A Europe-wide study conducted by the International Federation of Inspection Agencies (IFIA) has revealed that nearly 80% of products tested bearing the CE-mark through self-declaration of conformity (SDoC) did not comply with EU regulations. The survey also found that 16% of products 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.
For sensitive and high-risk products, a more robust approach that relies on independent third party, on either a mandatory or voluntary basis, should be taken to ensure that products placed on the market are safe, compliant and sustainable.
A press release summarising the finding is available on the IFIA website.
A full copy of the report is available here.
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
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
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.
The Central America region is a small market. The region contains around 43 million inhabitants (0.6 percent of total world population) who generate around 0.25 percent of the world’s Gross Domestic Product (GDP). While the region has successfully embarked on a regional integration agenda and has strong commercial links with the US, extra-regional trade-mainly with large fast-growing emerging economies-remains a challenge. Export performance is analyzed along three dimensions that, together, give a fairly comprehensive picture of competitiveness:
1) the composition, orientation and growth of the export basket;
2) the degree of export diversification across products and markets; and
3) the level of sophistication and quality of their main exports.
This analysis allows exports dynamics at the different margins of trade (intensive, extensive, and quality) to be evaluated and individual countries’ to be benchmarked with peers in the Central American region. The results of this report allow policy makers to identify key areas to explore in the overall discussion of export competitiveness in the Central American region. This paper relates to the literature on challenges and opportunities that trade liberalization can bring to the Central American region. Much of the recent literature focuses on the role of the free trade agreement negotiated by Costa Rica, the Dominican Republic, El Salvador, Guatemala, Honduras, and Nicaragua, with the US.
Given the importance quality infrastructure plays in advancing the trade agenda, greater priority should be given to developing accreditation, standards, and metrology and obtaining international recognition to unlock their export potential.
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.
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.