Examples by sector

In some sectors, there are sufficient motivating factors for governments, their regulators, and in certain cases manufacturers and other stakeholders, to work at the international level to promote policy and regulatory cooperation. This may be, for example, because of the sheer volume of trade that is carried out internationally in a particular sector. Principles agreed to in the resulting international agreements are incorporated into national laws and regulations adopted by the agreement’s Parties. Many of the examples presented here are of ISO and IEC standards being used to support this international regulatory and other policy work.

For more sector examples related specifically to electrotechnical standardization, please visit the IEC’s website at www.iec.ch/perspectives/government/sectors. 

Medical devices

Medical devices   Back to top

The medical devices industry, with products ranging from implantable cardiac pacemakers to wheelchairs, and from diagnostic test systems to syringes and needles, is both rapidly evolving and highly regulated. Standards play an important role in allowing the rapid introduction of new medical device technology while meeting the expectations of the public and regulators that medical devices are safe to use, perform as intended and offer benefits to patients that outweigh the risks.
Key features are:

  • the acceptance of standards as a key element in the regulatory framework for medical devices: while not mandatory, standards provide manufacturers with a presumption of conformance to specific regulatory requirements;
  • the participation of regulators alongside medical device manufacturers and professional users in the development of International Standards;
  • close cooperation between IEC, ISO, CEN, CENELEC, WHO and international regulatory harmonization initiatives to develop practical, effective and compliant medical device standards.

Who is involved?

There are many stakeholders involved in the medical device sector including manufacturers, regulators, health care providers, clinicians and patients.  Involving representatives from all stakeholder groups is essential to produce standards that promote safety and result in enhanced patient outcomes.  ISO and IEC, along with other standards developers, provide a forum where the stakeholders can collaborate to develop standards that achieve these goals while supporting compliance with the various regulatory frameworks in place around the world.

International Medical Device Regulators Forum

The International Medical Device Regulators Forum (IMDRF) is an organization of national regulatory authorities dedicated to promoting international convergence of regulatory requirements and practices. In particular, the IMDRF aims to promote harmonized regulation of the safety, performance, effectiveness and quality of medical devices and to serve as an information exchange through which countries with medical device regulatory systems under development can benefit from the experience of countries with established systems.

The IMDRF was founded in 2011 as the successor to the Global Harmonization Task Force (GHTF), which was a voluntary group of medical device regulators from Europe, the U.S.A., Canada, Japan and Australia and their industry partners. The GHTF was instrumental in developing guidance documents and recommended procedures that helped to promote convergence of the medical device regulatory systems of its members.

National Health Authorities

Despite the initiatives of IMDRF to harmonize medical device regulations and converge on a common regulatory system, regulation of medical devices still takes place at the national level.  Every country has designated one or more governmental bodies with the authority to oversee and regulate aspects of its health care system.  Their regulatory activities related to medical devices may include regulation of the development, manufacture and distribution of the medical devices, approval prior to commercial distribution, and post market surveillance of the safety and performance of the medical devices.
Many national regulatory authorities actively participate in the development of ISO and IEC standards by contributing experts appointed through their national member body.  These experts directly represent the viewpoints of their national or regional regulatory authorities and ensure the standards will meet the needs of countries across diverse geographies, cultures and economies. 

European Committee for Standardization (CEN)
European Committee for Electrotechnical Standardization (CENELEC)

The European Committee for Standardization (CEN) and European Committee for Electrotechnical Standardization (CENELEC) are the organizations charged with developing EN standards. EN standards can give presumption of conformance to Directives and Regulations of the European Union, including those governing the requirements for Medical Devices.  CEN and CENELEC formally cooperate with the ISO and IEC under the Dresden and Vienna Agreement to develop standards that can be applied throughout the whole world, thereby facilitating international trade.

World Health Organization

The World Health Organization (WHO) is the directing and coordinating authority for health within the United Nations system. WHO is charged with providing leadership on global health matters, shaping the health research agenda, setting norms and standards, articulating evidence-based policy options, providing technical support to countries and monitoring and assessing health trends?  WHO experts actively participate in the work of 45 ISO Technical Committees as a Category A liaison, including the committees listed below. 

ISO and IEC Committees

Many ISO and IEC committees develop standards that play an important role in the regulation of medical devices. These include:

  • IEC/TC 62, Electrical equipment in medical practice
  • IEC/TC 66, Safety of measuring, control and laboratory equipment
  • IEC/TC 87, Ultrasonics
  • ISO/TC 76, Transfusion, infusion and injection, and blood processing equipment for medical and pharmaceutical use
  • ISO/TC 121, Anaesthetic and respiratory equipment
  • ISO/TC 150, Implants for surgery
  • ISO/TC 168, Prosthetics and orthotics
  • ISO/TC 170, Surgical instruments
  • ISO/TC 172/SC 5, Microscopes and endoscopes
  • ISO/TC 172/SC 7, Ophthalmic optics and instruments
  • ISO/TC 194, Biological evaluation of medical devices
  • ISO/TC 198, Sterilization of health care products
  • ISO/TC 210, Quality management and corresponding general aspects for medical devices
  • ISO/TC 212, Clinical laboratory testing and in vitro diagnostic test systems

Many of these standards are used within the IEC’s System for Conformity Assessment, IECEE – CB Scheme for the issuing of International IECEE-CB Test Certificates which are used in both occasions:

  • for direct acceptance, in some countries
  • for the acceptance of tests and assessment performed in one country being accepted by the Authorities in another

In both cases, providing the Regulator and manufacturer with the very benefits of using both International Standards and an International Conformity Assessment System.

How is regulatory cooperation in this field achieved?

In line with the World Trade Organization's Technical Barriers to Trade Agreement, some national and regional medical device regulators have adopted systems that utilize standards to support their regulation. In these systems, standards are usually not mandatory but provide a presumption of conformance with specific regulatory requirements. A key to the success of this approach is the participation of regulators alongside medical device manufacturers and users in the development of International Standards and close cooperation between ISO/IEC and other bodies in the development of medical device standards.

As a result, many ISO and IEC standards are now globally recognized by medical device regulators.  For example:

  • IEC 60601 series is widely recognized as the fundamental safety standards for medical electrical equipment.
  • IEC 62366 has established a broadly recognized process model for achieving and validating optimal usability of devices.
  • ISO 13485 is widely accepted for establishing conformity with quality system requirements to demonstrate the consistent delivery of the medical device that has been approved by the regulatory authority.
  • ISO 10993 series are the global standards for demonstrating the biological safety and compatibility of materials used in medical devices.
  • The sterilization standards developed by ISO/TC 198 are utilized globally for ensuring the sterility of healthcare products.
  • ISO 14971, which was jointly produced by ISO TC 210 and IEC SC 62A, has become the benchmark for a medical device risk management process.

Although the medical device industry is highly regulated, global manufacturers clearly benefit from the reduction in trade barriers when countries agree on common approaches to meeting the regulatory requirements. 

Rusty cargo

Transport of dangerous goods    Back to top

This sector provides an example of the successful use of ISO standards at the regulatory level. One key feature of this success is the representation of the ISO Technical Committee during the drafting of the regulatory recommendations. Another key feature is that the recommendations deal with issues of health and safety, so extra confidence is required in these standards. A mechanism is therefore put in place by the regulator to check the appropriateness of each standard before making reference to it. This example shows how clearly expressed, regulatory needs can lead to revisions and improvements in ISO standards.

Who is involved?

United Nations Economic and Social Council’s Committee of Experts on the Transport of Dangerous Goods.

This is the main international regulatory forum of experts responsible for harmonizing requirements for the safe transportation of dangerous materials on international journeys. It is made up of experts from national government departments.

ISO/TC 58, Gas cylinders

ISO/TC 58 is responsible for preparing standards on gas cylinders, their fittings and characteristics for manufacture and use.

ISO/TC 220, Cryogenic vessels

ISO/TC 220 is responsible for standardizing the containers needed for the safe storage and transport of refrigerated liquefied gases.

How is regulatory cooperation in this field achieved?

The UN Recommendations for the Transport  of Dangerous Goods  define the international requirements for the transport of dangerous goods in order to prevent,  as far as possible, accidents to persons or property  and damage to the environment. They are addressed to governments and international organizations concerned with drafting regulations for the transport of dangerous goods by sea, air and land.

The UN Recommendations include a key section on requirements for the construction and testing of pressure receptacles, aerosol dispensers and gas cartridges. Throughout this section there  are many references to the ISO standards produced by ISO/TC 58, ISO/TC 197 and  ISO/TC 220.  This was achieved by ensuring effective representation of the ISO Technical Committee when the UN Recommendations were being drafted.
As key aspects of health and safety are involved, the appropriateness of each standard is assessed at the meetings of the UN Experts with the participation of delegates from the ISO Technical Committee. If the ISO work were to be deemed unsatisfactory, the ISO standard could be rejected and would need to be revised. Fortunately, this has not been necessary because of the close working relationship of ISO with the UN Committee of Experts backed up by the involvement of industry expert representatives in both organizations.

Road Vehicles

Road vehicles    Back to top

Work to harmonize worldwide regulations for road vehicles has been ongoing for over 60 years, since regulators first realized that accidents could be caused by the features of the cars involved. Cooperation with ISO has taken place from the start, and the relevance of ISO’s working methods and the technical quality of the ISO standards produced is appreciated by regulators taking part in this work. Of the 131 Economic Commission for Europe (ECE) regulations that exist on vehicle regulations, nearly half of them now make reference to well over 100 ISO standards.

Who is involved?

UNECE Working Party 29, World Forum for Harmonization of Vehicle Regulations

This group establishes worldwide regulations governing vehicle characteristics in the fields of the active safety of vehicles and their parts (crash avoidance), the passive safety of vehicles and their parts (crash worthiness), environmental considerations (relating to pollution of the environment, noise disturbances and conservation of energy), general safety considerations (windshield wipers and washers, controls and display, glazing), anti-theft, and special technical considerations.
New regulations and amendments are prepared by one of the six working parties subsidiary to WP.29, dealing with lighting and light signalling, brakes and running gear, passive safety, pollution and energy, noise, and general safety questions.

ISO/TC 22, Road vehicles

ISO/TC 22 deals with standardization concerning compatibility, interchangeability and safety, with particular reference to terminology and test procedures for evaluating the performance of road vehicles and their equipment, systems and subassemblies. All the technical domains of the vehicle construction are taken into account in one of the dozens of active subcommittees and working groups of ISO/TC 22. The structure of ISO/TC 22 is similar to the structures of WP.29 with active and passive safety, environment protection and other areas such as electronics and human machine interfaces.

ISO/TC 31, Tyres, rims, and valves

ISO/TC 31 deals with standardization concerning classification, size designation, dimensions, and ratings of tyres, rims and valves. All the technical domains of this subject area are covered in eight subcommittees.

How is regulatory cooperation in these fields achieved?

With nearly 800 published standards, ISO/TC 22 has addressed a large number of industry needs, with particular attention to harmonizing test methods, measuring methods, terminology and interchangeability requirements. From the outset, ISO/TC 22 has been represented in the meetings of WP.29. Both organizations try to avoid any duplication of work. Some demands have been made by WP.29 to ISO in the field of road vehicles, and ISO/TC 22 has answered positively by producing some of the numerous ISO standards to which the ECE Regulations refer. Similarly, ISO/TC31 has developed more than 75 standards in tandem with UN regulations, including test methods, noise, and rolling resistance measurement, among others.  In addition, experts from industry attend both ISO committee meetings as well as the WP.29 meetings.

Electric Vehicles

Public attention is turning increasingly to the introduction of electric vehicles of all kinds. Where motor vehicles were originally almost entirely mechanical, they are now complex systems wholly dependent on thousands of electric and electronic components for safe and reliable operation, a fact frequently overlooked. To stay in front of this trend, ISO and the IEC have entered into a Memorandum of Understanding called “ISO/IEC Agreement concerning Standardization of electrotechnology for Road Vehicles and the cooperation between ISO/TC22 “Road Vehicles” and the IEC Technical Committees”(2010).

Also, ISO directly participates in IEC Strategic Group 6 “Electrotechnology for mobility” which addresses the interaction between Plug-in electric vehicles and the electricity supply infrastructure. Electric Vehicles use high-voltage electrical systems so aspects related to safety and environment are extremely important, in addition to operational, communication and energy issues. As a result this industry is likely to be highly regulated and public policy makers as well as regulatory authorities are strongly encouraged to follow and participate in ISO and IEC work in this field. More information on electric vehicles and motors is available on the IEC’s website: www.iec.ch/perspectives/government/sectors.

Laboratory medicine

Laboratory Medicine    Back to top

Medical laboratories have historically been regulated at the local or national level, and since health care systems do not typically extend across borders, there was little external pressure to harmonize medical laboratory regulations.  Consequently, test results obtained in a hospital laboratory in one country were often not comparable to test results obtained in another country due to different calibration standards or laboratory practices. 

Now that patients have become much more mobile and may live for extended periods in different countries, the need for consistently accurate test results has grown.  Health care experts have estimated that as many as 70-80% of medical decisions are influenced by diagnostic test results.  At the same time, commercial chains of clinical laboratories have started to operate across national borders, and may receive blood and tissue samples to be tested that were ordered and drawn by physicians in other countries. 

International standards for quality, competence and safety in laboratory medicine offer national regulatory authorities an important alternative to prescriptive regulations. 

Who is involved?

International Laboratory Accreditation Cooperation

The International Laboratory Accreditation Cooperation (ILAC) is an international cooperation of laboratory and inspection accreditation bodies formed more than 30 years ago to help remove technical barriers to trade.  Accreditation to recognized medical laboratory standards has become a regulatory requirement in some jurisdictions.  This ensures the impartiality and competence of the laboratories and the accuracy of test results that are relied upon for medical decisions.  ILAC is a Category A liaison to ISO/TC 212 Clinical laboratory testing and in vitro diagnostic test systems.

International Bureau of Weights and Measures

The International Bureau of Weights and Measures (Bureau international des poids et mesures, BIPM) ensures world-wide uniformity of measurements and their traceability to the International System of Units (SI).  BIPM coordinates the activities of the national metrology institutes that provide the basis for accurate medical laboratory measurements over time and space.  BIPM is a Category A liaison to ISO/TC 212.

ISO/TC 212, Clinical laboratory testing and in vitro diagnostic test systems

ISO/TC 212 provides a unique forum where medical laboratory specialists, IVD research and development scientists and engineers, laboratory accreditation professionals and regulatory authorities come together to agree on standards for the quality, competence and safety of medical laboratory testing.


Professional Associations in the Field of Laboratory Medicine

Organizations such as the World Association of Societies of Pathology and Laboratory Medicine (WASPaLM) and the International Federation of Clinical Chemistry and Laboratory Medicine (IFCC) have long developed standards and guidelines for quality assurance, safety and medical laboratory accreditation.  In some countries, professional medical societies assume responsibility for regulating medical laboratories and monitoring their performance.  WASPaLM, IFCC and several regional professional associations are Category A liaisons to ISO/TC 212.

World Health Organization

The World Health Organization (WHO) is the directing and coordinating authority for health within the United Nations system.  A core function of WHO is setting norms & standard and promoting their implementation.  The WHO programme on in vitro diagnostics and laboratory technology is aimed at strengthening laboratory services and systems and promoting universal access to high quality laboratory diagnostic services.  WHO is a Category A liaison to ISO/TC 212.

How is regulatory cooperation in this field achieved?

The need for international standardization in laboratory medicine led to the formation of ISO/TC 212 in 1995.   Since then, ISO 15189, Medical laboratories -- Requirements for quality and competence, has become the predominant standard for accreditation of medical laboratories throughout the world.  Its rapid and widespread acceptance can be attributed to the fact that virtually all relevant stakeholders participated in its development and came to consensus on the requirements. 

The World Health Organization (WHO) has actively participated in the work of ISO/TC 212 since its inception and was a strong advocate for a quality management system standard for medical laboratories.  National health authorities from several countries, participating as experts through their ISO member bodies, ensured that patient needs and biosafety concerns were adequately addressed.  ILAC was instrumental in ensuring that the standards could be used to accredit medical laboratories on the basis of quality and competence. 
Companion standards developed by ISO/TC 212 are ISO 15190, Medical laboratories -- Requirements for safety, and ISO 22870, Point-of-care testing (POCT) -- Requirements for quality and competence. 

Technical standards to ensure accurate and comparable test results were also developed collaboratively by national experts from laboratories and manufacturers working together with regulators, including metrology institutes.  These standards form the basis for a flexible international calibration system that accommodates new technologies and ensures comparability of a patient’s test results regardless of where the testing was performed. 

The regulatory cooperation among ISO/TC 212 stakeholders continues to support the regulatory use of ISO 15189 and supporting standards. 

WHO promotes ISO 15189 as one of the best methods of laboratory strengthening and offers medical laboratories a web-based planning tool to guide them through implementing a quality management system in accordance with the requirements of ISO 15189. 

BIPM maintains an extensive database of higher-order reference materials, measurement methods/procedures, and reference laboratory services, based on the globally recognized standards developed by ISO/TC 212, to support the continued accuracy of medical laboratory test results. 
The role of international standards in harmonizing the regulation of medical laboratories, and ultimately ensuring the quality and comparability of patient test results around the world, has been dramatic. 

Trees

Environmental management – climate change    Back to top

There are numerous International Standards being used to support public policy in the field of environmental management. Standards to help address problems related to climate change are one important example.

Climate change has been identified as one of the greatest challenges facing nations, governments, business and citizens over future decades. Climate change has implications for both human and natural systems and could lead to significant changes in resource use, production and economic activity.
In response, international, regional, national and local initiatives are being developed and implemented to: limit greenhouse gas (GHG) concentrations in the Earth’s atmosphere (ISO 14064 series & ISO 14065); enable organizations to establish the systems and processes necessary to improve energy performance in order to reduce GHG emissions and other related environmental impacts and energy cost through systematic management of energy (ISO 50001); and manage the organization’s environmental responsibilities in order to reduce environmental impacts and identify ways to reduce waste and energy use (ISO 14001).

Who is involved?

The effects of climate change are impacting economies, societies and the natural environment at both global and local levels. As greenhouse gas (GHG) emissions continue to increase so will the severity of climate change impacts. Addressing climate change involves a complex combination of political, policy, business, technical, social and environmental issues that relate to all economic sectors and countries. In this regards, climate change initiatives and policies are being driven at all levels. At the international level, the United Nations Framework Convention on Climate Change, UNFCCC has established treaties such as the Kyoto Protocol to reduce GHG emissions. Other international organizations such as the Intergovernmental Panel on Climate Change, IPCC, the United Nations Environment Programme, UNEP, the World Meteorological Organization, WMO, and the United Nations Convention to Combat Desertification, UNCCD, are also actively studying and addressing climate change issues. Regional organizations in various regions of the world such as Europe and Asia are also working and coordinating climate change initiatives in addition to country specific’s (refer to table).

The three major standard organizations, ISO, IEC and ITU have standardization projects aimed to directly or indirectly tackle climate change. ISO is by far the standards organization with more committees and projects. For example, the ISO Climate Change Coordinating Committee, CCCC, ISO/TC207 Environmental Management and more specifically TC207/SC7 on GHG management and related activities have published or plan to publish standard in the near future to cover mitigation and adaptation to climate change.

How is regulatory cooperation achieved?

Regulatory cooperation is achieved through the establishment of treaties by international or regional organizations, which are adopted as laws and regulations by specific countries. Countries are ultimately responsible for developing the strategies and actions aimed to meet those treaties and laws and in most cases, international standards like those developed by ISO are used as the framework or basis for the regulations that support those treaties and laws.

Below are various examples of how ISO standards are being used to support GHG schemes and programs, and environmental management policies in countries around the globe.

Examples of ISO standards used in national, regional or international GHG schemes and programs

Country ISO Standard Programme/Scheme Mandatory Voluntary
Australia ISO 14065 carboNZero/CEMARS  (JAS- ANZ accredited )  
Belgium ISO 14064-1 National Communication  
Brazil ISO 14064-3 Carbon Disclosure Project  
Germany ISO 50001 Energy efficiency within the framework of tax capping: the amendment of Energy and Electricity Act intends to use EMAS and Energy MS according to ISO 50001    
  ISO 50001
ISO 14001
Energy efficiency within the framework of the European Energy Efficiency Directive: Energy Audits according to EN 1624701 or within the framework of EMS according to ISO 14001 or Energy MS according to ISO 50001    
Italy ISO 14065 Emission Trading Scheme  
  ISO 14065 Voluntary programme    
  ISO 14064-1 Voluntary programme    
  ISO 14064-3 Voluntary programme    
  ISO 14066 Emission Trading Scheme    
  ISO 14066 Voluntary programme  
Japan ISO14064-2 ISO14064-3 ISO14065 ISO14066 J-credit Scheme  
Poland ISO 14065
ISO 14064-3
COMMISSION REGULATION (EU) No
600/2012 of 21 June 2012 on the verification of greenhouse gas emission reports and tonne-kilometre reports and the accreditation of verifiers pursuant to Directive 2003/87/EC of the European Parliament and of the Council. Official Journal of the European Union  L 181/1, 12.7.2012
 
  ISO 14064-1 COMMISSION REGULATION (EU) No 601/2012 of 21 June 2012 on the monitoring and reporting of greenhouse gas emissions pursuant to Directive 2003/87/EC of the European Parliament and of the Council Official Journal of the European Union  L 181/30, 12.7.2012  
Portugal ISO 14064:1
ISO 14064:3
ISO 14065
Airport Carbon Accreditation Scheme form Airport Council International (Europe and Asia Pacific)  
  EN ISO 14065:2012

EU ETS
Regulation on Accreditation and Verification

 
Thailand ISO 14064- 1:2006 Domestic carbon market  
  ISO 14064- 2:2006 Domestic carbon market  
  ISO 14064- 3:2006 Domestic carbon market  
  ISO 14065:2007 Domestic carbon market  
  ISO 14066:2007 Domestic carbon market  
  ISO/TS 14067 Thailand Carbon footprint for product scheme  
  ISO/TR 14069 Thailand Carbon footprint for organization scheme  
Turkey TS EN ISO/IEC 17025 (2010) National GHG scheme/program  
  TS EN ISO/IEC National GHG scheme/program  
  TS EN ISO National GHG scheme/program  
  ISO 14064-1 National GHG scheme/program  
  ISO 14064-3 National GHG scheme/program  
  ISO/DIS 14067.2 International GHG scheme/program  
UK ISO 14065 Directive n.2003/87/EC of the European Parliament and of the Council of 13 October 2003 establishing a scheme for greenhouse gas emission allowance trading within the Community and amending Council Directive 96/61/EC.  
  ISO 14064-1 Defra (Dept. of Environment, Food and Agriculture) guidance on how to measure and report GHG emissions  
  ISO 14064-2 GHG protocol for GHG accounting  

 

Examples of ISO Environmental Management Standards used in support of other public policies

Country ISO Standard Programme/Scheme Scope and coverage Mandatory Voluntary
Germany EN ISO 14001 Harmonized standard in the European new legislation framework and the eco-management audit scheme    
  EN ISO 14004 Harmonized standard in the European new legislation framework and the eco-management audit scheme    
  EN ISO 14006 Harmonized standard in the European new legislation framework and the eco-management audit scheme    
Independent International Organisation for Certification (IIOC) Sweden ISO9001 or ISO14001   Recycling of electronics  
  Indonesia ISO 14001 3rd party Certification Manufacturing, Construction (inc. services), Chemical (inc. services), Mining (inc. services), etc.  
  Australia ISO 14001 Government Suppliers requested  
  Canada ISO14001      
  France 14001 Sustainable Development policy Public Administration (all Sector)  
  France 14001 Common Sustainable Development policy Public Account Consortium (EDF-GDF Suez-RATP-SNCF-AREVA)  
  Italy ISO 14001      
  Japan ISO 14001 Inspection on management matters for public works Public works  
  Japan ISO 14001 Support system of local governments    
  Japan ISO 14001 Requirements specified by customer All activities for customer  
Japan ISO 14001 Environmental Management Systems Registration Scheme    
UK 14K EMAS EU  
  14K ESOS UK  
  14K EP-OPRA UK
  14K Industrial Emissions Directive EU
  14K UK offshore guidance UK  
  ISO 14001 Executive Order 13423, “Strengthening Federal Environmental, Energy, and Transportation Management” US federal agencies  
           

 

Radio services

Radio services    Back to top

IEC/CISPR (International special committee on radio interference) is responsible for the protection of radio services and promotes international agreements on aspects of radio interference. IEC/TC 77 is responsible for the standardization in the field of immunity to radio and conducted interferences. Trade facilitation at an international level has become an integral part of CISPR and TC 77 activity, as it covers a range of products and systems to ensure in the protection of radio reception from interference sources as well as the immunity to external interferences sources for equipment such as electrical appliances of all types, ignition systems, electricity supply systems, industrial, scientific and electromedical systems, sound and television broadcasting receivers and information technology equipment. The recent development of electric vehicles and smart power distribution networks generated a high activity to ensure a coherent integration of these new technologies within the catalogue of IEC standards.

Who is involved?

CISPR and TC77 comprise experts from many areas, including radio regulatory authorities, test houses, manufacturers, numerous ISO and IEC committee liaisons, and international organizations such as the European Post and Telecommunications Conference (CEPT) and the International Telecommunication Union (ITU).

How is regulatory cooperation in this field achieved?

Virtually all countries belong to the ITU and hence have a responsibility to protect the reception of radio services from interference. With the wide proliferation of electrical and electronic products that use intensively radio communication (WIFI, Bluetooth, 4G mobile phones, remote controlled devices), there is a need to ensure that emissions from such products do not unduly affect radio reception. Consequently, the limits used in CISPR and TC 77 product standards are almost universally used in some form to ensure that products have emissions at acceptable levels and immunity at corresponding levels. As a result, although IEC standards are generally drafted with a view to being voluntary standards, almost all CISPR and TC 77 standards are embodied in some form in national legislation in many of the world’s major markets. The success of CISPR and TC 77 standards lies in the fact that the membership of CISPR and TC 77 is very broad, taking account of all interests. However, given the rapid developments in technology and changes in radio services, keeping CISPR and TC 77 standards effective and relevant presents a continuing challenge.

Railways

Railways    Back to top

IEC/TC 9, Electrical equipment and systems for railways, is responsible for the international standardization of the electrical equipment and systems used in railways. These include rolling stock, fixed installations, management systems for railway operation, and their interfaces and ecological environment. IEC/TC 9 standards not only cover railway networks but also metropolitan transport networks, including metros, tramways, trolley buses and fully automated transport systems as well as magnetic levitated transport systems. These standards relate to systems, components and software and they will deal with electrical, electronic and mechanical aspects, the latter being limited to items depending on electrical factors. These standards deal with electromechanical and electronic aspects of power components as well as with electronic hardware and software components. A major feature of the railway field is its specificity: even if some work items are similar to those covered in other industrial fields the relevant answers have to take into account the strain of coherence of the railway system as well as the interface specification need.

ISO/TC269 also was recently created to develop standards for products and services specifically related to the rail industry, including construction, operation and maintenance of parts and equipment, methods and technology, interfaces between infrastructure and vehicles and rail specific environmental aspects. This excludes those electrotechnical and electronic products and services for railways which are within the scope of IEC/TC 9.

Who is involved?

With the safety of passengers and the environment being of paramount importance, stringent regulations are required worldwide. A close relationship is maintained with the International Union of Railways (UIC) and the International Association of Public Transport (UITP). Through this cooperation, various worldwide solutions have been prepared to satisfy design needs and regulatory requirements. Examples include the safety of signalling or control-command systems, EMC, protective provisions for traction circuits, RAMS principles and methods, the design of automatic guided transportation systems and,  more generally, generic concepts ensuring safety for every urban system.

How is regulatory cooperation in this field achieved?

These developments are closely and actively followed by the industry and its designers in the main regions involved in the development of railways, i.e. Europe, North America and the Far East.  Specifications and standards needs identified worldwide allow for technical cooperation, railway system coherence and interoperability. The future priorities of IEC/TC 9 in particular emphasize the growing importance of urban transport and identify a need for standardization in order to avoid reinventing a costly new solution for each new metro system around the world.

Food products

Food products    Back to top

ISO standards play an important role in the food industry, both for trade purposes and in order to ensure that food is safe for consumption. Food safety is obviously a well-regulated area, so there is a long history of collaboration between the Codex (the international forum for food regulators) and ISO/TC 34, Food products.

Who is involved?

Codex and ISO activities are complementary. Codex, as a governmental organization, prepares documents to assist governments in their statutory and regulatory task of protecting their citizens from health hazards caused by food consumption. ISO, as a non-governmental organization, prepares standards on test methods to assist stakeholders along the whole food chain to fulfil both the statutory and regulatory requirements, as well as the requirements of consumers of these products.

How is regulatory cooperation in this field achieved?

The Codex Committee on Methods of Analysis and Sampling endorses analytical and test methods from various standards writing bodies, following recommendations from the relevant Codex Commodity Committee. In the field of milk and milk products, ISO/TC 34/SC 5, Food products — Milk and milk products, and the International Dairy Federation (IDF) work together to prepare methods of analysis that are published jointly. Most of these analytical methods are endorsed by the Codex Committee on Methods of Analysis and Sampling. Several analysis methods from ISO/TC 34/SC 9, Food products — Microbiology, have also been endorsed by this committee as have standards from ISO/TC 34/SC 4, Food products — Cereals and pulses, and ISO/TC 34/SC 11, Food products — Animal and vegetable fats and oils. More than 100 standards by ISO/TC 34 have now been endorsed by Codex as the official test method.

In 2005, ISO/TC 34 published ISO 22000, Food safety management systems — Requirements for any organization in the food chain, which is based on a management systems approach similar to that detailed in ISO 9001 as well as on the Codex hazard analysis and critical control point (HACCP) system. The HACCP system is widely accepted worldwide, but it has been implemented in different ways in different countries. In addition, retailer organizations have prepared documents (British Retail Consortium and International Food Standard) for the establishment and auditing of food safety systems, possibly including HACCP requirements. ISO 22000 should help to clarify and harmonize the present situation. Codex played an active role in the development of ISO 22000.

ISO/TC 34 also developed ISO 22005, Traceability in the feed and food chain — General principles and basic requirements for system design and implementation. The traceability of food products “from the farm to the fork” is an important requirement. This standard is intended to complement the Codex work on traceability, as it explains the design of a suitable system.
Nuclear plant

Energy management    Back to top

Promoting energy management

ISO 50001:2011, Energy management systems – Requirements with guidance for use, is a voluntary International Standard developed by ISO. It provides organizations with a recognized framework for integrating energy performance into their management practices and enables the development of action plans to continually improve energy performance and sustain these over time.

To achieve significant energy savings in the industrial sector, the International Energy Agency (IEA) recommends that governments should require large, energy-intensive industry, and encourage other industrial energy users, to conform to ISO 50001 or an equivalent energy management protocol (IEA, 2011). By referring to an international management standard in energy efficiency policies, policy makers can save time and resources as there is no need to develop and update national or regional standards and associated certification systems.

To date a number of governments around the world are referring to the ISO 50001 standard or using it as a core element in their industrial energy efficiency policies. Examples include:

  • The new German voluntary agreement with energy intensive industry entered into force in 2013. Industries that comply with the terms of the agreement are eligible for a tax rebate on energy tax. Under the new agreement companies need to introduce energy management systems or audits until the end of 2015 with certification according to EMAS or DIN EN ISO 50001.
  • The voluntary US Superior Energy Performance program is a certification program that provides industrial facilities with a roadmap for achieving continual improvement in energy efficiency while maintaining competitiveness. The program is based around the standard ISO 50001.
  • The Canadian government offers grants for industrial organisations that adopt systems and processes that improve energy performance. The funding covers costs towards accreditation, including development of energy baseline, energy use assessment, energy performance monitoring and reporting, professional fees and training (50% of eligible costs up to CAD 25 0000 in grant funding). To be eligible companies must project must implement the CAN/CSA ISO50001 Energy Management Systems Standard and submit energy performance improvement plan to NR CAN.
  • Ireland’s voluntary agreements known the Energy Agreements Programme (EAP), run by Sustainable Energy Authority of Ireland (SEAI), aim to stimulate energy efficiency activity within the largest consumers of energy in Ireland above and beyond business-as-usual. While the EAP is voluntary, participating companies are required to implement the international energy management systems standard ISO 50001.  During the initial three-year period of the agreement, SEAI provides technical support, networking assistance and financial support.
  • The Chilean Energy Efficiency Agency (AChEE) has launched the Pilot Program Implementation of ISO 50001 Energy Management Systems in 2013. Participating companies sign a technical cooperation agreement with the Agency to commit to implementing ISO 50001. The thirteen companies that have begun the process of implementing the standard expect to achieve international certification during 2014.
  • Companies with an annual energy consumption of more than 1,200 tons of coal equivalent in Kazakhstan are now obliged by law to conduct energy audits to develop efficiency programs to define energy-saving goals and build energy management systems according to ISO 50001.
  • Several countries are using a combination of long-term voluntary agreements and incentives to stimulate the uptake of energy management systems. Examples include Denmark (energy management requirement and carbon tax reduction, and The Netherlands (energy management requirement, support in implementing efficiency measures and a tax reduction).

Organisations that support the development of energy efficiency policies are also starting to utilise the ISO 50001 standard. For example, within the framework of the United Nations Industrial Development Organization (UNIDO) EnMS/ISO 50001 Programme, UNIDO provides policy advice and institutional capacity building for the development of a programmatic framework for EnMS and standards in industry in South Africa, Moldova, Russia, Turkey, Iran, Malaysia, Thailand, Viet Nam, Philippines, Egypt, Indonesia and Ecuador.

Number of ISO 50001 certified sites worldwide

Number of ISO 50001 certified sited worldwide
Source: R. Peglau (German Federal Environment Agency), 2014

Container ship

Ships and marine technology    Back to top

Regulatory bodies can have an important role in defining standards and requirements which affect safety, security and the environment, both at the organization/company level or at the individual level. The ships and marine sector provides a good example of what can be achieved over a period of time when appropriate links are maintained between the regulatory body and ISO and IEC Technical Committees.

The main lesson from this example is that the regulatory authority can be provided with continuous representation by ISO and IEC Technical Committees and their work when discussing how standards can help ensure uniform international implementation by industry. This is a good example of active utilization of the ISO and IEC liaison approach with other organizations, which requires long-term commitment, close cooperation and political sensitivity.

Who is involved?

International Maritime Organization (IMO)

IMO provides a forum and framework for cooperation among governments in the field of governmental regulation and practices relating to technical matters of all kinds affecting shipping engaged in international trade.  It encourages and facilitates the general adoption of standards in support of its international agreements concerning maritime safety, security, efficiency of navigation and prevention and control of marine pollution from ships.

ISO/TC 8, Ships and marine technology

ISO/TC 8 is responsible within ISO for the standardization of design, construction, structural elements, outfitting parts,  equipment, methods and technology and marine environmental matters  which are used in shipbuilding and the operation of ships, comprising sea-going ships, vessels for inland navigation, offshore structures, ship-to-shore interface and all other marine structures subject to IMO requirements. ISO/TC 8 is also responding to other standardization needs in the areas of security and piracy, polar navigation, ship recycling, and lifesaving equipment.

IEC/TC 18, Electrical installations of ships and of mobile and fixed offshore units

IEC/TC 18 is responsible for the electrical installations and equipment on ships and on mobile and fixed offshore units. Its standards form a code of practical interpretation of the requirements of the International Convention on Safety of Life at Sea.  IEC/TC 18 standards foster interchangeability of parts  and ease the selection and procurement of equipment, including cables for transport of energy,  signals and data  by indicating IEC standards of ratings, types,  dimensions, materials, quality and test  methods.

IEC/TC 80, Maritime navigation and radiocommunication equipment and systems

IEC/TC 80 is responsible for preparing standards for maritime navigation and radiocommunication equipment and systems making use of electrotechnical, electronic, electroacoustic, electro-optical and data processing techniques. Its standards requested by IMO or other regulating body are typically the technical standard that IMO will use as an interpretation of IMO decisions. The suite of shipborne equipment set by IEC/TC 80 must be compatible with shore navigation systems in all IMO signatory countries, thus ensuring that vessels can navigate in their waters.  IEC/TC 80 also addresses requirements for other international bodies, such as the International Association of Lighthouse Authorities (IALA), especially regarding Automatic Identification Systems (AIS) and other systems requiring compatibility with shore navigation systems.

How is regulatory cooperation in this field achieved?

By ensuring mutual representation at committee meetings and almost constant communication, these bodies have ensured that marine standards reflect the needs of the regulatory body and avoid any unwanted duplication of work. As well as ensuring representation at each other’s meetings, this sector has also developed other practical steps to facilitate the use of standards in regulations.

When work items are considered to be of mutual interest to IEC/TC 18, IEC/TC 80, ISO/TC 8, and IMO, these items are either requested by IMO or are initiated by the technical committees themselves. The mutual interest is recorded in the Strategic Policy Statements of IEC/TC 18 and IEC/TC 80 (www.iec.ch) and in the Annex of the Business Plan of ISO/TC 8 (www.iso.org/tc8). IMO has confirmed its interest by submitting a number of requests to ISO and the IEC. Many ISO and IEC standards and specifications have become pertinent documents in connection with the regulatory work of IMO.

As an international regulatory body with members comprising national governments, IMO has the capability, through these delegations, to prescribe and define its requirements at all levels. ISO and the IEC play a critical role in saving scarce resources in IMO by providing the industry input and by facilitating the implementation of IMO requirements. This allows maximum focus on the performance requirements by IMO and permits reference to the technical work of non-governmental organizations such as ISO and the IEC. This relationship is thus founded on long-term trust and confidence. It demands awareness of an IMO interest at the earliest stages and a timely response to meet its needs as well as those of industry stakeholders.

This fruitful working relationship, mutual trust and respect is based on years of close understanding. IEC/TC 18 and IEC/TC 80 and ISO/TC 8 have proved that standards can be developed in months, rather than years.  This has made the ISO and the IEC attractive and effective partners for IMO.