Using and Referencing IEC and ISO to support

Public PolicyThe following materials are extracted from the paperDeveloped by IEC and ISO.

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Hi All,

Who are IEC and ISO ?

They are both independent, non-government, not-for-profit Organizations.

They Develop & Publish fully conseus-based International Standards.

IEC was founded in 1906.ISO was founded in 1947.

IEC and ISO

Government Public and

Private Entities

Their Members

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 intoIEC or ISO Standards.

Ambition of IEC & ISOThey 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?

Share Similar Objectives with

• Enhancing Econmic Competitiveness & Efficiency

• Facilitating International Trade

IEC & ISOPublic Policy

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 PracticesFoster Technological Innovation through Standards

Public Sector Greater TransparencyCompetition 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 ?

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

Parallels between good policy-making practice and good standardization practice

Introduction ✘ Advantages & Benefits1. IEC & ISO standards Development Process

They are democartic – Everyone has a say !

Multi-stakeholder

Environment

Tech

nical

Views

Remarks from

Market Players

Social Interests

Economic Interests

Public &

Private

National & International Level

Introduction ✘ Advantages & Benefits2. IEC & ISO ensures Reliability & Foster Trust

Internationally Recognized.Provides access to all relavant Parties- discussion and influence outcomes.The standards are evovling along with the state-of-the-art technology

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.

Introduction ✘ Advantages & Benefits3. Global Participation & ApplicabilityAs 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 & Benefits4. 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 Consensus4) Effectivness and Relevance5) Coherence6) 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 support the requirements of laws) eg. Relating to the public responsibilities such as safety, security, health, social protection or the environment.

Incentive Systems

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 ConsiderationsShould 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 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 References to Specific Standards in legal Text

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 responsibilityUsing 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 ProceduresIEC/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 carriedOut 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, well-known set of requirements.

“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.

Pre-Market Assessment

Approval SystemsPost-Market Assessment

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 standardsIt 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

BrazilPreviously, 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.

RegulationInstrucao Normativa DC/ANVISA no 3 de 21/06/2011 – Establishesthe list of technical standards whose requirements must be met forcertification of compliance within the Brazilian System of ConformityAssessment (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

CanadaCabinet 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 inCanadian regulations without first being nationally adopted.For example :RegulationOrganic Products Regulations, 2009 (SOR/2009-176) (Canadian Food Inspection Agency)

National Policies on the use of Standards to support Public Policy

ChinaOne 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.

RegulationSafety Production Law of the People’s Republic of ChinaThe Order of the State administration of work safety of the People’sRepublic of China Implementation methods for safety productionlicense 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 StandardizationCENELEC: the European Committee for Electro technical StandardizationETSI: the European Telecommunications Standards Institute RegulationDirective 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

JapanThe 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.

RegulationElectrical 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

MexicoThe 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 AfricaThe 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.

RegulationWater 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 StatesThe 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 PolicyUnited 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”

Regulation46 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