Using and Referencing
IEC and ISO to support
Public Policy
The following materials are extracted from the paper
Developed by IEC and ISO.
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Who are IEC and ISO ?
They are both independent, non-government, not-forprofit Organizations.
They Develop & Publish fully conseus-based
International Standards.
IEC was founded in 1906.
ISO was founded in 1947.
IEC and ISO
Their Members
Government
Public and
Private
Entities
But it is country membership only not like IEEE.
For each organization in IEC & ISO, every country has one vote and a say into what goes into
IEC or ISO Standards.
Ambition of IEC & ISO
They promote World Trade and Economic Growth and encourage the development of
Products,
Systems and services that are safe, efficient & environmentally friendly.
Introduction
✘ What is an IEC & ISO International standards?
They represents Global Consensus on a solution to a particular Issue.
 They provide requirements, specifications, guidelines or
characteristics that can be used consistently to ensure that
materials, products, processes and services are safe to use and fit
for their purpose.
In other words, follow the standards, so your work will be internationally recognized !!
Remember they are voluntary !
Introduction
✘ What makes IEC & ISO International standards
useful for Public Policymakers?
IEC & ISO
Share Similar Objectives with
Public
Policy
• Enhancing Econmic Competitiveness &
Efficiency
• Facilitating International Trade
Introduction
✘ Why useful for Public Policy ?
Say you are developing a Product and export to foreign country
You need to
meet certain
Standards to
export your
products to
foreign
countries !!
Introduction
✘ Why useful for Public Policy ?
They act as powerful instruments of governance ! You can
follow IEC & ISO audit procedure to know if you are doing
right.
Private Sector
Follow Internationally Accepted Practices
Foster Technological Innovation through Standards
Public Sector
Greater Transparency
Competition in public Procurement
The country legislation makes reference to IEC/ISO Standards to put complex technical Contents
Out of The LAW book.
Introduction
✘ Why useful for Public Policy ?
Parallels between good policy-making practice and good
standardization practice
So, you can assure that your government follow Good Regulatory Practise
and Good Public Governance
Because the Standards/Practises are from Industrial Expert Opinions
It includes 1. Openness
2. Transparency
3. Effectiveness
4. Global Relevance
5. Consenus
Introduction
✘ Advantages & Benefits
1. IEC & ISO standards Development Process
They are democartic – Everyone has a say !
Multi-stakeholder
Environment
Social
Interests
Public
&
Private
National & International Level
Introduction
✘ Advantages & Benefits
2. IEC & ISO ensures Reliability & Foster Trust
These brands mean quality, confidence, reliability, trust
and safety.
Of course, it has to be genuine, went through proper audits !!
In doubt, you can request their copy of certificate.
Internationally Recognized.
Provides access to all relavant Parties- discussion and influence
outcomes.
The standards are evovling along with the state-of-the-art
technology
Introduction
✘ Advantages & Benefits
3. Global Participation & Applicability
As you know their members are made up of countries all over the world,
covering around 97% of the world’s Population.
- Encourage developing countries working with them
- Increase awareness of benefits of International Standards
- Many countries and companies around the globe choose to
recognize, accept, implement IEC & ISO standards.
Well, almost every companies nowadays are ISO certified, right ?? So,
imagine how important it is to get one !
Introduction
✘ Advantages & Benefits
4. Additional Benefits of Using IEC & ISO International Standards
Personally, it is most important – “Same level of Consumer
Protection” -whether it is in a Mature or an Evolving Countries.
Allow products to be supplied & used across different markets
-facilitate Regulatory Compliance
Reflect global agreed best practice and new technologies
Used for comformity assessment to enhance confidence in products,
Systems, Process, Services or Personnel
World Trade and International Standards
IEC & ISO international standards facilitate Trade !
World Trade Organization (WTO) is the inter-governmental organization
Agreement on Technical Barrier to Trade (TBT) exists to ensure national
regulations do not slow down international trade.
Here, international standards harmonize cross-countries regulations.
 WTO members use International Standards, guides & recommendations
 They play a part in preparation of International Standards in
standardization bodies
World Trade and International Standards
IEC & ISO international standards facilitate Trade !
WTO members in the TBT committee agreed on Six Core
Principles
1) Transpancey
2) Openness
3) Impartiality and Consensus
4) Effectivness and Relevance
5) Coherence
6) Addressing the concern of developing countries
How can IEC and ISO International
Standards be used to Support Public
Policy?
First of all, what is public policy ??
In this report by IEC & ISO, it is defined as any actions taken by
government to address public issues.
These actions are based on a system of values and norms and can be
Legislative or Non-legislative. IEC and ISO International Standards can be
used to support either kind of action.
Legislative Actions & Non-Legislative Actions
Legislative Actions
Non-Legislative Actions
Laws (or Acts of Parliament)
Funding priorities
Technical regulations (which
Incentive Systems
support the requirements of laws)
eg. Relating to the public
responsibilities such as safety,
security, health, social protection
or the environment.
Other actions include rules,
notices, orders, determinations
and warrants.
Awareness Campaigns
Public Procurement
Codes of Conduct
International Standards in Policy Making
IEC and ISO International Standards
can also support government policy
actions beyond legislation.
 Government Procurement
System can be regulated by
International Standards so that
main contractors align with
government requirements.
International Standards in Policy Making
Here are few examples of government adopting International Standards
 UN-Energy, UNECA access to IEC Technical Specification 62257
series, 62257-9-5. (Sustainable Energy Standards)
 Canadian Government offers assistance for Industries to adopt
CAN/CSA ISO 50001 Energy Management Systems Standard.
 Japanese government “Basic Policy for the promotion of Procurement of
Eco-friendly Goods & Services)- Adopting IEC/ISO into 72 JIS national
standards.
 Australasian Procurement and Construction Council (APCC) practices
ISO9001, Quality Management; ISO31000 Risk Management;
ISO26000, Social Responsibility; ISO14000, Environmental
management and more…
Methods of Using and referencing IEC/ISO
International Standards to support Regulations
General Considerations
Should the use of IEC/ISO International Standards be mandatory (Providing the
only solution) or voluntary
(Providing one possible solution) ?
What level of checks should be put in place to ensure the standard is suitable for
use & address the needs ?
Will the reference be to the whole standard or selected parts of it (ie. Only to
certain clauses or sub-clauses) ?
How will the regulation will be kept up-to-date if the IEC/ISO International
Standards are revised?
Methods of Using and referencing IEC/ISO
International Standards to support Regulations
Direct References to Specific Standards in legal Text
Direct Referencing
Specific Standard with its Identification
number & Title
(This method often supports mandatory use of a Standard.)
By direct referencing, regulators avoid reproduction of standards in Legal
Text.
Certain parts or even single clauses of standard can be referenced.
Direct Referencing
Direct Dated References
Direct Undated References
Direct Referencing
Direct Dated Referencing :
When the number and title of a standard is referenced and used
With its DATE of referencing.
Example :
▸▸ The information security management system shall conform to ISO/IEC XXXX : 2013, TITLE.
▸▸ The information security management system shall conform to ISO/IEC XXXX : 2013 (as amended),
TITLE.
Direct Undated Referencing:
The regulation quotes only the number and title of a specific standard and not the DATE.
Example :
▸▸ The information security management system shall conform to the latest edition of ISO/IEC XXXX, TITLE.
“Latest Edition >>> authorities to respond easily and quickly to technical changes.”
Indirect Referencing
Recognizing & Registering Standards on an official information source
external to the Regulatory Text.
Revision/Amended of Standard
No change to Legal Text.
Only to the List of Standards.
Such List should be made availabe to public through a website.
Example :
▸▸ Where the product complies with the relevant IEC or ISO
International Standard whose reference number has been published in
[refer to relevant official listing here], the relevant authorities shall
presume compliance with the requirements of this law.
Other Considerations
1. Ensuring no delegation of legislative responsibility
Using IEC/ISO International standards for technical regulation does not
Imply that regulators delegate responsibility to other parties.
Simply, regulators make use of existing consensus at International Level.
“Your LAW – Your Responsibility, only Reference to IEC/ISO for technical
things.”
2. Maintenance Procedures
IEC/ISO regularly revised and update their Standards/Procedures.
Public Policy Makers should be kept informed of such changes, by
Participating in relevant committee or making arrangements with the
Relevant IEC/ISO national member.
“Stay Up-to-Date”
Other Considerations
3. Conformity Assessment
It is the mean of determining whether products, services, processes, systems
And persons, meet specified requirements.
Public Policy Makers/Regulators may require that CA procedures are carried
Out by supplier, purchaser, or by an independent conformity assessment
bodies.
They have to specify which of these parties will carry out what Assessment
Activities – to protect/maintain quality standards.
“CA involves certification, inspection/testing of a product system or person.”
Other Considerations
3. Conformity Assessment (This is my job!)
First-Party Conformity Assessment
-Self Declaration by manufactueres, supported by test results from its own
laboratory or from an external laboratory that tests for manufactueres
Second-Party Conformity Assessment
-Organization/Person, eg. Procurement body, witness testing or performs
other verificaiton to standards directly, either on prototype or through
market surveillance.
Third-Party Conformity Assessment (I work for UL- Third part Certification!)
-When a independent CA body certifies, inspects and/or tests
products/systems
To the standards. The results are propriety to the CA Body and supplier.
Other Considerations
4. Market Surveillance
It is a key component of safety & quality infrastructure of a country.
IEC/ISO fascilitate market surveillance by providing a common, wellknown set of requirements.
Pre-Market
Assessment
Approval Systems
Post-Market
Assessment
“In UL, we do market surveillance by sampling @ factories, perform
verification tests, factory inspection, test on the shelf products.”
Governements regularly inspects and test the products in the market by
Referencing to ISO A guide to good practise in Market Surveillance.
Accessiblity of IEC/ISO International Standards
Transparency – a key principle of both good policy making and good
Standardization practice.
Regulations and Legislation – references to the standards.
“Standards should be easily accessible”
 It doesn’t mean they are available for free.
 IEC/ISO assert and maintain copyright in their International Standards at all
times.
The sale of standards is in the way that they are financed fairly and benefits the
users who pay to use it.
They are not-profit-organization but they need to cover operation cost.
Costs of Developing Standards
1.
Cost in time, travel, other expenses of thousands of experts working in
technical committee, some are paid by employers and some paid themselves.
2. Cost of running the secretariats of the technical committees, hosting meetings,
gathering views from national stakeholders, conducting national enquiries and
the distributing published standards
3.The cost incurred by IEC Central Office and ISO Central Secretariat to
maintain infrastructure of programme management, document distribution, and
tools for management, voting and collaborative working, supplying information,
providing procedure to their committee experts and national members.
National Policies on the use of Standards to
support Public Policy
Major economies of the world have developed policies to actively encourage
their use.
• Based on suitability, IEC/ISO standards may be used or reference directly in
regulations and other kinds of policy documents.
✘ Adoption- with minor amendments, addition appendix
National Stake holders will judge to suit needs and fit for country.
National Policies on the use of Standards to
support Public Policy
National & Regional Adoptions
-IEC/ISO can be formally adopted as national standards
It goes through separate consultation process at national or regional level.
Example :
IEC 60601-1, Medical electrical equipment, is :
▸▸ adopted as EN 60601-1 in Europe
▸▸ adopted as KS C IEC 60601-1 in the Republic of Korea
▸▸ adopted as ГОСТ МЭК 60601-1 in Russia
▸▸ adopted as ANSI/AAMI 60601-1 in the U.S.A.
ISO 14971, Medical devices — Application of risk management to medical
devices, is :
▸▸ adopted as ANSI/AAMI/ISO 14971 in the U.S.A.
▸▸ adopted as EN ISO 14971 in Europe
▸▸ adopted as JIS T 14971 in Japan
National Policies on the use of Standards to
support Public Policy
Brazil
Previously, government impose changes of behavior on private sector via compulsory measures.
The private sectors now playing a role in Regulatory Government – the standardization processes &
Conformity Assessment conducted by private sector are now acknowledge by Public Authorities.
Regulation
Instrucao Normativa DC/ANVISA no 3 de 21/06/2011 – Establishes
the list of technical standards whose requirements must be met for
certification of compliance within the Brazilian System of Conformity
Assessment (SBAC), equipment system under Health Surveillance,
under Resolution DC/ANVISA No. 27 of 2011.
National Policies on the use of Standards to
support Public Policy
Canada
Cabinet Directive on Regulatory Management are responsible for assessing the effectiveness and
appropriateness of regulatory/non-regulatory instruments for achieving public policy objectives.
They have to make use of all or parts of International Standards as a basics for policy objectives.
IEC and ISO International Standards may be referenced in
Canadian regulations without first being nationally adopted.
For example :
Regulation
Organic Products Regulations, 2009 (SOR/2009-176) (Canadian Food Inspection Agency)
National Policies on the use of Standards to
support Public Policy
China
One of the main forms of technical regulation in China is via the use of mandatory standards.
The Standardization Law of PRC states that certain standards categories such as pharmaceuticals,
occupational health & safety, transportation, environmental protection and engineering construction
can be mandatory standards depending on the risk that the product or activity poses.
Regulation
Safety Production Law of the People’s Republic of China
The Order of the State administration of work safety of the People’s
Republic of China Implementation methods for safety production
license for fireworks and firecracker production enterprises
National Policies on the use of Standards to
support Public Policy
Europe (the European Union)
European standardization is an integral part of European Union Single Market.
• Increase the competitiveness of enterprises and
• To remove barriers to trade at the international level.
Primary use of standards is a part of co-regulatory model known as “New Approach” to technical
harmonization since 1980s.
This has been updated and refined in “New Legislative Framework from 2008”
“Develop and Adopt European standards” = Harmonized Standards
National Policies on the use of Standards to
support Public Policy
Europe (the European Union)
The policies of the ESO (European Standardization Organizations) are to use international
standards (such as IEC, ISO and ITU standards) wherever they exist and are suitable.
 More than 70% of CENELEC’s harmonized standards are identical to or based on IEC
standards
 32% of CEN’s are identical to ISO standards.
CEN: the European Committee for Standardization
CENELEC: the European Committee for Electro technical Standardization
ETSI: the European Telecommunications Standards Institute
Regulation
Directive 2009/48/EC, Safety of Toys (Note : this is an example of a European ‘New Approach Directive’
that meets the requirements of the New Legislative Framework.)
Access to EU market ??
Your products have to be evaluated & certified based on these Standards !
National Policies on the use of Standards to
support Public Policy
Japan
The Japanese government encourages the use of voluntary Japanese Industrial Standards
(JIS) as references when technical standards are needed to support policy goals.
Many IEC/ISO standards are adopted nationally as JIS standards.
They may also be referenced directly as IEC and ISO standards.
• Over 10,000 JIS standards, 5,700 have corresponding International Standards where 5,600 are
harmonized with corresponding International Standards.
Regulation
Electrical Appliance and Material Safety Law – Technical requirements pursuant to the provisions of the
Ministerial Ordinance Specifying Technical Requirements for Electrical Appliances and Materials.
National Policies on the use of Standards to
support Public Policy
Mexico
The federal Law on Metrology and Standardization is the cornerstone, providing guidelines for the
development of Mexican Mandatory Standards (NOM), Mexican Standards & (NMX) and
Referenced Standards (NRF).
In several cases, NOMs are identical or based on international standards, for example
NOM-001-SEDE-2012, Electrical Installations (Utilization)
This NOM is equivalent to part 1 of the International Standard IEC 60364, Electrical Installations of
Buildings, Part 1 : Scope, Objectand Fundamental principles, regarding safety fundamentals.
Approximately 30 Mexican Standards for electric products are adoptions of IEC standards.
National Policies on the use of Standards to
support Public Policy
South Africa
The standard development is carried out by South African Bureau of Standards (SABS) the official
National Standards Body (NSB), which is authorized to do so in terms of the Standards Act.
IEC/ISO standards must be nationally adopted before being referenced.
Normally, legislator will consult the SABS regarding the application of the Standards. The regulation
is then published by the applicable government department.
Regulation
Water Services Act 108 of 1997 – Regulations under sections 9(1) and 73(1)(j) – Regulation
8 “ Use of effluent ”, sub regulation 8 (3)
National Policies on the use of Standards to
support Public Policy
United States
The United States considers standards to be fundamental factor in the nations’ economy and vital to
the world commerce.
American National Standards Institutes (ANSI) is responsible for the coordination of the private
sector standards system.
ANSI holds the Secretariat of the U.S member body in IEC and is the U.S member body within ISO.
Federal Policy regarding the use of Standards and conformity assessments is contained in certain key
provisions of National Technology Transfer and Advancement Act (NTTA).
National Policies on the use of Standards to
support Public Policy
United States
 Office of Management & Budget (OMB) manages the activities of NTAA requirement
- All Federal agencies & departments shall use technical standards developed or adopted by
voluntary consensus standards bodies.
- Federal agencies & departments shall consult with voluntary, private sector, consensus standards
bodies, and shall participate with such bodies in the development of technical standards.
“The full catalogues of IEC and ISO International Standards have the potential to be used or referenced in
regulation by U.S. federal government agencies, if deemed appropriate”
Regulation
46 CFR 111.105-11 Title 46 — Shipping Chapter I — Coast Guard, Department Of Homeland Security –
Part 111_Electric Systems — General Requirements, Subpart 111.105_Hazardous Locations,
Sec.111.105-11 Intrinsically safe systems. Sec. 111.105-11 Intrinsically safe systems
10 CFR 73.26, Nuclear Regulatory Commission – Part 73 : Physical Protection of Plants And Materials –
Sec. 73.26, Transportation of physical protection systems, subsystems components, and procedures.
Examples of IEC/ISO International standards
Sectors
Applicable
Air Transport
IEC
Electric Motor
IEC
Energy Management
ISO
Environment Management- Climate Change
ISO
Food Products
ISO
Laboratory Medicine
ISO
Medical Devices
IEC/ISO
Medium Power Transformers
IEC
Product Safety
IEC
Radio Services
IEC/ISO
Railway
IEC/ISO
Road Vehicles
IEC/ISO
Ships & Marine Technology
IEC/ISO
Standby Power , Television
IEC
Transport of Dangerous Goods
ISO
Conclusion
 Policy makers can make use of IEC & ISO International Standards in a variety ways and with
numerous benefits.
 It eliminates the technical barriers for international trading.
 They are widely recognized across the world.
 They offer the same benefits whether it is applied in developed or developing world.
“I hope we can see that ISO/IEC are helping consumers in a way that we get protected by
Internationally accepted Business Practices and Safety of products/systems” and “how policy
makers take consideration of IEC/ISO International Standards in the Regulation Context”.
Have a Nice Day !
KYAW SOE HEIN