What are standards in this context?

A standard is a document, established by a consensus of subject matter experts and approved by a recognized body that provides guidance on the design, use or performance of materials, products, processes, services, systems or persons.

Some details of the common elements of an International Standard and its development can be found in My ISO job. Many national standards follow the same format.

Standards can be developed by national, regional and international standards developing organizations and also by businesses or other organizations for their own internal use. They can also be developed by consortia of businesses to address a specific marketplace need, or by government departments to support regulations. This module is most concerned with standards produced by the international standards organizations, ISO and IEC, and their national members.

The formal definition from the International Organization for Standardization (ISO) and its sister organization, the International Electrotechnical Commission (IEC) is: a document, established by consensus and approved by a recognized body, that provides, for common and repeated use, rules, guidelines or characteristics for activities or their results, aimed at the achievement of the optimum degree of order in a given context.

Whereas IEC’s scope of work is specifically electrical and electrotechnical standardization, ISO’s work programme encompasses virtually all other areas except telecommunications which is covered by the International Telecommunication Union (ITU). However, a joint technical committee of ISO and IEC (JTC1)¹ deals with information technology standardization.

Standards are voluntary agreements, developed within an open process that gives all stakeholders, including consumers, the opportunity to express their views and have those views considered. This contributes to their fairness and market relevance, and promotes confidence in their use.

ISO has formalized these concepts within its Code of Ethics and its Strategic Plan, which both underline the importance of consumer participation in standards development.

An important process commonly associated with the implementation or use of standards is conformity assessment. This is the process of evaluating or measuring whether materials, products, processes, services, systems or persons meet requirements (such as those contained in a standard). ISO and IEC also develop procedures and standards for conformity assessment.

What do standards contain?

The International Standards published by ISO or by IEC are international consensus documents developed by representatives of the ISO or IEC member bodies coming together in international Technical Committees. International Standards contain technical specifications or other precise criteria, which ensure that materials, products, processes, services, systems, or persons are fit for their intended purpose (for more about consensus, see 1.4).

Standards have no predefined lifetime but undergo periodic review to ensure that they take account of the latest technological developments and market trends.

As noted above, standards do not necessarily just contain requirements (which are specifications, such as defining characteristics, tolerances and limiting values) for products.

They can also be test methods, codes of practice, management system standards, recommendations, or guidelines (guidance) on an agreed best practice.

Management system standards describe how businesses internally manage their production and continuous improvement processes, either for quality assurance purposes, or to address specific concerns such as food safety, environmental stewardship or security of information systems.

Standards are also developed for the growing services sector

Standards set criteria that affect health and safety or define labelling and packaging requirements for consumer products. They can deal with graphical symbols, certification of persons, or conformity assessment practices. These standards are of particular interest for consumers.

How do standards help?

Standards ensure consistency of essential features of goods and services, such as quality, ecology, safety, economy, reliability, compatibility, interoperability, efficiency and effectiveness.

Standards codify the latest technology and facilitate its transfer. Standards are therefore an invaluable source of knowledge.

Thus, standards avoid reinventing the wheel: they distil expert knowledge and make it available to all.

International Standards, in particular:

• Help make the development, manufacturing and supply of goods and services more efficient, safer and cleaner.
  
  
  An example: ISO 22000, Food safety management systems – Requirements for any organization in the food chain helps an organization or company that ships, packages or sells food and foodstuffs to have an effective system to help ensure the safety of these products.
• Make trade between countries easier and fairer because the same specifications are adopted for use in different countries as national or regional standards.
  • In many countries national standards are aligned with International ones, for example more than 60% of Malaysian Standards are aligned in this way.
    
    
  A specific example is ISO 14971, Application of risk assessment for medical devices, which was adopted as ANSI/AAMI/ISO 14971 in the USA; as EN ISO 14971 in Europe; and as JIST 14971 in Japan.
  • ISO 22000, Food safety management systems – Requirements for any organization in the food chain has been adopted as a national standard in 37 countries, including in Poland (PN-EN IS0 22000:2006) and in Thailand (TIS 22000-2548:2005).
  • 45 countries have adopted ISO 10002, Quality management – Customer satisfaction – Guidelines for complaints handling in organizations.
• Are an effective and commonly used support to national technical regulations.
  • Malaysia's Electrical Regulations scheme includes mandatory compliance with 31 categories of household appliances standards.
  • Compliance with toy safety standards is mandatory for example in Albania and Malaysia.
  • Safeguard users and consumers and make many aspects of their lives simpler.
    
    
    Examples of just a few of these areas are safety of toys, safety signs and, within IEC, safety and performance of household electrical appliances.
• Are coherent within a global system, either within a framework of mutually compatible standards, or as recognized formally by other standardizing bodies.

(Also see 2.2)

National, regional and international standards

The first thing to remember is that standards usually start at the country level. Most countries have their own national standards-making bodies, and most of these are members of ISO and will have all of the following roles:

• they publish, and may write, their own national standards
• they represent their country in regional and international standard-setting fora
• they hold a reference library of national, regional and international standards
• they sell copies of standards
• Some also offer conformity assessment services such as accreditation, certification or other commercial activities

National standards bodies may also group together to make regional standards. For example, national standards bodies in Europe are also members of the European Committee for Standardization (CEN) as well as members of ISO. Together with its sister organizations, CENELEC and ETSI, CEN has a special role to develop European Standards that can support European Union laws (known as ‘directives‘) or broader European public policies. Other regional standards groups exist as well, such as in Latin America (COPANT), or the Asia-Pacific region (PASC).

The use of standards may be voluntary, or they may be referenced in regulation (therefore mandatory). The "New Approach" in Europe is an example of this (see www.newapproach.org).

Standards are used in Europe to support pan-European legislation under this ‘New Approach’. Standards are mandatory when referenced in specific EU Directives, but otherwise the decision on their use remains voluntary.

Under the World Trade Organization (WTO) rules, governments are required to base their national regulations on standards produced by organizations like ISO and IEC, as much as possible (also see 1.3).

Partly because of these rules, and also because of the general globalization of trade, national and regional standards bodies are either adopting or otherwise using International Standards, where possible.

How standards relate to regulatory regimes

The important distinction between standards and legislation is that standards are voluntary, whereas legislation is mandatory. When regulatory authorities use standards as a basis for legislation, only then do they become mandatory, and then only within the jurisdiction covered by the legislation.

Regulatory authorities decide themselves whether to use Standards to support their technical regulations. Once this happens, there are various ways of referring to the legal text:

• Direct references to specific editions of a given standard (dated direct reference)
  
  
  Example: The hazardous waste material container shall conform to ISO XXX:2012 TITLE
  
• Direct references to a standard, without specifying the edition (undated direct reference)
  
  
  Example: The hazardous waste material contain shall conform to the latest edition of ISO xxx:2003 TITLE
  
• Indirect references to the use of the standard, such as use of official standards register which is kept up to date and made publicly available
  
  
  Example: Where the product meets the relevant ISO or IEC standard whose reference number has been published in (OFFICIAL LISTING), the relevant authorities shall presume compliance with the requirements of this law.

For more details and examples, see the information publication Using and referencing ISO and IEC standards for technical regulations in Section 8.

What is ISO?

ISO is a network of the national standards bodies (NSBs) of some 164 countries (in 2012), with one member per country. Among other activities, ISO's Central Secretariat in Geneva, Switzerland, coordinates the organization and development of International Standards.

ISO is a non-governmental organization: its members are not, as is the case in the United Nations system, delegations of national governments. Even so, ISO occupies a special position between the public and private sectors. This is because many of its members are part of the governmental structure of their countries, or are mandated by their government. Other members have their roots uniquely in the private sector, having been set up by national partnerships of industry associations, working cooperatively with the public sector.

Therefore, ISO is able to act as a bridging organization. It can develop solutions that meet both the requirements of business and the broader needs of society, including stakeholder groups like consumers and other users.

Who are ISO’s partners?

ISO cooperates with the IEC and ITU and they have joined to form the World Standards Cooperation (WSC) as the focus of their combined strategic activity.

These three organizations each have a strategic partnership with the World Trade Organization (WTO) aiming to promote a free and fair global trading system. ISO cooperates in the framework of several WTO Agreements, notably the WTO Agreement on Technical Barriers to Trade (WTO-TBT). Signatories to the TBT commit themselves to promoting and using international standards such as the type produced by ISO.

ISO cooperates closely with most of the specialized agencies and bodies of the United Nations that are involved in technical harmonization and assistance to developing countries.

ISO also maintains close working relations with regional standards organizations, many of whose members also belong to ISO.

In addition, across the board some six hundred specialized organizations representing trade or regulatory sectors and other stakeholder groups, including consumers, participate in developing ISO standards.

Only relevant stakeholders are involved in the development of any one standard.

In order to allow systematic classification and study of stakeholders, the ISO Technical Board has defined seven distinct categories for classification of experts participating in technical committees (TMB Resolution 75/2012). They appear in the table below.

Also see ISO’s Web site, ISO Online, for more details about ISO and its partners.

1.4.1 National standard

Typically a national standards body (NSB), or one of its member organizations will first determine the market need for a standard.

For example, this need might be a request from the government to use a standard as a technical regulation to support consumer protection, or it might be a request from an industry group to address interoperability problems or from a consumer group to describe the risks associated with adventurous activities.

The standardization body can then do one of three things:

• At the national level, an NSB can develop a new national standard, using a national technical committee that represents interested stakeholders (including, for example, consumer interests).
  • Note: different NSBs have different processes for involving stakeholders
• An NSB can adopt a national standard from another NSB, with the latter's prior agreement and payment of copyright fees and other commercial arrangements
• An NSB can adopt an already existing international standard as a national standard.

1.4.2 International Standard

One essential feature of international standards is that the process is formally laid down in the ISO/IEC Directives (the rules that govern the standards development procedure). All international standards development work must follow this process, which has been established to ensure transparency and fairness. These are two important principles that underpin the credibility of ISO and IEC.

In ISO (and IEC), a proposal for an International Standard is most usually submitted by an NSB:

• to the ISO Central Secretariat for further development, if it is an ISO member
• to the IEC Central Office if it is a member of IEC
• In some cases, an NSB can offer a national or regional standard to form the basis of an International Standard (“fast track procedure”) or as a sample text appended to a New Work Item Proposal (NWIP).

It can also come from a number of other sources, such as an ISO policy or governing body (e.g. COPOLCO), the ISO Secretary-General, a Technical Committee or an organization in liaison (e.g. OECD or CI).

An ISO International Standard represents a global consensus on the state of the art in the subject of that standard. This global consensus is reached over the course of a six-stage development process for International Standards, which is described in detail below.

ISO’s standards development process is designed to reflect the WTO principles of transparency, openness, impartiality and consensus, effectiveness and relevance, coherence, and addressing developing country concerns, so as to contribute to the credibility of the International Standards produced. For example, the process allows for input and consensus building, first among market players and experts at the drafting stages of the standards, and second among countries at the formal voting stages of the standards. As a result, all ISO International Standards effectively reflect a double level of consensus.

For more about the process click on this flowchart:

Review of International Standards (Confirmation, Revision, Withdrawal)

• All International Standards are reviewed at least once every five years by all the ISO member bodies. A majority of the P-members of the TC/SC decides whether an International Standard should be confirmed, revised or withdrawn based on a survey circulated to all ISO members about the adoption and use of the standard in question.
• For a more detailed description of the standards development process and ISO’s deliverables, see the ISO brochure ‘Joining in’, available free online at: http://www.iso.org/iso/joining_in_2012.pdf.

The average development time for an International Standard is approximately three years. Increasingly, the work is done electronically to improve speed to market and to conserve resources.

ISO also produces other types of documents that involve fewer consultation stages such as international Workshop Agreements (IWA), Technical Reports (TR) (therefore a lower degree of consensus), but are quicker to reach the marketplace.

The ISO Committee on consumer policy (COPOLCO)

ISO seeks to ensure that its standards are market-relevant and meet the needs of the end-user. This end-user is often a consumer who is exposed to an increasingly global offer of products and services. As standardization plays a significant role in assuring that products meet essential consumer requirements for health, safety, and quality for example, standards are a key tool in promoting consumer protection. See Section two for more about how standards benefit consumers.

Realizing that consumers were an important stakeholder in standards development, ISO established a policy development committee in 1978, the Committee on consumer policy (COPOLCO). COPOLCO reports directly to the ISO Council, the governing body of the organization.

COPOLCO has a membership of some 112 National Standards Bodies from among the ISO membership (as of January 2013), of which approximately three-quarters are from developing countries.

COPOLCO has the following general objectives:

• Making ISO/COPOLCO’s services available to ISO members worldwide
• Supporting the development of consumer participation in standards-making
• Studying how consumers can benefit from standardization
• Promoting the positive role of standards in consumer protection
• Encouraging the exchange of experience on standards work of consumer interest
• Channelling consumers’ views both into current standards projects and proposals for new work in areas of interest to consumers

COPOLCO achieves these objectives by:

• Coordinating participation by consumer representatives in selected areas of priority interest to consumers
• Developing publications to promote consumer participation in standards work and to train consumer representatives for this task
• Coordinating training activities and representation at events involving consumers and standardization issues
• Organizing annual workshops that bring together representatives of consumers, public authorities, manufacturers and standardization experts
• Preparing a range of Guides for experts, to help them address consumer issues and priorities more adequately when they draft standards
• Preparing proposals for new standards projects
• Informing consumers and other interested persons through a freely available online newsletter and social media sites

In relation to standards development at the national level, COPOLCO membership encourages networking. This assists consumer representatives at the national level to benefit from the experiences of consumers in other countries.

For specific contributions that COPOLCO has made to ISO's work, see section 4.2

See the dedicated consumer area of ISO Online for more about COPOLCO.

COPOLCO’s partners

COPOLCO cooperates closely with several other ISO policy development committees, as "internal" partners. The ISO Committee on developing country matters (ISO/DEVCO) concentrates, inter alia, on helping ISO's developing country members build capacity and therefore participate effectively in the ISO system, equally with other countries. COPOLCO and DEVCO work closely together on training workshops to help NSBs and consumer organizations work more effectively together in standards development.

Go to DEVCO website

COPOLCO also cooperates with the ISO Committee on conformity assessment (ISO/CASCO) on matters of common interest, including product recall, market surveillance, and use of marks of conformity assessment.

COPOLCO works with three external partners (liaisons):

• Organization of Economic Cooperation and Development (OECD)’s Committee on consumer policy (OECD/CCP). A number of standardization initiatives from COPOLCO have drawn on the research and studies by the OECD.
  
  
  • Go to OECD (www.oecd.org) website
    
    
• Consumers International, the worldwide organization for consumer groups. Consumers International is a federation of consumer organizations dedicated to the protection and promotion of consumers’ rights worldwide through empowering national consumer groups and campaigning at the international level. More than 220 organizations, from 115 countries, participate in CI. Note: Many CI members attend the COPOLCO plenary meeting each year as members of the national COPOLCO member delegations.
  
  
  • Go to CI (www.consumersinternational.org) website
    
    
• International Organization for Legal Metrology (OIML) is an intergovernmental treaty organization which promotes the global harmonization of legal metrology procedures. Legal Metrology is the entirety of the legislative, administrative and technical procedures established by, or by reference to public authorities, and implemented on their behalf in order to specify and to ensure, in a regulatory or contractual manner, the appropriate quality and credibility of measurements related to official controls, trade, health, safety and the environment. OIML’s work has relevance for consumers, inter alia, in the area of calibration for measuring equipment. This is critical for the accuracy of safety tests, and consumer tools such as utility meters. It is also vital for consumer product testing laboratories.
  
  
  • Go to OIML (www.oiml.org) website

These liaisons participate in COPOLCO’s annual meetings and workshops, and also contribute to the development of COPOLCO’s publications and research.

The IEC also participates in COPOLCO, as does ANEC, the European consumer voice in standardization.

COPOLCO also organizes training activities to foster consumer representation in standards development, in partnership with ISO/DEVT, the capacity-building arm of ISO’s Committee on developing country matters (DEVCO). Through the generous support of the Swedish International Development Cooperation Agency, several ISO members and sponsoring organizations, seven regional training events took place in various locations around the world. Following these, there were two ‘train the trainer’ events (one in English, one in French), as well as a number of follow-up workshops which are still continuing. There is now relevant training expertise available in more regions and countries, which can undertake training on consumers and standards. For more information, contact ISO/DEVT (devt@iso.org).

The presentations and proceedings of all of these workshops are publicly available in a dedicated area of ISO Online.

ISO also produces the following helpful materials that are available in the resource section of this module:

• Supporting stakeholders – Disseminating ISO Documents to National Mirror Committees (ISO), 2009
• The consumer and standards – Guidance and principles for consumer participation in standards development (ISO), 2003
• How ISO/IEC Guides add value to International Standards (ISO), 2007
• My ISO job – Guidance for delegates and experts (ISO), 2008
• Guidance for national standards bodies – Engaging stakeholders and building consensus (ISO), 2010
• Involving consumers – Why and how (ISO), 2011
• Joining in – Participation in International Standardization (ISO), 2012