Top Banner

of 73

Adopting Regulation

Feb 07, 2018

ReportDownload

Documents

  • 7/22/2019 Adopting Regulation

    1/73

    Adopting and referencing IEC International

    Standards for use in technical regulations

    Abridged course for IEC National Committees

    and Affiliate Countries

    by

    Graham Holloway

    Independent consultant

  • 7/22/2019 Adopting Regulation

    2/73

    Adopting and referencing IEC InternationalStandards, their use in regulation, and theinfluence of the WTO

    A model of a WTO-compliant regulatory system

    ISO/IEC Guide 21 rules for adopting

    International Standards Interactions with regulators

    2

  • 7/22/2019 Adopting Regulation

    3/73

    IS can be adopted By companies, consortia Nationally Regionally

    IS can be referred to In company procedures, marketing literature In other standards (national, regional, international) In technical regulations

    In some countries IS can be used directly

    In others, they may not be used unless first adopted asnational standards

    3

  • 7/22/2019 Adopting Regulation

    4/73

    Technical regulations are needed to support policies ofgovernments, regulators at all levels

    Q: How much regulation is necessary?

    Q: Shouldnt everything be regulated?

    Market system and when it breaks down

    Technical regulations are MANDATORY (Compulsory)

    Technical regulations contain technical and administrative provisions

    The technical provisions can most conveniently be provided by theuse of standards

    4

  • 7/22/2019 Adopting Regulation

    5/73

    Technical regulations are established and administered by avariety of bodies, often in the public sector

    Need is to adopt or refer to IS within a technical regulation but how?

    What about the WTO Agreements?

    Most research is done in the private sector

    Need for consensus of EXPERTS (BUT the regulator has

    the right to set regulations WITHOUT expert opinion!) Need to update regularly

    Technical regulations are legal documents, but lawyers usuallyarent technical experts!

    5

  • 7/22/2019 Adopting Regulation

    6/73

    National technical regulations, conformity assessment proceduresand standards should not constitute unnecessary barriers tointernational trade (CA includes inspection, testing, certification )

    Need for balance between Members legitimate right to regulate; and Threat posed by unnecessary TBTs

    Use IS, guides and recommendations, or relevant parts of them, asthe basis for national regulations and conformity assessmentprocedures (there are some exceptions to this )

    Play a full part, within the limits of resources, in preparing IS, guidesand recommendations

    For example by taking part in IEC Technical Committees!

    6

  • 7/22/2019 Adopting Regulation

    7/73

    Free market system The theory:

    Bad products or unsafe services (not fit for purpose, notconforming to standards) automatically rejected byknowledgeable consumers

    Market advantage for producers of good products/services No incentive to produce bad or unsafe products

    Product standards and quality systems play a role

    Competition in all markets

    Prices forced down by healthy competition Only efficient producers survive (economies of scale)

    Everybody is happy!

    7

  • 7/22/2019 Adopting Regulation

    8/73

    Free market system The reality:

    For most products or services the system works well

    Competition and price pressure can lead to lower quality inthe long run

    Question: What happens when quality comes down to levelsof fitness for purpose?

    Answer: Low cost, low quality producers gain market share,but price pressure continues

    Therefore the temptation exists for producers to start tosupply sub-standard products/services to stay in business

    Not everyone is so happy any more

    8

  • 7/22/2019 Adopting Regulation

    9/73

    In many societies, consumers are not well informed, andhave little control over what is on the market

    International Standards are part of the answer, but astandards and quality culture needs to exist

    Governments cannot be expected to predict where allquality problems will arise; market surveillance istherefore lacking

    Even if conformity assessment providers (test labs,

    certification bodies etc.) exist There is need to be laws to prevent bad (unsafe,

    poisonous, damaging ) products from being sold

    9

  • 7/22/2019 Adopting Regulation

    10/73

    When health and safety, or the environment are affected,the free market system breaks down, and the populationbecomes vocal:

    Governments therefore need to act decisively

    Put in place a technical regulation system

    10

  • 7/22/2019 Adopting Regulation

    11/73

    Yes, especially where trade with other members isaffected

    Notifications have to be made of all proposed technical

    regulations BUT: where urgent problems arise or threaten to arise:

    Safety, health, environmental protection, national security even the quality of exports:

    Certain steps may be relaxed or omitted They still have to be notified later

    There are other relaxations for developing countries

    11

  • 7/22/2019 Adopting Regulation

    12/73

    12

    A model of a technical regulatory system

    Government

    Legislation

    Regulator

    Technical

    regulations /Standards

    ConformityAssessment Sanctions

  • 7/22/2019 Adopting Regulation

    13/73

    Applies to all levels of government:

    National, provincial (state), municipal

    Covers products, services and actions

    For which compulsory provisions are needed

    Over and above the free market system

    Private contracts are not regulations

    National government is the supreme regulator in itsterritory

    Although it has to respect its commitments underinternational agreements

    13

  • 7/22/2019 Adopting Regulation

    14/73

    14

    A model of a technical regulatory system

    Government

    Legislation

    Regulator

    Technical

    regulations /Standards

    ConformityAssessment Sanctions

  • 7/22/2019 Adopting Regulation

    15/73

    Must be established by law

    Must be a legal persona juristic person in the country

    Powers must be made known (and their limitations)

    Should not have conflicts of interest with standards orconformity assessment bodies

    Implications for governance structure

    15

  • 7/22/2019 Adopting Regulation

    16/73

    16

    A model of a technical regulatory system

    Government

    Legislation

    Regulator

    Technical

    regulations /Standards

    ConformityAssessment Sanctions

  • 7/22/2019 Adopting Regulation

    17/73

    Regulator sets the regulations

    Public enquiry

    Impact assessment

    Backed by government

    Need to include

    Specific purpose, scope, who is affected

    Technical provisions that are to be complied with Administrative provisions: Rules for provision of samples,

    conformity assessment, costs, sanctions

    17

  • 7/22/2019 Adopting Regulation

    18/73

    WTO recommends

    The use of relevant International Standardsas a basis for their technical regulations,except

    when such International Standardswould be ineffective or inappropriate

    for instance because of fundamental

    climatic or geographical factors orfundamental technological problems

    18

  • 7/22/2019 Adopting Regulation

    19/73

    19

    A model of a technical regulatory system

    Government

    Legislation

    Regulator

    Technical

    regulations /Standards

    ConformityAssessment Sanctions

  • 7/22/2019 Adopting Regulation

    20/73

    Conformity assessment is a mechanism that can be usedto assess compliance with standards

    Conformity assessment is a separate subject in itself,and its application differs from sector to sector

    In electrotechnology, IEC has responded to industryneeds via 3 Conformity Assessment Systems

    For further information on IEC Conformity Assessment,contact the IEC Central Office, or visithttp://www.iec.ch/conformity

    20

  • 7/22/2019 Adopting Regulation

    21/73

    IECEESystem of Conformity

    Assessment Schemes for

    Electrotechnical Equipment

    and Components

    IECExSystem for Certifi cation to

    Standards Relating to

    Equipment for use in

    Explosive Atmospheres

    IECQQuality Assessment System

    for Electronic Components

    CAB - Conformity Assessment Board

    CB-FCS

    Scheme

    CB Scheme

    PV Programme

    E3 Energy

    Efficiency

    Hazardous

    Substances

    Ex Equipment

    Ex Services

    Ex Personnel

    Active &Passive

    components

    ProcessesHSPM

    Avionics

    21

  • 7/22/2019 Adopting Regulation

    22/73

    Obligations of WTO members:

    Use a standards and regulatory development processthat is open, transparent, and includes participants from

    all interested parties Have a conformity assessment system that upholds the

    principles of most-favoured nation treatment andnational treatment

    Publish proposed technical regulations and conformityassessment procedures

    22

  • 7/22/2019 Adopting Regulation

    23/73

    Based on International Standards, e.g. ISO/IEC 17025,Guide 65 (soon to be ISO/IEC 17065, ISO/IEC 17020,etc.)

    Use accredited service providers and IEC CA Systems

    Mutual Recognition Agreements and MultilateralAgre

Welcome message from author
This document is posted to help you gain knowledge. Please leave a comment to let me know what you think about it! Share it to your friends and learn new things together.