The World Health Organisation’s International Health Regulations have been developed to prevent, protect against, control and provide a public health response to the international spread of disease in ways that are commensurate with and restricted to public health risks, and which avoid unnecessary interference with international traffic and trade. Economies are required to develop certain minimum core public health capacities. Access to accredited laboratories provides clear evidence of an economy’s sustainable ability to respond.
Further information is available on the WHO website.
The drive to improve the quality of care for patients, whilst delivering efficiency and productivity, is a key objective for NHS England (NHSE), the UK public sector organisation that leads the National Health Service (NHS). Through diagnostic and therapeutic procedures, Medical Physics and Clinical Engineering (MPACE) directly impact the majority of patients and the care and treatment they receive. It is therefore essential that these services consistently deliver high quality care by maintaining the safety and the accuracy of equipment used and ensuring that procedures are evidence based, safe and effective.
UKAS, the UK national accreditation body, was approached by NHSE and the professional body – the Institute of Physics and Engineering in Medicine (IPEM), to develop accreditation for clinical engineering and physical science services. Accreditation for MPACE services will be against BS 70000.
Further information is available on the UKAS 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.
The Ministry of Health and Family Welfare has introduced Medical Devices Rules to conform to best international practices. Previously, only 15 categories of medical devices were regulated as drugs and so were not fully geared to meet the requirements of medical devices sector in the country. The new Rules seek to remove regulatory bottlenecks to make in India, facilitate ease of doing business while ensuring availability of better medical devices for patient care and safety.
Medical devices will, under the new Rules, be classified, based on associated risks, into Class A (low risk), Class B (low moderate risk), Class C (moderate high risk) and Class D (high risk). The manufacturers of medical devices will be required to meet risk proportionate regulatory requirements that have been specified in the Rules and are based on best international practices.
With a view to bring in a high degree of professionalism in the regulation of medical devices, a system of ‘Third Party Conformity Assessment and Certification’ through Notified Bodies is envisaged. The Notified Bodies will be accredited by the National Accreditation Board for Certification Bodies (NABCB). The NABCB will, before accrediting Notified Bodies, assess their competence in terms of required human resources and other requirements. These Bodies will undertake verification and assessment of Quality Management System of Medical Device Manufacturers of Class A and Class B category and may, on as required basis, be called upon to render assistance for regulation of Class C and D medical devices also.
These Rules envisage the creation of a robust eco-system for all stakeholders including innovators, manufacturers, providers, consumers, buyers and regulators. It is also hoped that this policy will support entrepreneurship, market entry and economic growth that, in turn, would produce high-paying, high-quality jobs.
Further information is available here.
European Accreditation (EA) has played a key role with the European Commission Initiative on Breast Cancer (ECIBC) for the development of a European quality assurance (QA) scheme for breast cancer services (BCS) coordinated by the EC Joint Research Centre (JRC).
This voluntary scheme, based on revised European Guidelines for Breast Cancer Screening and Diagnosis, is to be underpinned by accreditation in accordance with Regulation (EC) 765/2008. All aspects of BCS including diagnosis, surgery, treatment, nursing care and palliative care will be covered by the QA scheme; the main focus will be the quality of care and experience of the patient. The QA scheme for BCS needs to be very flexible in order to ensure inclusivity for the many different healthcare systems, ranging from rudimentary to mature, throughout Europe. To operate effectively, the scheme needs to make use of different standards, tools and techniques.
EA’s mission is to provide comprehensive guidance for the scheme’s different stakeholders, i.e. national authorities, professional bodies, national accreditation bodies (NABs) and conformity assessment bodies (CABs). Managing a well-established process for the production and publication of application, technical advisory and guidance documents, EA will provide generic publications describing the accreditation framework, toolkit, processes and procedures for accreditation.
Diagnostic imaging machines providing services such as MRI, Ultrasound and CT scans are inspected by accredited inspection bodies to ensure safe, high quality care with reliable outcomes that patients can trust.
In South Africa the Directorate: Radiation Control of the Department of Health is responsible for enforcing the Hazardous Substances Act, 1973 (Act 15 of 1973) applicable to hazardous substances, as well as the regulations published under this act. There are currently 7887 licenced dental x-ray units and 5606 licenced general diagnostic X-ray units in South Africa.
it is a regulatory requirement that users of diagnostic x-ray equipment, for example medical and dental facilities, must ensure that a series of Quality Control (QC) tests are done on all diagnostic X-ray units and processors. Those carrying out the testing must be accredited by the South African accreditation body (SANAS).
Further information is available on the Department of Health website.
The Ministry of Health (MOH) issued a “National Telemedicine Guidelines” in January 2015 to outline a holistic approach to execute the delivery of telemedicine services in Singapore to ensure both patient and provider safety. Under the guidelines, critical equipment, such as telemedicine equipment, is to be calibrated by accredited laboratories (accredited by Singapore Accreditation Council (SAC) or SAC Mutual Recognition Arrangement partners). Leveraging on accredited laboratories ensure measurements are traceable to the International System of Units (SI), minimizing any significant effect on the test results.
Further information is available the department’s website:
An inspection body sub-program for medical electrical equipment and systems has been adopted in Canada to support Health Authorities and to protect the safety of Canadian health workers and patients when exposed to devices like CT scanners, ultrasound machines, defibrillators and X-ray equipment. This program accredits inspection bodies to provide certification to SPE-3000 Model code for the field evaluation of medical electrical equipment and systems in relation to safety from electrical shock and fire and mechanical hazards.
Further information is available from the Nova Scotia Government website.
Third party testing labs must meet certain accreditation criteria in order to be allowed to test useable marijuana and marijuana products under the I-502 regulatory system in Washington State. The program confirms that cannabis laboratories are compliant with state and local regulations and that they adhere to the same standards. It provides confidence to patients as well as regulators that their test results on these products are accurate and consistent.
Further information is available on the Washington State government website.
To fill the regulatory vacuum in quality certification space for medical devices in the country, the Association of Indian Medical Device Industry (AIMED) in collaboration with the Quality Council of India (QCI) and the National Accreditation Board for Certification Bodies (NABCB) introduced a voluntary quality certification scheme for medical devices.
The Scheme enhances patient safety, and provide enhanced consumer protection along with much needed product credentials to manufacturers for instilling confidence among buyers. This move also aims to eliminate trading of sub-standard products or devices of doubtful origins, a widespread and injurious phenomenon in the Indian market.
More than twenty government and non-governmental organisations have joined the scheme’s steering committee to support the scheme, including the Department of Commerce, Confederation of Indian Industry (CII), National Health System Resource Centre (NHSRC), Bureau of Indian Standards (BIS), Central Drug Standard Control Orgnanization (CDSCO), Centre for Bio Medical Engineering , IIT Delhi, Indian Medical Association (IMA), Association of Healthcare Providers (AHPI), Engineering Export Promotion Council (EEPC), and Associated Chamber of Commerce and Industry of India (ASSOCHAM).
Further information is available on the CQI website.
The Ministry of AYUSH, the Government Department tasked with providing attention to the development of Education and Research in Ayurveda, Yoga and Naturopathy, Unani, Siddha and Homoeopathy systems, has launched a voluntary certification scheme for Yoga training schools.
The focus of the Scheme for Voluntary Certification of Yoga Professionals is to certify the competence of Yoga Professionals who provide Yoga lessons/classes. Further information is available on the Ministry of AYUSH website.
The UK’s Department of Health has adopted an accredited certification scheme to support people in using health and social care information and, in doing so, help people to make confident, informed decisions about their health and social care. The Information Standard mark can help people make these decisions with confidence because it offers reassurance that health and social care information carrying the mark is from a reliable source.
The Information Standard can be part of helping people to:
- understand their health and care
- make effective decisions for themselves and their families
- help with uncertainty as to what information they should trust
Further information is available here.
Management and use of IVD point of care test devices
The Medicines and Healthcare products Regulatory Agency (MHRA) states that Any site providing a POCT service should undergo accreditation. Accreditation is assessment, by an external body, of the competence to provide a service to a recognised standard. By having this independently confirmed, POCT providers are able to give reassurance to users of their service.
Further information is available from the MHRA website.
Pathology testing in Australia is carried out at both public and private laboratories. Partial reimbursement of the costs of medical testing is permitted under the universal public health insurance scheme in Australia (known as Medicare).
For reimbursement claims to be accepted, the pathology laboratory used must be an accredited pathology laboratory under the Health Insurance Act 1973 (Cth) (HI Act). One of the conditions of gaining this status is the maintenance of an accreditation by the National Association of Testing authorities (NATA), the relevant national accreditation body in Australia.
NATA have a formal Memorandum of Understanding with the federal Department of Health and Ageing (DoHA) which endorses its accreditation role.
Medical testing (pathology) laboratories apply to NATA to be accredited in accordance with relevant guidelines issued by the National Pathology Accreditation Advisory Council (NPAAC) which reflect the requirements of ISO 15189, Medical laboratories – Requirements for quality and competence. As a competent accreditation body NATA itself fulfils the requirements of ISO/IEC 17011, Conformity assessment – General requirements for accreditation bodies accrediting conformity assessment bodies.
Through this conformity assessment scheme the federal government of Australia controls the quality of medical testing laboratories indirectly through controlling the access to funding. Access is only granted after the laboratories meet accreditation requirements and demonstrate their adherence to relevant standards. The federal Department of Health and Ageing (DoHA) do not directly accredit laboratories but instead rely upon the national technical accreditation system through NATA to achieve this outcome. This saves DoHA the direct expense of undertaking the accreditation service, and removes the Department from a conflict of interest that might be perceived if they were to accredit public health laboratories.
Further information is available on the Australian Department of Health website.
NHS England has issued a service specification requiring that all pathology laboratories dealing with cancer screening programmes are formally accredited by United Kingdom Accreditation Service (UKAS) or equivalent, to ensure the quality and reliability of results.
The reconfiguration of Genetic Laboratory service provision in England is supporting the creation of a world class resource in the use of genomics and genetic technologies within the NHS, and the provision of high quality, equitable and cost effective services across the pipeline from sample acquisition, to data analysis, validation and clinical interpretation, with support for patients and families. This will be critical in ensuring that genomic information and genetic testing is integrated across the NHS together with clinical genomic services to improve the prevention and diagnosis of disease and to support treatment decisions by identifying the right targeted therapies in order to maximise efficacy and outcomes and to reduce adverse effects.
The development of genomic medicine in the NHS will lead to improvements in the ability to diagnose, treat and prevent disease and to provide high quality personalised care for all. It will support the UK Strategy for Rare Diseases and the impact will affect all ages as the interaction between genetic factors and environmental modifiers is understood better thus improving diagnostic services for patients more generally.
Further information is available on the NHS England website.
UKAS, the UK Accreditation Body, has signed a Memorandum of Understanding (MoU) with the Human Tissue Authority (HTA) relating to work in the post mortem sector. The collaboration between the UKAS and the HTA aims to reduce the burden of regulation on organisations that are subject to site-visit inspection by the HTA and assessment by UKAS, whilst maintaining public confidence in post mortem services.
Further information on how accreditation is supporting the regulation of post mortems and mortuaries is available on the HTA website.
The Egyptian government, represented by Ministry of Health and Population, has been guided to accredit the medical laboratories in Egypt to ISO 15189:2003 and its future versions as international accreditation standard for medical labs including governmental, private and blood banks.
This has led to the accreditation of many private mega labs, with branches across different governorates all over the country with the result that accreditation has become the fundamental base in the market of medical laboratories.
As an MRA signatory, supported the government in publishing quality and accreditation awareness, EGAC has granted accreditation to many governmental medical labs, blood researches labs with critical functions especially in the industry of vaccines and medical products. Great results obtained cleared the improvement of the performance and reduced uncertainties associated with decisions that affect the protection of human health and the environment.
In the Czech Republic, the genetic testing of human genome can only be carried out exclusively by medical laboratories that have been accredited to the requirements of ISO 15189 by the Czech Accreditation Institute. This obligation is confirmed in the Act No. 373/2011 Coll., on specific health services.
Accreditation according to the ISO 15189 is considered to deliver reliable results and advantages for medical laboratories in their negotiations with Health Insurance Companies on contracts and payment from Public Health Care System.
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.
In Japan, the Ministry of Health, Labour and Welfare (MHLW) use accredited medical laboratory accreditation (ISO 15189 – Medical laboratories – Requirements for quality and competence) to manage the quality control of medical laboratories carrying out in clinical trials.
IANZ (International Accreditation New Zealand) accreditation is applicable to all organisations providing medical examinations, including community laboratories and those in the public hospital system. With accreditation, medical laboratories receive formal recognition of the organisation’s technical competency after assessment of their processes, resources, facilities, staff and other key factors and skills which relate to, and impact on the quality of the service provided.
Most medical testing laboratories in the private sector and in hospitals around the country are accredited by IANZ, giving assurance that tests essential for human health are carried out accurately and competently.
Accreditation is based on ISO 15189 Medical laboratories – Requirements for quality and competence. This standard is based upon ISO/IEC 17025 and ISO 9001. (New Zealand)
Health Authority in Dubai (DHA) requires that to be licensed all clinical laboratories are required to be accredited by any accreditation agency such as ISO: 15189 Medical Laboratory Standards adopted by Dubai Accreditation Center (DAC). (Dubai)
Chief Inspector of UK Hospitals releases Policy Statement outlining how existing accreditation schemes can help to inform Care Quality Commissions programme of inspections.
ASEAN member countries have agreed to establish the ASEAN Economic Community (AEC) to create a flow of goods and services flow freely in the ASEAN region with the expectation of improving the economy of the member countries of the sector ASEAN. One of ASEAN integration sector priorities is medical equipment, which in the context of ASEAN’s AEC will be arranged in the Medical Devices Directive (AMDD). The medical equipment sector has an important role in the diagnosis, prevention, monitoring, and treatment of disease and in improving quality of life.
The AMDD requires ASEAN countries to implement standardized medical device classification criteria and device placement systems, and to establish post-marketing surveillance alert systems. The Medical Device Product Working Group (MDPWG), which is one of 11 bodies of the ASEAN Consultative Committee for Standards and Quality (ACCSQ), developed the draft AMDD.
Conformity assessment will be a key part of this programme, involving global standards, such as ISO 13485 Medical devices – Quality management systems – Requirements for regulatory purposes, certification and accreditation.
The ISP, the Public Health Institute in Chile, relies on product certification bodies to ensure the reliability of medical devices. (Chile)
The Royal Australian and New Zealand College of Radiologists (RANZCR) make extensive use of accreditation in a number of areas to support the delivery of quality radiology practices in Australia and New Zealand. Accreditation is used in such areas as medical and diagnostic imaging. (New Zealand)
In the UK, Improving Quality in Physiological Services (IQIPS) is a programme developed by the Royal College of Physicians with support from the Department of Health. The IQIPS accreditation framework has been developed to improve, promote and recognise good quality practice across nine physiological disciplines. Accreditation is awarded by the UK Accreditation Service under contract with the RCP. (UK)
In the UK, Imaging Services Accreditation Scheme (ISAS) is a programme jointly developed by the College of Radiography and the Royal College of Radiologists, with support from the Department of Health. ISAS is now used by the UK Regulator, the Care Quality Commission, as evidence to support its hospital inspection regime.
In Norway, the Ministry of Health & Care Services has introduced a range of measures to strengthen the public health system. One of these requirements is for the establishment of environmental management systems and subsequent certification of the management system according to ISO 14001 standard by the end of 2014 for all hospitals. (Norway)
Certification to ISO 9001 has been attained by the Hospital of the Ministry of Defence in Bratislava, Slovakia. This helped the hospital to be considered by certain healthcare customers who saw the attainment of ISO 9001 certification as a requirement for them to use the hospital, but this also opened up the hospital’s services to a wider customer base as more organisations were able to recognise the hospital’s commitment to quality through its certification.
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.
Following the introduction of Regulation (EC) No 765/2008 setting out the requirements for accreditation and market surveillance relating to the marketing of products, the Commission has published a report to review its impact between 2013 and 2017.
This report confirms that the European accreditation infrastructure created by the Regulation has provided added value, not only for the single market but also for international trade. Accreditation has wide support from European industry and the conformity assessment community for ensuring that products meet the applicable requirements, removing barriers for conformity assessment bodies and helping entrepreneurial activities to flourish in Europe. The Regulation established a trustworthy and stable accreditation system in all Member States, as well as EFTA countries and Turkey.
The report concludes that more than 34450 accreditations were delivered (in regulated and non-harmonised areas) covering a wide range of activities by the end of 2016. This has been a significant contributory factor in deepening the single market and seemless trade.
A full copy of the report is available from the EU Commission website.
The 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.
Accreditation is usually a voluntary programme in which trained external peer reviewers evaluate a healthcare organisation’s compliance and compare it with pre-established performance standards. The aim of this study was to evaluate the impact of accreditation programmes on the quality of healthcare services.
The work concludes that there is consistent evidence that shows that accreditation programs improve the process of care provided by healthcare services. There is considerable evidence to show that accreditation programs improve clinical outcomes of a wide spectrum of clinical conditions. Accreditation programs should be supported as a tool to improve the quality of healthcare services.
You can read more about this study here.
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
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.
‘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
PCA, the Polish Accreditation Body, has published a video to show the benefits of accreditation of medical laboratories. The video can be viewed on YouTube.
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.
ISO 13485:2016 – Medical devices – A practical guide has been authored by technical experts of ISO/TC 210. The handbook is intended to guide organizations in the development, implementation and maintenance of their quality management system in accordance with ISO 13485. Organizations active in the medical device sector, such as manufacturers, importers, distributors, service providers, certification bodies or regulatory bodies, can benefit from this publication.
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 short briefing note to set out how standards can deliver quality assurance in the health sector; from dentistry to optics to traditional Chinese medicine. A copy of the note is available from the ISO website.
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.
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 realising the benefit of recognising the quality management system standard ISO 13485 – Medical Devices – Quality Management Systems – Requirements for Regulatory Purposes.
This international standard provides the basis for medical device regulations to be harmonized around the world.
Accreditation is a tool to demonstrate the competence of medical laboratories and ensure the delivery of timely, accurate and reliable results. 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.