NATIONAL AND INTERNATIONAL STANDARDIZATION

1
NATIONAL AND INTERNATIONAL STANDARDIZATION
By SALEHA A. JALIL UNIDO-WAITRO WORKSHOP ON
SIGNIFICANCE OF TESTING AND CONFORMITY ASSESSMENT
IN GLOBAL TRADE - CHALLENGES FOR RESEARCH
TECHNOLOGY ORGANISATIONS (RTOs) 18 - 22 APRIL
2005 SIRIM Berhad, Shah Alam, MALAYSIA
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LEVELS OF STANDARDIZATION
Level Approval International
Standards International Standards bodies
e.g. ISO, IEC, CAC, ITU, IMO Regional Standards
Regional Standards bodies e.g. CEN,
CENELEC National Standards National Standards
bodies e.g. DSM, TISI, ANSI, BSI,
JISC Other Standards Internationally used
standards published by voluntary/government
organizations e.g. ASTM, Internet Society,
API, US
Pharmacopoeia Organization Standards
Individual company or organization with
standards
3
z
Level
International
Regional
Agriculture
Engineering
Commerce
Chemicals
Transport
Education
Forestry
Building
Textiles
Science
National
Food
Company
x
Subject
Terminology
Classification
Aspect
Methods of testing and analysis
Specifications
Code of practice
y
Diagrammatic representation of standardization
space
Standards, Technical Regulations and SPS Measures
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BRIEF HISTORY OF STANDARDIZATION - MALAYSIA-1
1966 Establishment of the Standards Institute of
Malaysia (SIM) 1969 SIM became member in
ISO 1970 SIM managed the Codex Alimentarius
Contact Point for Malaysia 1970s Malaysia - P
member in ISO/TC 34, 45, 104 , 122 1975 Establish
ment of SIRIM (Standards and Industrial Research
Institute of Malaysia) - Merger of SIM and the
National Institute of Science and Industrial
Research (NISIR) 1975 Malaysia hosted the 23rd
Meeting of ISO/TC 45 1975 - Gradual increase in
use of Malaysian Standards for government
procurement, 1990 certification and
regulation. Continued use of foreign, especially
British Standards 1983 Malaysia
- Convenor for ISO/TC 45/SC 3/WG 4 (Natural
Rubber) 1989 Malaysia - Convenor for ISO/TC
45/SC 4/WG 5 (Gloves) Malaysia hosted the 37th
Meeting of ISO/TC 45
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BRIEF HISTORY OF STANDARDIZATION - MALAYSIA-2
1990 Malaysia in ISO Council for 1991 -
1992 National IEC was formed and Malaysia become
IEC member 1991 Malaysia assumes responsibility
for Secretariat of ISO/TC 45/SC 4 1995 Malaysia
assumes responsibility for Secretariat of ISO/TC
45 1996 Re-elected as ISO Council for 1995 -
1996 SIRIM become the government fully-own
company 1997 Establishment of the Department of
Standards Malaysia (DSM) as National
Standards Body (NSB) and appointment of SIRIM
Berhad as the sole National Standards
Development Agency DSM become the NSB for
Malaysia Ministry of Health manages the Codex
Contact Point 2000 Malaysia elected as a member
in ISO Council and TMB Malaysia participated in
ISO e-ballot pilot programme Malaysia become P
member in IEC/TC 61 and SC C, SC D 2003 Malaysia
in ISO/TMB until 2005 2003 Malaysia assumes
responsibility for Secretariat of ISO/TC
157 2004 Malaysia assumes responsibility for
Secretariat of ISO/TC 45/SC 1
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RELATIONSHIP BETWEEN NATIONAL STANDARDS AND
INTERNATIONAL STANDARDS

• National standards
• designed to serve local needs and reflect
  local
• economic and social factors
• - are established through agreement at national
  level.
• International standards
• designed to serve international trade of goods
  and
• services
• - are established through agreement at
  international
• level.
• DUE TO GLOBALISATION ALL TRADING NATIONS ARE
  INCREASINGLY HARMONISING THEIR STANDARDS AND
  MALAYSIA IS NO EXCEPTION

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NATIONAL STANDARDIZATION
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MALAYSIAN STANDARD
Malaysian standard is a consensus document
developed by Standards Development Committees
within the Malaysian Standards Development System
and approved by the Minister of Science,
Technology and Innovation in accordance with the
Standards of Malaysia Act 1996 (Act 549)
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MALAYSIAN STANDARDS DEVELOPMENT STRUCTURE
Minister, Ministry of Science, Technology and
Innovation
Malaysian Standards and Accreditation Council
Director-General, Department of Standards
Malaysia (DSM)
DSM (NSB)
National Standards Committee
National Accreditation Committee
National IEC Committee
--------------------------------------------------
--------------------
Industry Standards Committees (ISCs)
Standards-Writing Organizations (SWOs)
ISC A TC/WG ISC B TC/WG ISC C
TC/WG ISC D TC/WG ISC E TC/WG ISC F
TC/WG ISC G TC/WG ISC H TC/WG ISC I
TC/WG ISC J TC/WG
ISC K TC/WG ISC L TC/WG ISC M
TC/WG ISC N TC/WG ISC P TC/WG ISC Q
TC/WG ISC R TC/WG ISC W TC/WG ISC Y
TC/WG ISC Z TC/WG
MPMA C CA MRB CIDB MPOB MCMA MTIB TEEAM
SSD FMM-MIGMA IFEM MWPA DOSH IEM DID
SIRIM Berhad (National Standards Development
Agency)
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INDUSTRY STANDARDS COMMITTEES (ISCs)

• ISC A Food and Agriculture
• ISC B Chemicals and Materials
• ISC C Consumer Products, Personal Safety and
  Services
• ISC D Building and Civil Engineering
• ISC E Electro-technical Engineering
• ISC F Mechanical Engineering
• ISC G IT, Telecommunications and Multimedia
• ISC H Petroleum and Gas
• ISC I Halal Standards
• ISC J Plastics and Plastics Products
• ISC K Packaging and Distribution
• ISC L Road Vehicles
• ISC M Fire Safety and Prevention
• ISC N Rubber and Rubber Products
• ISC P Iron and Steel
• ISC R Medical Equipment and Devices
• ISC Q Textiles and Apparels
• ISC W Occupational Health and Safety
• ISC Y Quality Management and Quality Assurance

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STANDARDS-WRITING ORGANIZATIONS (SWOs)

• SWOs
• Selected Malaysian organizations appointed to
• undertake standards development in specific
  sectors
• OBJECTIVES
• To broaden the base of the national system
• To accelerate production of Malaysian Standards
• CURRENT STSTUS
• 15 appointed SWOs. These SWOs programme are
• coordinated by the ISCs and SIRIM Berhad

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STANDARDS-WRITING ORGANIZATIONS (SWOs)
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SIRIM BERHAD and DSM RELATIONSHIP

• DSM - Department of Standards Malaysia is the
  National
• Standards Accreditation Body Standards of
  Malaysia Act,1996
• (Act 549).
• SIRIM Berhad is appointed as the sole National
  Standards
• Development Agency by agreement and under
  provisions of the
• Standards of Malaysia Act, 1996 with the tasks
  of
• managing the standards development
  infrastructure
• managing Malaysian representation in regional and
  international standards bodies
• organizing standards promotional programmes and
  international standards meetings and
• publishing, printing, selling and distributing
  Malaysian Standards.

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SIRIM Berhad - NATIONAL STANDARDS DEVELOPMENT
AGENCY - THE INFRASTRUCTURE BEING MANAGED
Industry Standards Committees (ISCs)
20 Technical Committees/Working Groups (WGs)
250 Current standards projects undertaken
600 Standards-Writing Organizations (SWOs)
15 Committees members involved
2,500
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REFERENCE DOCUMENTS FOR PRINCIPLES AND CONCEPTS
IN MALAYSIAN STANDARDS DEVELOPMENT
ISO/IEC Guide 2 Standardisation and
related activities - General vocabulary ISO/I
EC Guide 59 1994 - Code of Good
Practice for Standardization and WTO
Agreement on Technical Barriers To Trade -
Annex 3 - Code of good practice for the
preparation, adoption and application of
standards
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ISO/IEC GUIDE 2

• Contains essential definitions such as
• Harmonised standards
• Consensus
• Interchangeability
• Normative document
• Provision
• Recommendation
• Ammendment
• Revision
• Dated/Undated reference (to standards)

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PATICIPATION IN STANDARDS DEVELOPMENT

• Guide 59 - Clause 6
• Accessible to all interested parties
• Balanced representation
• Participation at international level
• (Also in TBT agreement Clause G)

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Participation in Standards Development Process
is accessible to all interested parties through
representation at
gt Industry Standards Committees (ISCs) gt
Technical Committees (TCs) gt Working Groups
(WGs) and gt Public comment process. Interested
party may initiate new work proposals for
standardization or comment on existing standards
or draft standards.
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REPRESENTATIONS FROM
Institutions of Higher Learning
Government Agencies
Industries
Professional Bodies
REPRESENTATIONS
Consumer Associations
Trade and Manufacturer Associations
Research Organizations
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CODE OF GOOD PRACTICE FOR THE PREPARATION,
ADOPTION AND APPLICATION OF STANDARDS (1)
The standardizing body shall
accord same treatment to national and foreign
products
ensure standards are not prepared to create
unnecessary obstacles to international trade
participate in the development of international
standards
Standards, Technical Regulations and SPS Measures
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CODE OF GOOD PRACTICE FOR THE PREPARATION,
ADOPTION AND APPLICATION OF STANDARDS (2)
The standardizing body shall
publish a work programme once every 6 months
allow a period of 60 days for comments
take into account the comments received.
Standards, Technical Regulations and SPS Measures
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TRANSPARENCY
CGP O. Once the standard has been adopted, it
shall be promtly published. Other requirements
for work programme publication, making drafts
available for public comment. G 59- Clauses 4.2,
4.4, 4.7. include provisions for appeals and
response to external requests for new or revised
standards (Clause 4.6).
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CONSENSUS
CGP H .. (The standardising body) shall make
every effort to achieve national consensus on the
standards they develop. CGP N .. shall take into
account, in further processing, comments received.
Consensus assures balance of interests is
maintained and standards serve commonlly agreed
objectives equitably
Details also in G 59 - Clauses 4.1, 4.5
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PERFORMANCE-BASED STANDARDS
CGP I. Wherever appropriate, the standardising
body shall specify standards based on product
requirements based on performance rather than
design or descriptive characteristics.
Why? Standards should not restrict trade or
innovation but serve needs
Details in G 59- Clauses 5.1 to 5.9
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NATIONAL OBLIGATIONS TOWARDS INTERNATIONAL
STANDARDIZATION
1. As a signatory to the World Trade Organization
(WTO) Agreement on Technical Barriers to Trade
(TBT), Malaysia is obliged to use international
standards, or the relevant parts of them, as a
basis for the standards it develops, except where
such international standards or relevant parts
would be ineffective or inappropriate. 2. Malays
ia, has a relatively well developed
standardization infrastructure and is well placed
to benefit from increased participation and has
the ability to influence standards development at
international level for economic
interests. 3. Trade liberalization at regional
(ASEAN, APEC) and international level (WTO) has
directly made it necessary to increase focus on
participation and alignment to International
Standards.
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ALIGNMENT WITH INTERNATIONAL STANDARDS
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• SIGNIFICANT DEVELOPMENTS IN INTERNATIONAL
  STANDARDIZATION AND VOLUNTARY STANDARDS (1)
• Many nations are placing increased focus on
• international standards and allocating a
• greater part of their budget to
• international standards than national
• standards.
• International Standards are increasingly adopted
  at regional (e.g. in the EU) and national level.

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SIGNIFICANT DEVELOPMENTS IN INTERNATIONAL
STANDARDIZATION AND VOLUNTARY STANDARDS (2)
International Standards are implemented at
operating level by manufacturers, traders,
purchasers, regulators and other parties is
increasing. International Standards are
explicitly acknowledged in the Agreement on
Technical Barriers to Trade of the World Trade
Organization (WTO/TBT Agreement a key basis for
trade and obligation for signatories to utilize).
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• SIGNIFICANT DEVELOPMENTS IN INTERNATIONAL
  STANDARDIZATION AND VOLUNTARY STANDARDS (3)
• These International Standards usually reflect the
  current state of art and agreed needs and
  requirements.

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ADOPTION OF INTERNATIONAL STANDARDS

• To adopt a common understanding of how to align
  national standards with international standards,
  Malaysia has adopted ISO/IEC Guide 21 1999 -
  Adoption of International Standards as Regional
  or National Standards.

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ALIGNMENT OF MALAYSIAN STANDARDS TO
INTERNATIONAL STANDARDS

• In 1996 (26 of MS aligned to International
  Standards)
• In 2004 (49 MS aligned to International
  Standards)

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REVIEW OF MALAYSIAN STANDARDS (1)

• Standards be reviewed on a periodic basis
  (ISO/IEC Guide 59 - Code of good practice for
  standardization).
• Malaysian Standards be reviewed after every 5
  years or earlier.
• Review may be initiated based on request by
  interested parties.

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REVIEW OF MALAYSIAN STANDARDS (2)

• Review will result in either
• Confirm or endorse the standard as current if
  there are no amendments or changes to it
• Make technical and/or editorial amendment/
  technical corrigendum to the standard

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REVIEW OF MALAYSIAN STANDARDS (3)

• Revise the standard or
• Withdraw the standard.

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INTERNATIONAL STANDARDIZATION
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MAJOR INTERNATIONAL ORGANIZATIONS (1)
International Organization for Standardization
(ISO) Established in 1947 and is a worldwide
federation of National Standards Bodies from some
146 countries. Dealing with most fields,
products and systems not falling within IEC
domain or the telecommunications domain served
by the International Telecommunication Union
(ITU). Published 15,000 ISO Standards. Website
www.iso.org
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MAJOR INTERNATIONAL ORGANIZATIONS (2)
International Electrotechnical Commission
(IEC) Established in 1906 and membership is
through National IEC Committees from about 50
member countries. Dealing with electrotechnical
field. Published 11,000 IEC Standards. Website
www.iec.ch
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MAJOR INTERNATIONAL ORGANIZATIONS (3)
International Telecommunication Union
(ITU) Established in 1865 (United Nations
Agency). Its members are experts from government
departments responsible for regulating
telecommunications at national level, industrial
and scientific companies, broadcasting bodies,
and regional and international organisations.
It has 189 member States and over 650 sectoral
members from industry. Dealing with
telecommunications field. Published a vast
number of ITU-T Recommendations that are
generally complied with because they guarantee
the interconnectivity of networks and
technically enable services to be provided on a
worldwide scale. Website www.itu.int
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MAJOR INTERNATIONAL ORGANIZATIONS (4)
Codex Alimentarius Commission Established in
1963 by the Food and Agriculture Organization of
the United Nation (FAO) and the World Health
Organization (WHO) and membership is from some
160 countries. Promote the coordination of all
food standards work undertaken by international
governmental and non- governmental organizations,
and to prepare and publish such
standards. Website www.codexalimentarius.net
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MAJOR INTERNATIONAL ORGANIZATIONS (5)
and numerous other intergovernmental organization
s representing specific sectors e.g.
International Labour Organization (ILO),
International Maritime Organization (IMO),
International Atomic Energy Agency
(IAEA), International Air Transport Association
(IATA), International Civil Aviation
Organization (ICAO), etc.
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WHY INVOLVED IN INTERNATIONAL STANDARDS
ACTIVITIES?

• Possibility of influencing international
  standards development, decisions and agenda at
  early stage
• To avoid future international standards creating
  technical barriers to our products/services
• Monitor developments
• Source of up-to-date technical information
• To be in line with obligations in WTO/TBT
  agreement, APEC and ASEAN
• Networking with customers and experts
• Understand concerns and issues first hand

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PARTICIPATION IN THE WORK OF INTERNATIONAL
TECHNICAL COMMITTEES AND SUB-COMMITTEES OF ISO/IEC

• All national bodies have the right to participate
  in the work of technical
• committees and sub-committees.
• In order to achieve maximum efficiency, each
  national body shall clearly
• indicate to the office of the CEO, either
• to participate actively in the work, with an
  obligation to vote
• on all questions formally submitted for voting
  within the technical committee or sub-committee
  and on CD and Final Draft International Standards
  (FDIS) and, whenever possible, to participate in
  meetings (P-member), or
• to follow the work as an observer, and therefore
  to receive
• committee documents and to have the right to
  submit comments and to attend meetings
  (O-member), or
• to be neither P-member nor O-member (non-member).

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PARTICIPATION IN ISO - A COMPARISON
Country Secretariats P memberships France
82 632 Japan 34 558 Australia
12 293 Thailand 0
68 Malaysia 4 85 New Zealand
2 73 Sweden 33 447
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MALAYSIAS PARTICIPATION IN INTERNATIONAL
STANDARDIZATION
ISO
IEC
DSM
NIEC
SIRIM BERHAD
ISO Secretariats TC 45 TC 45/SC 1 TC 45/SC 4 TC
157
Industry Standards Committees
Standards-Writing Organisations
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MALAYSIAS MEMBERSHIP STATUS IN ISO AND IEC 2005
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MALAYSIAS PARTICIPATION IN ISO AND IEC UP TO
2004
2004 2003 2002 2001 2000 Participating
member 85 70 66 58 52 Observer
member 201 119 120 120 68 Meetings attended
37 25 6 14 13 New projects
0 2 2 0 0 Votes submitted
678 520 403 382 318
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INTERNATIONAL ORGANIZATION FOR STANDRDIZATION
(ISO) ORGANIZATIONAL STRUCTURE
GENERAL ASSEMBLY
TECHNICAL MANAGEMENT BOARD
POLICY COMMITTEES
REMCO
COUNCIL COMMITTEES
COUNCIL
TECHNICAL ADVISORY GROUPS
CENTRAL SECRETARIAT
ADHOC ADVISORY COMMITTEE
TECHNICAL COMMITTEES
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INTERNATIONAL ELECTROTECHNICAL COMMISSION (IEC)
ORGANIZATIONAL STRUCTURE
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ISO/IEC STANDARDS DEVELOPMENT PROCESSES AND
DELIVERABLES
Timeframe for voting NP -3 mths CD -3
mths DIS/CDV- 5 mths FDIS- 2 mths
CD or PAS
NEW WORK ITEM PROPOSAL
STAGE 1
DIS/CDV or TS
STAGE 2
BUILDING EXPERT CONSENSUS
CONSENSUS BUILD- ING WITHIN TC/SC
STAGE 3
FDIS
ENQUIRY ON DIS
STAGE 4
Final text for International Standard
FORMAL VOTE ON FDIS
STAGE 5
International Standards
STAGE 6
PUBLICATION OF ISO
WORKSHOP ROUTE
IEC/ITA or ISO/IWA
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OTHER ISO/IEC DELIVERABLES

• TECHNICAL SPECIFICATION (TS)
• when the subject is under development or future
  development
• but no immediate possibility of an agreement to
  publish a
• standard
• procedures are like NP, WD, CD
• 2/3 majority vote of P-members
• the reasons shall be published in the forward.
• Not more than 3 years, it shall be reviewed for
• I) extension for another 3 years, or
• ii) conversion into IS, or
• iii) withdrawal.

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OTHER ISO/IEC DELIVERABLES

• PUBLICLY AVAILABLE SPECIFICATION (PAS)
• an intermediate specification prior to the
  development of a full IS.
• Not fulfilling the requirements for an IS
• valid for 3 years, and may be extended to
  another 3 years following
• which it shall be revised as a standard or
  withdrawn.

• TECHNICAL REPORT (TR)
• informative
• containing data from survey, state of the art of
  a national body, etc.
• Regularly reviewed by TC/SC to ensure validity.
• Withdrawal by TC/SC.

• GUIDES
• on matters related to international
  standardisation.
• not prepared by TC/SC but by the ISO policy
  committee or IEC
• advisory committee

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ESTABLISHMENT OF NEW TECHNICAL COMMITTEE
The proposal shall be submitted to national
bodies and acceptance criteria are
a two-thirds majority in favour and
at least five national bodies have expressed to
participate actively.
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REGIONAL STANDARDIZATION ORGANIZATIONS

• ASEAN Consultative Committee on Standards
  Quality (ACCSQ)
• APEC Standards Conformance Subcommittee (SCSC)
• Pacific Accreditation Cooperation (PAC)
• Asia Pacific Laboratory Cooperation (APLAC)
• Asia Pacific Legal Metrology Forum (APLMF)
• Asia Pacific Metrology Programme (APMP))

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INFORMATION ON STANDARDS

• National Standards Bodies
• The internet e.g. the World Standards Services
  Network (WSSN) is a network of websites of
  standards organizations around the world.
  Through the websites of its members, WSSN
  provides information on international, regional
  and national standardization, and related
  activities and services. The WSSN site provides
  direct links to ISO, IEC, ITU, National members
  of ISO and IEC, Regional standards bodies
  recognized by ISO, IEC, ITU, and International
  standards bodies.
• Commercial catalogues

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USEFUL WEBSITES
http//www.sirim.my http//www.dsm.gov.my
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ABREVIATIONS

• ANSI - AMERICAN NATIONAL STANDARDS INSTITUTE
• APEC - ASIA-PACIFIC ECONOMIC COOPERATION
• API AMERICAN PETROLEUM INSTITUTE
• ASEAN - ASSOCIATION OF SOUTH EAST ASIAN NATIONS
• ASTM - AMERICAN SOCIETY FOR TESTING AND MATERIALS
• BSI BRITISH STANDARDS INSTITUTE
• CAC - CODEX ALIMENTARIUS CODE
• CEN EUROPEAN COMMITTEE FOR STANDARDIZATION
• CENELEC - EUROPEAN COMMITTEE FOR ELECTROTECHNICAL
  STANDARDIZATION
• CD - COMMITTEE DRAFT
• CDV - COMMITTEE DRAFT FOR VOTING
• CGP - CODE OF GOOD PRACTICE
• DIS - DRAFT INTERNATIONAL STANDARD
• DMS DRAFT MALAYSIAN STANDARD
• DSM DEPARTMENT OF STANDARDS MALAYSIA
• EU - EUROPEAN UNION
• FAO - FOOD AND AGRICULTURE ORGANIZATION OF THE
  UNITED NATION
• FDIS - FINAL DRAFT INTERNATIONAL STANDARD

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ABREVIATIONS

• FDMS - FINAL DRAFT MALAYSIAN STANDARD
• G - GUIDE
• IEC - INTERNATIONAL ELECTROTECHNICAL COMMISSION
• IECEE - CONFORMITY TESTING AND CERTIFICATION OF
  ELECTRICAL EQUIPMENT
• IECEx - SYSTEM FOR QUALITY ASSESSMENT OF
  ELECTRONIC COMPONENTS
• IEC/ITA - IEC INTERNATIONAL TECHNICAL AGREEMENT
• IECQ - SCHEME FOR CERTIFICATION TO STANDARDS FOR
  ELECTRICAL EQUIPMENT FOR EXPLOSIVE ATMOSPHERES
• IMO - INTERNATIONAL MARITIME ORGANIZATION
• ISC - INDUSTRY STANDARD COMMITTEE
• ISO - INTERNATIONAL ORGANIZATION FOR
  STANDARDIZATION
• ISO/IWA - ISO INTERNATIONAL WORKSHOP AGREEMENT
• ITU - INTERNATIONAL TELECOMMUNICATION UNION
• JISC - JAPANESE INDUSTRIAL STANDARDS
• MS MALAYSIAN STANDARD

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ABREVIATIONS
NIEC - NATIONAL IEC COMMITTEE NP - NEW WORK
ITEM PROPOSAL NSB NATIONAL STANDARDS BODY PAS -
PUBLICLY AVAILABLE SPECIFICATION SC -
SUB-COMMITTEE SWO STANDARDS-WRITING
ORGANISATION TBT - TECHNICAL BARRIERS TO TRADE TC
TECHNICAL COMMITTEE TISI -THAILAND INDUSTRIAL
STANDARDS INSTITUTE TMB - TECHNICAL MANAGEMENT
BOARD TR - TECHNICAL REPORT TS - TECHNICAL
SPECIFICATION WD - WORKING DRAFT WG WORKING
GROUP WHO - WORLD HEALTH ORGANIZATION WTO - WORLD
TRADE ORGANIZATION
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