Article 20 of the Chinese Regulations on Biosafety Management of Pathogenic Microorganisms Laboratory (State Council Decree No. 424) state that Biosafety level 3 (BSL-3) and BSL-4 laboratories shall obtain CNAS accreditation.
Article 21 states that BSL-1 and BSL-2 laboratories are not permitted to conduct experimental activities of highly pathogenic microorganisms. BSL-3 and BSL-4 laboratories that are allowed to conduct experimental activities of highly pathogenic microorganisms shall meet the following conditions: (a) the purpose of the experiment and the experimental activities to be carried out shall be in accordance with the regulations of Ministry of Health or Veterinary Bureau of the Ministry of Agriculture; (b) the laboratory shall obtain CNAS accreditation.
Article 7 of the administration of Software Processes and Capability Maturity Assessment (CNCA No.4 announcement in 2005) states that the establishment of an assessment body shall have a management system that meets the requirements of software process and capability maturity assessment, and accreditation. This approach provides businesses with a powerful tool for understanding and then improving general business process performance.
The implementation Measures on Information System Integration and Service Qualification Operation and Maintenance Sub-qualification (Trial) (promulgated by China Information Technology Industry Federation on August 18, 2015) states that an organisation shall establish a complete IT service management system, which has run continuously and effectively for not less than one year, and has obtained a certificate granted by an accredited third-party certification body.
The administration of Testing and Certification of the Payment Service System of Non-financial Institutions (promulgated by the People’s Bank of China (PBOC)  No. 14) states that the testing organisation shall obtain qualification approval in accordance with relevant provisions of certification, obtain CNAS accreditation, and PBOC authorisation of testing the payment service system of non-financial institutions. The certification body shall be established upon the approved of CNCA, accredited by CNAS, and authorised by PBOC to certify the payment service system of non-financial institutions.
Article 4 of the administration on Laboratories for Quality Control and Technical Evaluation of Industrial Products (Ministry of Industry and Information Technology  No. 93, Chapter II) sets out the laboratory’s basic conditions, tasks and obligations, including that it shall have national laboratory qualification approval or obtain CNAS accreditation.
The legal framework for the type-approval of automotive products covers three categories of vehicles: motor vehicles and their trailers, motorcycles, and tractors. The objective of this framework is to facilitate the free movement of motor vehicles and trailers in the internal market by laying down harmonised requirements designed to achieve common environmental and safety objectives.
Following the emissions scandal involving a German car manufacturers, the Commission announced that it would reinforce the type-approval system, in particular by ensuring adequate supervisory mechanisms to ensure a correct and harmonised application of the type-approval procedures. It is proposed that this is achieved through the use of appropriate accredited conformity assessment.
Further information is available on the Commission website.
The Defence Electronics and Components Agency (DECA) provides support solutions for Typhoon by providing innovative repair-not-replace solutions. DECA is an MOD and industry partner that aims to provide benchmark support services as the principal in-house government organisation dedicated to maintenance, repair, overhaul, upgrade and procurement in the defence avionics, electronics and components field.
DECA inspects composite cylinders in support of Typhoon. These specialist cylinders, which carry nitrogen and air, are smaller and lighter than the steel cylinders traditionally used and require specialist support capabilities. The cylinders are inspected, examined, and hydrostatic tested to BSEN 11623:2002 and BSEN 1802:2002 standards and pressure tested up to 6526 psi before being prepared for dispatch to front line Typhoon units.
To ensure that this work is carried out effectively, this facility is UKAS accredited and is able to perform hydrostatic testing up to 10,000psi. Further information is available on the DECA website.
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.
Until recently, only food, agricultural and forestry could benefit from Protected Geographical Indications (PGI) at European level.
A 2014 French law broadened this protection to manufactured goods as well as natural resources: they are related to a territory based on their specific characteristics, know-how or manufacturing process, and must be controlled by accredited bodies. This French regulatory scheme is based on the PGI one, the main difference being in the approval procedure managed by the French National Institute of Industrial Property (INPI) instead of the National Institute of Origin and Quality (INAO) for PGI.
Geographical Indication for manufactured goods is based on four cumulative elements:
- Denominating a geographical area or specific place;
- Used to designate a craft or manufactured product;
- Originating from this area;
- Featuring a quality, reputation or characteristics exclusively specific to the area.
Geographical Indications authenticate and protect local/regional products, know-how and professionals and therefore contribute to economic, cultural, touristic and social development. To be granted this label of quality and origin, operators concerned by the same product gather together and prepare a requirements document that will have to be approved by INPI. Accredited certification or inspection bodies are in charge of controlling the products. So far, two Geographical Indications have been approved: Brittany’s Granite and Liffol’s Seating.
This French initiative reinforces the traceability and quality guarantees offered to consumers and the French competent authorities are currently pursuing their action to have a European official recognition for those Geographical Indications and broaden their protection.
Photo Credit: Hôtel Fouquet’s Barriere by Jean-Pierre Besse – Credit: Fabrice Rambert
Making Accreditation Mandatory in Sri Lanka for Taking Technical Decisions
In order to create a quality conscious culture in Sri Lanka, it was the view of the Cabinet Ministers that technical measures on the issues related to quality, environment, food safety, occupational health and safety, energy etc. must be controlled and monitored through stipulated standards and technical regulations.
The Cabinet of Ministers of Sri Lanka has taken a decision and proposed to implement relevant regulations by making conformity assessment procedures such as testing (including medical testing and calibration), inspection and certification mandatory and using accreditation as a means of providing assurance and trust on consumers. The proposal contains following main three activities;
a) To use regulations and implement conformity assessment procedures such as testing, inspection and certification by regulators for controlling activities in relation to quality, environment, food safety, occupational health and safety, energy etc.
b) To update regulations in which conformity assessment procedures are not mentioned and/or accreditation is not used as a means of acceptance and to include statement to reflect “not to use any facility that is not assessed and accredited”.
c) To develop a conformity assessment framework which is composed of testing laboratories, inspection bodies and/or certification bodies as applicable, within and outside the regulatory bodies to facilitate accreditation.
Attention has also been drawn on the frequently questioned market fairness issues related to the assurance of safety and public utility measures in relation to accuracy of water meters, electricity meters, taxi meters etc.
Hon. Minister of Science, Technology has requested from relevant Ministries and Regulatory bodies to take immediate measures to comply with the above Cabinet Decision.
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.
Under the Electricity (Safety) Regulations 2010, a supplier’s declaration of conformity is required before placing on the market any low voltage or extra-low voltage fittings or appliances that have been declared as medium risk by the regulator. These products include certain Electric Wires and Cables; Switches for Circuit, Installation Protective and Connection Devices; Electrical Tools; Electric Welding Machines; Household and Similar-use Appliances; Audio and Video Products; Lighting and Electrical Appliances; and Power Transformers, Power Supply Units and Similar Products. The supplier’s declaration of conformity must be in accordance with ISO/IEC 17050 Part 1, and the official government supplied forms reflect the suggested format contained in this International Standard.
Further information is available on the WorkSafe New Zealand website, the regulator for ensuring the safe supply and use of electricity and gas.
The Government through the Kenya Bureau of Standards (KEBS), the National Standards Body (NSB) requires that all goods to be imported into the country must first be inspected, tested and or certified by accredited Inspection Bodies, Test laboratories or certification bodies.
KEBS has contracted partners under the Pre-Export Verification of Conformity (PVoC) for exports to Kenya. These partners use their accredited facilities to inspect, test and certify products including motor vehicles against relevant Kenya standards or approved standards.
Such goods once inspected and tested are issued with certificates of conformity (CoC) at the country of origin and consequently KEBS import standardization mark.
The Government and the Kenyan business community benefit from goods being cleared quickly and at minimal cost. The need to re-inspect, re-test and re-certify goods is eliminated. Additionally, time taken to deliver goods from Kenya’s ports of entry to the neighbouring countries that use Kenya’s ports of entry is significantly shortened.
Overall, this programme that is anchored on accreditation has supported the work of regulators such as KEBS, Ministry of Health, Radiation Protection Board, and KEPHIS among others.
Further information is available on the KEBS website.
In Sweden, a Government Ordinance requires all public authorities to consult the Swedish National Accreditation Body (SWEDAC) before issuing any regulations containing a requirement for conformity assessment activities. This ensures that the public authority receives expert advice on the practicality of the measure being considered and on the potential for avoiding the need for regulation where accredited conformity assessment activity could deliver the same outcome.
Further information on Swedish Regulation (2011:811) Accreditation and Conformity Assessment can be accessed Swedish Regulation. (In Swedish).
The Vehicle Certification Agency (VCA) is an Executive Agency of the United Kingdom Department for Transport (DfT), charged with operating the system of automotive type approval in the UK. VCA is the designated UK Approval Authority and a Technical Service for all type approvals to automotive EC Directives and most United Nations (UN) Regulations. VCA is accredited to provide assurance to the market.
Further information is available on the DfT webiste.
Licence holders must ensure that gambling products have been tested by a test house before they are released to the market. The UK Regulator, the Gambling Commission, publishes a list of approved test houses that are approved to test compliance against the relevant technical standards and requirements including:
- gaming machines technical standards
- remote gambling and software technical standards
- bingo and casino technical requirements
The list includes details of which technical standards and requirements each test house can check compliance against. All test houses be accredited to ISO/IEC 17025 by an ILAC Signatory accreditation body.
Further information is available on the Gambling Commission website.
In Brazil the authority for technical regulations is represented at federal level by several agencies, depending of the area of competence. The regulations can be developed ex officio or upon request of a third party. These regulations are generally based on International Standards, among which ISO standards. Even if the regulation is identical to the international regulation, potential impact of regulations needs to be notified to the World Trade Organization (WTO). The National Institute of Metrology, Quality and Technology (INMETRO) is responsible for this. INMETRO is also responsible for conformity assessment bodies’ accreditation. More information can be found in the Guide to Brazil´s Toy Compliance Requirements.
The choice of conformity assessment activity is based on specific characteristics of the product and can range from certification, inspection to declaration of conformity by the supplier. It is usually voluntary-based, but if the object of conformity affects consumers’ health, safety or environment, conformity assessment should be performed by an accredited third party. A good example of this process is the certification of toys’ safety. All toys placed on the Brazilian market must be certified by an accredited certification body.
The toy safety certification process can use different certification systems that comprise specific technical regulations:
- MERCOSUR Standard on Toy Safety NM 300:2002, Parts 1-6;
- NM 300 – 1:2002, Safety of Toys, Part 1: General, mechanical and physical properties, which are based on ISO 8124-1:2000;
- NM 300 – 2:2002, Safety of toys, Part 2: Flammability, with normative references to ISO 2431:1993;
- NM 300-4:2002, Safety of toys Part 4: Experimental sets for chemistry and related activities, with normative references to ISO 8317:1989- Child – resistant packaging;
- Additional requirements or methodologies such as the one to approve the Procedure for Certification of Toys and toxicological testing.
More information can be found on the ABNT website: www.abnt.org.br
The toy safety certification also requests accredited certification bodies and laboratories, where the common elements of the systems request the compliance based at least on:
- ISO/IEC 17025:2005, General requirements for the competence of testing and calibration laboratories, including sampling. It covers testing and calibration performed using standard methods, non-standard methods, and laboratory-developed methods.
- As an IAF/ILAC MLA signatory, INMETRO also shall request confident testing, where a mandatory rule for laboratories is the proficiency testing participation based on ISO 17043:2010, Conformity assessment – General requirements for proficiency testing. The standard specifies general requirements for the competence of providers of proficiency testing schemes and for the development and operation of proficiency testing schemes.
- Guide ISO/IEC 65:1996, General requirements for bodies operating product certification systems. This Guide has been replaced by: ISO/IEC 17065Conformity assessment – Requirements for bodies certifying products, processes and services. This new version has been fully revised with more and better terms and definitions, resources, and guidance. Christian Priller, Convenor of the ISO/CASCO working group that developed ISO/IEC 17065 standard says:
“…..Product certification is perhaps the most visible type of certification because it is usually accompanied by a mark that is recognized and appreciated by regulators, consumers and other stakeholders. It is therefore crucial that we ensure the reliability of these claims. I am confident that the new ISO/IEC 17065 will increase trust and comparability of product certification around world.” (ISO News, 3 October 2012).
Hotels are classified on a star scale going from 1 to 5 – assessing the quality of the facilities – by the French national authorized tourism operator Atout France. In the framework of the development and modernization law of French tourism services, the decree 2009-1652, dated 22 December 2009, requires accreditation of inspection bodies carrying out controls of hotel facilities applying for this classification. The criteria is more competitive, modern and rigorous to further upgrade the overall standards of hotels in France. In this way, accreditation contributes to the national policy aim to improve hotel classification by providing national and international guests with more reliable information, therefore confirming France as one of the tops tourism destination in the world.
Further information can be found on the Atout France site. (in French)
The Indian Directorate General of Foreign Trade has relaxed its import rules of steel and steel products, and will rely on the ILAC and IAF arrangements to maintain quality assurance.
Quality certification should be either from a product certification body (ISO Guide 65/ISO 17065) accredited by an IAF MLA signatory, or from an ISO 17020 inspection body accredited by an ILAC Signatory.
Further information is available from the DGFT website.
Japan Calibration Service System (JCSS) of IAJapan is one of several ways to satisfy requirements by Telecommunications Business Act and Radio Act with references to Measurement Act Article 135 and 144.
Enforced from January 26 2004, measuring instruments used for the examination or inspection calibrated by accredited laboratories by Japan Calibration Service System (JCSS) of IAJapan is one of several ways to satisfy requirements by Telecommunications Business Act Article 87 and Radio Act Article 24-2 which refers to Measurement Act Article 135 and 144.
Telecommunications Business Act, Article 87 (pages 48 to 49) (Act No. 86 of December 25, 1984)
Radio Act, Article 24-2 (page 14) (Act No. 131 of May 02, 1950)
Measurement Act, Article 135, Article 144 (Act No. 51 of May 20, 1992)
*On English translation of Telecommunications Business Act and Radio Act, Ministry of Internal Affairs and Communications (MIC) has not translated in compliance with the terms translated by Ministry of Justice (MOJ).
Please note that “correction” translated by MIC, written as the term referred to Measurement Act, is translated by MOJ as “calibration.”
Japan Calibration Service System (JCSS) of IAJapan is one of several criteria to identify measuring instruments traceable to international or national measurement standards set out by the Nuclear Regulation Authority based on the Nuclear Reactor Regulation Laws.
Clarification of methods for confirming calibration and traceability of measuring instruments in the nuclear power plants can be found here (in Japanese)
Source: Information on Former Nuclear and Industrial Safety Agency
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 Swedish authority Transportstyrelsen – the Swedish Transport Agency uses accredited inspection bodies according ISO/IEC 17020 for the periodic inspection of vehicles, according Swedish law SFS 2002:574 and SFS 2009:211.
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:
GCC Member states United Arab Emirates , Kingdom of Bahrain, Kingdom of Saudi Arabia, Sultanate of Oman, State of Qatar, State of Kuwait and the Republic of Yemen operate a single regulatory system to control products in the GCC market.
The System is comprised of two sets of Technical Regulations (TR):
1) Horizontal Regulations applied to all products wishing to access the GCC Single market which are:
a) GCC Conformity Marking TR.
b) The General TR for product Safety.
c) Conformity Assessment Modules.
d) Notified Bodies Selection and Notification.
e) Market Surveillance technical Regulation
f) Product Liability technical Regulation
g) Rapid Exchange of Information System(AGEL)
2) Vertical Regulations each addressing a Category of Products including:
a) Toys (Approved)
b) Low Voltage Devices (Approved)
c) Other products (in process)
Accreditation is considered an essential tool for the implementation of the regulatory system as it is used in all regulations to assure the competence of notified bodies.
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 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.
The National Service of Customs in Chile specifies that the testing of fine copper and copper concentrates must be carried out in an accredited laboratory. (Chile)
Similarly, in Serbia the Serbian Directorate of Measures and Precious Metals (DMDM), part of the Serbian National Metrology Institute, has implemented ISO/IEC 17025 to ensure international recognition of its national measurement standards, measurement and calibration results, and calibration certificates issued by DMDM. (Serbia)
The New Zealand Government requires that Electromagnetic compatibility (EMC) of high risk (Level 3) items such as industrial, scientific or medical products must be tested in a lab accredited by an ILAC MRA (Mutual Recognition Arrangement) signatory. (New Zealand)
The Chinese Government’s recognition of New Zealand certification and testing for electrical goods benefits exporters under the “Electrical and Electronic Equipment (EEE) Mutual Recognition Agreement”.
Under Chinese Law, certain products require Chinese Compulsory Certification (CCC) run by the Certification and Accreditation Administration of the People’s Republic of China (CNCA). That process involves testing of the product in an accredited laboratory, inspection of the factory production line and certification of the whole process by an accredited certification body, recognised by the Chinese Government under the CCC scheme. This agreement enables New Zealand to become the first country in the world to test, inspect and certify electrical products outside of China for the Chinese market. (China and New Zealand)
Advice from the New Zealand Ministry of Consumer Affairs produces a range of guidance on the import of safe products under the Fair Trading and Consumer Guarantees Trading Acts. One element of this is statements of conformity assessment for specific products where ‘goods may require certification to prove that they comply with product standards. Unless your consignment has certification to prove that it complies with the relevant Standard, it is likely to be stopped at Customs. You, as the importer, are liable for producing the necessary documents to prove that the goods may be brought into the country. Test Certificates must be from a laboratory which is accredited for the specific tests required’.
This covers a range of products, including toys, bikes and cots.
High hazard toys (and some other consumer items) must be tested in an accredited lab. (New Zealand)
The New Approach was established in the European Union to ‘recast technical harmonisation within the European Union (EU) on a new basis by only harmonising the essential requirements of products and by applying the “general reference to standards” formula and the principle of mutual recognition in order to eliminate technical obstacles to the free movement of goods.’
The New Approach has a number of objectives, all seeking to use standardisation, to achieve aims such as supporting the single European market – especially for products, reducing barriers to trade, increasing product safety, delivering an efficient system based on consensus standards.
Product areas covered by the New Approach vary from toys to pressure equipment, from boilers to boats, from medical devices to explosives. The full range of products can be seen under the New Legislative Framework.
Within the framework of an association agreement between Tunisia and the European Union, a mutual recognition agreement is being developed in the field of conformity assessment through an accord entitled ACAA (Agreement on Conformity Assessment and Accreditation of industrial products).
This project, which has brought in public and private expertise in the field of standardisation, accreditation, metrology, analysis and tests as well as market surveillance, aims at supporting the Tunisian administration for the preparation of the ACAA.
Priority sectors involved in this project include products from the mechanical, electrical and construction industries. The aim is to simplify import/export and customs formalities.
Further information is available on the EU website.
The Trans-Pacific Partnership (TPP) is a trade agreement, released on November 5th 2015, between twelve Pacific Rim countries. The agreement’s goal is to promote economic growth; support the creation and retention of jobs; enhance innovation, productivity and competitiveness; raise living standards; promote transparency, good governance, and enhanced labour and environmental protections.
Accreditation, recognised by existing regional and international mutual recognition Arrangements (the ILAC MRA and IAF MLA) is referenced as being as a key measure to support trade through the removal of technical barriers.
The twelve Pacific-rim countries include Mexico, New Zealand, Australia, Brunei, Chile, Singapore, Canada, Japan, Malaysia, Peru, Vietnam and the USA.
The 2017 Good Governance Report, published by the Institute of Director’s (IOD) flagship corporate governance publication which ranks the UK’s largest listed companies based on their corporate governance performance, now uses accredited certification to ISO 9001 as one of the data sources.
The IOD supports, represents and set standards for business leaders in the UK.
The report, which is compiled for the IoD by Cass Business School and in its third year, has expanded the number of indicators to give a more comprehensive view of how well the company performs for its shareholders, employees and customers. These indicators are grouped into five broad categories of corporate governance: Board Effectiveness; Audit and Risk/External Accountability; Remuneration and Reward; Shareholder Relations; and Stakeholder Relations. Specific indicators are chosen in order to reflect a broad conception of corporate governance which not only takes into account the interests of shareholders but also considers how governance is working for other key stakeholders. The implementation of an accredited management system has been included to demonstrate strong corporate governance.
A full copy of the report is available from the IoD website.
In November 2015, the UK’s Better Regulation Delivery Office (BRDO) commissioned Professor Christopher Hodges to produce a brief introduction to examine the theories and practice of how to control corporate behaviour through regulatory techniques, drawing on the principal theories of deterrence, economic rational acting, responsive regulation, and the findings of behavioural psychology.
The paper provides regulators and others with an interest in developments in regulatory delivery with an overview of the research theories and empirical evidence, and of the author’s proposition of a new theory of ‘ethical regulation’.
The basic idea is one of a collaborative approach between businesses, their stakeholders and public officials, based on a shared ethical approach. It recognises that compliant behaviour cannot be guaranteed by regulation alone, and that ethical culture in business is an essential component that should be promoted and not undermined. It also notes that regulatory and other systems need to be designed to provide evidence of business commitment to ethical behaviour, on which trust can be based, and that regulation will be most effective where it is based on the collaborative involvement of all parties.
The paper cites the use of accreditation as an example of collaboration between regulators and businesses in the management of risk and compliance.
A copy of the report is available on the Government’s Better Regulation website.
Economic research carried out by NZIER, a specialist consulting firm, reveals that accreditation facilitates $27.6 billion of New Zealand’s exports – over 56% of total goods exports.
Exporters need to be known and recognised overseas as delivering high-quality, safe goods and services to market. IANZ, the New Zealand accreditation body, provides precisely this ‘seal of approval’, which reduces exporters’ transaction costs and risks, and supports ongoing government and business efforts to lift the value-added from exports.
An illustrative economic modelling exercise provides an indication of the additional value that accreditation delivers to New Zealand exporters. If an 8% ‘accreditation price premium’ that an overseas survey suggests exporters receive from accreditation were to be removed, it would cost accredited exporters around $4.5 billion, and cause New Zealand’s GDP to drop by 0.63% or $1.65 billion.
IANZ also plays an important role in the domestic economy. Its accreditation services support industries that account for $35.8 billion of New Zealand’s GDP, and which employ almost 358,000 workers (17% of total employment).
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.
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.
The ISO 9001 – Impact and Relevance in Brazil is based on UNIDO Project 140107 “Impact assessment of ISO 9001 Quality Management System Certification in Brazil”, co-funded by Inmetro and UNIDO. The overall objective of the project was to assess the effectiveness of the ISO 9001 certification process in Brazil from the perspective of certified organisations and their customers, as well as by conducting a number of “market surveillance” visits to a sample of certified organisations.
This study provides useful information about the take-up by and benefits for those who have decided to seek an accredited certification of their quality management system based on ISO 9001. The results of this study in Brazil are generally positive. They show that organisations do get value from accredited certification to ISO 9001; that users can rely on accredited certification to ISO 9001 as a reasonable basis for having confidence that the products or services provided by a certified organisation will fulfil their expectations; and that, despite commercial and competitive pressures that can undermine the impartiality and effectiveness of audits and certification, the audits and certifications are, in most instances, effective and valuable.
A full copy of the ISO 9001 – Impact and Relevance in Brazil report can be downloaded from the UNIDO website.
UKAS, the UK accreditation body, carried out a survey to capture feedback on the value of accreditation for conformity assessment bodies that have stable scopes in established technical sectors. The survey aimed to gain insight into the reasons for maintaining accreditation, to identify the positive outcomes that are realised through accreditation, and to investigate the value of selected elements of the accreditation process.
Respondents identified that there are clear external factors for maintaining accreditation:
- 67% maintain accreditation as it is perceived as the right thing to do
- 82% maintain accreditation due to customer expectations
- 46% maintain accreditation due to government expectations or requirements
The survey also identified that these businesses derive both internal and external commercial benefit from their accredited status:
- 93% of respondents agree that accreditation provides confidence to their customers and stakeholders
- 76% agree that accreditation differentiates them from their competitors
- 85% agree that accreditation improves the quality and validity of their work
- 71% agree that accreditation helps them to win new or maintain existing business
A copy of the report can be downloaded from the UKAS website.
The 2015 measurement survey of both customers and non-customers of NPL and its key partners (LGC, National Gear Metrology Laboratory, National Institute for Biological Standards and Control, National Measurement and Regulation Office and TUV NEL) provided compelling evidence that:
- Measurement supports key sectors
- Measurement customers need the best
- Measurement customers are leaders
- Measurement accelerates innovation
Download a copy of the report.
This report is the outcome of a research project conducted between June and November 2013 which explored how voluntary standards markets might be applied to financial services regulation and sought to provide independent verification of their potential in the financial services sector.
The central finding of this report is that voluntary standards could play a greater role in rebuilding a safer and more trusted financial services sector. The report illustrates the use of standards in other industries, the drivers behind their development, the application of existing standards in the financial services sector, other areas in financial services to which standards markets might also be applied, and who might be the potential users of new standards for areas of financial services.
A copy of the report, published by BSI, the Chartered Institute for Securities & Investment and Long Finance in November 2013, can be downloaded from the BSI website.
Professor Michael Mainelli, Z/Yen Co-Founder
Chiara von Gunten for BSI and the Chartered Institute for Securities & Investment (CISI)
This report provides an overview of the opportunities for standards development in the insurance industry (particularly wholesale insurance) that emerged throughout this study, based on interactions with industry professionals and associations during workshops, informal discussions, and responses to an online questionnaire.
The research showed that voluntary standards market approaches would be particularly suitable around product development, product information and processes in insurance. Respondents confirmed the striking need for standards aiming to improve transparency, information quality and access in order to increase customer satisfaction and product comparability in insurance. Such standards could take the form of a ‘Fair Insurance’ product information standard (similar to the Fairbanking scheme but for insurance). These could build upon recent achievements, such as the first life insurance product that was awarded (in August 2014) a trusted mark in accordance with the Sergeant Review of Simple Financial Products and based on an independent certification process run by BSI – the BSI Kitemark for Financial Products.
A full copy of the report can be downloaded from the longfinance website.
Michael Mainelli, Z/Yen Co-Founder
Chiara von Gunten and Therese Kieve, BSI and Long Finance
This report provides an overview of the opportunities for standards development in the investment and asset management (I&AM) industry that emerged throughout this study, based on interactions with industry professionals and associations during workshops and informal discussions, and responses to an online questionnaire.
While voluntary standards could help to strengthen the I&AM industry in the long run and thus contribute to restoring trust, related industry efforts have generally been undermined by short-term concerns over asset gathering and revenue generation, which makes industry-wide consensus difficult to achieve. As a result, recent improvements to the way the industry operates have come through regulation (e.g. EU UCITS or AIFM) rather than being initiated by the industry itself. Despite this, this study finds that voluntary standards could have particular value around the design of product and services, related information and processes in I&AM.
A full copy of the report is available on the longfinance website.
Michael Mainelli, Z/Yen Co-Founder
Chiara von Gunten and Therese Kieve, BSI and Long Finance
To have an in-depth understanding of the actual impact of ISO 9001 certification on organisations, Certification and Accreditation Administration (CNCA) and UNIDO jointly conducted a survey of the effectiveness of ISO 9001 quality management system certification in China from September 2012 to September 2013. China has overtaken the early implementers of ISO 9001 and now represents approximately 30% of the 1.1 million ISO 9001 certificates issued worldwide. The survey covers the whole of China (except Taiwan, Hong Kong and Macau). Over 9000 questionnaires were sent out to ISO 9001-certified organizations and institutional purchasers in China, and 6974 effective completed questionnaires were collected. Physical on-site visits were conducted by trained experts at 958 certified organizations.
According to the survey results:
- 93% of all the institutional purchasers surveyed expressed that they regarded ISO 9001 certification as an important criterion for evaluation of their suppliers.
- 75% said their perception of the credibility of ISO 9001 CBs operating in China is “good” or “very good”.
- Purchasers had a good level of satisfaction with their ISO 9001-certified suppliers.
- Of the various parameters studied, the highest level of satisfaction is with the product quality of ISO 9001-certified suppliers (98% purchasers stated that they were satisfied, including 7% of all purchasers who were very satisfied).
- Compared with non-certified suppliers (or comparing the same supplier before and after certification), most purchasers think that the performance of certified suppliers is notably better than that of non-certified suppliers (or the same supplier before certification).
Among all the certified organizations surveyed;
- 51% said the most important reason for them to implement a QMS was to obtain competitive advantages, for internal improvement or to achieve corporate or top management objectives
- 43 % said the most important reason was to gain market access or to respond to customer pressure or tender requirements
- 6% said it was for marketing and/or public relations.
- 98% of the organizations surveyed said that regardless of the overall cost, the implementation of ISO 9001 had been a good or a very good investment.
- Most of the certified organizations said they obtained substantial benefits from the implementation of an ISO 9001-based QMS. 9% of the certified organizations estimated that it brought a benefit of up to RMB 100,000, either in cost savings and/or increased profits. 39% believed it to be between RMB 100,000 to 1,000,000. (c.US$ 15,000 – US$ 150,000)
- 37% estimated that it could bring more than RMB 1,000,000 of benefits (either cost savings or increased profits).
A full copy of the report can be read on the UNIDO website.
Several studies highlight the economic benefits of standards, while the benefit of taking part in standardization remains a rather unexplored mystery to date. In theory, standard setters not only benefit from the possibility to monitor and shape the development of standards but also access a wide range of knowledge sources in the standards committee. Therefore, the authors investigate how the participation within formal standardization is related to the performance of 1561 German companies. A Cobb-Douglas production function is estimated in order to use the Solow-residuals as indicator for the firm performance. Participation within formal standardization is measured by the number of committee seats at the German Institute for Standardization (DIN). The results suggest that participation within formal standardization is positively related to firm performance in the manufacturing sector. In the service sector, no clear evidence for such a relationship is found.
A copy of the research paper can be downloaded from the Springer website.
Paul Wakke – Chair of Innovation Economics, Technische Universität Berlin
Knut Blind – Chair of Innovation Economics, Technische Universität Berlin
The authors base their paper on data from a global company survey of certified companies carried out by the International Accreditation Forum (IAF) in 2010/11. They use multivariate Probit and ordered Probit models to analyze how company internal and external factors influence the perception of benefits from accredited certification. Benefits from accredited certification are divided into added value for the organization, increased sales and regulatory compliance. As for company external factors, they find that benefits from certification are higher for companies that went through a challenging certification process, had a competent certification body team, and are aware of the importance of accreditation. Internal factors are related to different motives for seeking certification. They find that the benefits from accredited certification are largest when companies become certified in order to improve their own business performance. Dividing the sample in high-income and middle income countries shows that the latter put more emphasis on company internal improvement through certification and are more likely to benefit from certification when they employ an external consultant. Finally, they can show that benefits are unequally distributed among companies. That is, smaller companies have a lower probability to benefit from certification compared to larger companies.
A copy of the report is available on the ResearchGate website.
Axel Mangelsdorf, Berlin Institute of Technology and Chair of Innovation Economics
Tilman Denkler, BAM Federal Institute for Materials Research and Testing, Germany
In this paper, the authors explore the relationship between firms’ external knowledge sourcing and their decision to participate in standardization alliances. Based on micro data they show that the importance of external knowledge is positively correlated with participation in standardization. This suggests that firms aim to access the knowledge of other companies and stakeholders in order to increase their own knowledge base. The analysis also shows that firms cooperating with different actors are more likely to join standardization. Due to the positive relationships with incoming knowledge spillovers and forms of cooperation, they conclude that standardization represents a specific form of collaborative knowledge-sharing and knowledge-creating strategy. In addition, we are able to show that absorptive capacity measured via companies’ research intensity promotes the involvement in standardization.
External knowledge sourcing and involvement in standardization-Evidence from the community innovation survey (PDF Download Available). Available from:
Knut Blind, Berlin Institute of Technology
Henk de Vries, Rotterdam School of Management
Axel Mangelsdorf, BAM Federal Institute of Material Research and Testing, Germany
The national quality infrastructure (NQI) is the institutional framework that establishes and implements standardization, including conformity assessment services, metrology, and accreditation. Governments play a crucial role in designing, developing, and implementing an effective NQI. Developing an NQI begins with an assessment of the current system and identification of areas where reforms are required. The legal framework should establish transparent, independent institutions within a national structure that can work with international organizations such as the World Trade Organization (WTO). The World Bank and other donor agencies are assisting a number of countries in the development of NQIs in order to encourage industrial development, reduce barriers to trade and entrepreneurship, and facilitate global technical cooperation.
Download the report from the World Bank website.
Research carried out by the Centre for Economics and Business (Cebr) concludes that standards boost UK productivity and improve performance, kick-start innovation, and support UK domestic and international trade.
The report analyses the macroeconomic and microeconomic impact of BSI’s consensus based voluntary standards across the UK economy. It concludes that they are a vital part of the strength of UK industry and play a crucial and often invisible role in supporting economic growth.
The main findings are that:
- £8.2 billion is the amount that standards contribute to the UK economy
- 37.4% of UK productivity growth can be attributed to standards
- 28.4% of annual UK GDP growth can be attributed to standards, equivalent to £8.2 billion
- £6.1 billion of additional UK exports per year can be attributed to standards
The full report can be downloaded from the BSI website.
Katerina D. Gotzamani, Ypatia D. Theodorakioglou (Department of Business Administration, University of Macedonia, Thessaloniki, Greece); George D. Tsiotras (General Secretary of Central Macedonia, Greece, ex‐Rector of the University of Macedonia, Thessaloniki, Greece)
The article examines the usage and relative importance of quality measurements in the UK’s largest service companies. The authors analyse the relationship of both internal and customer‐based quality measurements to the importance placed on accreditation to an ISO 9000 standard. The effect of process structure is explored by categorising the service firms as being in front‐room or back‐room dominant service sectors. The authors find that the service firms, which consider accreditation to be important, have a different emphasis on quality than other service firms do.
Significantly, their emphasis shifts from one that is in line with their process structure to a more balanced one, where both internal and customer‐based quality measurements receive similar attention. This leads them to conclude that accreditation to an ISO 9000 standard can make a profound difference to the way quality is perceived and measured in large service firms.
Gavin Dick, Staffordshire University Business School, Stoke on Trent, UK; Kevin Gallimore, Manchester Metropolitan University, Crewe, UK; Jane C. Brown (Nurse Manager, North Staffordshire Combined Health Care NHS Trust, Stoke on Trent, UK
Gavin Dick, Kevin Gallimore, Jane C. Brown, (2002) “Does ISO 9000 accreditation make a profound difference to the way service quality is perceived and measured?“, Managing Service Quality: An International Journal, Vol. 12 Iss: 1, pp.30 – 42
ISO 9000 certification adds to the fact of being a management tool, source of competitive advantages, its potential to stimulate the advance of industry towards TQM. Many studies have been published that seem to confirm this, but a close review of available publications has allowed us to detect the absence of such an investigation in Spain. That is why an empirical work has been planned, its main goal being to analyse how relevant certification may be in the progress of Spanish companies towards TQM. Mail surveys were carried out on 3,864 certified organizations; 749 (19.4 per cent) responded. The answers of participating companies reflect that although certification leads to a basic quality level, it is also true that it generates a degree of steadiness and a constant demands for updatinh and adaptation of the system it is based on, transforming it into a perfect foundation for more advanced quality practices.
Carmen Escanciano, Esteban Fernández, Camilo Vázquez, (2001) “Influence of ISO 9000 certification on the progress of Spanish industry towards TQM“, International Journal of Quality & Reliability Management, Vol. 18 Iss: 5, pp.481 – 494
Notes that it has become a competitive necessity for firms doing business globally to acquire the ISO 9000 certification, despite the misgivings many have with regard to its true effectiveness. Turkey, an emerging industrial economy, has a significant stake in the EU markets. At present, there is no systematic study documenting the status of ISO 9000 implementation in Turkey, the profile of the certified firms, their motivation, and their organizational experience during and after the certification process; whereas such studies have begun to emerge in other countries.
Provides a background on the Turkish quality movement, and reports the results of a survey conducted among large Turkish companies that attempts to provide answers to the issues raised above. The findings are revealing and should help an international manager doing or planning to do business in Turkey, or his Turkish counterpart thinking about getting certification.
Erdal Erel, Jay B. Ghosh, (1997) “ISO 9000 implementation in Turkish industry“, International Journal of Operations & Production Management, Vol. 17 Iss: 12, pp.1233 – 1246
This study identifies the costs, benefits and the satisfaction level with ISO 9000 implementation in Saudi Arabian firms. A survey of 140 ISO 9000 certified manufacturing companies was carried out. The results suggest that these manufacturing companies were satisfied with ISO 9000 as far as the benefits gained from certification and its costs were concerned. They considered the benefits of ISO 9000 certification to exceed the costs of attaining the standards, and believed that ISO 9000 contributed to organisational survival and success.
Hesham Magd, Nasser Kadasah, Adrienne Curry, (2003) “ISO 9000 implementation: a study of manufacturing companies in Saudi Arabia“, Managerial Auditing Journal, Vol. 18 Iss: 4, pp.313 – 322
This research paper aims to explore the relationship between ISO 9000 certification and organisational performance by developing an ISO 9000 relationship model.
Mei Feng, Milé Terziovski, Danny Samson, (2008) “Relationship of ISO 9001:2000 quality system certification with operational and business performance: A survey in Australia and New Zealand‐based manufacturing and service companies“, Journal of Manufacturing Technology Management, Vol. 19 Iss: 1, pp.22 – 37
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 Economics of Accreditation’ commissioned by the Department for Business Innovation and Skills has assessed the economic benefits derived from the accreditation of certification, measurement and inspection services. Researchers from Birkbeck, University of London, surveyed a selection of businesses and other independent analysis to create the report. Its aim was to provide a financial evaluation of accreditation’s contribution to the UK economy, which it valued at more than £600 million per annum.
A central element of the analysis is the multiplier effect of accreditation, indicating that UKAS and the other institutions in the quality infrastructure jointly amplify each other’s effects, so leading to an impact greater than the sum of the parts. This set of interdependencies and cross-amplifying effects combine to create a significant financial advantage for those using accreditation to distinguish their products and services.
Standards are a vital component in the conformity assessment arsenal to address public policy issues. International standards developed by consensus used in conformity assessment are in two key categories:
- The standards on which assessment is based, whether for products & services or process (management system standards)
- The standards which guide many of the key processes, such as certification, accreditation, inspection, etc. More of details of these standards, referred to as the ISO CASCO Toolkit can be found here.
A number of major research reports have been produced in a number of economies which help quantify and explain the contribution standards makes to these economies. These reports are:
- The Economic Benefits of Standardisation (2012) Standards Australia
- The Economic Benefits of Standards to New Zealand (2011), Report to The Standards Council of New Zealand and The Building Research Association of New Zealand
- The Economics of Standardization: An Update (2010) to The Economics of Standardization (2000) UK Department of Business, Innovation and Skills (BIS)
- The Economic Impact of Standardization: Technological Change, Standards Growth in France (2009) AFNOR
- Economic Value of Standardization (2007) Standards Council of Canada
- June 2015: The Economic Contribution of Standards to the UK Economy, UK Department of Business, Innovation and Skills (BIS)
- Economic benefits of standardization Part A: Benefits for business; Part B: Benefits for the economy as a whole (2000) DIN German Institute for Standardization
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.
A survey covering quality management system development, certification, accreditation and economic benefits, using a variety of research tools to judge the awareness and use of accredited certification to ISO 9001 by purchasing organizations. Research included a survey of purchasing organizations (the present and potential customers of ISO 9001 certified suppliers); interviews with some of these; survey of ISO 9001-certified organizations and visits to some of these.
As the commissioning organization UNIDO (United Nations Industrial Development Organisation) DIrector-General Kandeh K. Yumkella felt, ‘It is pleasing to see that the results have demonstrated (with some exceptions) that the implementation of ISO 9001 and the associated certification has been a good investment of resources, from both the perspective of the certified organizations and that of their customers (the major purchasing organizations in the regions).’
Some of the key findings were:
There are clear empirical economic benefits to the effective implementation and accredited certification of quality management systems in the manufacturing sectors of the Asian developing countries in which the project was conducted.
Credibility of ISO 9001
Overall, the perceptions of both the ISO 9001 standard and accredited certification to ISO 9001 in the region are good, though the role of accreditation is not well understood either by purchasers or by certified organizations
Purchasers’ perceptions of their ISO 9001-certified suppliers
The purchasers surveyed were mainly satisfied with the performance of their ISO 9001-certified suppliers (with some exceptions), and, in general, ISO 9001-certified suppliers performed ‘better’ or ‘much better’ than non-certified suppliers, based in a number of parameters.
In order to improve trade prospects and the quality of products and services in West Africa, this directory provides a list of accredited testing laboratories, inspection bodies and certification bodies in the region (as of August 2017). The directory was sponsored by UNIDO to ensure that public and private organisations are aware and have access to a network of accredited suppliers. It also hopes to inspire other conformity assessment bodies to become part of the programme.
The directory is available from the UNIDO website.
A Strategic Roadmap for the Quality Infrastructure of the Americas was launched at the Joint General Assembly of ILAC and IAF which supports their common goal – ‘tested, inspected or certified once and accepted everywhere’.
The Roadmap, funded by the Spanish contribution to the United Nations Industrial Development Organization (UNIDO) Trade Trust Fund, provides a high-level overview of the key topics that need to be addressed in order to leverage the collaborations between regional standards, metrology and accreditation organizations and their constituent members. This will support inclusive and sustainable industrial development, specifically, intra and inter-regional trade.
This initiative to develop a high-level strategic roadmap for Quality Infrastructure (QI) development and improvement in the Americas was conceived during the UNIDO General Conference in 2013, under the leadership of three main regional entities, namely COPANT (Standards), SIM (Metrology) and IAAC (Accreditation). Subsequently, in 2014, the three entities created the Quality Infrastructure Council of the Americas (QICA), established to provide and promote effective deployment of QI in the Americas, as well as collaboration between national and regional initiatives.
The Roadmap proposes five steps to provide a systematic and efficient approach to QI development in line with national and regional needs. This Roadmap should be considered as an evolving planning tool that is to be reviewed and updated periodically to reflect changing priorities, environment, contexts and the emergence of new challenges and opportunities.
Further information is available on the UNIDO website.
Watch this short video on the Quality Infrastructure in Grenada, providing an introduction to standards, conformity assessment and metrology.
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
The UK Accreditation Body, UKAS, has prepared ‘the case for accreditation’ aimed at large consultancies and research organisations. The briefing note is intended to provide an introduction to support UKAS’ engagement with these organisations, so that they are in a position to understand that accreditation is a proven tool to solve the issue of delivering consumers, suppliers, purchasers and specifiers with the assurance that services will be run efficiently, goods will conform, and working environments will be safe.
It is hoped that standards and accreditation will be referenced in future sector research or position papers.
A copy of the briefing note is available from the UKAS website.
The Philippine Accreditation Bureau (PAB) has produced a video to increase public awareness on and demonstrate the benefits of accreditation. It aims to further encourage wider acceptance and use of accreditation and build trust in conformity assessment — a tool that helps businesses not only to comply efficiently and effectively with regulations and standards around the globe but also to gain competitive advantage and to expand into new and wider markets.
This short presentation best responds to the question “How do we look for the best quality?” This is a tough question to answer with the vast number of products and services in the market. The video shows how accreditation can help consumers in whittling down their choices to safe, reliable and quality products and services which pass through accredited conformity assessments.
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.
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.
With examples from everyday life, this video, produced by COFRAC in France, highlights the fact that accreditation impacts, even if we are not always aware of it, numerous activities benefiting from conformity assessment services.
As someone who is involved in the selection of suppliers and, possibly, responsible for making purchasing decisions, you may have seen or used products and services that are promoted using reference to ISO 9001:2015. This informative text provides some answers to these questions and will inform you about how you can get the most out of using ISO 9001 as a supply chain tool.
A full copy of the brochure is available from the ISO website.
A booklet created by European Accreditation sets out how the ISO CASCO toolbox can support the work of Regulators.
View the booklet on the EA website.
UNIDO’s Trade Capacity Building Branch has published a briefing paper to set out how it can support Developing Economies develop the effective building blocks of using accredited testing, inspection and certification, using hamonized standards, in order to boost trade.
Download a copy of the briefing from the UNIDO website.
A short video to show how standards, metrology and accreditation can help sustainable development in Developing economies.
Click to view.
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 IAF MLA ensures the mutual recognition of accredited certification between signatories to the IAF MLA, and subsequently acceptance of accredited certification in many markets based on one accreditation.
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.