Public Health England (PHE), UK executive agency sponsored by the Department of Health, recognises the importance of the role of food, water and environmental microbiology laboratories and provides a range of PT schemes.
Food and water examination laboratories play a vital role in protecting people’s health by ensuring that food and waters are safe and do not pose a threat to health. One of PHE’s goal is protecting the country from infectious diseases and environmental hazards, including the growing problem of infections that resist treatment with antibiotics. In support of this goal, PHE provides tools such as proficiency testing (PT) schemes and reference materials to support food and water microbiology laboratories in assuring their results.
In order to demonstrate that the PHE PT schemes are underpinned by professional, scientific and technical expertise, they are accredited by UKAS, the UK’s accreditation body.
Further information is available on the PHE website.
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.
Three food certification schemes (BRC, IFS and FSSC 22000) have now been accepted by the Netherlands Food and Consumer Product Safety Authority (NVWA) as meeting its criteria. This can lead to adapted or reduced NVWA supervision for those organisations certified under these three schemes.
This is explained at www.ketenborging.nl, ‘After the horse meat scandal (in 2012), it is clear that food safety and integrity in the food production chain must be better safeguarded. To this end, the Dutch Minister of Health, Welfare and Sport and the Dutch Minister for Agriculture established the Food Confidence Task Force in March 2013 together with the meat, dairy and animal feed sectors, with the objective of taking measures to restore consumer confidence in food products. The Task Force presented its action plan in June 2013 and has started the implementation of this plan.
A substantial element in regaining consumer confidence is securing food safety and integrity. This means both public and private safeguarding of food safety and integrity are important in implementing the Task Force’s actions. Private quality schemes play an important role here. In cooperation with the Netherlands Food and Consumer Product Safety Authority (NVWA), the Task Force has defined a set of criteria for quality schemes that must strengthen the private safeguarding of food safety and especially food integrity. Transparency and the exchange of information are key elements of these criteria.
Short description of the procedure:
- Quality schemes are requested to include these criteria, as far as they have not yet been included.
- Quality schemes that have proven to comply with these criteria can be placed on the website www.ketenborging.nl, to acknowledge that the quality scheme meets these criteria.
- Businesses can check this website to see if their partners are certified by a quality scheme that meets the abovementioned food safety and integrity criteria, and bring this in line with their operations.
- In its risk profile and as such in its supervision of individual businesses in the food production sector, the NVWA takes into consideration whether or not the business is certified by a quality scheme that has been proven to meet the criteria. This means that participation in such a quality scheme can both enhance the business’s image and result in reduced supervision. This entails a reduction in costs for the business, to the extent that the business must pay for this supervision.
Through this initiative, the meat, dairy and animal feed sectors can show they are serious about food safety and food integrity and act accordingly.’
It is responsible for:
- monitoring and taking action on reports of bad effects from veterinary medicines
- testing for residues of veterinary medicines or illegal substances in animals and animal products
- assessing applications for and authorising companies to sell veterinary medicines in the UK and the EU
- controlling how veterinary medicines are made and distributed
- advising government ministers on developing veterinary medicines policy and putting it into action
- making, updating and enforcing UK legislation on veterinary medicines
The organisation has accredited certification for quality management (ISO 9001) and information security management (ISO 27001) to demonstrate the systems and processes they have in place, the quality of staff and their commitment to improve the efficiency and effectiveness of the services they provide to customers.
Further information is available on the UK Government website.
The Veterinary Public Health Laboratory (VPHL) and Animal and Plant Health Centre Laboratory (APHCL) are the regulatory analytical laboratories of the Agri-Food & Veterinary Authority of Singapore (AVA). As the authority, AVA recognises the value of accreditation to international standards and the AVA laboratories are accredited by the Singapore Accreditation Council (SAC) under ISO/IEC 17025. The accreditation provides assurance that they are adequately equipped, staffed by competent personnel and have a demonstrated capacity to produce accurate testing results in supporting regulatory compliance.
Further information is available from: http://www.ava.gov.sg/explore-by-sections/food/laboratory-services/overview
Safeguarding Canada’s reputation for quality fish and seafood—as well as the livelihoods of those who work in the industry—depends on the ability to deliver accurate, reliable, and consistent test results for detecting aquatic animal diseases.
On-going growth in the global trade of wild and farmed fish and seafood products brings with it increased risk of transferring aquatic pathogens (disease-causing agents) from one place to another, which have the potential to be devastating to wild fisheries and aquaculture operations by affecting the ability of infected marine species to grow, reproduce, or survive.
In order to ensure the credibility of testing results, Fisheries and Oceans Canada took the decision to ensure that its in-house diagnostic laboratories National Aquatic Animal Health Laboratory System (NAAHLS) are accredited to ISO/IEC 17025.
Accreditation provides trading partners with confidence in Canada’s diagnostic testing and management of aquatic animal health. Sound diagnostic testing also enables the Canadian Food Inspection Agency (CFIA) to attest to the health status of Canada’s fish and seafood exports, and to ensure that imports from other countries pose no risk of transferring infectious aquatic pathogens to Canada.
Further information is available on the Fisheries and Oceans Canada website.
JAS-ANZ, the New Zealand and Australian Accreditation Body, supports PrimeSafe the regulatory authority for the safety of meat, seafood and pet food. A Food Safety Management Scheme (FSMS) supports PrimeSafe in it’s management of establishments’ compliance to the Victorian Meat Industry Act 1993, the Victorian Meat Industry Regulations 2015, the Seafood Safety Act 2003, and the Seafood Safety Regulations 2014 through accrediting conformity assessment bodies that audit the compliance of meat establishments to the prescribed standards.
The benefits to PrimeSafe from this arrangement are:
- Allows PrimeSafe to set overall policy requirements or detailed technical requirements yet rely on the CABs to evaluate compliance;
- Concentration of valuable resources on policy and scheme management issues;
- Reduced personnel costs related to audit activities by removing the need for PrimeSafe to employ and train its own audit personnel; and
- The elimination of duplicate audits, as the CAB can also audit against customer requirements in an integrated audit.
Further information is available on the PrimeSafe website.
The Ecuadorian Agency for Agro Quality Assurance – AGROCALIDAD regulates the actors in the chain of organic production in the country through “General Regulations to Promote and Regulate Organic – Ecological – Biological Production in Ecuador “, issued by means of Ministerial Agreement No. 299 published in the official register No. 34 on July 11, 2013.
This regulation establishes that organic product certification must be made by conformity assessment bodies legally constituted in the country, which have been accredited by the Ecuadorian Accreditation Service – SAE with ISO / IEC 17065 standard and registration with the Ecuadorian Agency for Agro Quality Assurance -AGROCALIDAD.
Thus, with the support of accreditation in Ecuador, AGROCALIDAD monitors the technical and administrative performance of certification bodies for organic products, its inspectors and certified producers, to ensure the condition and organic status of the products produced, processed and marketed in the local market and for export with the organic denomination.
An introduction to the agency’s policy on organic food production can be viewed on the Agrocalidad website.
More detailed policy information can be downloaded here.
The National Health Service, Food Safety and Quality (SENASICA) and the Mexican Accreditation Entity (EMA) work in partnership to coordinate efforts to promote the standardization and harmonization of procedures, requirements and related accreditation, and approval of certification bodies, verification units and testing laboratories. Accreditation strengthens the prestige and competitiveness of agrifood products produced in Mexico, which account for 6.2% of exports. Accreditation drives better performance of bodies and delivers a high degree in reliability of results.
Further information is available on the SENASICA website.
The application of the European regulation opened the way for the implementation of new inspection tools for food safety. Official inspections occur throughout the food chain to confirm the level of conformity of the facility. In accordance with regulatory requirements, the NF V01-015 standard relating to the inspection of hygiene levels in commercial catering facilities was issued in May 2016.
Regulatory requirements will specify to what extent the results of this inspection activity could be taken into account by the relevant authority in the framework of official inspections for food safety. Accreditation of inspection bodies will help ensure a high level of hygiene and, as a direct consequence, the protection of consumers.
Further information can be found on the Ministry of Agriculture website.
Organic products range from fresh fruits and vegetables straight from the farm to wines and cheeses aged over several years. Accredited certification provides an equally strict control system for operators (farmer, processor and trader) on an ongoing basis.
Thousands of inspections are performed per year by competent people with the costs covered by the private sector. Organic production combines best environmental practices, a high level of biodiversity and the preservation of natural resources. It is a production method using natural substances and processes. Organic production delivers public goods contributing to the protection of the environment.
Further information is available on the European Commission website.
In the UK, food assurance schemes help to provide consumers and businesses with guarantees that food has been produced to particular standards. These schemes are mainly voluntary arrangements although many food businesses make certification in an assurance scheme a specification requirement for their suppliers.
The Food Standards Agency (FSA) maintains close contact with assurance schemes because of their potential to promote farm practices that contribute to recommended policy. They also monitor whether communications and claims made by assurance schemes are accurate.
Generally, food assurance schemes are run as accredited product certification schemes. These schemes use regular independent inspections to check that members are meeting specific standards and often use logos on consumer products to indicate this fulfilment. Examples of the schemes include:
- Assured Food Standards (Red Tractor)
- Lion Eggs – a quality code of practice that ensures eggs have been produced to the highest standards of food safety
- the Quality Meat Scotland (QMS) – offers consumers a legal guarantee that the meat they buy has come from animals that have spent their whole lives being raised to very strict standards
- Farm Assured Welsh Livestock (FAWL) – strengthens consumer confidence by providing assurance of farm standards in Wales
- the Northern Ireland Farm Quality Assurance Scheme (NIFQAS) – provides high standards for farmed meat in Northern Ireland
- Scottish Quality Cereals (SQC) – a food safety certification scheme for crops that ensures high standards of farm management and operations and therefore the wholesomeness or safety of the food produced or the health of the environment or countryside
- the Agricultural Industries Confederation (AIC) – an assurance scheme for animal feed and fertiliser sold to professional and non-professional users, and on documentation accompanying grain for feed and food use
There are also a number of smaller ‘niche’ schemes that aim to meet particular consumer demands, such as higher animal welfare and environmental or organic standards.
Further information is available on the UK Government website.
Improvement of catering services is an ongoing process. Steps taken/being taken to further improve the catering services include (i)Third Party Audit of catering services to be conducted at periodic intervals by independent accredited and reputed certification bodies as empanelled by the zonal Railways. (ii) Introduction of e-Catering so that passengers can book the food of their choice through internet (iii) Introduction of Pre-cooked Food (ready to eat) meals of reputed brands to improve the quality, hygiene and to provide variety of options of meals to the passengers. Pre-cooked food is tested periodically by accredited laboratories for which the report shall be in compliance with FSSAI standards.
Further information is available on the Indian Railways website.
The Ministry of Industry, Investment and Commerce, recognises the accreditation of the Pesticide Research Laboratory (PRL) of the University of the West Indies (UWI), as critical to strengthening Jamaica’s quality infrastructure and improving service standards.
The accreditation plays an important role in the facilitation of trade, particularly as it relates to export promotion in the agricultural sector, while supporting the country’s food safety policy.
Results are now well placed to be accepted on a global basis, thus facilitating export of local as well as regional products. Accreditation is a critical component of a strengthened National Quality Infrastructure (NQI), is valuable to the development of a logistics-centred economy, and allows for realisation of the full benefits of the National Export Strategy.
Further information is available on the Jamaican Government website.
Regulation 37 Standards for testing
For the purposes of section 16(3)(a) of the Act the prescribed standards for the testing, analysis and diagnostic examination of any sample or specimen for the purpose of determining whether it is infected with a disease are:
- the standards relevant to that disease in the Australian and New Zealand Standard Diagnostic Procedures as approved by the Primary Industries Standing Committee as amended and in force from time to time;
- in any other case, the standards relevant to that disease in the Australian Standard Diagnostic Techniques for Animal Diseases as published by the Standing Committee on Agriculture and Resource Management in 1993 as amended and in force from time to time.
For the purposes of section 16(4) of the Act the prescribed standard of accreditation for the facilities and operational practices of veterinary diagnostic laboratories is accreditation in accordance with ISO/IEC 17025 General requirements for the competence of testing and calibration laboratories.
Further information is available on the Victoria State Government website.
The UK is proposing to establish a project to develop accreditation for the certification of Quarantine Units (QUs). This is in support of the Welsh Government’s plan to introduce changes to the standstill rules relating to cattle, sheep and goats, for farms operating approved QUs. A pilot programme is inviting expressions of interest from organisations that wish to seek accreditation under ISO 17065 for the certification of QUs.
Further information on QUs is available in the Welsh Government’s public Consultation on the Introduction of Quarantine Units.
Operating a risk-based system of audits, where, ‘the frequency of audits for licensees is set in line with the level of risk inherent in the product processed at the facility. The greater the assessed risk, the greater the number of audits required’, The Prime Safe scheme in the Australian state of Victoria works across all areas of the meat, poultry and seafood supply chain.
The scheme also recognises the benefit of certification to ISO 9001 as, ‘Any meat processing facility subject to a quarterly audit schedule and has incorporated into its operations an accredited ISO 9001:2008 quality assurance system can have their audit frequency adjusted to a biannual audit schedule (subject to PrimeSafe approval)’.
The Netherlands Food and Consumer Product Safety Authority are investigating the opportunity of using third-party certification as a means of reducing the inspection regime for organisations in the food industry.
The concept is that certification to schemes such as FSSC 22000 and GlobalGAP deliver a more significant level of assurance for the Dutch authorities, enabling them to reduce the level of inspection required.
This project is currently being worked on with further progress expected soon.
The NSW Food Authority is the NSW government agency responsible for regulating food production and food safety throughout the state. The Authority has an obligation under the Food Act 2003 and Food Regulation 2010 to conduct audits in certain licensed food businesses
The Authority has developed a Regulatory Food Safety Auditor System to approve persons other than Authority employees to conduct regulatory food safety audits of licensed food businesses in NSW. These third-party auditors have numerous requirements to fulfil before they can be accepted
In order to support food hygiene, food quality and food security, the Spanish Government requires certification and inspection bodies to hold accreditation.
Further information can be found in the Official State Bulletin (in Spanish).
The Ministry of National Economy and Ministry of Health in cooperation with the Palestine Standards Institute, revised the maximum allowable expiry date for Yogurt TR 8-2005. The Regulators extended the expiry date from 21 days to 30 days for approval through an accredited Laboratory that the product can stand. This decision reduces the amount of returned products, increases production, and gives the national product a competitive advantage. (Palestine)
The Ministry of Agriculture of the Czech Republic (and the Czech Accreditation Institute) relies on accredited certification to ensure the professional competence of “controlling organizations” (certification and/or inspection bodies).
These organisations are those that secure the controlling activities related to issuing of certificates on organic farming, organic food or other organic products.
Accreditation is carried out according to the requirements of ČSN EN ISO/IEC 17065 (certification bodies providing product certification) and ČSN EN ISO/IEC 17020 (inspection bodies).
The Czech Agriculture and Food Inspection Authority of the Czech Republic relies on accreditation to regulate many areas of food production. For example wine testing for the purpose of wine classification must only be carried out by accredited laboratories.
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
In response to the Horsemeat scandal in Europe, the UK Government published a report to recommend that accredited testing, inspection, and certification provides a mechanism to ensure food integrity and to prevent food crime. A copy of the full report is available here.
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 Minister of Railways Shri D. V. Sadananda Gowda has said that in order to improve the quality, hygiene of on-board catering services and to provide variety, the Indian Railways proposes to introduce pre-cooked (ready-to-eat) meals of reputed brands in a phased manner. Presenting the Railway Budget 2014-15 in Parliament he said, to bring perceptible improvement in the catering services, he proposes to introduce Quality Assurance Mechanism through third party audit by the National Accreditation Board for Certification Bodies (NABCB) accredited organisations.
The issue of radioactive contamination in food caused by the Great East Japan Earthquake, March 11, 2011, has raised the importance of laboratory accreditation against international standards more than before.
Accreditation of laboratories under ISO/IEC 17025 is the system to accredit the laboratory with the technical competence to the international compliance. Test reports issued by the laboratory accredited by accreditation body as the signatory to the ILAC Multilateral Recognition Arrangement (MRA) supports the smooth logistics and can make a contribution to the export of agriculture products or food.
For the measurement and analysis of radioactive materials in food, the Japanese Ministry of Agriculture, Forestry and Fisheries (MAFF) issued the notification that laboratories accredited under ISO/IEC 17025 are reliable analysis organizations for the analysis and presentation of this data.
The Ministry of Agriculture, Forestry and Fisheries (MAFF) in Japan have also used accreditation as part of the process to valididate the safety of meat and eggs exported to Hong Kong, helping to deliver safe food across international borders.
In New Zealand a 2007 amendment to the 1956 Health Act stipulated that drinking water for domestic consumption must be tested in labortories ‘accredited by International Accreditation New Zealand or any other prescribed body for the purposes of this section’ or conforming to the ISO/IEC 17025 standard. (New Zealand)
Under the New Public Drinking Water Supply Program, the Government of Nova Scotia, Department of Environment require drinking water quality testing is to be completed by approved laboratories in accordance with the Policy for the Accreditation of Laboratories. (Canada)
As part of the New Zealand Government’s support of their food industry’s export drive, the Ministry for Primary Industries states that all animal products for export (dairy products, as well as meat, fish, shellfish, honey etc.) must be tested in an accredited laboratory. (New Zealand)
SERNAPESCA, the National Fishing Service in Chile, relies on accredited laboratories and inspection bodies to ensure the safety of seafood. Accredited testing laboratories are required to carry out activities such as sampling of seafood products, testing of process water and marine sediments. (Chile)
The Food Control Department in Dubai requires that food sector companies including manufacturing companies, food storage/warehousing companies and 4 & 5 star hotels should be certified for ISO 22000 (Food safety management systems – Requirements for any organization in the food chain)/HACCP by accredited certification bodies. This scheme helps the local regulator to regulate the food market in better way. (Dubai)
SAG, the Agriculture and Livestock Service in Chile, relies on accredited testing laboratories, product certification bodies, and inspection bodies to manage the quality of livestock and food production. (Chile)
The Department of Agriculture, Food and the Marine requires its Virology division to be accredited in order to fulfil its objectives to provide laboratory support for disease control and eradication programmes, and to perform tests for statutory and import / export purposes. The Virology Division is accredited for a range of tests to ISO/IEC 17025.(Ireland)
Botswana Vaccine Institute (BVI) is a public company established through the technical cooperation between MERIAL and the Government. Accredited testing and certification ensures the quality of the vaccines that they manufacture, generates internal efficiencies, reduces waste and saves money. It also improves market access and the eligibility for new tenders, which is demonstrated by year-on-year growth. (Botswana)
The New Approach was established in the European Union to ‘recast technical harmonisation within the European Union (EU) on a new basis by only harmonising the essential requirements of products and by applying the “general reference to standards” formula and the principle of mutual recognition in order to eliminate technical obstacles to the free movement of goods.’
The New Approach has a number of objectives, all seeking to use standardisation, to achieve aims such as supporting the single European market – especially for products, reducing barriers to trade, increasing product safety, delivering an efficient system based on consensus standards.
Product areas covered by the New Approach vary from toys to pressure equipment, from boilers to boats, from medical devices to explosives. The full range of products can be seen under the New Legislative Framework.
The 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.
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.
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.
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
Using a new database on standards in China, the authors estimate the impact of voluntary and mandatory standards–either harmonized to international norms or purely domestic–on Chinese food exports. The dataset covers seven Chinese products over the period 1992–2008. The authors find that standards have a positive effect on China’s export performance, as the benefits to standardization in terms of reducing potential information asymmetry and signalling enhance food safety, and quality in foreign markets seem to surpass compliance costs. The estimation results show that the positive effect of Chinese standards is larger when they are harmonized to international measures. The results suggest that there are clear benefits to China’s steps to base their domestic standards and regulations on international measures.
A copy of the report is available on the ResearchGate website.
Axel Mangelsdorf, BAM Federal Institute for Materials Research and Testing, Germany, and Technical University Berlin, Chair of Innovation Economics
Alberto Portugal-Perez ,World Bank
John S. Wilson, World Bank
The authors examine how third party certification with quality management standards and mutual recognition of certification through international agreements of accreditation bodies creates trust between trading partners and increases bilateral trade. They focus on the food, beverage and tobacco industry and use augmented gravity models for the 2000-2008 period. Their results show that quality management certifications are positively correlated with bilateral trade. Certifications help to reduce information asymmetries and signal commitment to quality production processes. Moreover, the results show that mutual recognition of certification has a positive and significant effect on trade. Members of the mutual recognition agreement for quality management standards have higher bilateral trade flows than non-members. Mutual recognition is in particular beneficial for markets access in high-income countries. They conclude that technical cooperation programs for developing countries’ conformity assessment services might be effective means to increase trade performance of developing countries.
A copy of the report can be found on the ResearchGate website.
Knut Blind, Berlin
Institute of Technology, Chair of Innovation Economics, Fraunhofer Institute for Open Communication Systems (FOKUS)
Axel Mangelsdorf, Berlin Institute of Technology, BAM Federal Institute for Materials Research and Testing, Germany,
John S. Wilson, The World Bank
In this paper, the author examines the trade impact of private standards on exports of manufactured food products. A database covers information from about 12,000 food manufacturing companies from 88 countries – including 53 developing countries — that are certified with retailer-based International Featured Standard (IFS). Using a dynamic gravity model for the period 2008 to 2013 and find that IFS certifications are significantly positively correlated with exports suggesting that private standards certifications push exports of manufactured food products. Controlling for geographical distance and common language and other trade related variables, we find that standards certifications have the largest impact for European countries, followed by American and Asian countries.
The paper is available from the ResearchGate website.
Author: Axel Mangelsdorf, Technische Universität Berlin
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.
Christos V. Fotopoulos, Evangelos L. Psomas, (Department of Business Administration of Food and Agricultural Enterprises, University of Ioannina, Agrinio, Greece); Fotis K. Vouzas (Department of Business Administration, University of Macedonia, Thessaloniki, Greece)
‘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‘
‘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 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.
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.
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.
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.
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.
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 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.