swedish Government website.
European Accreditation (EA) has worked closed with the Directorate-General Climate Action (DG CLIMA) of the European Commission (EC) to implement accreditation according to EN ISO 14065 and Commission Regulation (EU) N° 600/2012 for the EU emissions trading system (EU ETS), namely greenhouse gas verification.
The main activities of the EA-EC cooperation consisted of:
– Peer-evaluating policies and procedures established by EA NABs for accreditation of verifiers against EN ISO 14065, the Regulation, the related guidelines provided by DG CLIMA and EA-6/03 M : 2013 EA Document for recognition of Verifiers under the EU ETS Directive and any additional criteria being defined (in advance of subsequent revision of EA-6/03);
– Training EA peer-evaluators for NAB accreditation of EU ETS verifiers;
– Establishing an EA-EU ETS Network of experts on EN ISO 14065 and the Regulation;
– Setting up national databases for publication of accredited verifiers: EA NABs providing accreditation of EU ETS verifiers set up a national database of accredited verifiers to allow public access to information (data and scope) on verifiers accredited by each EA NAB. According to the Regulation, EA should also facilitate and harmonise access to these national databases in order to enable efficient and cost-effective communication between EA NABs, national authorities, verifiers, operators, aircraft operators and competent authorities. The databases of EA NABs for their EU ETS accredited verifiers is available on the EA website.
EA has worked with DG CLIMA to develop the most relevant delegated acts that further specify the rules for verification and accreditation in Regulation (EU) N° 757/2015 on monitoring, reporting and verification of carbon dioxide emissions from maritime transport.
In order to make the railway systems more inter-operable and secure in Sweden and Europe, Swedac accredits notified bodies, certification bodies, inspection bodies and laboratories in the field.
Accreditation takes place within all railway areas such as infrastructure, energy, signalling, rolling stock and trains intended for passenger services. The regulatory framework is developed by the European Railway Agency, ERA, jointly with Member States’ competent authorities. In Sweden’s case, this is the Swedish Transport Agency. If European law is missing, the national rules are applicable.
When building new, or making changes to the rail system, notified bodies check if the changes comply with the requirements stipulated in the technical specifications developed in Europe. They are determined by the European Commission and must be followed by all Member States.
When it comes to risk assessment of railway safety, also here applies a European regulation that says, if substantial changes are made in trains and railway infrastructure, an inspection body shall assess that the one that makes the change have a risk management processes to be able to ensure safety on Europe’s railways SWEDAC also accredits laboratories that perform testing of trains and railway infrastructure, including components, in order to determine the functionality and security required. The test is then used as the basis when, for example, a notified body shall determine whether the train or the infrastructure meets the safety and compatibility requirements, such as fire testing of textiles to be used in trains.
Further information is available on the Swedish Transport Agency website.
European Accreditation (EA) and the Standards Council of Canada (SCC) has signed a bilateral cooperation agreement aimed to support the Canada and European Union (EU) Comprehensive Economic and Trade Agreement (CETA). CETA is a new trade agreement between the EU and Canada.
The bilateral cooperation agreement (BCA) signed by EA and the SCC will enable the implementation of the Conformity Assessment Protocol provided for in the CETA agreement, allowing for the mutual acceptance by Canada and the EU of test results and product certifications. This will help facilitate trade and open doors for EU and Canadian companies. Such a mutual recognition of accreditation bodies through the CETA Conformity Assessment Protocol will help to address these issues by allowing conformity assessment bodies in Canada and the EU to be recognized in certain areas through one mutually-accepted accreditation.
The type approval is a national system for verifying construction products with the requirements in the Swedish building regulations. The type approval shall be granted only if the product is not covered by a harmonized standard or a European Technical approval, ETA. Type approved construction products are labeled with the National Board of Housing, Building and Planning‘s mark of type approval, “the fork”. More information about the system is available at the National Board of Housing, Building and Planning, which issues regulations in the area. The type approval is issued by certification bodies that are accredited by SWEDAC.
SWEDAC accredits also inspection body type A for the production control.
More information is available from the National Board of Housing, Building and Planning website.
ERA, the European Railway Agency (an agency of the European Union) supports the use of accreditation by Member states to ensure interoperability on railways. Accredited conformity assessment will cover railway infrastructure and construction projects; energy; control, command and signalling; and rolling stock.
The use of accreditation is voluntary, however when a Member State decides not to use accreditation, it shall provide the European Commission and other EU Member States with all the documentary evidence necessary for the verification of the competence of the conformity assessment bodies it selects for the implementation of the Community harmonisation legislation in question.
The use of this harmonised accreditation scheme is expected to increase mutual trust amongst the relevant stakeholders.
Further information is available on the ERA website.
The European Space Agency (ESA), an international organisation with 20 member states, has adopted accredited certification to ISO 27001 to protect sensitive information and confidential data.
The information security management system (ISMS) allows the organisation to confidently manage the security of its data, minimise risk and protect stakeholder information.
Further information is available from the ESA website.
Organic products range from fresh fruits and vegetables straight from the farm to wines and cheeses aged over several years. Accredited certification provides an equally strict control system for operators (farmer, processor and trader) on an ongoing basis.
Thousands of inspections are performed per year by competent people with the costs covered by the private sector. Organic production combines best environmental practices, a high level of biodiversity and the preservation of natural resources. It is a production method using natural substances and processes. Organic production delivers public goods contributing to the protection of the environment.
Further information is available on the European Commission website.
The World Bank-GFDRR report Building Regulation for Resilience: Managing Risks for Safer Cities released in April 2016 outlines the benefits of strong and effective building regulatory frameworks. The report provides a resource to assist policy makers, governments, donor entities, as well as key private sector players in leveraging good-practice building regulation to underpin risk reduction strategies. It addresses vulnerability reduction in cities across the developing world and proposes to support disaster-prone countries in implementing effective regulatory reform.
The use of accredited testing, inspection and certification are referenced as tools to support local regulators and building control.
The United Nations Economic Commission for Europe (UNECE or ECE) has published a Common Regulatory Framework for Equipment Used in Environments with an Explosive Atmosphere 2011 requiring the use of accredited conformity assessment bodies.
Part 4 – Common Regulatory Objectives, Recognition of conformity assessment bodies
The accreditation of conformity assessment bodies and test laboratories has to follow the applicable ISO/IEC International Standards. The accreditation body has to be member of International Laboratory Accreditation Cooperation/International Accreditation Forum (ILAC/IAF). One member of the assessor team needs competence in the field of explosion protection.
Certificates have to be in line with ISO System No. 5 requirements of the applicable ISO/IEC Guide
Certificates have to be in line with ISO System No. 5 requirements of the applicable ISO/IEC Guide
Further information is available on the UNECE website.
PRAISE is a project co-funded by the European Commission and implemented by European Transport Safety Council (ETSC) on Preventing Road Accidents and Injuries for the Safety of Employees (PRAISE). The project aims to advance work-related Road Safety Management and provide the know-how to employers who have to take on that challenge. It also aims to present the work-related road safety standards of EU Member States and carry out advocacy work at the EU level: work-related road safety is an area of road safety policy that clearly needs renewed political commitment.
Their 2012 report ‘Preventing Road Accidents and Injuries for the Safety of Employees: Work Related Road Safety Management Programmes’ stated that, ‘ISO 39001… will provide a useful framework for the continual improvement of road safety work.’
As part of Pillar 1 on Road Safety management, the UN’s Global Plan for the Decade of Action for Road Safety 2011-2020 Activity 3 is to, ‘Develop a national strategy (at cabinet or ministerial level) coordinated by the lead agency ‘promoting road safety management initiatives such as the new ISO traffic safety management standard ISO 39001’.
This global plan was set up by the UN General Assembly under resolution A/RES58/289 on “Improving global road safety”, a task taken forward by the World Health Organisation.
The ISO website ‘Using and referencing ISO and IEC standards to support public policy‘ references a wide range of instances where different standards are used to deliver food safety policy.
Leading food standards include ISO 22000, Food safety management systems — Requirements for any organization in the food chain and ISO 22005, Traceability in the feed and food chain — General principles and basic requirements for system design and implementation.
The work of the ISO Technical Committee responsible for food safety standards (TC 34) has been a key contributor to the CODEX International Food Standards, with over 100 standards generated by TC 34 endorsed by CODEX.
Further information from the ISO website
The ISO website ‘Using and referencing ISO and IEC standards to support public policy‘ references a wide range of instances where different standards are used to deliver environmental policy.
Leading standards include ISO 14001 Environmental Management System standard and ISO 50001 Energy Management System standard, as well as standards used to limit greenhouse gas (GHG) concentrations in the Earth’s atmosphere (ISO 14064 series & ISO 14065).
These standards have been used in a variety of mandatory and voluntary schemes from carbon trading to sustainable development policy.
Further information from the ISO website
Energy efficiency is at the core of the European Union energy strategy for 2020.
With Directive 2012/27/EU European Union has established a common framework of measures for the promotion of energy efficiency within the Union in order to ensure the achievement of the Union’s 2020 20% headline target on energy efficiency and to pave the way for further energy efficiency improvements beyond that date.
Two routes are offered by the regulation under the energy efficiency improvement measures to be taken by Member States is that companies have an energy management system in accordance with ISO 50001 standard certified by an accredited conformity assessment body. This has been enforced in the French regulation since July 2013.
The New Approach was established in the European Union to ‘recast technical harmonisation within the European Union (EU) on a new basis by only harmonising the essential requirements of products and by applying the “general reference to standards” formula and the principle of mutual recognition in order to eliminate technical obstacles to the free movement of goods.’
The New Approach has a number of objectives, all seeking to use standardisation, to achieve aims such as supporting the single European market – especially for products, reducing barriers to trade, increasing product safety, delivering an efficient system based on consensus standards.
Product areas covered by the New Approach vary from toys to pressure equipment, from boilers to boats, from medical devices to explosives. The full range of products can be seen under the New Legislative Framework.
The European Union Agency for Network and Information Security (ENISA) is a centre of network and information security expertise for the EU, its member states, the private sector and EU citizens. The organisation carried out a study to identify and analyse the current landscape of ICT security certification laboratories in EU Member States, comparing them also with third countries practices. The study noted that certification plays an important role in raising the level of trust and security in ICT products and services. This is also valid for new systems that make extensive use of digital technologies and which require a high level of security. National initiatives have been emerging to set high-level cybersecurity requirements for ICT components on traditional infrastructure, including certification requirements. Important as they may be, they may nurture risks such as market fragmentation and challenges to interoperability.
The findings of this study will constitute the basis for the Agency’s proposal towards an EU wide ICT products and services certification framework to ensure greater harmonisation to strengthening the European digital economy.
A copy of the report is available on the ENISA website.
This study, which resulted from a research project commissioned by the German Federal Ministry for Economic Cooperation and Development (BMZ), aimed to assess the impacts that quality services contribute to improve the understanding at the political, entrepreneurial and academic levels about the relevance of quality infrastructures to the functioning of innovation systems, how they enhance the performance of economic agents and improve the outcomes of social, economic and environmental policies.
The key objectives aimed to identify the following positive areas:
- the identification of the range of positive and negative effects that they have in societies;
- to advise policy makers on how the accomplishment of their strategic goals may be facilitated through the development of quality services;
- To raise awareness of consumers, firms and industries about the existence of such an institutional complex, i.e. how it shall be used as a platform where various economic agents are to participate and interact in order to address to a multitude of social, economic and environmental challenges;
- to learn ways of improving the functioning of the existing quality infrastructure.
A copy of the report is available on the Physikalisch-Technische Bundesanstalt (PTB) website.
Standardisation and standards have often been perceived as a contradiction to innovation. This report provide conceptual arguments and empirical evidence that standardisation as such and standards can be used as to promote innovation especially in three different areas. After a brief section on the general economic functions of standards, the relationship between research and standardisation is examined by first showing both standardization as a technology transfer channel and standards as enablers and facilitators for research. The second area focuses on the difficult but promising issue of transferring intellectual property rights (IPR) into standards, and shows how this can be beneficial both for IPR holders and standards implementers. The third newly emerging field concerns the role of standards and standardization in procurement processes, which are more and more forced to address and promote innovation. In the final chapter, the results are summarised and recommendations for policy makers are derived.
A copy of the report is available on the National Endowment for Science, Technology and the Arts (NESTA) website.
Author: Knut Blind, TU Berlin, Rotterdam School of Management and Fraunhofer FOKUS
Following the introduction of Regulation (EC) No 765/2008 setting out the requirements for accreditation and market surveillance relating to the marketing of products, the Commission has published a report to review its impact between 2013 and 2017.
This report confirms that the European accreditation infrastructure created by the Regulation has provided added value, not only for the single market but also for international trade. Accreditation has wide support from European industry and the conformity assessment community for ensuring that products meet the applicable requirements, removing barriers for conformity assessment bodies and helping entrepreneurial activities to flourish in Europe. The Regulation established a trustworthy and stable accreditation system in all Member States, as well as EFTA countries and Turkey.
The report concludes that more than 34450 accreditations were delivered (in regulated and non-harmonised areas) covering a wide range of activities by the end of 2016. This has been a significant contributory factor in deepening the single market and seemless trade.
A full copy of the report is available from the EU Commission website.
The Researchers examine the impact of formal standards on trade in global value chains (GVCs) in Europe. Using a gravity model approach for panel data, they estimate the influence of national, European and international standards on trade in value-added and gross trade flows within Europe. They find that national standards on their own hamper trade in European value chains while European and international standards foster trade. European standards have greater influence on trade in inner-European value chains whereas international standards have positive effects on imports into Europe from third countries. European standards therefore reduce information asymmetries between market actors in the value chains of the European Single Market. International standards serve as a means of global communication between international trade partners. In addition, they find a positive effect of an interaction term between national and European standards in European value chains confirming the necessity of national standardization.
Authors: Knut Blind, Axel Mangelsdorf, Crispin Niebel, & Florian Ramel (November 2017)
A full copy of the report is available here.
A publication titled “Good practices: Experience in the Market Surveillance of ISO 9001 quality management systems” has been released by the United Nations Industrial Development Organization (UNIDO).
The report presents the lessons learnt and good practices in applying Market Surveillance methodology to monitor the effectiveness of ISO 9001 certification in manufacturing enterprises and to evaluate the performance of respective accredited certification bodies.
The report concludes that the proper use of ISO 9001–based quality management systems assists developing countries in promoting sustainable trade, thereby helping them achieve inclusive and sustainable industrial development and the 2030 development agenda.
A full copy of the report can be downloaded from the UNIDO website.
Reducing unnecessary trade costs is an important aspect of International Regulatory Co-operation (IRC). But trade costs are only one of the many considerations that countries take into account when engaging in bilateral, plurilateral or multilateral efforts to address non-tariff measures that are related to differences in regulations. They are also concerned about pursuing domestic regulatory objectives. This report develops an analytical framework to help understand the trade-offs between trade costs and domestic regulatory objectives that will determine outcomes of IRC. It shows the possible scope and landing zones of IRC initiatives, ranging from simple information exchange to negotiations to harmonize regulations between countries. The analytical approach is based on economic game theory and provides a basis for regulators and trade negotiators to determine which specific IRC approach would be promising to pursue.
The report states that the ILAC and IAF global arrangements provide the platform for trade cost reductions. A full copy of the report is available from the OECD website.
ILAC and IAF, the global accreditation associations, have contributed to research conducted by OECD to analyse the impact of international organisations (IOs) in supporting regulatory co-operation. The research identified that International organisations (IOs) play a growing role as standard setting bodies in supporting regulatory co-operation with evidence showing that IOs contribute to International Regulatory Co-operation (IRC) by:
- offering platforms for continuous dialogue on regulatory issues;
- facilitating the comparability of approaches and practices;
- providing member countries with flexible mechanisms to identify and adapt to new and emerging regulatory areas or issues;
- contributing to the development of a common regulatory language
- developing international legal and policy instruments.
The OECD gathered unique evidence from 50 international organisations on their governance, operational modalities, rule-making practices and approaches to assessing implementation and impacts, which is presented in the report International Regulatory Co-operation: the Role of International Organisations in Fostering Better Rules of Globalisation (launched 2 November 2016). This comparative analysis takes into account the diversity of mandates, expertise and strengths of the 50 participating IOs.
By establishing the international accreditation arrangements based on the mutual recognition of certificates and reports issued by conformity assessment bodies, the development of common rules and policies, and the harmonising of accreditation practices, the report identified that ILAC and IAF play a growing role in supporting regulatory co-operation.
This OECD work on IRC and IOs is part of a broad study into the various mechanisms available to governments to promote regulatory co-operation, and their benefits and challenges. A full copy of the report is available from the OECD website.
While there is a substantial body of literature on the economic theory of international standards, and their presumed effects, much less is known about how international standards work in practice. This paper surveys empirical studies investigating the relationship between international standards and trade. The main focus is on econometric studies using secondary data on international standards and trade, but surveys and some of the literature investigating the relationship between standards and other economic measures, such as productivity, growth and welfare are also summarised.
The paper sets out some conclusions that can be drawn from the econometric studies that have sought to estimate the relationship between international standards and trade:
- In most studies, when exporting countries use international standards, this has in most cases a positive (or at least neutral) effect on their export performance.
- When exporting countries use national standards (i.e. standards specific to country x), that may lead to superior export performance by x.
- When the importing countries also adopt international standards, the most common effect is also to increase imports. The exceptions can in part be explained.
- When the importing country uses national standards, the results are more diffuse. For studies that relate exclusively to voluntary standards, the effects are distributed quite evenly. For studies that relate to regulations (i.e. mandatory standards), the effects on imports tend to be negative.
A full copy of the report is available from the OECD website.
This report provides a comprehensive account of quality systems for private sector development: what works on the ground and what doesn’t, and why. It explains why quality and standards matter for export growth, productivity, industrial upgrading, and diffusion of innovation, all central ingredients in improving economic growth and generating real gains in poverty reduction. The report examines the diversity of institutions, linkages, and arrangements involved in quality systems, identifying success factors and obstacles in the quality strategies of particular countries. A portion of the volume is devoted to experiences in Latin America and the Caribbean, a region with a great deal at stake in the drive to improve quality. Policy makers in Latin America and throughout the developing world will find Quality Systems and Standards for a Competitive Edge to be a valuable tool for meeting the challenges of building trade competitiveness in the new global economy.
A full copy of the report is available on the World Bank website.
In many countries in Eastern Europe and Central Asia (ECA), the National Quality Infrastructure (NQI) does not support business competitiveness, though this is one of its functions in organization for economic co-operation and development countries. In most of the Commonwealth of Independent States (CIS) countries, it even impedes competitiveness. The most common economic benefits of adopting standards include increased productive and innovative efficiency. Standards lead to economies of scale, allowing suppliers to achieve lower costs per unit by producing large, homogeneous batches of products. Standards spur and disseminate innovation, solve coordination failures, and facilitate the development of profitable networks. Participation in world trade increasingly requires that suppliers comply with standards determined by lead buyers in global value chains. The nature of participation in the global economy has changed dramatically over the past two decades. Rarely do producers turn raw materials into final products and sell them directly to customers. Improving the quality of goods and services and diversifying into sectors where quality matters can be a sustainable source of global competitiveness. Some of the productive tasks associated with high-quality goods have high learning and technological externalities. In those sectors, producers tend to form tight relationships with global buyers who transfer their knowledge and support the producers’ quality-upgrading processes. Diversifying into a broad range of sectors also reduces macroeconomic volatility, but quality upgrading becomes necessary to enter new sectors that compete on quality.
A full copy of the report is available on the World Bank website.
Citation “Racine, Jean-Louis. 2011. Harnessing Quality for Global Competitiveness in Eastern Europe and Central Asia. World Bank. © World Bank. https://openknowledge.worldbank.org/handle/10986/2305 License: CC BY 3.0 IGO.”
National Quality Infrastructure (NQI) reforms are an important part of broader efforts aimed at enhancing trade and investment opportunities, opening markets for new innovative products, and improving the business environment. As demand to access new markets and compete with higher quality products rises, the World Bank Group is committed to supporting government’s efforts to build a more harmonized and integrated NQI. This leaflet sets out how the World Bank can support the development of standards, accreditation and metrology systems to boost economic performance and cross-border investment decisions.
A full copy of the leaflet is available here. World Bank NQI Leaflet
Standards define how products, processes, and people interact with each other and their environments. They enhance competitiveness by offering proof that products and services adhere to requirements of governments or the marketplace. When used effectively, they facilitate international trade and contribute to technology upgrading and absorption. This brief discusses the importance, the central elements, and constraints to success of national quality infrastructure.
A full copy of the policy document is available on the World Bank website.
This report draws on UNECE assessment models and incorporates the lessons learnt from the needs assessment studies on Belarus and Kazakhstan, carried out by the UNECE secretariat in 2010 and 2011, respectively. The methodology is meant to bring to the fore:
- A common understanding of key regulatory and procedural barriers to trade. While actors may have a broadly shared intuitive view of such obstacles, they may differ at the technical level when it comes to attributing causes to each obstacle and to estimating the magnitude of its impact.
- A common approach to addressing the identified barriers in a manner that is responsive to the specific needs of each country and every actor in the international trade supply chain.
- Conflicting policy objectives related to trade development and trade facilitation.
- Procedures and regulations that could be improved through systematic:
- Simplification – the elimination of all unnecessary elements and duplication in formalities, processes and procedures;
- Harmonization – the alignment of national formalities, procedures, documents, information, and operations with acceptable international commercial norms, practices and recommendations.
- Standardization – the implementation of internationally recognized formats for procedures, as well as documentary and information requirements.
- Capacity shortfalls in the existing trade support institutional framework (understood as comprising infrastructure, trade support organizations and state agencies, including those involved in supporting quality control), which could be improved through targeted investments.
- Shortcomings in existing public-private sector consultative mechanisms related to the development and implementation of regulatory policies
A special focus is also given to assessing national standardization policies, technical regulations, quality assurance, accreditation and metrology (SQAM) system, in terms of its capacity to contribute to a conducive trading environment where regulatory and procedural barriers are reduced to a minimum.
A full copy of the report is available on the UNECE website.
This report gathers together OECD working papers on the tools, governance and institutions of better regulation and their impact on policy outcomes. It includes both technical and analytical material, prepared by staff and experts in the field. Together, the papers provide valuable context and background for OECD publications on regulatory policy and governance.
The paper relies on an empirical stocktaking of mutual recognition agreements (MRAs) among selected OECD countries, the systematic review of mutual recognition clauses in trade agreements, case studies of the specific experience of the EU internal market, the Trans-Tasman arrangement, and the MRA between the US and the EU, and an extensive review of the literature. The report references the ILAC MRA and the IAF MLA as case studies.
A full report is available on the OECD website.
Anabela Correia de Brito, Céline Kauffmann, Jacques Pelkmans
The authors examine the impact of technical standards on trade in global value chains (GVCs), and find that while national standards hamper trade in European value chains, European and international standards foster trade. European standards have greater influence on trade in value-added whereas international standards have strong effects on gross trade flows. European standards therefore connect market actors in European value chains. Because gross trade figures contain value from outside of Europe, international standards facilitate trade with market actors from non-European countries. In addition, the authors find a positive trade effect of the interaction term between national and European standards. These standards generate gains from trade when their specifications are combined in the production process.
The paper is available from the ResearchGate website.
Florian Ramela, Axel Mangelsdorf, Knut Blind
The paper addresses the role of technical standards in bilateral trade relationship between the European Union (EU) and China. Traditional aggregate demand functions for imports and exports have been applied to estimate the effects of national and international standards. The panel dataset covers 14 years (1995–2008) and 36 two-digit technological fields based on the International Classification of Standards (ICS). The results indicate negative effects of purely national Chinese standards but positive effects of Chinese international standards for European exports. European standards and European standards aligned with international standards have a positive impact on exports and imports. Based on these results, we conclude that both China and the EU should increase their efforts to harmonise national standards.
The role of technical standards for trade between China and the European Union (PDF Download Available). Available from: https://www.researchgate.net/publication/230770619_The_role_of_technical_standards_for_trade_between_China_and_the_European_Union
Axel Mangelsdorf, BAM Federal Institute of Material Research and Testing, Germany
Further, building on the theory of performance frontiers, we investigate these relationships across plants located in different economic regions of the world (plants are classified into emerging, developing and industrialized regions). We suggest that recent emphasis on these environmental initiatives has been greatest among plants located in emerging economies, compared to their counterparts in industrialized and developing nations. In addition, we contend that the influence of these initiatives is greatest for plants located in emerging and developing economies when compared to plants in industrialized nations. These notions are tested with data collected from 1211 plants located in these three economic regions. Overall, this study contributes to the investigation of strategies for sustainable business development, highlighting important implications for both theory and practice.
Tobias Schoenherr, The Eli Broad Graduate School of Management, Michigan State University, Department of Supply Chain Management, USA
‘The role of environmental management in sustainable business development: A multi-country investigation‘, International Journal of Production Economics, Volume 140, Issue 1, November 2012, Pages 116–128
The World Trade Organization (WTO) Economic Research and Statistics Division produced the report ‘International Standards and the WTO TBT Agreement: Improving Governance for Regulatory Alignment‘ (Erik Wijkström and Devin McDaniels, WTO, 19 March 2013), with some key points on the value of key conformity assessment tools such as ISO standards and ILAC accreditation.
Of particular interest as regards conformity assessment is 3.1.1, the section on Specific Trade Concerns, ‘One of the core functions of the TBT Committee is acting as a forum to address trade issues – these are referred to as “Specific Trade Concerns” (STCs). These are concerns that one or several Members have with the design or implementation of another Member’s measure. An analysis of the TBT (Technical Barriers to Trade) Committee’s records shows that about one third of all STCs raised in the TBT Committee are associated in one way or another with the subject of international standards. By “associated” we mean that international standards have been mentioned by a delegation in the discussion of a particular trade concern – either by reference to a specific body or organization, or through general reference to the existence (or non-existence) of some source of international guidance.’
‘While over forty different bodies or organizations are mentioned, a number of them recur frequently in discussion. The International Organization for Standardization (ISO) is mentioned in 30% of STCs associated with international standards; the International Laboratory Accreditation Cooperation (ILAC) in 10%.’
The report gives a number of examples of the kind of problem, including: ‘Lead in pottery. The European Union objected to a Mexican draft standard for glazed pottery, ceramics and porcelain, which mandated more stringent lead and cadmium limits than those laid down in the relevant international ISO standards (ISO 6486-1/2). Specifically, the European Union was concerned that Mexican authorities would no longer accept test results accompanying EU ceramic tableware conducted in compliance with these ISO standards. Mexico explained that while its draft standard was partially based on ISO standards, it deviated in certain aspects due to a greater level of health protection required by Mexico, and due to the circumstances of Mexico as a developing country.’
The conclusion of this kind of problem is that ‘The vast majority (around 90%) relate to some form of “challenge” on international standards (from one Member to another). The tone of the discussions may range from a polite request for clarification about the use or non-use of international standards in a measure, to a direct accusation that a Member is not following a specific (and in their view relevant) international standard and therefore violating a WTO discipline.’
The use of international standards and systems in world trade, such as ISO and ILAC which stick to the ‘Six Principles’ of Transparency, Openness, Impartiality and Consensus, Effectiveness and Relevance, Coherence and Development Dimension, would reduce the instances of the STCs.
Companies use standards as a tool to signal their investments in quality upgrading and performance. The authors argue that the impact of this signal depends on the trust in the accreditation system and the development status of a country. Representing the workhorse of research in international trade, the authors use a gravity model to examine the trade effects of ISO 9000 diffusion and cooperation in accreditation. The model is estimated by applying a country-pair fixed effects regression approach with instrumental variables and multilateral resistance terms to a panel data set covering a 13-year period from 1999 to 2012. This allows them to test their hypotheses with respect to the moderating role of international cooperation in accreditation on the trade effects of ISO 9000 diffusion. They show that certification promotes trade and that signatories to the Multilateral Recognition Arrangement of the International Accreditation Forum (IAF MLA) trade significantly more. The IAF MLA is of particular importance to the trade among developing countries. For policy makers, our results highlight the importance of support for accreditation institutions in developing countries.
A full copy of the report is available from the Research Gate website.
Authors: Axel Mangelsdorf, Knut Blind, Jakob Pohlisch
Setting up a Quality Infrastructure System is one of the most positive and practical steps that a developing nation can take on the path forward to developing a thriving economy as a basis for prosperity, health and well-being.
UNIDO published this short video to set out the fundamental principles of developing a national quality infrastructure to ensure that the system contributes to governmental policy objectives in areas including industrial development, trade competitiveness in global markets, the efficient use of natural and human resources, food safety, health, the environment and climate change.
The concept of the Environmental Technology Verification programme is to offer a verification procedure to cutting edge environmental technologies that may otherwise find it difficult to establish their environmental added value. The verification procedure allows for an independent assessment and validation of the manufacturer’s claims on the performance and environmental benefits of their technology.
This video prepared by the ETA-Danmark and DANETV provides an introduction to ETV. Sub-titles are available in Czech, Finnish, French, German, Italian, Polish, Spanish and Swedish. To select the language, open the scroll menu ‘Subtitles/CC’ on the bar under the video.
To support World Accreditation Day 2018, a short video was produced to demonstrate how accreditation delivers a safer world. The expectation of safe workplaces, safe products, safe transport, safe food, in fact all aspects of our lives is universally shared. Statistics however show that the expectation is not being matched by the reality.
A series of short case study videos can also be viewed on the ILAC / IAF YouTube channel.
ISO 13485:2016 – Medical devices – A practical guide has been authored by technical experts of ISO/TC 210. The handbook is intended to guide organizations in the development, implementation and maintenance of their quality management system in accordance with ISO 13485. Organizations active in the medical device sector, such as manufacturers, importers, distributors, service providers, certification bodies or regulatory bodies, can benefit from this publication.
The United Nations Economic Commission for Europe (UNECE), has updated its trade recommendations to include references national accreditation systems and the global arrangements. UNECE Working Party 6 on Regulatory Cooperation & Standardization Policies which works to:
- Promote the use of standards by policy-makers and business as a tool for reducing technical barriers to trade, promote increased resilience to disasters, foster innovation and good governance
- Promote the use of standards in the implementation of UN-wide goals, including the implementation of the Agenda 2030 and the Sendai framework for action
Sixteen UNECE recommendations have been adopted to address standardization and regulatory issues. They set out good practice regarding Regulatory cooperation, Metrology, Standards and Norms, Conformity assessment, and Market surveillance.
While these recommendations are not binding and do not aim at rigidly aligning technical regulations across countries, they are used to encourage policy makers to base their regulations on international standards to provide a common denominator to the norms that apply in different markets.
All sixteen recommendations can be downloaded from the UNECE website.
The recommendations that reference accreditation are:
Recommendation G: Acceptance of Conformity Assessment Results
ISO/CASCO has published a new brochure describing how “ISO Technical Committees (ISO/TCs) are often required to choose between developing requirements for a management system for an organisation’s activities, or developing requirements for the competence of an organisation to carry out its activities”.
Not only does this document assist ISO/TCs in understanding the difference between the two standards, but it is also helpful for organisations in the process of deciding whether to implement a management system or a competency based system. In addition, the brochure indicates the benefits and values of meeting either set of requirements.
The ISO/CASCO document – Frequency Asked Questions: Competency or Management System Based Standards?” is available here.
ISO has published a guide for SME’s wishing to implement a quality management system (QMS), providing practical advice and concrete examples tailored specifically for small businesses. A copy of the guidance is available from the ISO website.
UNIDO has published a briefing note to set out how setting up a Quality Infrastructure System can be one of the most positive and practical steps that a developing nation can take on the path forward to developing a thriving economy as a basis for prosperity, health and well-being. A Quality Infrastructure is a system contributing to governmental policy objectives in areas including industrial development, trade competitiveness in global markets, efficient use of natural and human resources, food safety, health, the environment and climate change.
Download a copy of the briefing note from the UNIDO website.
UNIDO has published a new brochure which highlights the contribution of accredited conformity assessment services to the implementation of the 2030 Agenda for Sustainable Development. UNIDO’s vision to address today’s economic, social and environmental challenges is enshrined in the Lima Declaration, adopted by UNIDO Member States in December 2013. On this basis, UNIDO pursues “Inclusive and Sustainable Industrial Development” to harness industry’s full potential to contribute to lasting prosperity for all.
17 Sustainable Development Goals (SDGs) with 169 associated targets constitute the core of the UNIDO 2030 Agenda for Sustainable Development. These provide a new development framework that seeks to transform the world and guide all global, regional and national development endeavours for the next 15 years. UNIDO’s programmatic approach is guided by three interrelated thematic priorities: creating shared prosperity, advancing economic competitiveness, and safeguarding the environment.
Maintaining strategic partnerships and technical cooperations, together with the use of standards and compliance related activities, also form an important part of UNIDO’s approach. The relationship between UNIDO, the International Accreditation Forum (IAF), and ILAC is one such partnership. This strategic partnership in the field of accreditation enables UNIDO, IAF and ILAC to coordinate activities in complementary and mutually supportive areas of operation, in order to enhance the impact of industrial development on economic growth.
A copy of the brochure is available on the UNIDO website.
The significance of an accreditation system for trade and the economy, as well as practical advice for the establishment of accreditation bodies, are the focus of a newly released publication titled, “Establishing accreditation in developing economies – A guide to opening the door for global trade”.
Prepared by the United Nations Industrial Development Organization (UNIDO), in cooperation with the International Accreditation Forum (IAF) and the International Laboratory Accreditation Cooperation (ILAC), the publication was launched at the ILAC – IAF joint General Assembly. The guide aims to support the common goal of “tested, inspected or certified once and accepted everywhere”.
It is comprised of two parts. The first part focuses on the need for accreditation and the benefits that an accreditation system can bring to good governance. It provides policymakers with a framework for establishing an accreditation body or partnering with neighbouring economies to form a shared system, which can bring an economy closer to its trading partners through mutually recognized arrangements of accreditation.
The second part offers comprehensive practical advice and building blocks to those who are tasked with establishing an accreditation body. It presents information on the essential operational requirements for accreditation bodies, and outlines available resources, as well as potential challenges. Case studies then follow to offer an illustration of practical applications of the guidance provided in the publication.
A copy of the brochure is available on the UNIDO website.
As someone who is involved in the selection of suppliers and, possibly, responsible for making purchasing decisions, you may have seen or used products and services that are promoted using reference to ISO 9001:2015. This informative text provides some answers to these questions and will inform you about how you can get the most out of using ISO 9001 as a supply chain tool.
A full copy of the brochure is available from the ISO website.
A booklet created by European Accreditation sets out how the ISO CASCO toolbox can support the work of Regulators.
View the booklet on the EA website.
UNIDO’s Trade Capacity Building Branch has published a briefing paper to set out how it can support Developing Economies develop the effective building blocks of using accredited testing, inspection and certification, using hamonized standards, in order to boost trade.
Download a copy of the briefing from the UNIDO website.
A short video to show how standards, metrology and accreditation can help sustainable development in Developing economies.
Click to view.
Accreditation is a tool to demonstrate the competence of medical laboratories and ensure the delivery of timely, accurate and reliable results. Read more…
Accredited laboratories, inspection bodies, and certification bodies play a key role in both the provision of traditional energy sources and the development of renewables. Energy providers rely on accurate testing to monitor a range of areas from measuring flow and pressure to production output levels. Inspections are carried out to ensure that installations are safe. While certification demonstrates that providers have the appropriate processes and procedures in place to deliver the products and services.
Accredited testing, inspection and certification supports the provision of safe food and clean drinking water. Read more..
Regulators are increasingly relying on independent third party declarations of compliance to support their enforcement and monitoring activities.
The ILAC MRA and the IAF MLA remove the need for products and services to undergo additional tests, inspections and certification in each country where they are sold. These Arrangements remove technical barriers and therefore support cross-border trade.
The ILAC MRA supports international trade by promoting international confidence and acceptance of accredited laboratory data and inspection body data. Technical barriers to trade, such as the retesting of products, each time they enter a new economy would be reduced.
SGS has created a portfolio of solutions to support compliance with regulatory requirements, enhance government revenue, facilitate trade, support efficiency and promote good governance along with sustainable development.
Using standards in technical regulations promotes international regulatory coherence; helps companies, communities and organizations move toward a more resilient and sustainable model of production and consumption; and helps to protect environmental resources.
The video was developed by the Working Party for Regulatory Cooperation and Standardization Policies (WP6) of the United Nations Economic Commission for Europe. The video depicts the Standards for the SDGs event, which took place as a side session to the 41st ISO General Assembly (GA) and brought together representatives of the standards community, UN agencies, corporate entities, diplomats and national policymakers.
UNECE’s Working Party on Regulatory Cooperation and Standardization Policies (WP6) works to promote the use of standards for the achievement of UN-wide goals, including the implementation of the Agenda 2030 and the Sendai framework for action: