ISO Regional Workshop On Standards and Technical Regulations 2016 - Martin Kellermann

Project to strengthen institutional
infrastructure on standards and

regulations to support business
and industry in the Middle East and
North Africa during 2013-2017
(MENA STAR)
Amman, Jordan
16-18 August 2016
ISO regional workshop

Standardization and technical regulation - Good
practice similarities and differences in development and implementation
Martin Kellermann
SIDA Contribution No: 52030192
ConclusionReport:StandardizationandTechnicalRegulation
Contents
Acronyms and abbreviations ................................................................................................... 3
Introduction ............................................................................................................................. 4
Purpose of this conclusion report............................................................................................ 5
Part 1 - Policy making in respect of technical regulation and standardization ........................ 7
1.1.
National Quality Policy .............................................................................................. 7
1.2.
From Public Policy to National Quality Infrastructure ............................................. 12
Part 2 - Good practices in respect of standardization and technical regulation .................... 14

2.1.
Good standardization practices .............................................................................. 14
2.2.
Good regulatory practices ...................................................................................... 17
2.3.
Regulatory reform ................................................................................................... 18
Part 3 - Technical Regulation................................................................................................ 21

3.1.
Technical regulation building blocks ....................................................................... 21
3.2.
Technical regulation development and implementation ......................................... 25
Part 4 - Technical regulation and quality infrastructure interfaces ........................................ 29

4.1.
Standards in technical regulation ........................................................................... 29
4.2.
Metrology in technical regulation ............................................................................ 31
4.3.
Accreditation in technical regulation ....................................................................... 34
Part 5 - Regulatory impact assessments and other challenges ............................................ 36

5.1.
Regulatory Impact Assessment (RIA) .................................................................... 36
5.2.
Cooperation between quality infrastructure and technical regulation systems ....... 39
5.3.
Common challenges ............................................................................................... 41
ANNEX A: NQI and technical regulation systems in the MENA STAR countries ................. 45
National Quality Infrastructure ........................................................................................... 45
Technical regulation systems ............................................................................................ 46
ANNEX B: The workshop ...................................................................................................... 47
Workshop modalities ......................................................................................................... 47
Workshop feedback ........................................................................................................... 48
Acronyms and abbreviations

BIPM
CAB
CAC
CMC
EU
GDP
IAF
IEC
ILAC
ISO
JSMO
KCDB
MENA
MoTI
NAB
NMI
NSB
NQI
OECD
OIML
RIA
SADC
SADCAS
SANAS
SDO
SIDA
SME
SPS
TBT
WTO
International Bureau for Weights and Measures

Conformity Assessment Body
Codex Alimentarus Commission
Calibration and Measurement Capability
European Union
Gross Domestic Product
International Accreditation Forum
International Electrotechnical Commission
International Laboratory Accreditation Cooperation
International Organization for Standardization
Jordanian Standards and Metrology Organization
Key Comparison Date Base
Middle East and North Africa (region)
Ministry of Trade and Industry
National Accreditation Body
National Metrology Institute
National Standards Body
National Quality Infrastructure
Organization for Economic Cooperation and Development
International Organization for Legal Metrology
Regulatory Impact Assessment
Southern African Development Community
SADC Accreditation Service
South African National Accreditation Service
Standards Development Organization
Swedish International Development Agency
Small and Medium Enterprise
Sanitary and Phyto-sanitary
Technical Barrier to Trade
World Trade Organization
Introduction
Standards and especially technical regulations have become the subject of much debate at
the international and regional levels as regards their importance in trade. Most of the complaints lodged at the World Trade Organization regarding the WTO TBT Agreement in recent
years deal with standards and technical regulation. Differences in approach to technical regulation, challenges regarding the validity of compulsory measures relating to standards and a
lack of understanding on some of the fundamental differences between standards and technical regulations abound.
Given this background, the challenge for policy makers, standardization organizations and
regulatory agencies in smaller economies is to find the best approach to standardization and
technical regulation development and implementation within the realities of their country, but
which is still acceptable to trading partners and which complies with regional and international
good practices and international trade related agreements.
To explore how best to approach these challenges, ISO Central Secretariat in cooperation
with the Jordanian Standards and Metrology Organization (JSMO) organized a regional workshop in Amman, Jordan with participation from eight Arabic speaking countries in August
2016. The workshop objective was to provide the participants with knowledge of technical
regulation development and implementation through discussions on international requirements, technical regulation building blocks and their modalities. Moreover, the important role
that the National Quality Infrastructure (NQI) plays and frequently experienced challenges and
conflicts of interest to be avoided were also considered.
The workshop was part of the MENA STAR project designed to support sustainable development in the Middle East and North Africa. The project was financed by the Swedish International Development Agency (SIDA) and implemented by the International Organization for
Standardization (ISO).
For more details of the workshop see Annex A.
Purpose of this conclusion report

With the aim of providing a practical approach to the understanding of standardization and
technical regulation, and a methodology to evaluate these at the national level for effectiveness, efficiency and compliance with international good practices, this conclusion report is
structured in a number of parts and annexes.
The first part provides a concise overview of good policy making practices, highlighting the
need for policy development in respect of the quality infrastructure and technical regulation
before any re-engineering of the same is undertaken. This part also introduces the basic
elements of the national quality infrastructure.
The second part provides an overview of good standardization and technical regulation
practices as they have evolved over the past decades. Some of these are codified in
international agreements, others are the most effective and efficient practices to follow for
the moment.
The third part provides an overview of technical regulation, its building blocks and good
development practices. There is no single way of technical regulation. Countries have to
find a way that is acceptable to the international community, but which at the same time is
doable and affordable.
The fourth part explores the interfaces between standardization and technical regulation.
The important role that standards, metrology and accreditation play in the implementation
of technical regulations is given specific attention as this is an area which many policy
makers and regulatory agencies find challenging.
The fifth part deals with specific challenges smaller economies experience in the implementation of technical regulation, especially the growing importance of regulatory impact
assessments. A number of conflicts of interest that are experienced relating to customs
and practices that were fine a decade or two ago, but have become unacceptable in the
meantime are also discussed and ways of dealing with them are enumerated.
Annex A contains an overview of the national quality infrastructures and technical regulation systems of the participating countries at the time of the workshop. As these quality
infrastructures and technical regulation systems are undergoing fundamental changes,
this information is given for demonstration purposes only, and should not be used to make
any judgement calls as to their compliance with good practices for other reasons.
Annex B contains a description of the workshop modalities and its evaluation by the participants as information for use in similar workshops in the future.
Establishing and maintaining a national quality infrastructure is an expensive and long-term

business. Even more so for technical regulation regimes that are frequently ad hoc, fragmented, uncoordinated and in dire need of a total re-engineering exercise before the country
can benefit fully from the world trading system. But, developing countries experience significant resource constraints and are often frustrated when trying to, or are pressurized to, emulate the systems of the developed countries and major trading blocks. This however, is not
always necessary nor desirable. Innovative and more affordable solutions need to be found.
This conclusion report seeks to provide policy makers, standardization organizations and regulatory authorities in developing countries with an overview of crucial technical regulation and
standardization issues, and also seeks to assist in establishing systems that meet international
requirements and good practices. It should be kept in mind however, that standardization and
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technical regulation systems continue to evolve as the world trading system evolves, and developing economies will need to keep abreast of such developments if they wish to continue
to experience the benefits of international trade.
Part 1 - Policy making in respect of technical regulation

and standardization
Standardization and technical regulation is too important to leave to the technocrats. They
must be embedded in government policy focussed on socio-economic development.
Standards and technical regulation have assumed centre stage in many discussions, negotiations and the like regarding trade matters at international and regional levels. Many countries
have recognized that both should be guided by proper policy. Hence National Quality Policies
are being developed and implemented in a growing number of developing economies. This
part of the conclusion report endeavours to shed light on good policy making with a specific
focus on National Quality Policies.
1.1. National Quality Policy

Good policy making practice
William Jenkins provides a very succinct definition of national policy: National Policy can be
seen as a set of interrelated decisions taken by a government concerning the selection of
goals and the means of achieving them within a specified situation where those decisions, in
principle, are within the power of the government to achieve. It is important to note that government has to make the decision, and it selects policy goals within a specific situation. Therefore, when developing a National Quality Policy dealing with standardization and technical
regulation, the government must understand the situation of the country as regards its main
trading partners, and the international context in which the policy is being developed. The
policy must be achievable and its implementation is just as important for its success as is its
enumeration. It is of no use if the policy is of such a nature that implementation is impossible
within the resource constraints of the country. This is where the country should guard against
unrealistic pressures from its larger trading partners.
Some of the characteristics of good policy making, with specific reference to the National
Quality Policy, includes the following:
Policy is forward looking. This means that the National Quality Policy outcomes should
be properly defined and take a long view, typically five to ten years.
Policy is outward looking. The National Quality Policy should take cognisance of the
national, regional and international situations as they relate to the scope of the policy. The
experiences of other countries, especially those in the region, may provide salutary lessons as to what is achievable and what not. Countries that have embarked on a total reengineering of their standardization activities and technical regulation regimes may provide important information as to which approaches should be avoided.
Policy recognizes socio-economic, cultural and political variations. No country is
exactly the same. Hence the realities of its socio-economic stage of development, its vision for the future, and its cultural dimensions need to be taken into account, even for the
National Quality Policy. The same applies to the political realities of the country, i.e. the
relationship between the Parliament, Cabinet and Ministries needs to be factored into the
policy.
Policy is innovative and flexible. Standardization and technical regulation is evolving
rapidly. Systems that served the country well in the past may no longer be effective, or
may have become a barrier to trade. Hence, the National Quality Policy should question
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the established way of dealing with things, especially calcified organizational structures
and responsibilities entrenched in old legislation need to be fundamentally reviewed, and
new and creative ideas need to be encouraged. Change has to be persuasively implemented, even though associated risks have to be identified and managed.
Policy is joined up. The National Quality Policy deals primarily with cross-cutting issues.
There are many ministries and their agencies that develop and implement technical regulations. The national quality infrastructure consists of many players, i.e. standards, metrology and accreditation bodies as well as conformity assessment service providers in the
public and private sector. The National Quality Policy should therefore look beyond the
institutional boundaries, it should set cross-cutting objectives and it should define the joint
working arrangements to guard against overlaps and gaps.
Policy is inclusive. The National Quality Policy will influence the lives of many entities
that will have to implement it. It is therefore important to consult widely during its development, to ensure that all those affected are reached. This is best conducted through a
regulatory impact assessment.
Policy is evidence based. The National Quality Policy must be based upon the best
available evidence from a wide range of sources, both from within and without the country,
including relevant international and regional organizations. It should be assured that the
evidence is available in an accessible and meaningful format.
Policy is reviewed and evaluated. Once the National Quality Policy has been developed
and is being implemented, it should remain under constant review to ensure its continued
effectiveness because the international domain is evolving so rapidly. It is also important
to review whether its implementation is really dealing with the problems or challenges it
was designed to address. In this way the experience of what works and what does not
can be built into the further policy refinement and implementation.
Value chain for economic growth and poverty reduction

It is generally recognized that enhanced trade should lead to economic growth, the impact of
which will ultimately lead to poverty reduction. Trade helps an economy grow in several ways:
It encourages economies to specialise and produce in areas where they have a relative
cost advantage over other economies. Over time, this helps economies to employ more
of their human, physical and capital resources in sectors where they get the highest returns, boosting productivity and the returns to workers and investors.
Trade expands the markets local producers can access, allowing them to produce at a
more efficient scale to keep down costs. Even in populous developing economies, low
incomes often mean that producers potential local market is small, so trading with the
world is vital.
Trade diffuses new technologies and ideas, increasing local workers and managers
productivity. Technology transfers through trade and investment are particularly valuable
for developing economies, which employ less advanced technologies and typically have
less capacity to develop new technologies themselves.
Removing tariffs on imports gives consumers access to cheaper products, increasing their
purchasing power and living standards, and gives producers access to cheaper inputs,
boosting their competitiveness by reducing their production costs.
Figure 1: Competitive and safe products, trade, economic growth and poverty
Fair
competition
Safe
products
Removalof
nontariff
barriers
Technology
Transport
Communication
Peace
Civilrights
Goodgovernance
Market
access
TRADE
Economic
Growth
Poverty
reduction
Competitiveproducts
Tariffand
quota
reductions
Entrepreneurship
Employment
Productivity
Education
Enhancedhealth
Genderequality
Source:SIDA/NORAD
An important factor essential for trade is a supply side that gains market access through competitive and safe products, in which standards and technical regulations play an important role
(see highlighted elements in Figure 1). There are other factors that also play a role such as
infrastructure, finances, macro-economic and social policies, education, health and gender
equality as shown in Figure 1. They are not less important than market access and competitive products, but they will not be discussed in this conclusion report.
National Quality Policy Context

The National Quality Policy does not exist in a vacuum; it has to be promulgated within the
context of industrial development, export or trade promotion and other relevant government
policies see Figure 2. To be complete, the National Quality Policy should deal with both the
quality infrastructure and technical regulations as it is not so much standards that lead to unnecessary trade restrictions and frustrations, but primarily technical regulations as they are
mandatory by law.
A National Quality Policy can have a positive impact on industrial development and on trade.
It is therefore incumbent on governments to develop the National Quality Policy carefully, align
it with country realities (i.e. resource constraints, political structures, business environment,
etc.), market demands, international good practice and formal agreements. It is also important
that the policy is reviewed every so often (e.g. in a 5-year cycle), because the standardization
and technical regulation domain is evolving rapidly.
International policy context

At the international level, the WTO Agreement on Technical Barriers to Trade (TBT Agreement) and its sibling, the WTO Agreement on Sanitary and Phyto-Sanitary measures (SPS
Agreement) endeavour to create a system facilitating trade yet not neglecting the safety and
health of the population, fauna and flora and the environment in individual countries. The
principles of the WTO TBT Agreement are based on the notion that standards and technical
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Figure 2: National Quality Policy cross-cutting domain
Trade
Policy
Science &
Technology
Policy
Environment
al Policy
QualityPolicy
Industrial
Policy
(coordinatesstandardsand
technicalregulationissues)
Food Safety
Policy
Consumer
Protection Policy
Source:Authorselaboration
regulation should not become unnecessary barriers to trade. Hence, technical regulations
should be based on international standards, transparency in development and implementation
of the same should be practiced by all, and conformity assessment systems should be recognized amongst trading partners. The National Quality Policy should therefore align seamlessly
and fully with the requirements of the WTO TBT Agreement, and should also take the WTO
SPS Agreement into consideration where relevant. Much the same arguments can be put
forward for regional trade agreements.
Importance of a National Quality Policy

Due to the importance of trade for socio-economic development, and the current focus on
standards and technical regulations in discussions and negotiations at the international level,
every country is virtually obliged to develop appropriate policy measures to provide guidance
for the establishment of acceptable quality infrastructures and especially technical regulation
systems that will be recognized by main trading partners. The development and implementation of a good National Quality Policy is therefore of paramount importance.
A National Quality Policy necessary because:
a. It is the basis for strategies for quality infrastructure components (standardization, accreditation, metrology and conformity assessment);
b. Its linked with other strategies for national development, industrial development, competitiveness, etc.;
c. It sets the structure for sectors and responsibilities of regulatory bodies to reduce overlaps;
and
d. The NQP with its action plan and budget ensures the proper implementation of quality
infrastructures according to national needs.
Group 3, Session 1
10
Figure 3: Policy Elements and Implementation Logic
POLICY
Policy Vision
Policy Objectives
Implementing
Institution
Policy Measures
Activities
Budget
Policy Outcomes
Time Line
IMPLEMENTATIONPLAN
Content of a National Quality Policy

The content of a National Quality Policy will to some extent depend on custom and practice of
the country. The generic building blocks of a policy and its implementation plan are shown in
Figure 3. There are however a few elements within these building blocks that should always
be included in a National Quality Policy.
It is important that the National Quality Policy provides for a clear articulation of the functions of the various quality infrastructure entities and the regulatory authorities. This is to
ensure that overlaps and gaps are minimised and that the whole system operates at optimum efficiency.
The organizational structures and responsibilities of the entities for standards, metrology
and accreditation should be carefully described. Conflicts of interest amongst them should
be studiously avoided.
The way in which technical regulations are to be developed and implemented, and the
responsibilities of the various entities involved need to be carefully described. These
would include how technical requirements are handled and who is responsible for the administrative procedures. It is good practice to liberalize conformity assessment service
provisions in technical regulation, but
demand that service providers, whether from the public or private sector, be technically
competent, i.e. accredited.
The resources for the continued existence and financial sustainability of the quality infrastructure entities needs to be described, with the government taking responsibility for the
three fundamentals, namely standards, metrology and accreditation. Conformity assessment services should operate on the user pays principle throughout.
Legislation for the quality infrastructure and technical regulation entities probably exists,
but it may be outdated and in need of revision. The revision should be clearly articulated
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in the National Quality Policy even though this is a daunting task in many developing countries.
The development and oversight of the Implementation Plan for the National Quality Policy
should be clearly spelt out with a relevant Ministry, usually the Ministry responsible for the
implementation of the WTO TBT Agreement at the national level, being given the leading
role.
1.2. From Public Policy to National Quality Infrastructure

In transforming the National Quality Policy into a National Quality Infrastructure a number of
elements need to be considered. These include:
The components of a quality infrastructure;

The generally accepted models of the quality infrastructure that would satisfy the WTO
TBT Agreement principles;
Good practice approaches as advocated by the World Bank and which are based on a
decentralised system with the various bodies acting as legally autonomous entities;
Ensuring that standards, metrology and accreditation form the basis for all quality infrastructure activities and services; and
Ensuring the technical competency of the conformity assessment service providers.
The quality infrastructure organizational components

The fundamental components of the quality infrastructure are the entities responsible for
standards, metrology and accreditation. The National Standards Body (NSB) is responsible
for the development and publication of national standards, the National Metrology Institute
(NMI) is responsible for the establishment and maintenance of national measurement standards, and the National Accreditation Body (NAB) ensures that conformity assessment service
providers are technically competent. These organizations are not only responsible for the
fundamentals in the country, but they are also the vehicles through which the country attains
international recognition for its quality infrastructure services, such as:
The NSB connects with the international world of standardization through membership of
international bodies such as ISO, IEC and CAC. By participating actively in their technical
committees, the NSB looks after the interests of the country in respect of the development
of international standards.
The NMI ensures the countrys calibration and measurement capabilities (CMCs) are recognized through listing of the same on the Key Comparison Data Base (KCSB) managed
by the BIPM after determining their accuracy through intra-regional comparisons.
The NAB ensures conformity assessment services in the country enjoy international recognition by becoming a signatory of the multilateral recognition arrangements of ILAC and
the IAF after demonstrating compliance with relevant international accreditation standards.
Whereas the organizations responsible for the fundamentals of the quality infrastructure in
developed countries are frequently separate or independent entities, this is not always possible in developing countries due to resource constraints. Hence, standards and metrology are
often combined in one organization, or less frequently, standards and accreditation. The major issue is that conflicts of interest should be avoided, e.g. the body responsible for accreditation services must not provide any conformity assessment services. On the other hand,
NSBs frequently provide conformity assessment services, which is not a problem if the NSB
is not responsible for accreditation.
12
Metrology services consist broadly of legal metrology and industrial metrology. The former is
a form of technical regulation, and is the responsibility of the state through which measuring
equipment is controlled to the extent that trade, law enforcement and measurements in health
services are accurate. The latter consists of calibration services and the measurement systems that industry and society practice in many ways. Both these need to have their working
measuring equipment traceably calibrated to the national measurement standards maintained
by the NMI. Calibration laboratories should be accredited to ISO/IEC 17025.
Conformity assessment service providers, i.e. inspection bodies, testing laboratories and certification bodies, may be public or private sector entities. Whereas governments develop the
initial conformity assessment infrastructure in many countries, the tendency these days is increasingly for the private sector to provide such services. Some of the largest of these are
multinational organizations that operate in all the major markets of the world. But, government
organizations in developing countries still provide such services especially for servicing the
SME sector that finds it difficult to pay for private sector conformity assessment services.
The technical competency of conformity assessment service providers is now almost exclusively determined by accreditation in some form or another, e.g. inspection bodies to ISO/IEC
17020, test laboratories to ISO/IEC 17025 and certification bodies to ISO/IEC 17021 and
ISO/IEC 17065 for system and product certification respectively. In some sectors of the economy, multinational private sector accreditation bodies are preferred to national accreditation
bodies, e.g. the automotive sector.
Other players in a quality infrastructure

The three fundamentals and conformity assessment service providers are not the only players
in the quality infrastructure. Other entities that could play a meaningful role in proper service
delivery for example include a national quality institute, an association of quality practitioners,
a national laboratory association, an association of management system and product auditors
and a national productivity institute. The associations are generally established by like-minded
professionals and serve as forums where common issues can be debated and solved,
whereas the national quality and productivity institutes may be established by governments.
However, if there is little support for the latter from the private sector, they will find it very
difficult to be effective. Hence, in many countries where they are flourishing, they have been
established by the private sector that has made quality and productivity important tenets of
their business models.
Other issues in the quality infrastructure

The influence of the quality infrastructure entities goes far beyond the implementation of technical regulations and manufacturing. Other examples of domains that benefit from an effective
and efficient quality infrastructure include:
Effectiveness of public infrastructure services in construction, energy, water and gas supplies, defence, transportation and communication systems;
Further consumer protection through control of unfair trading practices;
Credibility of forensic services and justice systems;
Quality of the urban and natural environment;
Interoperability of products and systems; and
Transfer of technology and worlds best practices in technical, productivity, quality, business excellence and management systems arenas.
The lack of an effective and efficient quality infrastructure could therefore have a profound
impact on the socio-economic development of a country and the quality of life of its inhabitants.
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Part 2 - Good practices in respect of standardization and

technical regulation
A powerful force is driving the world towards a converging commonality, and that force is
technology. . . . The result is a new commercial reality the emergence of global markets for
standardized consumer products on a previously unimagined scale of magnitude.
Theodor Levitt
With the context and elements of the quality infrastructure and technical regulation defined,
the question then arises as to what are good practices in this respect. Good international
practices have evolved over the past decades and continue to evolve. Some of these have
found their way into international agreements, others are just effective and efficient practices
to be considered.
2.1. Good standardization practices

Good standardisation practices follow a number of principles. Over the years seven have
crystalized that can be considered as fundamental:
1. Standardization is an act of simplification as a result of the conscious effort of society. It
calls for the reduction in the number of things. It not only results in the reduction of present
complexities, but aims at prevention of unnecessary complexity in the future.
2. Standardization is a social as well as an economic activity and should be promoted by the
involvement of all concerned. The establishment of a standard should be based on a
general consensus.
3. The mere publication of a standard is of little value if it is not implemented. Implementation
may necessitate sacrifices by the few for the benefit of the many.
4. The action to be taken in establishing standards is essentially one of selection, followed
by fixing.
5. Standards should be reviewed at regular intervals and revised as necessary. The interval
between revisions will depend on the particular circumstances.
6. When performance or other characteristics of a product are specified, the standard must
include a description of the methods and tests to be applied in order to determine whether
or not a given article complies with the standard.
7. The necessity of legal enforcement of the standard should be considered deliberately,
having regard for the nature of the standard, the level of industrialization and the laws and
conditions prevailing in the society for whom the standard has been prepared.
The standards development process should be based on transparency (i.e. all development
activities should be open to public enquiry), inclusiveness (i.e. the process should be open to
any stakeholder that wishes to participate) and consensus. The latter is not unanimity, but is
defined as general agreement, characterized by the absence of sustained opposition to substantial issues by any important part of the concerned interests and by a process that involves
seeking to take into account the views of all parties concerned and to reconcile any conflicting
arguments.
14
Technical committees
Standards should be prepared in technical committees representative of all stakeholders, i.e.
the public sector, private sector, NGOs, academia and the like. In developing economies, it
is generally the NSB that is responsible for the establishment and management of technical
committees at the national level. As economies develop, it may be useful to spread the load,
by decentralizing the development of some standards to other organizations recognized as
Standards Development Organizations (SDOs) by the NSB. It is however good practice for
the NSB to retain the legal monopoly to publish national standards. This facilitates easy access to the whole body of national standards by local and foreign interested parties alike.
At the international level, technical committees are established by the international standards
organisations such as ISO. IEC and CAC in a decentralised manner. The chair and secretariat
is usually assigned to a specific member, e.g. a specific NSB. Other members are invited to
participate in the technical committee. For popular international standards such as the ISO
9000 or ISO 14000 series many countries participate, whereas for others fewer countries are
involved. Generally, an international technical committee will not be established for subjects
where less than five members are interested. It is important for developing countries to participate actively in the few international technical committees that are of strategic importance
for their countrys industry. It is not logical to try and participate in as many as possible in
subjects that are not so important. A well thought-through strategy should be implemented by
the NSB in this regard.
Standards development and publication processes

The WTO TBT Agreement provides for good standardization practices in its Annex 3: Code of
good practice for the preparation, adoption and application of standards. The NSBs of WTO
member states are required to formally signify compliance to Annex 3. Amongst others, some
of the elements contained in Annex 3 include: (i) National standards should be based on international standards to the fullest extent possible, (ii) draft standards should be made available for public comment for at least 60 days, and (iii) the standards development programme
should be made publicly available every six months. The WTO Committee on Technical Barriers to Trade has also published a far-reaching decision on Principles for the development of
international standards, guides and recommendations with relation to Articles 2,5 and Annex
3 of the Agreement which details specific requirements for international standards organizations and to some extent their regional and national counterparts.
In addition to the WTO TBT Agreement requirements, ISO and IEC have published joint Directives that should be utilised as the basis for the development process of standards. Although the Directives speak about international standards, the principles should be transcribed
for the regional and national levels. At the national level, this could be made public in the form
of a national standard, i.e. a standard for a standard. In many countries this standard is
provided free of charge. The complete process of standards development from the initial approval of the project, the technical committee stages, public comment, editing, approval by the
NSB Board/Council/Minister and ultimate publication is described, as well as the very important issue of an appeals mechanism.
Once a standard has been developed, it should be published as soon as possible. In the past
many copies were printed and stored until they were sold. The electronic media has totally
overtaken this practice, and NSBs should be able to provide national standards for sale in
electronic form on the internet. Hard copies must still be provided to interested parties that do
not have easy access to the internet (e.g. SMEs), but these should be provided by print-ondemand systems, thereby dispensing with the expense of printing thousands of copies that
15
have to be binned once the standard is revised in its five-year cycle. National standards that
are adopted ISO or IEC standards may not be provided free of charge, they need to be sold
in terms of agreements between ISO, IEC and the NSB.
Key performance indicators

Standards development is an expensive activity. Hence, it is good practice to measure some
key performance indicators in order to enhance its performance and efficiency. Typical are
the time to market and cost per page indicators, with average age of published standards
also of importance.
In the time to market indicator the total time from approval of the project until the standard
is available to the public is measured and managed. Typical times for NSBs would be two
years for an indigenous standard (i.e. a standard that has to be developed from basic
principles at the national level) and nine months for standards that are adoptions of international or regional standards. The times for the various stages of standards development
are then derived from the overall time.
The cost per page key performance indicator is a more recent approach that tries to
establish the development costs of the standard as seen by the NSB. All the costs of the
standard development departments should be included, as well as relevant overhead
costs of management. Initially this cost could be managed downwards as the process
becomes more efficient, but after a while a minimum cost would have reached and then
the increase needs to be kept to a minimum. Indigenous standards and adoptions need
to be dealt with separately.
The average age of published standards will give an indication as to whether the standards
are revised in the five-year cycle for example that most NSBs have adopted.
These key performance indicators can be successfully utilised by NSBs to make a case for
continuous funding from their government for the development of national standards, as few
if any NSBs in developing economies will be able to fund this important activity from the sale
of standards alone.
Some common challenges

Many NSBs have been in existence for decades. Over time practices have evolved and have
become established and entrenched, some of them good others less so. Amongst the practices that are posing serious challenges to the efficient functioning of the standards development process, the following are typical:
Technical committees are not fully representative of all the stakeholders. An overabundance of public sector and general lack of private sector representatives which may be
due to past political systems and practices is typical, frequently exacerbated by a lack of
technical expertise amongst the participants. Consumer organizations are often underrepresented as well. Furthermore, if the NSB decides unilaterally which organizations
may be represented further limits the options for some interested parties, thereby violating
one of the principles of standards development.
Standards development projects are not aligned with the real needs of the country or with
important stakeholder groups such as regulatory authorities or the private sector. Projects
that interest NSB staff are given priority. Such standards, even though they may look good
on annual reports, do little for the country and are basically a waste of scarce resources.
16
Technical committee members are paid sitting fees. The argument is that if sitting fees
(e.g. to pay for transport) are not paid, there is little interest in attending technical committee meetings. The counter argument is that if nobody is interested, then the standard may
in reality not be needed. Industry and other stakeholders will participate if the standard is
important to their business. The only exception may be consumer organizations and
NGOs that do not have the wherewithal to attend technical committee meetings and hence
should be supported in some manner. This practice puts a burden on the NSB budget and
frequently limits the number of standards that can be developed annually and therefore
may need to be reviewed.
The preparation for and management of technical committee meetings is suboptimal. Typical challenges include papers reaching members late with the result that they cannot prepare themselves properly before the meeting, chairpersons and secretariats are not
properly trained, time is wasted by translating international standards in committee rather
than beforehand by professionals, and more. The way we have always done it may have
to be radically re-engineered to enhance the efficiency of technical committee meetings
for the benefit of all. One of the consequences of such optimization would be better stakeholder participation nobody wants to attend meetings that are considered a waste of
time.
2.2. Good regulatory practices

Technical regulation is an intervention of government in the workings of the market place.
However, before discussing good regulatory practices, it is useful to keep in mind that public
goals vary over time and differ from society to society. On the other hand, products, services,
ideas, opinions and people are transmitted and move continuously around the globe the
world has become a small place indeed, challenging the peculiarities of smaller societies.
Therefore, technical regulation in particular is subject to wide-ranging scrutiny as are the perceptions of the risks involved.
Key international trends

Technical regulation is one of the most widely used policy instruments of governments to ensure the safety and health of its citizens, fauna and flora and the environment. But, regulation
not only creates benefits, it also carries costs for society. Hence, ensuring high quality regulation has become a key priority for many governments. Some of the key international trends
in this respect include the following:
The ubiquitous WTO activities foster trade liberalization. No country can afford not to participate in this WTO inspired trade liberalization in spite of difficulties that surface from time
to time.
The trading blocks that have been or are being established in many regions are all pushing
towards deep integration amongst their members with regard to trade related systems in
common markets, including technical regulation.
The growing commercialization of former government activities and globalization in general has brought the private sector to the forefront. It is challenging the necessity of the
fragmentation of regulatory systems within countries and across trading blocks. It is looking for a much more common approach as a cost saving measure, thereby limiting the
costs of compliance with technical regulation.
17
Good regulatory practice according to the OECD

The OECD countries have been considering regulatory processes for a decade or two, realizing that they are an impediment to trade liberalization. The OECD has therefore defined seven
principles that good regulatory practices should abide by, namely regulatory interventions
must:
1. Be necessary to serve identified policy goals;
2. Have a sound legal basis;
3. Produce benefits that justify costs;
4. Minimize costs and market distortions;
5. Be clear, simple and practicable;
6. Be consistent with other policies and regulations; and
7. Be compatible with competition, trade and investment locally and internationally.
Having set the principles for good regulatory practices, many countries have embarked on
regulatory reform programmes to optimise their regulatory systems, including technical regulation regimes.
2.3. Regulatory reform

The process of regulatory reform can be divided into three phases, namely deregulation, regulatory quality improvement and regulatory management, which can be progressively implemented (see Figure 4). Many countries start with a drive to deregulate, i.e. getting rid of obsolete regulations. The next logical step would be to improve the performance of the institutions that are involved in technical regulation. In addition, the decision making mechanism as
to when to implement technical regulations is improved by utilising regulatory impact assessments (RIA). But all of these steps are to some extent tinkering with the current, normally
fragmented, system. It is only when the system is addressed holistically, i.e. when regulatory
management is considered, that real progress is achieved.
18
Figure 4: The stages of regulatory reform

Characteristics of reform
Policy objectives of reform
Managing aggregate
regulatory effects
Setting frameworks
Improving flexibility in
regulatory regimes
Producing low cost but
quality regulations
Improving regulatory
processes
Improving access to
regulations
Elimination
Reduction, and
Simplification of
regulation
REGULATORY
MANAGEMENT
REGULATORY
QUALITY
IMPROVEMENT
DEREGULATION
System based
Pro-active
Instrument based
Pro-active
Focus on quality, one
instrument at a time
Instrument
based
Re-active
Source:OECD
Deregulation
Most countries have a real mix of technical regulations on the statute books. Some are decades old, as well as many recently developed ones. Many of the older ones are no longer
relevant, or technically outdated, and are sometimes even unknown to the authorities. A concerted effort should therefore be made to embark on a deregulation exercise. As a first step
all the existing technical regulations on the statute books should be identified. It is actually
frightening to witness the lack of transparency in this regard. Technical regulations dating
back to the 1920s are still on the statute books, but nobody even knows about them, and to
find information about them is not so easy.
Regulatory quality improvement

It is possible, using a variety of sources and methods, to arrive at fairly good estimates of what
damage or improvement to levels of protection is likely to result from new or revised technical
regulation. These estimates can be combined with information about the probable costs of
various ways of satisfying technical regulation in order to generate a regulatory impact assessment (RIA).
Therefore, mechanisms through which technical regulation are developed and implemented
are rapidly becoming the subject of serious, systematic enquiry and analysis. That work has
to combine three basic components: technical knowledge of the issue; economic analysis of
all alternative ways of achieving the desired impact; and consensus building, to ensure that all
parties believe that the approach chosen represents the most suitable option available.
The second element of regulatory quality improvement has to do with the improvement at the
technical, organizational and performance level of the many institutions that are involved in a
19
modern technical regulation regime. These include technical regulation development, standards and conformity assessment issues, metrology and accreditation, all of which are discussed in great detail throughout this conclusion report.
Building a Regulatory Management System

In most economies technical regulations are developed and implemented by many ministries,
authorities or agencies. Assessments in various parts of the world have highlighted a number
of weaknesses in their approaches to technical regulation that are in need of serious overhaul.
Some of the common issues highlighted by these assessments indicate that
Authorities have developed their own unique way of doing so over time. These customs
and practices may or may not comply with WTO TBT Agreement requirements;
Invariably, overlaps and duplication developed;
Regulatory authorities, having grown accustomed to a position of absolute power in the

past, do not easily shift toward a more consultative approach; and
The use of voluntary standards as the basis for technical regulation is not the norm.
To deal with these weaknesses in a systematic way, an effective national regulatory management system has to be developed, agreed to at the highest political level and rigorously implemented. Two very important elements of such a regulatory management system are a
technical regulation framework and a coordination mechanism.
Firstly, a national technical regulation framework is required so that all the responsible Ministries and Agencies can follow common principles and procedures in developing and implementing technical regulations. This framework has to be developed taking the international
and regional agreements and major trading links into consideration, as well as the needs of
society regarding safety and health issues. It has to be approved by the highest political authority in the country in order to give it legitimacy as it is a cross-cutting issue. This approval
can be in the form of an Act of Parliament, a Cabinet Decree, or a Government Policy, i.e.
whatever is the norm for the country. Such an approach has the advantage that suppliers,
once familiar with the overall system, can then easily find their way to the appropriate regulatory authorities and the relevant information, in other words transparency is enhanced. It is
also one of the more efficient ways to ensure that the country keeps on complying with its
WTO TBT Agreement obligations.
Secondly, a mechanism to coordinate all the activities of the various regulatory authorities has
to be established. This is necessary to get over the silo mentality of most ministries and
agencies. Hence, in many countries a form of oversight authority has been established, which
has the authority and responsibility to ensure that all the regulatory authorities comply with the
national technical regulation framework. These oversight institutions have varying mandates
depending on local conditions and the extent of their activities, and are known by many names,
for example Office of Regulatory Reform (Australia), Authorized Body for Technical Regulation
(Kyrgyzstan), Czech Office for Standards, Metrology and Testing (Czech Republic), US Office
of Management and Budget (USA). These oversight bodies need to have the relevant legal
and perceptual authority to deal with Ministries and Agencies who are powerful in their own
right. Hence, they are often accountable to the Prime Minister, Presidents Office or similar.
20
Part 3 - Technical Regulation

Technical regulation is the imposition of legal requirements for products by governments that
could have a deleterious effect on the health and safety of their population, fauna and flora or
the environment, or that could lead to gross deceptive practices. Technical regulations can
very easily become barriers to trade. Hence the WTO TBT Agreement seeks to ensure that
this does not happen whilst at the same time acknowledging that governments must be able
to exercise their responsibilities in this respect. The same applies in principle to the WTO SPS
Agreement.
Challenges that have to be overcome to establish an effective and holistic

technical regulation system include Re-organization of institutions;
Promulgation of legislation;
Inadequate human resources and capabilities; and
Mobilization of financial resources.
Group 3, Session 1
3.1. Technical regulation building blocks

There is no international rule on how technical regulation should be structured at the national
level, but there are some good practices that can be considered. To better understand these
practices, it is useful to define technical regulation in terms of a number of building blocks (see
Figure 5) and then consider each of these building blocks in turn.
Technical requirements
The technical requirements in a technical regulation can be defined in one of three ways:
a) Technical requirements can be included in the legislation. This is a time honoured way,
but it has severe restrictions in respect of rapidly advancing technologies. It means that
the legislation needs to be revised continuously and this does not happen in practice. Such
regulation tends to get and remain out of date, renders the regulation ineffective and unenforceable. It is therefore the most expensive way of dealing with this building block.
b) The technical requirements can be dealt with by referencing standards. These could be
national, regional or international standards. Normal practice is to reference national
standards as these are freely available in the country from the national standards body.
These could be adoptions of international standards (i.e. completely equal), based on international standards (in which case small national deviations are allowed) or indigenous
standards that bear little or no relationship to international standards. The first two options
are the best from an international trade perspective.
Referencing standards is a very cost-effective option. In the first place, standards are
developed by a consensus process amongst all stakeholders; hence development costs
are spread. Secondly, standards are revised continuously, therefore the technical regulation can be revised automatically as soon as a revised standard is published. Thirdly,
21
because stakeholders are involved in the development of the standard, the technical regulation enjoys a higher degree of acceptability from those that have to comply with them.
Fears that suppliers will lower the requirements to suit them are not borne out in practice,
and the regulatory authority has the final say whether a specific standard is referenced or
not anyway.
c) Deem to satisfy or indirect referencing is the most modern concept and is used for example in the EU Directives. In this case the regulation does not reference a specific standard or details the technical requirements, it contains only essential requirements. A separate list of officially sanctioned standards is published, and compliance with these standards confers a presumption of compliance with the regulation. The standard remains voluntary. In such systems suppliers can theoretically choose another standard to provide
compliance evidence with the regulation, but that then becomes a two stage process. The
supplier first has to convince the regulatory authority that the chosen standard provides
the same degree of compliance than the standard in the officially sanctioned list.
Figure 5: Building blocks of technical regulation

Policy
Legislation
Technical
requirements
Conformity
assessment
Regulatory
authority
Sanctions
Included in text
Inspection
Approvals
Administrative
Referenced stand-
Testing
Market surveillance
Court of Law
Deem to satisfy
standard
Certification
Sanctions
Product/process character-
Administrative
provisions
Source: Authors elaboration
22
Conformity assessment
In well-designed systems the supplier has to provide evidence of compliance with the technical
requirements to the regulatory authority. The regulatory authority should not take over the
responsibility for the testing and certification to certify compliance. Because if the regulatory
authority does so, it also accepts the responsibility for the integrity of the product, and that
should always remain with the supplier. Two approaches are good practice, namely:
a) The conformity assessment is conducted by the supplier. This is known as a self-declaration of conformity. It is by far the most cost-effective way, but the question remains
whether the supplier can be trusted to provide genuine results. In countries with a strong
judicial system that can deal with untrustworthy results effectively and quickly, this option
is implemented more frequently nowadays than in the past. In the EU for example, for
toys, electronic components and other low risk products falling within the scope of New
Directives, suppliers can apply the CE-marking on their own responsibility once they have
satisfied themselves that the products meet all the requirements. Other examples are
telecommunication equipment in Australia, Canada and the USA.
b) The more common approach is that independent, third party conformity assessment service providers get involved. In this case a number of scenarios are possible, namely:
The regulatory authority utilises its own laboratories to conduct the testing and certification work. This approach is favoured by authorities because they believe that the
results are more trustworthy. The approach is not favoured in international trade, and
is considered an unnecessary barrier: Any other competent laboratory is excluded, and
it is seen as a way to extract rent. Authorities that operate their own laboratories to
conduct the audit testing during market surveillance to determine whether products do
comply are not an issue.
The regulatory authorities appoint a laboratory of their liking to do the work. This has
fallen out of favour in the international markets the legal monopoly the laboratory
enjoys is considered an unnecessary barrier to trade.
The regulatory authority nominates/designates a number of laboratories and certification bodies that are accredited to do the work. This is the approach favoured by many
countries. It ensures the technical competency of the service providers, and it gives
the regulatory authority a measure of control over the service providers on issues that
are not considered in the accreditation process, e.g. legal liability in the country.
The regulatory authority unilaterally accepts results from accredited service providers.
This approach is frequently followed by regulatory authorities in developing economies
that do not have the required facilities in the country. It is a very pragmatic approach,
but it does carry the risk that in the case of improper testing or certification the regulatory authority has little or no legal recourse as regards the service provider in a foreign
country.
c) The technical competency of the service provider is of paramount importance in all cases.
The trend world-wide is that such service providers should be accredited in accordance
with accepted international standards and that their measurement equipment is traceably
calibrated to the national measurement standards. This will also ensure that their results
are acceptable much wider than just the local market.
23
Regulatory authority
The regulatory authorities have a threefold responsibility, namely:
a) Pre-market approval of products falling within the scope of regulation. This is a costly
procedure, and should only be utilised in high risk cases. The supplier provides the relevant conformity evidence to the regulatory authority who issues a marketing release certificate. It is widely practiced in the automotive industry (e.g. homologation of vehicle
types), the telecommunication industry (e.g. type approval of cell-phones) and in legal metrology (e.g. type approval of measuring equipment used in trade). After type approval,
the supplier is responsible for ensuring that the products supplied to the market place
remain at the same level of integrity as the one that was tested.
Many developing countries have implemented a system of mandatory certification to administer their technical regulations (i.e. mandatory or compulsory standards) as a pre-marketing condition. Suppliers are forced to apply for the national product certification mark
from the national standards body. Only once the products have been so certified, are they
allowed to be placed on the market. This system has become very problematic in that it
is seen as a serious barrier to trade as regards imported products. In todays world of
increased international trade with products emanating from all over the world and from
very remote places it is also logistically nearly impossible to maintain. Demanding that all
of these manufacturers should apply for the national product certification mark is logistically not feasible. And demanding it only from the local manufacturers puts them at a
disadvantage viz. a viz. imported product.
b) Market surveillance is a post-marketing activity. Regulatory authorities audit products falling within the scope of regulations that have been placed in the market. By taking samples
and having them tested, regulatory authorities soon find out if products in the market meet
stated requirements or not. Proper planning is of paramount importance in market surveillance because it is an audit process, i.e. only a small percentage of the products can be
checked. Estimates by the EU and the USA indicate that about 1 to 2% of the relevant
products in the market are checked annually. Hence, authorities are increasingly enhancing their effectiveness by utilising risk assessment techniques to identify products and/or
suppliers that need to be audited more frequently than others.
Proper market surveillance includes both planned as well as unplanned activities: Planned
surveillance activities to ensure that high risk products and suppliers are checked at regular intervals, and unplanned activities when the regulatory authority becomes aware of
specific irregularities that have to be dealt with immediately.
c) Sanctions need to be instituted by the regulatory authority once non-compliant products
are discovered in the market place.
Sanctions
Products do not always comply with the regulation requirements. This means that steps need
to be taken by the regulatory authority to have the products taken off the market and dealt with
in an appropriate manner. Two levels of sanctions are commonly implemented, namely:
a) Administrative sanctions are imposed directly by the regulatory authority. The authority
will direct the supplier to inform the public, ban the sale of the product, withdraw the product
from the market place, have the product repaired or adjusted until it complies, have the
product re-exported to the country of origin or even destroyed. The choice will depend on
the nature of the non-conformity and its consequences on the population, fauna and flora
24
or environment. Environmental concerns have to be taken into account if the product

needs to be destroyed.
b) Should the supplier not heed the directive of the regulatory authority, the issue needs to
be taken to a higher judicial institution, namely the courts. Care should be taken that the
ban on the sale of the product remains in place until the court verdict is handed down, or
during any appeal process to ensure that non-compliant products are not disposed of in
the interim.
3.2. Technical regulation development and implementation

The responsibility for the development of technical regulation lies with the state and its competent authorities. Technical regulations are part of the body of legal instruments of a country
or region. The enforcement of technical regulations, too, is the responsibility of the state and
its authorities. How the tasks are to be accomplished is the sovereign decision of the state.
The WTO TBT Agreement does not take away any of this sovereignty, but establishes requirements WTO member states have to follow to ensure technical regulations do not become
unnecessary barriers to trade. The development and implementation of a technical regulation
therefore requires a well-structured and deliberate approach.
Technical regulation development

Technical regulation is expensive to implement, not only for the supplier but also for the authorities costs that will eventually be borne by the purchaser. The envisaged impact of
technical regulation is that it should protect the people, fauna and flora and the environment
against the deleterious effects of unsafe products. Technical regulation is inherently a barrier
to trade. In order to ensure therefore that the envisaged effect is in keeping with the consequences of its imposition, it is considered good practice to conduct a regulatory impact assessment beforehand.
A typical work flow of the development of a technical regulation is shown in Figure 6. The
process typically starts with the identification of a specific market failure. The relevant Ministry
then decides that the failure should be dealt with by a technical regulation. As a first step, the
Ministry causes a regulatory impact assessment to be conducted. The regulatory impact assessment will guide the authorities in making a decision to either go ahead with the development and implementation of a technical regulation, or to decide on a non-regulatory approach,
e.g. to let the market regulate itself.
The Ministry may establish an internal working group to develop a draft technical regulation,
or its functionaries may be able to so on their own. The technical requirements should be
based on a standard. If there is no standard available, the national standards body should be
tasked with the development of an appropriate one. Once the standard is available, it can be
referenced, and the draft technical regulation can be completed.
In order to comply with WTO TBT Agreement requirements, the draft technical regulation
needs to be notified to the WTO for comment by WTO member states, and at the same time
it should be published for public comment in the country. The responsibility for notifying the
draft technical regulation lies with the appointed Notification Body, usually the Ministry of Trade
and Industry or similar. The comment period should not be less than 60 days. Once all the
comments have been received, they need to be considered for inclusion. The final draft technical regulation is then sent to the relevant legislative authorities together with the regulatory
impact assessment for consideration, approval and promulgation.
25
Technical regulation implementation

The successful implementation of a technical regulation is dependent on a number of players.
These can include the suppliers, conformity assessment service providers, warehouse operators and retail outlets and the regulatory authorities. The implementation of a new technical
regulation should therefore be considered carefully. It is especially the coordination of all the
activities that is important. A typical flow chart of the implementation of a new technical regulation is shown in Figure 7.
Even before a technical regulation has been promulgated, the regulatory authority should discuss the implementation strategy and timing with the affected economic operators. A good
practice is to establish a suppliers forum where the issues can be discussed. In some cases,
the implementation may have to wait for upgrading of manufacturing facilities, e.g. refineries
require capital investment to change their output to a higher grade fuel, plastic manufacturers
have to change production methods to provide thicker plastic bags, etc. It is also useful to
discuss conformity assessment modalities, any levies that will need to be paid and the general
approach to market surveillance. In this way the regulatory authority will gain the goodwill and
support of the economic operators.
The relevant laboratories will need to gain accreditation if they do not have it yet, and the
regulatory authority has to designate relevant ones if that is the system they will be using. The
suppliers have to have their products tested and certified. If the products do not comply, they
will have to institute measures to redesign the products, upgrade manufacturing practices, and
in some cases even upgrade transport and warehousing arrangements. The regulatory authority needs to establish capacity for market surveillance, and the inspectors have to be
trained and registered.
There may be older, non-complying product in the market that has to be dealt with. It may be
appropriate to allow for a transition period during which all new products have to comply, but
non-compliant product can still be marketed for a short period of time. After this time all products have to comply. This may mean the withdrawal of non-compliant products from the market, and their disposition.
Implementing a technical regulation is therefore much, much more than just promulgating it
and then waiting for the market place to react.
26
Figure 6: Technical regulation development work flow

Identify market failure
Leave market to regulate it-
Promulgate Technical Regula-
Conduct RIA
TR?
Relevant
Ministry
Establish working group
MoTI
Notify WTO
Develop draft TR
NSB
Technical
Committee
Standard?
Comments
WTO members
Submit Final
Draft TR to
legislative
authority
National
Standard
Reference standard
Draft Technical
Regulation
Publish for public

comments
Incorporate
comments
Final Draft Technical

Regulation
27
Figure 7: Technical regulation implementation work flow
Relevant Ministry or
Regulatory Authority
Establish supplier forum
Suppliers
Importers
Laboratories
Certification bodies
Accreditation body
Laboratory &
Certification Body
Technical
Regulation
Establish
surveillance
body
Discuss and agree
Technical Regulation
Transition
Market surveillance
Conformity assessment
Conduct market
surveillance
Designate
service
providers
Test and
certify
Obtain
accreditation
Manufacture
Declaration of conformity
Supplier
Import
Foreign
test report
OK?
28
Part 4 - Technical regulation and quality infrastructure interfaces

It has already been shown that the services of the quality infrastructure are essential for the
implementation of technical regulation. In this part of the conclusion report, the way in which
a number of quality infrastructure services support technical regulation are discussed.
It is better to have exclusive referencing (undated) to standards in technical regulations because:
It is easier for regulatory bodies not to continuously amend their regulations when standards are amended;
The other advantage is flexibility of economic operators to use any of the versions during
the transitional period; and
The challenge for economic operators getting information from the NSB, on valid standards
specifically in the countries where they want to export, is less.
Group 3, Session 2
4.1. Standards in technical regulation

The question can be asked why standards should be used in the first place other than that the
WTO TBT Agreement requires countries to base their technical regulation on international
standards should they exist and be relevant. The relevant Ministry or regulatory authority has
the possibility to mobilise technical experts when a technical regulation is being developed,
because it would seldom have all the required expertise in-house. This however, would be an
unnecessary duplication of the activities of the national standards body. It would certainly be
much more efficient to take the result of the standards technical committee the standard
and use it in technical regulation. The advantages of doing so are largely self-evident.
The legislator can rely on recognized solutions and does not invest in re-inventing the
wheel;
The overall development system is cost-effective, i.e. development costs are shared by
participating stakeholders, for the most part transferred from the public to the private sector;
Standards are developed in a participative, transparent and consensus manner and their
final approval must receive support of the main interested parties, resulting in a high degree of acceptance;
Standards can be readily revised to reflect technological developments and in this way
remain up-to-date it is more difficult to revise self-contained technical regulations; and
To the extent that many sources of expertise are available for the standardization work,
using standards in technical regulation may be more effective in so far as it will better
reflect technical reality in the market.
Methods of referencing standards in technical regulation

The text of the standard or excerpts thereof, can be incorporated word-for-word in the technical
regulation. This method of incorporation is a very static form of the use of standards, and has
turned out to be impractical in many cases. The main challenge is that the technical regulation
29
Figure 8: Referencing of standards in technical regulation

Standard
Incorporated in text
Referenced in text
Direct (exclusive) reference
Dated
Indirect (indicative) reference
Undated
is not reviewed regularly, and the technical requirements which may have been initially up-todate, are no longer so. This has a negative impact on the validity of the technical requirements, and seriously compromises the implementation of the technical regulation.
It is much more practical to reference standards. There are however a number of possibilities
of doing so, each with their own advantages and challenges. The first possibility is considered
as direct referencing, sometimes also known as exclusive referencing. In this case the standard is referenced by number, title and scope. This is known as the undated direct reference,
whereas if the date of publication of the standard is added to the list, then we have a dated
direct reference. The most sophisticated referencing methodology is known as an indicative
or indirect reference, also known as deem to satisfy standards in some jurisdictions. The
various methods are shown graphically in Figure 8.
Direct reference
A direct reference of the standard by number, title and scope is clear and unambiguous. No
other standard can be used to provide evidence of compliance of the product with the technical
regulation. It does confer the status of mandatory to the standard. Two possibilities present
themselves:
The date of publication of the standard is not mentioned, i.e. an undated reference. This
has the advantage that should the standard be revised, the technical regulation is up-dated
automatically. This method of referencing is utilised widely by both developed and developing countries. The risk for the legislator is that control over the technical requirements
is delegated by default to the standards body publishing the standard. Experiences in
many countries have shown however, that the risk is not as great as some would fear. If
national standards are referenced, the legislator can retain some control by remaining
involved in the standards technical committee, and as a good practice measure, can even
be given the chair of the committee.
The date of the standard is mentioned, i.e. a dated reference. This has the theoretical
advantage that the legislator remains in control of the technical requirements. The risk
however, of the technical regulation becoming out-of-date because the legislator fails to
30
update the reference as and when the standard is revised, is very real. There are a number of examples of such occurrences even in developed countries, e.g. the referencing of
ISO standards for containers which have been replaced by revised standards. This makes
a mockery of the implementation of the technical regulation, as containers are no longer
manufactured in accordance with the older ISO standards anywhere in the world.
Indirect reference
The indirect referencing is based on the notion that the technical regulation does not contain
a direct reference to the standard. The technical requirements are limited to the essentials,
written in a style that is largely timeless and does not list specifics that could be subject to
technological developments. The need for continuous updating the technical regulation is
thereby set aside. The legislator then publishes the standards deemed relevant in a separate,
but official list over which the legislator has control. Compliance with such standards leads to
a presumption of compliance with the essential technical requirements of the technical regulation.
The legislator remains in control of the technical requirements, but the risk of outdated standards remains and has to be manged by the legislator. The standards remain voluntary,
thereby making it easier to comply with copyright requirements of adopted ISO or IEC standards. Theoretically, solutions other than provided for in the referenced indicative standards
are possible, but the reality is much more complicated. The supplier has to persuade the
legislator that another standard will lead to the same result, i.e. fulfil the essential technical
requirements of the technical regulation.
Although purported to be the most resourceful system of referencing standards, it has not
found widespread acceptance in most jurisdictions, as it also requires a sophisticated juridical
system, especially effective product liability legislation. The most pervasive use of indirect
referencing are the New Directives of the European Union. Harmonised European Standards
(EN Standards) published in the Official Gazette of the European Commission as indirect references, form the basis of technical requirements. In some countries National Building Regulations are also utilise indirect referencing regarding building materials, as new types of useful building materials are continuously being developed and utilised.
4.2. Metrology in technical regulation

Metrology is as old as mankind, and emperors in ancient times already enforced compliance
with defined measurement standards as far back as 4000 years ago in trade and in buildings.
Because it has been around for so long, metrology is often overlooked in technical regulation.
Yet it remains one of the most pervasive necessities in implementing the same. Measurements affect our daily lives, we buy clothes according to size and food in accordance with
weight and volume, our cell-phones connect because frequency spectrums are minutely controlled based on measurements, science depends in totality on accurate measurements the
list is endless.
Metrology is considered as consisting of three domains:
General metrology, which deals with problems common to all metrological questions;
Legal metrology, which relates to mandatory technical requirements in trade, health, law
enforcement and others; and
Industrial metrology, which are measurements performed in production and quality control.
31
The first two are usually the purview of the state, whereas the third one is a broad and crosscutting activity at the level of 10 15% of overall production costs. In total, metrology can
account for as much as 6% of GDP of the country, not a small amount.
General metrology and the national metrology system

Most countries subscribe to the SI-System. This system, established as far back as 1875 as
an international treaty, consists of seven base units for which international definitions in terms
of natural constants exist, i.e. length (metre), mass (kilogram), time (second), electric current
(ampere), thermodynamic temperature (kelvin), mount of substance (mole) and luminous intensity (candela). All other measurement units are derived from these seven. The National
Metrology Institute (NMI) responsible for the national measurement standards, has to turn
these definitions into an actual measuring apparatus. The large NMIs of developed economies can do so on their own, but the NMIs of most developing economies would obtain these
from dedicated suppliers. These may not be as accurate as the custom-made ones, but they
should be more than adequate for the needs of the country.
Figure 9: National metrology system
Bureau International des
Poids et Mesures (BIPM)
National Metrology
Institute (NMI)
Definition of the unit
Foreign primary standard
Calibration laboratories
Legal metrology department
National primary standard
Reference standard
National
Metrology
Enterprises
Industrial standard
End users
Measurements
System
Source: EUROMET
The major challenge for the developing country is the international acceptance of its best calibration and measurement capabilities (CMCs) and the listing thereof in the international Key
Comparison Data Base (KCDB) managed by the BIPM. In order to achieve this recognition,
the NMI has to participate in inter-laboratory comparisons amongst the NMIs of the regional
metrology organisation recognized by the BIPM. For most areas of the world this is not a
problem, but the Arabic speaking region has not yet such a regional metrology organization.
Hence countries in the region find it very difficult to gain this important international recognition
at the time of writing of the conclusion report.
32
The national measurement standards are the basis on which traceable calibration of all measuring equipment in the country is derived from. This is called the national metrology system
and is schematically shown in Figure 9. From the figure it can be seen that if the country does
not have its own national measuring standard, an appropriate standard from a neighbouring
country can be utilised. This may be the only way many Arabic speaking countries can gain
traceability to international standards until such time that the regional metrology organisation
is established and accepted by the BIPM.
Any measurement conducted by the NMI should be of the highest accuracy, and all other
measurements in the country derive from this. Good practice indicates that any measurements to be made in technical regulation implementation, should be traceable to the national
measurement standard. Many countries have promulgated appropriate legislation in this regard.
Measuring equipment in daily use needs to be calibrated regularly as its accuracy may drift
over time. Calibration services are provided by independent calibration laboratories in the
public and private sector, or larger manufacturing organizations may have their own. The
calibration laboratories should be accredited to ISO/IEC 17025 and their reference standards
should obviously be traceably calibrated to the national measurement standards, thereby completing the traceability chain from the international definition to the national measurement
standard down to the actual measurement being made by the end user.
Legal Metrology
Trade, health services, law enforcement, environmental control and many other key services
rely heavily on measurements. The state wishing to ensure an equitable situation as regards
measurements, can establish a legal metrology system whereby such measuring equipment
has to comply with specified requirements by law. This is called Legal Metrology, of which
Trade Metrology or Weights and Measures is a subset. Legal Metrology is a form of technical
regulation and it is normally implemented through primary legislation supported by many regulations promulgated in terms of the primary legislation. The activities of Legal Metrology
include the following:
Type approval of measuring equipment used in trade, health care, law enforcement, etc.
followed by their calibration and verification;
Control pre-packaged goods packed at source rather than in retail outlets; and
Market surveillance.
Type approval follows the successful testing of the relevant measuring equipment against
regulations and standards, where after the equipment may be utilised for its intended purpose.
Before putting it into service it has to be calibrated and verified that it meets the legally defined
accuracy requirements. The calibration and verification has to be repeated at prescribed intervals.
The pre-packaging control is based on regulations based on international or regional recommendations such as the OIML Recommendations to ensure that the purchaser gets the quantity that is being paid for. In some cases, the pre-packaging quantities are also prescribed for
basic goods in order to protect purchasers against deceptive practices, e.g. soft drinks can
only be marketed in 330ml bottles and tins, butter in 250g, 500g and 1kg packs, etc.
The Legal Metrology Department is a government based entity the same way as are regulatory
agencies responsible for the enforcement of technical regulations. The calibration and verification of measuring equipment can be devolved to independent calibration laboratories that
are accredited and so designated by the Legal Metrology Department. However, the Legal
33
Metrology Department retains the market surveillance function, and ensures in this way that
the Legal Metrology legislation is properly enforced.
4.3. Accreditation in technical regulation

Accreditation is the third fundamental of the quality infrastructure after standards and metrology. Whereas the other two have been around for a long time, accreditation has only come
to the fore in the last fifty years. Today accreditation is considered to be just as important as
the other two in creating an effective and efficient quality infrastructure in that it provides the
means to determine the technical competency of inspection bodies, laboratories and certification bodies thereby engendering trust in their services.
Role of accreditation
Accreditation is formally defined as third-party attestation related to a conformity assessment
body conveying formal demonstration of its competence to carry out specific conformity assessment tasks. From the definition it is clear that the accreditation body has to be independent. This is also the big difference between accreditation and ISO 9001 certification for example. ISO 9000 certification assesses whether the quality management system complies with
the standard but says little about the level of service delivery or product quality, whereas accreditation goes one step further in that it also assesses whether the outcome of the service
is at the appropriate level.
In the regulatory sector, government authorities implement laws covering the approval of products and services for reasons of safety, health, environmental protection, fraud prevention or
market fairness and consumer protection. In the non-regulated sector, many industries have,
both within an economy as well as globally, set up systems for conformity assessment and
approval, aiming at achieving a minimum technical level, enabling comparability, and also ensuring competition on equal terms.
In both of these domains, it is important for interested parties to know that conformity assessment bodies are competent to perform their tasks. For that reason, there is an increasing
demand for impartial attestation of their competence. Such attestation is done by accreditation
bodies that are impartial and independent in relation to the conformity assessment bodies and
the conformity assessment bodies' clients. Accreditation bodies normally operate in a nonprofit distributing manner and conduct regular assessments of conformity assessment bodies
to ensure that conformity assessment bodies conform with relevant international standards.
Accreditation bodies
Accreditation bodies are established in many countries to ensure that conformity assessment
bodies are subject to oversight by a competent body. The question immediately arises as to
who determines whether the accreditation bodies are competent. Accreditation bodies have
to comply with international standards, specifically ISO/IEC 17011, and their competency is
determined by peer assessments. These are arranged through the International Laboratory
Accreditation Cooperation (ILAC) and the International Accreditation Forum (IAF). Internationally recognised accreditation bodies, which have been evaluated by peers as competent,
sign international recognition arrangements through ILAC and IAF that enhance the acceptance of products and services across borders, thereby creating a global infrastructure to
support trade, regulatory approval processes, and confidence in the marketplace.
Establishing a national accreditation body is a long term process. Anecdotal evidence suggests that it will take an accreditation body about five to seven years to gain international
34
recognition. Furthermore, studies in developed countries have shown that an accreditation

body should have about 200 to 250 accredited organizations on its books before it can break
even. Hence, governments in smaller countries have to fund accreditation bodies for a fairly
long time. Even in more advanced economies, the state still supports accreditation bodies for
their international liaison activities because these are so important for the acceptance of the
products and services of the country in the export markets.
In some economies more than one accreditation body has been established, each servicing a
specific sector. Although no international ruling exists that there should be only one national
accreditation body per country, the tendency has been to merge multiple accreditation bodies.
The reasons are fairly obvious: It is costly to maintain more than one accreditation body in
smaller economies, each accreditation body has to obtain international recognition on its own,
and the question arises which one speaks on behalf of the country in international and regional
forums dealing with accreditation. The European Commission for example decreed a few
years ago that each EU member state shall have only one national accreditation body for its
technical regulation domain. As a result, a few countries, e.g. Germany and Italy, had to
merge their multiple accreditation bodies.
Regional accreditation bodies have been established in some trading blocks to provide accreditation services in smaller economies that find it difficult to establish their own accreditation
body. This is a workable solution even though the logistics are quite daunting, and differences
in language amongst regional member states has its own challenges. In such cases, some of
the larger states in the region may still establish their own national accreditation body. Should
this be the situation, a formal agreement needs to be reached between the regional body and
the national bodies to ensure cooperation and to determine who operates in which countries
to avoid destabilizing competitive behaviour. This is the situation in SADC for example, where
SADCAS has been established as a regional accreditation body, working alongside the national accreditation bodies such as SANAS (South Africa) and MAURITAS (Mauritius). In this
case, SANAS operates in all SADC member states other than Mauritius and South Africa, and
the other two operate only in their own countries.
A regional accreditation body can be viable on condition that: (i) The appropriate budget
provided by all participating states is assured, (ii) the expertise on establishing and managing
it is available, and (iii) national regulations of each country enforces the use of accredited
CABs in the industry.
Groups 2 and 3, Session 2
35
Part 5 - Regulatory impact assessments and other challenges

As international trade grows, consumer expectations regarding safety and health increase and
government resources come under more pressure, many of the customs and practices of the
past are being re-evaluated in order to render them more effective and efficient. The quality
infrastructure and technical regulation systems of countries and even regions are no exception. In this part of the conclusion report, a number of these are discussed and emerging good
practices are enumerated.
5.1. Regulatory Impact Assessment (RIA)

RIAs most important contribution to the quality of decisions is not the precision of the calculations used, but the action of analysing questioning, understanding real-world impacts
and exploring assumptions.
OECD
Good regulatory practice suggests that a proper study be conducted before a technical regulation is developed and implemented to determine if the envisaged technical regulation will
actually deal with the market failure, what the costs of implementing it would be, whether the
benefits warrant the costs of implementation and which adverse effects will be manifested.
This is called a Regulatory Impact Assessment (RIA). World-wide, a rapidly growing number
of economies have introduced the obligation to carry out an RIA for different kinds of regulation, especially technical regulations.
It is important to note, however, that a full RIA may not always be necessary, as it is a costly
and time consuming activity. It may therefore be prudent to define and describe different types
of RIA, varying in stringency and required resource investment, depending on the expected
impact of proposed technical regulation. The observation of the OECD quoted at the beginning of this section is noteworthy in this respect it is not about the absolute accuracy of the
monitory figures in the RIA because many will be assumptions anyway, but it is more about
coming to a better understanding of the dynamics of the proposed technical regulation and its
impacts, positive and negative, on the state, economic operators and society.
A proper RIA can help in dealing with the following challenges: Over regulation, inappropriate
regulation, lack of regulation and unenforceable regulation. Many economies have developed
guides for conducting an RIA. The EU approach is described below. Others may be equally
relevant, and each country should consider establishing a definitive guide to be used by all, to
facilitate better decision by policy and strategy makers. The EU guide is based on seven
questions.
1. What is the problem and why is it a problem?
2. Should the country act alone or in concert with others?
3. What should be achieved?
4. What are the various options to achieve the objectives?
5. What are their economic, social and environmental impacts and who will be affected?
36
6. How do the different options compare in terms of their effectiveness and efficiency (benefits and costs)?
7. How will monitoring and subsequent retrospective evaluation be organised?
What is the problem and why is it a problem?

An RIA starts by verifying the existence of a problem, identifying who is affected, estimating
the problems scale, analysing its causes and consequences, and assessing its likelihood to
persist in the absence of a technical regulation intervention by the government. The answer
to this question should give policy-makers the information needed to decide whether there is
a problem for which a technical regulation may be warranted. A typical analysis would include
the following:
Verify the existence of the problem, i.e. market failure, regulatory inefficiency, etc.;
Identify who is affected, i.e. individuals, enterprises, other stakeholders;
Estimate the scale and analyse the underlying causes and consequences; and
Assess the likelihood of the problem persisting.
Should the country act alone or in concert with others?

Having established the existence of a problem, its scale and the causes, the RIA analysis
should verify whether the country could resolve it effectively on its own, or whether the region
would be better placed to do so. The answer to this question should give policy-makers the
information needed to decide whether a response at regional level would be more effective.
What should be achieved?

The RIA should set out what the technical regulation should achieve. The objective of the
technical regulation should be clearly identified, including the level of technical regulation ambition and the criteria or indicators against which alternative options would be compared and
the success of any initiative assessed. In defining the objective, it is important to determine
the logical chain between the problem and the solution. Any objective should be S.M.A.R.T.
(i.e. Specific, Measurable, Achievable, Relevant and Time-bound).
What are the various options to achieve the objectives?

There are different ways to achieve technical regulation objectives. The RIA should allow for
an informed decision about which one to pursue. To do so, available options should be identified and screened with a view to selecting the most relevant ones for further analysis and
comparison. At the end of this process, the most relevant technical regulation options should
have been identified for further examination in the impact analysis stage.
The widest range of options should be considered in the beginning: Regulatory/non-regulatory, less or more prescriptive, national, regional or international. Then the options should be
screened to discard the irrelevant, retaining the most relevant. Thereafter the retained options
should be subjected to a detailed examination. The one option that should always be retained
is changing nothing. This should be used as the benchmark for evaluating the other options.
Future developments, especially in fast moving technologies should not be overlooked. At
least two options other than changing nothing should be considered. If two different options
are not available, identifying two sub-options as alternatives would be useful.
37
What are their economic, social and environmental impacts and who will be affected?
Once a set of technical regulation options is selected, an assessment should be carried out of
their economic, social and environmental impacts and of who will be affected. At the end of
this process, policy makers should know to what extent different technical regulation options
would meet their objectives, with what benefits, at what cost, with what implications for different stakeholders, and at what risk of unintended consequences.
Such an assessment should be robust, assessing all the relevant advantages and disadvantages. It is usually an iterative process which starts with a wide reach and progressively
focusses more deeply. Internal as well as external expertise is usually required to conduct
such an in-depth evaluation. Three focus areas need to be specifically considered: (i) Those
that have to comply, (ii) those that have to implement and enforce, and (iii) the final beneficiaries.
The evaluations should be broad in nature, assessing the economic, social and environmental
impacts. Specifics should include: (i) Increase in compliance costs for economic operators,
(ii) enforcement costs for the authorities, (iii) possible gains or falls in market efficiency with
respect to competitiveness and innovation, and (iv) impacts on the environment, climate
change, education, social inclusion and poverty reduction. Affected parties should include
businesses of different sizes (especially the SME sector as compliance costs will be more of
an issue for them than for larger organizations), citizens, workers, learners and consumers.
The long-term or recurrent risks should be considered as regards their frequency and certainty. In assessing the technical aspects of the impact, it is important to remain concrete and
to relate the evaluation to the practical implications of the options.
It is important to state the impacts in quantitative terms where possible. As these would frequently be based on some assumptions, these should be stated. The impacts should be
monetised as far as possible, but spurious precision should be avoided. It is far better to state
ranges of outcomes or confidence intervals rather than trying to determine impacts to the
nearest dollar. Impacts can also be stated in qualitative terms as support for the quantitative
evaluation as a further practical implication for the affected parties. In this case a clear distinction should be made between facts, stakeholder views and expert opinions.
How do the different options compare in terms of their effectiveness and efficiency (benefits and costs)?
Based on the assessment of the various impacts and their distribution across affected parties,
the RIA should compare the different options with regard to their effectiveness, efficiency and
coherence, as well as their compliance with the proportionality principle. At the end of this
process, the RIA would present the relevant information for policy-makers to make a choice
and, where appropriate, suggest a preferred option.
This demands a clear comparison of impact results to facilitate choosing the preferred option.
Typical methodologies that are utilised include a cost-benefit analysis, cost-effectiveness analysis, compliance cost analysis and even a multi-criteria analysis of all of the above.
How will monitoring and subsequent retrospective evaluation be organised?

Having the entire technical regulation cycle in mind, the RIA should identify monitoring and
evaluation arrangements to track whether the technical regulation actually delivers the intended result and to inform any future revision of the technical regulation. At the end of this
38
process, policy makers should know how the technical regulation will be monitored and evaluated, allowing for future adjustments whenever needed.
5.2. Cooperation between quality infrastructure and technical regulation systems

In a world where information technology has become pervasive across societies, and where
technology is creating convergence of products and services, coordination and cooperation
between the quality infrastructure organizations and the regulatory authorities is of paramount
importance. There are good practices that have evolved in the past decades, some formal,
others of an informal nature. Both will be explored in this section of the conclusion report.
Formal coordination mechanism related to the whole system

In recent times, a good practice coordination structure between the quality infrastructure and
the technical regulation system is starting to emerge for developing economies. This is shown
schematically in Figure 10. The fundamentals of the quality infrastructure, i.e. standards
(NSB), metrology (NMI) and accreditation (NAB) are usually government related organizations
accountable to the Ministry of Trade and Industry or similar as this is the ministry most likely
to be responsible for the implementation of the WTO TBT Agreement in the country. A variation seen in some countries is that they are accountable to the Ministry of Science and Technology. In most developing economies, the NSB also provides testing and certification services. In smaller economies it may be necessary to combine the NSB and NMI in a single
entity due to resource constraints.
Over and above these three fundamentals, government may also establish a number of laboratories in various ministries. By the same token, the private sector will also start to get involved
and establish private sector conformity assessment service providers. As the industrial development of the country advances, private sector conformity assessment service providers
will eventually overtake the public sector ones this is a natural progression in all economies.
The sum total of all of these organizations form the quality infrastructure of the country.
Technical regulations are developed and implemented by a number of ministries and their
regulatory agencies. In a well-orchestrated technical regulation system, the services of the
whole of the quality infrastructure is utilised to determine the technical requirements and provide for the conformity assessment of products and services falling within the scope of technical regulations. There is not a separate system for doing so as this would be a very expensive and unnecessary option.
But technical regulation is complex and becoming more so every day. It is therefore important
that formal coordination systems are put in place to ensure that the country meets its WTO
TBT Agreement obligations, and that the technical regulation system is not fragmented, ad
hoc and ineffective in parts. In many countries this is taking the form of a Technical Regulation
Office that seeks to coordinate the activities of the quality infrastructure and the regulatory
authorities insofar as they relate to technical regulation development and implementation.
This Technical Regulation Office must have regulatory powers if it is to be successful, and it
should be accountable to an appropriately high office in the government.
39
Figure 10: National metrology system
TradePolicy
QualityPolicy
Office of Technical Regulation
MinistryofTradeandIndustries
(MoTI)
Coordination of technical regulation

activities and agencies
International and regional cooperation
Ministries (Various)
TechnicalRegulationDevelopment
Notification
COORDINATION
National Standards
Body (NSB)
Develop & publish

standards
Member of ISO/IEC
Testing laboratories
Certification services
National Accreditation
Body (NAB)
National Metrology
Institute (NMI)
Maintain national
measurement
standards
Calibration services
Type testing
Membership BIPM
Accreditation services
Membership ILAC & IAF
Recognition
arrangements
Regulatory Agencies
Laboratories &
Certification Bodies
Private organizations, state
enterprises, scientific
institutions
Testing
Certification
Inspection
Market surveillance
Sanctions
ACCREDITATION
40
Informal coordination and cooperation

A number of possibilities exist for the quality infrastructure to engage with the technical regulation system. Some of these include: (i) Standing membership of a regulatory authority on
relevant NS, NMI and NAB technical committees, (ii) information on new and revised standards is provided continuously to regulatory authorities, (iii) marketing visits of NSB, NMI and
NAB managers to regulatory authorities, and (iv) Invitation of regulatory authorities to special
functions, e.g. opening of new laboratory, accreditation of current laboratory, etc. The possibilities are endless, and NSBs, NMIs and NABs should go out of their way to engender such
cooperation and coordination. Waiting for the regulatory authorities to initiate such cooperation is usually not so successful.
Formal coordination between regulatory authorities and the NSB, NMI and NAB
There is nothing to stop the NSB, NMI or NAB to conclude and sign formal cooperation agreements between them and relevant regulatory authorities. In the realm of standards for example, the regulatory authority could be given preferential treatment if it needs a new standard to
be developed. The regulatory authority could be offered the chair of the technical committee,
and it could even be given a final veto right as regards the approval of the standard. The latter
is a rather radical step and to some extent flies in the face of consensus principles for standards development, but if there is good cooperation between the NSB and the regulatory authority it will seldom be invoked.
5.3. Common challenges

In developed economies the fundamentals of the quality infrastructure, i.e. standards, metrology and accreditation are generally provided by totally independent organizations. This is not
the case in developing economies that experience serious resource constraints. Furthermore,
the NSBs, NMIs and NABs in developed economies are seldom regulatory bodies, are supposed to be service providers to both the regulatory and non-regulatory domain. In many
developing economies the NSBs enforce mandatory standards, and NMIs are involved in Legal Metrology. As trade expands, the developed economies are trying to persuade developing
economies to do as they do, and the developing economies are saying they cannot afford to
do so. This section of the conclusion report looks at some of these challenges and possibilities
of mitigation.
Standards, metrology, accreditation and conformity assessment services

In some jurisdictions national standards bodies do not provide conformity assessment services, in fact in the EU, for example, they are basically not allowed to do so. In the rest of the
world it is fairly common practice for the NSBs to provide such services. Is this a conflict of
interest?
It is not a conflict of interest, and the situation in the EU has come about due to their specific
technical regulation system which provides for the notification of many conformity assessment
service providers in order for suppliers to have a choice. It is therefore largely a political decision. In many developing economies, the NSB needs to maintain its conformity assessment
services to generate funds for the development of future standardization work due to diminishing financial support from governments.
On the other hand, the construct whereby NSBs are responsible also for accreditation whilst
they provide conformity assessment services is an undeniable conflict of interest. In such
cases the government and NSB have to make a decision either to separate accreditation and
41
establish it as an independent entity, or to separate the conformity assessment services from

the NSB.
Mandatory standards and national product certification marks

In many developing countries, standards are declared mandatory or compulsory and the NSB
is then charged with the responsibility to administer or enforce them. This system may have
served countries well in the past, but it is increasingly becoming a stumbling block in trade
with the more advanced common markets such as the EU. Even if the standard is declared
mandatory by the Minister, and not by the NSB, the system is still considered undesirable by
major trading blocks.
A number of undesirable features are usually mentioned in this regard.
The standards are no longer voluntary, thereby supposedly violating a WTO TBT Agreement principle. On the other hand, it can be argued that if a standard is referenced in a
technical regulation, it also loses its voluntary character. Anecdotal evidence does indicate however, that the NSB does tend to favour the development of standards which are
destined to be declared mandatory rather than standards that the industry needs, but
which will remain voluntary. The reason for this is that the NSB will be paid for the administration, fees or levies by law that augment the budget.
A second difficulty is that the legislation either does not provide for the modalities for conformity assessment, or it requires the national product certification mark as the measure
of compliance. The latter is a undisputed barrier to trade for imported products, the former
leaves it wide open for the NSB to make their own rules as it goes along. Neither situation
is good for the country.
Mandatory standards were and still are being used extensively for food safety when there
were no other systems in place. But, they are not the appropriate mechanism for food
safety systems. The international standards published by the Codex Alimentarus Commission (CAC) state very clearly that a proper food safety system looks at the total chain
of production, from field to fork. Mandatory standards deal with the processed food commodity only.
There are some countries that were able to modernize their system of mandatory standards
and retain it for manufactured products. The changes to make it fully compliant with the WTO
TBT Agreement and international good practices included some of the following:
The legislation was enhanced to provide for all the building blocks of a technical regulation,
i.e. not only the technical requirements (i.e. the standard) and sanctions, but also the conformity assessment modalities;
Regulatory impact assessments and public enquiries were conducted before a standard
was declared mandatory;
The WTO TBT Secretariat was notified about the implementation of a new mandatory
standard;
The regulatory responsibilities of the NSB was separated and placed in an independent
regulatory agency;
Mandatory standards were no longer utilised for food safety control this was based on a
much broader concept of control over the whole of the value chain; and
Where the national product certification mark was a legal precondition, this was changed
to being a good indication that the product complied with the mandatory standard leading
to a lower surveillance frequency for such suppliers from the regulatory agency.
42
The NSB is a regulatory agency

The issue of the NSB being a regulatory body is closely aligned with the issue of mandatory
standards discussed in the previous section. There are two challenges that relate to this issue:
(i) the NSB develops mandatory standards or technical regulations, and (ii) the NSB administers mandatory standards.
Developing and implementing technical regulations is the responsibility of the government as
they are ultimately part of the body of legislation of the country. The WTO TBT Agreement is
also very clear on this issue. Standards are developed in an open, consensus driven mode,
whereas this is not necessarily the case for technical regulations. If the NSB develops technical regulation in the form of mandatory standards or otherwise, it is seen as a conflict with
respect to its role of developing voluntary standards, i.e. it is very difficult to do proper justice
to both. The situation is further compounded if the NSB is also charged with the implementation of the technical regulation, i.e. the mandatory standard. It will quickly be seen by industry
as a policeman and not as an organization established to help industry to uplift the quality of
products and services.
This challenge can only be fully mitigated if the development of technical regulations in whatever format is made the responsibility of the relevant ministry. The NSB remains responsible
for the development of the standard on which the technical regulation should be based. This
is a subtle division of responsibilities, but a necessary one. Secondly, the NSB should not be
involved in the implementation of the technical regulation, i.e. market surveillance and imposition of sanctions. The NSB can provide conformity assessment services on request to the
suppliers and to the regulatory agency in competition with others, provided that these services
are appropriately accredited. The regulatory function should be placed in an agency independent from the NSB.
Conformity assessment by regulatory agencies

In many developing countries the regulatory agencies also provide testing and certification
services to suppliers for them to show compliance of the product with the technical requirements of the technical regulation. This is mostly a historical situation, going back to times
when the regulatory authority was the only organization capable of doing so. This is now
considered a conflict of interest: The regulatory authority provides conformity assessment services for which it gets paid, and then it acts thereafter as the regulator sitting in judgement on
the compliance of the product or otherwise. This is tantamount to writing the examination and
then marking it yourself. It also means that the regulatory authority accepts the responsibility
for the integrity of the product to a large degree, i.e. it takes this responsibility away from the
supplier.
In modern market related economies this is no longer a tenable situation. The supplier has to
be responsible for the integrity of the product at all times. Secondly, the supplier should have
a choice of conformity assessment service providers that are technically competent. By being
given a choice, a monopoly (e.g. the regulatory authority only accepting its own testing and
certification) with its tendency to extract rent is largely avoided.
Although the issue regarding NSBs making the transition from a regulatory authority for technical regulation to a conformity assurance service provider in competition with others is being
given attention in some developing economies, exactly the same arguments hold true for the
food safety environment. Developing economies that are in the process of establishing food
safety authorities will do well to ensure that a similar rent extracting system is not re-established in this field. The issue of competency should be addressed through accreditation, not
43
by elevating conformity assessment by the regulatory authority above all others by law, i.e.
creating a legal monopoly.
All of the above does not mean that the regulatory authority should not establish and maintain
their own laboratories. But, these laboratories should be used only for audit testing, i.e. verifying the compliance of products. They should not be used for certifying the products falling
within the scope of mandatory standards or technical regulations as a pre-condition for marketing them.
44
ANNEX A: NQI and technical regulation systems in the MENA STAR

countries
The NQI and technical regulation systems in the MENA STAR countries show a wide variety
of approaches. Some of the systems are being re-engineered as a result of trade partner
pressure, others are still in the initial stages of development. It is especially the technical
regulation regimes that are coming under pressure to show better alignment with major trading
partner preferences.
NOTE: It is important to note that the NQI and technical regulation systems of many of the
MENA STAR countries are undergoing changes and re-engineering. The description following
should therefore not be taken as the latest situation, but should be updated with fresh information as and when a more informed discussion is to take place. The description is included
to show the wide variety of approaches and some of the challenges at the time of writing of tis
report, when compared to good practices described in the main body of this report.
National Quality Infrastructure

In developed countries the three fundamentals of a National Quality Infrastructure (NQI),
namely standards, metrology and accreditation are separate organizations, albeit mostly still
aligned with the state either as statutory bodies or as not-for-profit private companies with a
formal agreement signed with the state. Conformity assessment services are fully liberalised,
with accreditation playing the major role in determining the competency of conformity assessment bodies (CABs) operating in especially the technical regulation domain. In the MENA
STAR countries this is not always the case.
In a few countries three independent organizations have been established for the fundamentals, for example Algeria (IANOR-standards, ONML-metrology and ALGERAC-accreditation),
Egypt (EOS-standards, NIS-metrology and EGAC-accreditation) and Tunisia (INNORPIstandards, ANM-metrology and TUNAC-accreditation). In some countries the metrology and
standards functions have been combined. Typical examples include Morocco (IMANOR) and
Palestine (PSA). These two countries have established accreditation as independent entities
separate from the NSBs. There are however also countries where the three fundamentals are
still within one organization, e.g. Iraq (COSQC). In the latter it is doubtful whether the accreditation unit will be able to become a signatory of the ILAC or IAF multilateral recognition arrangements due to the conflict of interest between accreditation and conformity assessment
activities within COSQC.
Jordan is an interesting case. JSMO consists of specific units that are responsible for standards, accreditation, metrology and conformity assessment (including market surveillance for
mandatory standards). In 2015 the standards and accreditation units were separated by a
legislative instrument to report directly to the Minister of Trade and Industry, whereas the rest
still report to the JSMO Board. But all are still part of JSMO with a common state budget.
Whether this will be adequate to demonstrate the independence of the accreditation unit as
required by ILAC and IAF for their multilateral recognition arrangements was still to be determined.
As regards testing and certification most countries have not only the NSB providing such services, but also other Ministries and in some case also private laboratories. Egypts national
accreditation body (EGAC) has accredited a substantial number of laboratories already. It
could therefore start considering liberalizing its conformity assessment domain in respect of
45
technical regulation implementation. In Jordan a number of JSMOs laboratories are accredited, in most of the other countries they are still few and far between. This is one of the challenges in establishing a modern technical regulation system in almost all of the countries.
Technical regulation systems

Most of the MENA STAR countries had a technical regulation system based on the implementation of mandatory standards in some form. In some it is the responsibility of the NSB, in
others the various Ministries themselves are responsible for the development and implementation of these. In Iraq for example, all national standards are automatically mandatory, and
COSQC is responsible for their implementation. It is debatable whether such a system is still
effective in the much more open markets of today. They are a remnant of a system that sought
to control the output of manufacturers in the absence of market forces, e.g. in the former Soviet
Union.
In some MENA STAR countries, the system has been or is slowly being replaced by a more
modern approach that sees the promulgation of technical regulations with more timeless, essential requirements included. The technical realization of these requirements are then provided by reference to standards in various forms, from direct, undated references to indirect
references published in official gazettes as deem to satisfy criteria.
Palestine for example has started with the establishment of a system similar to that of the
European Union. But it is not operational yet due to the general lack of a supportive conformity
assessment infrastructure and lack of market surveillance activities by the Ministries responsible for their implementation. Jordan and Egypt are considering similar approaches to support trade agreements with the EU. These two countries will however not replace all of their
previous system, only for the products that will be subject of the trade agreements with the
EU. Hence, Jordan and Egypt will have hybrid technical regulation systems in place for quite
some time to come. Such a duality will bring about its own challenges in the market place,
and it is debatable whether this can be good for the country in the long run.
These changes are driven by the push from major trading partners such as the EU to transform
the older systems based on mandatory standards concepts to EU type technical regulations
with their indirect referencing. Whilst it is a laudable exercise to review the older systems,
care should be taken to establish a system that is within the capabilities of the country to
manage, and which provides for a holistic approach across all ministries and their agencies
that develop and implement technical regulations. A fragmented approach is not the most
effective way forward as it creates uncertainty in the market place, adds to the transaction
costs and ultimately renders the local industry less competitive.
46
ANNEX B: The workshop

The workshop modalities as well as feedback form the participants is summarized below.
Workshop modalities
The workshop was held at the Marriot Hotel, Amman from 16 18 August 2016 and was
attended by over 20 delegates from eight countries from the MENA region, i.e. Egypt, Iran,
Iraq, Jordan, Lebanon, Morocco, Tunisia and also Palestine. The workshop was facilitated by
Martin Kellermann and Iain Muir both from South Africa and the ISO Programme Manager,
Nesreen Al-Khammash participated as well. There was a good balance of delegates from
national standards bodies and regulators. There was also representation, albeit smaller, from
conformity assessment bodies and industry and commerce see figure below.
Steakholdergroups
Conformity
assessment
body
Standards
body
Government
orregulator
Industry&
commerce
After a formal opening of the event, the workshop took the form of formal presentations by the
facilitators and presentations from six invited countries on standardization and technical regulation in their own countries. The workshop also included three discussion groups where the
delegates were given questions based on the topic being discussed. Each group would appoint a leader and a rapporteur for the topic and afterwards would present their answers to
the other groups. The delegates enjoyed this experience and contributed well in the preparation of their presentations and in the feedback.
Throughout the workshop, language did not present any challenges. It is believed that this is
due mainly to the excellent translators who were not only very experienced linguists in Arabic,
English and French but also highly qualified technically and able to grasp, very quickly, the
concepts and terminology of the workshop.
Towards the end of the workshop, the delegates were invited to stay in touch with each other
with the objective of expanding the knowledge gained in the workshop and the practical application in their own countries. A follow up assignment was allocated to the delegates based
on the workshop topics, the delegates of each country to collectively develop a Cabinet Position Paper on the following basis:
47
Scope: The fundamental overhaul of the technical regulation regime in the country to align
it with international good practices and render it more effective and efficient.
Content: (i) Overview of current systems, (ii) best practice for the future taking country
realities into account, (iii) major implementation steps (SMART), and (iv) envisaged impact
of the re-engineering.
Length: Maximum 10 pages, 11 point Arial, 1.5-line spacing.
The responses to this assignment were due by November 2016, where after these would be
evaluated and commented by the experts as feedback to the participants.
Workshop feedback
The post workshop survey commissioned by the ISO Training Academy returned positive
comments, indicating strongly that the delegates enjoyed the workshop and found it very beneficial. Some of the specific feedback information is shown in the following figures.
I will apply what I learnt during the
workshop to my professional
activities
Please rate your overall satisfaction

with the workshop
Completel
ysatisfied
Moderately
satisfied
Sometimes
Always
Frequen
Very
satisfied
The survey also indicated a potential need for further training in a number of topics in particular regulatory impact assessment.
The end.
48

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Project to strengthen institutional

infrastructure on standards and

ISO regional workshop

National Quality Policy .............................................................................................. 7

From Public Policy to National Quality Infrastructure ............................................. 12

Part 2 - Good practices in respect of standardization and technical regulation .................... 14

Good standardization practices .............................................................................. 14

Good regulatory practices ...................................................................................... 17

Regulatory reform ................................................................................................... 18

Part 3 - Technical Regulation................................................................................................ 21

Technical regulation building blocks ....................................................................... 21

Technical regulation development and implementation ......................................... 25

Part 4 - Technical regulation and quality infrastructure interfaces ........................................ 29

Standards in technical regulation ........................................................................... 29

Metrology in technical regulation ............................................................................ 31

Accreditation in technical regulation ....................................................................... 34

Part 5 - Regulatory impact assessments and other challenges ............................................ 36

Regulatory Impact Assessment (RIA) .................................................................... 36

Cooperation between quality infrastructure and technical regulation systems ....... 39

Common challenges ............................................................................................... 41

Acronyms and abbreviations

International Bureau for Weights and Measures

Purpose of this conclusion report

Establishing and maintaining a national quality infrastructure is an expensive and long-term

Part 1 - Policy making in respect of technical regulation

1.1. National Quality Policy

Value chain for economic growth and poverty reduction

National Quality Policy Context

International policy context

Figure 2: National Quality Policy cross-cutting domain

Importance of a National Quality Policy

Figure 3: Policy Elements and Implementation Logic

Content of a National Quality Policy

1.2. From Public Policy to National Quality Infrastructure

The components of a quality infrastructure;

The quality infrastructure organizational components

Other players in a quality infrastructure

Other issues in the quality infrastructure

Part 2 - Good practices in respect of standardization and

2.1. Good standardization practices

Standards development and publication processes

Key performance indicators

Some common challenges

2.2. Good regulatory practices

Key international trends

Good regulatory practice according to the OECD

2.3. Regulatory reform

Figure 4: The stages of regulatory reform

Policy objectives of reform

Regulatory quality improvement

Building a Regulatory Management System

Invariably, overlaps and duplication developed;

Regulatory authorities, having grown accustomed to a position of absolute power in the

Part 3 - Technical Regulation

Challenges that have to be overcome to establish an effective and holistic

3.1. Technical regulation building blocks

Figure 5: Building blocks of technical regulation

or environment. Environmental concerns have to be taken into account if the product

3.2. Technical regulation development and implementation

Technical regulation development

Technical regulation implementation

Figure 6: Technical regulation development work flow

Leave market to regulate it-