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.
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.
The Department of Homeland Security’s BioWatch Program provides early detection of a bioterrorism event and helps communities prepare a coordinated response. The combination of detection, rapid notification, and response planning helps federal, state, and local decision-makers take steps to save lives and mitigate damage.
BioWatch is managed by the Office of Health Affairs in the Department of Homeland Security, supported by other federal agencies, and operated by a network of scientists, laboratory technicians, emergency managers, and public health officials in each of the 30+ BioWatch jurisdictions.
The BioWatch QA Program ensures that the BioWatch Program continues to provide actionable results with high confidence to local public health decision makers. The QA Program was established in 2011 to ensure field and laboratory operations are conducted according to program policies, protocols, and QA and quality control (QC) requirements to ensure the defensibility of results. Laboratories must be accredited to participate.
Further information is available on the Government website.
The Clark County Department of Building and Fire Prevention in Nevada has gained accreditation to demonstrate competence to administer an effective system of code enforcement, fire prevention, life safety programs, to the community it serves.
Accreditation is awarded to the International Accreditation Service’s (IAS) Fire Prevention/Life Safety Department Accreditation program. To achieve accreditation, Clark County demonstrated compliance with the IAS Accreditation Criteria for Fire Prevention/Life Safety Departments (AC426).
Further information is available on the IAS website.
In the United States, the U.S. Federal Communications Commission (FCC) has adopted a rule that permits recognition of Self Declaration of Conformity for certain information technology devices. For other equipment, such as personal computers and attachments thereto, the FCC allows the equipment declared compliant by the supplier, under a process called Declaration of Conformity, provided that supporting test results are obtained from a recognised laboratory.
Further information is available on the FCC website.
The US Department of Energy (DOE) has amended its chronic beryllium disease prevention program regulation. The amendments improve and strengthen the current provisions and continue to be applicable to DOE Federal and contractor employees who are, were, or potentially were exposed to beryllium at DOE sites. Samples that are collected must be analysed by an accredited laboratory to ensure that the testing is carried out by a competent body.
Further information is available on the federal register.
Third party testing labs must meet certain accreditation criteria in order to be allowed to test useable marijuana and marijuana products under the I-502 regulatory system in Washington State. The program confirms that cannabis laboratories are compliant with state and local regulations and that they adhere to the same standards. It provides confidence to patients as well as regulators that their test results on these products are accurate and consistent.
Further information is available on the Washington State government website.
The National Defense Authorization Act (NDAA) marks changes for military on all levels— including the launch of pioneering legislation of quality assurance of certification programs and standards for professional credentials obtained by members of the Armed Forces. Accreditation for certification bodies would meet the requirements of the legislation.
This law puts in place a mechanism for quality assurance of certifications thereby recognizing only those certification programs that meet a national/international standard. Programs accredited under the Personnel Certification Accreditation Program (PER) are in compliance with the legislation. This is specifically described in the legislation, Section 559 – Quality Assurance of Certification Programs and Standards for Professional Credentials obtained by members of the Armed Forces.
Further information is available on the ANSI 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.
The Office of Management and Budget (OMB), the business division of the Executive Office of the President of the United States that administers the United States federal budget and oversees the performance of federal agencies, published a revised Circular on the federal use and development of voluntary standards:Federal Participation in the Development and Use of Voluntary Consensus Standards and in Conformity Assessment Activities. U.S. federal agency use of the global accreditation infrastructure continues to grow in line with the OMB conformity assessment policy.
Download the circular from the Office of Management and Budget website.
The US Justice Department requires department-run forensic labs to obtain and maintain accreditation and requires all department prosecutors to use accredited labs to process forensic evidence when practicable. Additionally, the department has decided to use its grant funding mechanisms to encourage other labs around the country to pursue accreditation.
The new policies arose out of recommendations made by the National Commission of Forensic Science (NCFS), which was established to advance the field of forensic science and make suggestions to the Attorney General on how to ensure that reliable and scientifically valid evidence is used when solving crimes.
Further information is available from the US Justice Department 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.
LED Lighting Facts is a U.S. Department of Energy programme that involves LED products for general illumination from manufacturers who commit to testing products and reporting performance results according to industry standards. The programme requires the use of accredited testing laboratories and will accept results from laboratories accredited by ILAC MRA signatories.
Further information is available from the official programme website.
The US Energy Department, to support its energy conservation programme, has clarified its Energy Conservation Standards and Test Procedures for Fluorescent Lamp Ballasts.
It is adopting the requirement that testing “must be conducted by test laboratories accredited by an Accreditation Body that is a signatory member to the ILAC MRA.
Further details of can be found on the DoE website.
The EPA has recently revised the requirements for testing and certification of new residential wood heaters and other products listed in 40 CFR Part 60. These new requirements call for accreditation of third party certification bodies to the ISO/IEC 17065:2012, ISO/IEC 17020:2012, and ISO/IEC 17025:2005 standards by an ILAC MRA and IAF MLA signatory accreditation body in order to gain recognition from the EPA to certify the products covered in this part of the Code of Federal Regulations.
Further information is available here.
The Houston Police Department (HPD) has used certification to ISO 9001 in a number of carefully selected Divisions.
The HPD Property and Emergency Communications Divisions used the implementation and certification of ISO 9001 to drive efficiencies in these two departments. Having initially been certified in 2011, in 2015 the HPD is now looking at expanding the scope of their ISO 9001 certification to include the Budget & Finance, Mental Health and Inspections Divisions.
At the announcement of the certification, Police Chief Charles A. McClelland Jr said, “We are constantly examining ourselves and looking for efficiencies because our resources are very precious. This certification indicates we are following best practices in the industry and we’re the leaders”.
Further details here.
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
In describing the benefits of the standard, the Department states, ‘In the business world, a popular adage states that you can’t manage what you don’t measure. This principle applies to the world of energy management—an area of growing interest and concern to enterprises around the world due to its potential to help control costs, boost energy efficiency, improve environmental quality and enhance competitiveness’.
The Department of Energy has worked with a number of key bodies to develop the Superior Energy Performance® program, where ‘SEP fosters a results-oriented approach to using the ISO 50001 global energy management system standard, emphasizing measurable savings through a transparent, independent, and highly regarded verification process.’
Further details can be seen here
The US Nuclear Regulator (the US NRC) recognises the ILAC MRA for licensees and suppliers of basic components for use on power plants and fuel reprocessing plants by using laboratory accreditation by Accreditation Bodies (ABs) that are signatories to the ILAC Mutual Recognition Arrangement (MRA).
This replaces the need to perform commercial-grade surveys for the procurement of calibration and testing services performed by domestic and international laboratories accredited by signatories to the ILAC MRA.
Under Title 47 of the United States Code of Federal Regulations, the FCC requires that a laboratory that has been accredited (to ISO/IEC 17025) with a scope covering the required measurements shall be deemed competent to test and submit test data for equipment subject to verification, Declaration of Conformity, and certification under the Equipment Authorization Procedures. In addition, the FCC also requires that to be designated as a TCB (Certification Body) under this section, an entity shall, by means of accreditation, meet all the appropriate specifications in ISO/IEC Guide 65 (now ISO/IEC 17065) for the scope of equipment it will certify.
Since 2002, the FCC Equipment Authorization Program has experienced a 13% growth rate each year, and in 2014, the product certification bodies recognized under this program processed over 21,000 grants of equipment certification. The US Customs and Border Patrol Agency receive over 1 million filings per month, requesting importation of these certified devices – whose compliance to FCC rules is reliant upon accredited conformity assessment activities.
More information regarding FCC requirements for test laboratories and product certification bodies under the Equipment Authorization Program can be found at:
The Federal Aviation Administration (FAA) requires the use of laboratories accredited by ILAC MRA signatories to determine airworthiness. Precision tools and test equipment must be calibrated in accredited laboratories which repair station personnel use to make airworthiness determinations.
Testing of crash mitigation equipment and devices need to be tested in accordance with Federal Highway Administration (FHWA) specifications by a laboratory accredited by an ILAC MRA signatory accreditation body.
The FHWA determined that using accredited laboratories will improve the agency’s ability to trust that crash test laboratories are qualified to conduct and evaluate tests intended to determine the crashworthiness of roadside safety features. FHWA also determined that laboratory accreditation is widely recognised as a reliable indicator of technical competence.
The Food and Drug Administration (FDA) issued draft guidance on data packages that addressed its preference to have food tested by laboratories accredited by an ILAC MRA signatory accreditation body to assure data credibility in 2008.
The Food Safety Modernization Act, enacted on Jan. 4, 2011, gives a statutory mandate to the FDA for recognition of laboratory accreditation associated with the testing of food. FDA is developing regulations to implement this provision.
The Food Safety Modernization Act calls for laboratory accreditation with FDA appearing to lean toward using the ILAC MRA to recognise accreditation bodies. The FDA also supports US state public health laboratories to get accredited by ILAC MRA signatories by August 2017.
The ENERGY STAR and WaterSense programs include requirements that test data from third-party laboratories come from labs accredited by signatories to the ILAC MRA. Both programs are administered by the U.S. Environmental Protection Agency, but participation is voluntary rather than mandatory. EPA cites these international arrangements to provide greater assurance to consumers that products carrying the ENERGY STAR and WaterSense labels meet strict program requirements.
For more information on the ENERGY STAR programme, click here.
Further information on the WaterSense programme is available here.
In addition, there is a proposed rule to control formaldehyde emissions from composite wood products to require test results from a laboratory accredited by an ILAC MRA signatory accreditation body.
This policy decision cited scheduling delays and increased expenses as a reason for using laboratories accredited by an ILAC Signatory rather than the use of Coast Guard-employed inspectors. Additionally, the USCG called out the modern trading system where many manufacturers produce lifesaving equipment for multiple-flag vessels, and must have their equipment approved by each nation. Using third-party accredited testing laboratories would allow manufacturers to satisfy requirements from multiple nations, which avoids the need for duplicative tests.
The DoD Environmental Laboratory Accreditation Program uses only accreditation bodies that are ILAC MRA signatories. A Cooperative agreement must be agreed, and the DoD requires additional quality control requirements supplementing ISO/IEC 17025.
The U.S. General Services Administration requires star of life ambulances procured by the U.S. government to be tested by an independent laboratory accredited in accordance with ISO/IEC 17025 by an accreditation body that is a signatory to the ILAC MRA.
All of the GSA’s ambulance standards are used to validate that their contractors are producing a quality product, and the MRA is one tool among many in their assessment of quality. They accept accreditation from MRA signatories but still perform source inspections on each ambulance ordered and procured for federal agencies under a GSA contract.
The agency still does its own inspection but has confidence that the critical components of the ambulance have been tested by competent laboratories.
The CPSC issued regulations to recognise test data associated with children’s products coming from laboratories accredited by an ILAC MRA signatory accreditation body. CPSC registers laboratories that can perform compliance testing based on a simple application process identifying the relevant scope of accreditation from an ILAC MRA signatory accreditation body.
This move enabled CPSC to leverage its limited resources, yet provide for the acceptance of test data originating from the countries of export and reducing the need for redundant testing upon import.
Many children’s products continue to be added within the scope of this requirement for accreditation.
In the UK, Lancashire Constabulary set a precedent by being the first Police Force outside of the Metropolitan Police Service (MPS) to set up their own in-house Forensics Service, thereby saving over £500,000 a year.
To ensure compliance to ISO/IEC 17025, the Forensics Lab has achieved UKAS Accreditation for a number of tests enabling it to run crime scene investigations and demonstrate its capability for forensic provision equals that of external providers and private companies. (UK)
In July 2003, the Records and Identification Bureau of the Phoenix Police Department, Arizona, became the first law enforcement unit in the United States to certify its quality management system to ISO 9001. This case study describes the pioneering implementation of the standard in an “industry” where life-altering decisions are made 24/7 – 24 hours a day, seven days a week and resulted in savings of $11 million. (USA)
In July 2003, the Records and Identification Bureau of the Phoenix Police Department, Arizona, became the first law enforcement unit in the United States to certify its quality management system to ISO 9001. This case study describes the pioneering implementation of the standard in an “industry” where life-altering decisions are made 24/7 – 24 hours a day, seven days a week. (USA)
The U.S. Food and Drug Administration has adopted the use of accreditation in its oversight of imported foods. The FDA recognises accreditation under the voluntary Accredited Third-Party Certification Program.
Accreditation bodies recognised by FDA have the authority to accredit third-party certification bodies, which once accredited, can conduct food safety audits and issue certifications of foreign food facilities (including farms) and the foods – both human and animal – that they produce.
The FDA has also launched a Voluntary Qualified Importer Program (VQIP), a voluntary fee-based program which offers expedited review and entry of human and animal food into the United States. Importers interested in participating in VQIP will be required to meet a number of eligibility requirements, which include ensuring the facilities of their foreign supplier are certified under the Accredited Third-Party Certification Program.
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
There has been an increase in interest towards corporate activities aimed at reducing or eliminating the waste created during the production, use and/or disposal of the firm’s products. Prior research has focused on the need for such activities, while current research tries to identify those components that encourage or discourage such activities. As a result of the introduction of ISO 14001, attention has turned to corporate environmental management systems (EMS). The underlying assumption is that such a system is critical to a firm’s ability to reduce waste and pollution while simultaneously improving overall performance. This study evaluates this assumption. Drawing on data provided by a survey of North American managers, their attitudes toward EMS and ISO 14001, this study assesses the relative effects of having a formal but uncertified EMS compared to having a formal, certified system.
The results strongly demonstrate that firms in possession of a formal EMS perceive impacts well beyond pollution abatement and see a critical positive impact on many dimensions of operations performance. The results also show that firms having gone through EMS certification experience a greater impact on performance than do firms that have not certified their EMS. Additionally, experience with these systems over time has a greater impact on the selection and use of environmental options. These results demonstrate the need for further investigation into EMS, the environmental options a firm chooses, and the direct and indirect relationships between these systems and performance.
Steven A Melnyka, Robert P Sroufeb, Roger Calantonea, – a Department of Marketing and Supply Chain Management, The Eli Broad Graduate School of Management, Michigan State University, USA; b Department of Operations and Strategic Management, Wallace E. Carroll School of Management, Boston College, USA
Melnyk, S.A., Sroufe, R.P., Calantone, R., (2003), ‘Assessing the Impact of Environmental Management Systems on Corporate and Environmental Performance’, Journal of Operations Management, Vol. 21, Issue 3, 329-351
Voluntary environmental programs are codes of progressive environmental conduct that firms pledge to adopt. This paper investigates whether ISO 14001, a voluntary program with a weak sword—a weak monitoring and sanctioning mechanism—can mitigate shirking and improve participants’ environmental performance. Sponsored by the International Organization for Standardization (ISO), ISO 14001 is the most widely adopted voluntary environmental program in the world. The analysis of over 3,000 facilities regulated as major sources under the U.S. Clean Air Act suggests that ISO 14001-certified facilities reduce their pollution emissions more than non-certified facilities. This result persists even after controlling for facilities’ emission and regulatory compliance histories as well as addressing potential endogeneity issues between facilities’ environmental performance and their decisions to join ISO 14001.
Matthew Potoski, Iowa State University; Aseem Prakash, (Potoski), University of Washington (2005), ‘Covenants with weak swords: ISO 14001 and facilities’ environmental performance’, Journal of Policy Analysis and Management, Volume 24, Issue 4, pp 745- 769.
‘Covenants with weak swords: ISO 14001 and facilities’ environmental performance‘, Journal of Policy Analysis and Management, Volume 24, Issue 4, pages 745–769, Autumn (Fall) 2005
The research published in ‘Green clubs and voluntary governance: ISO 14001 and firms’ regulatory compliance’ (Potoski, M., Prakash, A., 2005), looks at the role of certification as a type of voluntary program, increasingly used as policy tools. Referred to as a ‘club’, these clubs ‘promulgate standards of conduct targeted to produce public benefits by changing members’ behaviors’. In particular, the research sought to understand if certification to ISO 14001 reduces time spent complying with government regulation, in this case the Clean Air Act in the US. To do this, an empirical analysis of 3700 US facilities compared the regulatory records of certified and non-certified facilities.
The conclusion of the research ‘indicates that joining ISO 14001, an important nongovernmental voluntary program, improves facilities’ compliance with government regulations. We conjecture that ISO 14001 is effective because its broad positive standing with external audiences provides a reputational benefit that helps induce facilities to take costly progressive environmental action they would not take unilaterally’.
The report goes on to say , ‘The results imply that as a group ISO 14001 certified facilities have better compliance records than if they had not joined the program’. At the heart of this is the behaviour that membership of the ‘club’, in this case being certified, promotes. For example the report states, ‘We conjecture that ISO 14001’s mandated third-party auditing mitigates wilful noncompliance by compelling members to measure up to club standards while ISO 14001’s EMS standards address noncompliance stemming from ignorance by directing members’ attention to root causes of regulatory noncompliance’.
Matthew Potoski, Iowa State University; Aseem Prakash, University of Washington
Potoski, M., Prakash, A. (2005), ‘Green clubs and voluntary governance: ISO 14001 and firms’ regulatory compliance’, American Journal of Political Science, Vol. 49; Issue 2; pp 235-248.
Formally adopted in 1996 by the International Organization of Standardization, ISO 14000 represents a new voluntary international environmental standard, which will likely be adopted by the vast majority of corporations. Its major focus is on the structure, implementation, and maintenance of a formal environmental management system. While the literature is clearly divided in its assessment of ISO 14000, an underlying common theme is that the decision to achieve ISO 14000 certification constitutes a major undertaking for most firms. Such an undertaking, it is argued, does not take place in a vacuum. Rather, it is a response to a number of factors or influences. However, no research to date has empirically identified these factors and explained how they can be leveraged into a competitive advantage. In this article, we use qualitative case studies to identify which factors affect the decision to attain ISO 14000 certification and we also explain how these factors can influence the level of success achieved during the certification process.
Sime Curkovica, Robert Sroufeb, Steve Melnykc – a Management Department, Haworth College of Business, Western Michigan University, USA;b Operations and Strategic Management Department, The Wallace E. Carroll School of Management, Boston College, USA; c Marketing and Supply Chain Management Department, The Eli Broad Graduate School of Management, Michigan State University, USA
Curkovic, S., Sroufe, R., Melnyk, S.A. (2005), ‘Identifying the Factors Which Affect the Decision to Attain ISO 14000′, Journal of Energy, Vol. 30, No. 8, pp 1387-1407.
The purpose of this paper is to study the impact of ISO 14001 and other significant factors on solid waste generation rates of organizations. The research is based on a survey conducted on a random sample of industrial companies that operate in United States. The paper reveals that companies’ solid waste generation rates are significantly reduced by certification and identifies several factors of ISO 14001 that are most significant in terms of solid waste reduction. The paper also reveals that solid waste disposal costs are also significant and influence the solid waste generation of industrial companies.
Matthew Franchetti, The University of Toledo, College of Engineering, Mechanical, Industrial, and Manufacturing Engineering Department, USA
Franchetti, M, (2011) ‘ISO 14001 and solid waste generation rates in US manufacturing organizations: an analysis of relationship’, Journal of Cleaner Production 19, (2011) pp 1104-1109.
‘Resolving information Asymmetries in Markets: The Role of Certified Management Programs‘ (Toffel, 2006) examines if ‘a voluntary management program’ (in this study’s case ISO 14001) that features an independent verification mechanism (certification) is achieving its ultimate aims’.
The research involves data from thousands of companies in the USA to evaluate their environmental performance. The research reports, ‘evidence that the ISO 14001 Environmental Management System Standard has attracted companies with superior environmental performance’.
Two key elements of the conclusion state that ‘third party certification may be a critical element to ensure that voluntary management programs legitimately distinguish adopters from non-adopters’. This is greatly assisted by the view that, ‘As an alternative to more prescriptive industry-specific management practices, voluntary management programs can also ensure performance improvement among its participants by requiring such improvements as a condition for ongoing participation’.
The second key element of the conclusion is a clear message for the concept of certification as a means of delivering public policy objectives, namely that, ‘regulators should seriously consider using ISO 14001 adoption as an indicator of superior (environmental) performance’.
Toffel, M.W., Harvard Business School, Harvard University
‘Resolving Information Asymmetries in Markets: The Role of Certified Management Programs’, Toffel, M.W., (2006)
The idea of tools such as certification as a means of managing key issues, often addressed by policy-makers with regulation and legislation, is examined in ‘Self-regulatory Institutions for Solving Environmental Problems: Perspectives and Contributions from the Management Literature‘ (King, Toffel, 2007) In particular, the use of ISO 14001 certification as a ‘self-regulatory institution’ is examined.
The report suggests that the creation of a robust ‘self-regulatory institution’, such as consensus-based standards (such as ISO), certified by third-party certification who themselves are accredited by accreditation bodies, can deliver significant environmental benefits. The report’s conclusion presents a very optimistic view of systems such as ISO 14001, ‘For readers interested in practical solutions to environmental problems, the research presented in this chapter suggests that self-regulation should be taken seriously.
Many firms have voted with their feet and joined prominent examples of self-regulatory institutions. Managers in these firms appear to believe that participating in these institutions will help them solve real problems. Initial empirical research suggests that some of these institutions might, indeed, help firms reduce market inefficiencies. Some appear to reduce asymmetries in information, others to facilitate coordinated investment in solutions to common problems. In the aggregate, the research reviewed reveals a world not of inevitable tragedy but of possibility’. Backed up by a range of empirical research, the report presents a compelling case for considering systems such as ISO 14001 certification as a tool to make a real impact on environmental performance.
King, A., Tuck School of Business, Dartmouth College; Toffel, M., Harvard Business School
King, A., Toffel, M., (2007), ‘Self-regulatory Institutions for Solving Environmental Problems: Perspectives and Contributions from the Management Literature‘
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
ISO 9000 is the most popular and widely adopted meta-standard for quality and operational improvements in manufacturing supply chains. However, few studies have quantitatively examined its impact on supply chain efficiency. In this paper we measure the material and cash flow efficiency of ISO 9000 certified firms in terms of inventory days and account receivable days. We analyzed changes in these time-based efficiency indicators prior and after ISO 9000 implementation in 695 US-listed manufacturing firms. We found that ISO 9000 certified firms shortened the number of inventory days by 3.68 days 1 year after ISO 9000 implementation. They showed continuous improvement and shortened the number of inventory days by 8.75 days (8.29% shorter) 3 years after certification. Account receivable days and overall operating cycle time also showed similar significant reductions after ISO 9000 implementation. The results reveal that ISO 9000 adoption helps improve the material and cash flows in manufacturing supply chains.
Chris K.Y. Lo, Andy C.L. Yeung, T.C.E. Cheng, Department of Logistics and Maritime Studies, The Hong Kong Polytechnic University, Hung Hom, Kowloon, Hong Kong
Lo, C.K.Y., Yeung, A.C. L., Cheng, T.C.E., (2009), ‘ISO 9000 and supply chain efficiency: Empirical evidence on inventory and account receivable days’, International Journal of Production Economics, Volume 118, Issue 2, pp 367-374.
Several studies have examined how the ISO 9001 quality management systems standard predicts changes in organizational outcomes such as profits. This is the first large-scale study to explore how employee outcomes such as employment, earnings, and health and safety change when employers adopt ISO 9001. We analyzed a matched sample of nearly 1,000 companies in California. ISO 9001 adopters subsequently had far lower organizational death rates than a matched control group of nonadopters. Among surviving employers, ISO adopters had higher growth rates for sales, employment, payroll, and average annual earnings. Injury rates declined slightly for ISO 9001 adopters, although total injury costs did not. These results have implications for organizational theory, managers, and public policy.
The ISO 9000 series of quality management systems standards, introduced in 1986, has been adopted at over 560,000 locations worldwide. Anecdotal evidence suggests that firms can achieve internal benefits such as quality or productivity improvements or that certification can help firms maintain or increase their market share, or both. Others argue that the standard is too generic to cause performance improvement but can be seen as a signal of good management. In this paper, we track financial performance from 1987 to 1997 of all publicly traded ISO 9000 certified manufacturing firms in the United States with SIC codes 2000–3999, and test whether ISO 9000 certification leads to productivity improvements, market benefits, and improved financial performance. We employ event-study methods, matching each certified firm to a control group of one or more non-certified firms in the same industry with similar pre-certification size and/or return on assets. We find that firms’ decision to seek their first ISO 9000 certification was indeed followed by significant abnormal improvements in financial performance, though the exact timing and magnitude of this effect depend on the specification of the control group. Three years after certification, the certified firms do display strongly significant abnormal performance under all control-group specifications. The degree to which the precise results vary across control-group specifications indicates that event studies should always include extensive sensitivity analysis, for instance matching by size and performance separately and jointly, using both single firms and portfolios as controls.
Corbett, C.J., Montes-Sancho, M.J., Kirsch, D.A; (2004), ‘The Financial Impact of ISO 9000 Certification in the US: An Empirical Analysis‘, Management Science; V. 51; No. 7; pp 1046-1059
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
AIHA Laboratory Accreditation Programs, the US accreditation body, has produced a shot video to guide applicants through the accreditation process. View the video on Youtube.
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.
This short video, produced by ANSI in the US, shows how accreditation supports food safety.
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.