INTERNATIONAL STANDARD ORGANIZATION BY M.KARTHIK RAJA ASST.

PROF JAGANS COLLEGE OF PHARMACY NELLORE

INTERNATIONAL ORGANIZATION FOR STANDARDIZATION in English "OIN" in French for ORGANISATION INTERNATIONALE DE NORMALISATION "ISO", derived from the Greek isos , meaning EQUAL

STANDARDS ARE FOR?

Ensure desirable characteristics of products and services with  quality,  environmental friendliness,  safety,  reliability,  efficiency and interchangeability all the above with acceptable economical cost.

NEED FOR STANDARDS

Products and Services meet our expectations Granted Unaware of the role of standards
PRODUCTS, SYSTEMS, MACHINERY AND DEVICES

work well
The organization responsible

and safely

EET STANDARDS

ISO

ISO STANDARDS: WHAT DO THEY DO?  make the development, manufacturing and supply of products and services more efficient, safer and cleaner  facilitate trade between countries and make it fairer  provide governments with a technical base for health safety and environmental legislation, and conformity assessment  share technological advances and good management practice  disseminate innovation

 safeguard consumers, and users in general, of products and services  make life simpler by providing solutions to common problems

It provides technological, economic and societal benefits for

businesses innovators customers governments trade officials developing countries consumers everyone to improve quality of life the planet

How to recognize an ISO standard In paper form, an ISO standard is published in A4 format - which is itself one of the ISO standard paper sizes. It may be anywhere between a four-page document and one several hundred pages' long. ISO standards are also available as electronic downloads and many are available as part of a collection on CD or in handbook. An ISO standard carries the ISO logo and the designation, "International Standard".

WHO DEVELOPS ISO STANDARDS ? ISO standards are developed by technical committees comprising experts from the  industrial  technical and which have asked STANDARD  business sectors These experts may be joined by representatives of government agencies, testing laboratories, consumer associations, non-governmental organizations and academic circles. The experts participate as national delegations, chosen by the ISO national member institute for the country

HOW ISO STANDARDS ARE DEVELOPED?

Technical committee discuss debate argue reach consensus draft agreement.

circulated

ISO's membership comment and balloting. public review feedback

Draft International Standard (DIS)

for making draft standards

voting is in favor document, with eventual modifications, circulated to the ISO members Final Draft International Standard (FDIS) If that vote is positive published International Standard.

Every working day of the year, an average of eight ISO meetings are taking place somewhere in the world. In between meetings, the experts continue the standards' development work by correspondence. Increasingly, their contacts are made by electronic means and some ISO technical bodies have already gone over entirely toworking electronically, which speeds up the development of standards and cutstravel costs.

How ISO standards are developed

Technical committee meet to discuss, debate and argue until they reach consensus on a draft agreement. This is circulated as a Draft International Standard (DIS) to ISO's membership as a whole for comment and balloting. Members have public review procedures for making draft standards known and available to interested parties and to the general public. The ISO members then take account of any feedback they receive in formulating their position on the draft standard. If the voting is in favour, the document, with eventual modifications, is circulated to the ISO members as a Final Draft International Standard (FDIS). If that vote is positive, the document is then published as an International Standard. Every working day of the year, an average of eight ISO meetings are taking place somewhere in the world.

Stages of the development of International Standards An International Standard is the result of an agreement between the member bodies of ISO. It may be used as such, or may be implemented through incorporation in national standards of different countries. International Standards are developed by ISO technical committees (TC) and subcommittees (SC) by a six-step process:
Step Stage 1 Stage 2 Stage 3 Stage 4 Stage 5 Stage 6 Proposal stage Preparatory stage Committee stage Enquiry stage Approval stage Publication stage

Stage 1: Proposal stage

The first step in the development of an International Standard is to confirm that a particular International Standard is needed. A new work item proposal (NP) is submitted for vote by the members of the relevant TC or SC to determine the inclusion of the work item in the programme of work. The proposal is accepted if a majority of the P-members of the TC/SC votes in favour and if at least five P-members declare their commitment to participate actively in the project. At this stage a project leader responsible for the work item is normally appointed Stage 2: Preparatory stage Usually, a working group of experts, the chairman (convener) of which is the project leader, is set up by the TC/SC for the preparation of a working draft. Successive working drafts may be considered until the working group is satisfied that it has developed the best technical solution to the problem being addressed. At this stage, the draft is forwarded to the working group's parent committee for the consensus-building phase

Stage 3: Committee stage As soon as a first committee draft is available, it is registered by the ISO Central Secretariat. It is distributed for comment and, if required, voting, by the P-members of the TC/SC. Successive committee drafts may be considered until consensus is reached on the technical content. Once consensus has been attained, the text is finalized for submission as a draft International Standard (DIS). Stage 4: Enquiry stage The draft International Standard (DIS) is circulated to all ISO member bodies by the ISO Central Secretariat for voting and comment within a period of five months. It is approved for submission as a final draft International Standard (FDIS) if a twothirds majority of the P-members of the TC/SC are in favour and not more than one-quarter of the total number of votes cast are negative. If the approval criteria are not met, the text is returned to the originating TC/SC for further study and a revised document will again be circulated for voting and comment as a draft International Standard.

Stage 5: Approval stage The final draft International Standard (FDIS) is circulated to all ISO member bodies by the ISO Central Secretariat for a final Yes/No vote within a period of two months. If technical comments are received during this period, they are no longer considered at this stage, but registered for consideration during a future revision of the International Standard. The text is approved as an International Standard if a twothirds majority of the P-members of the TC/SC is in favour and not more than onequarter of the total number of votes cast are negative. If these approval criteria are not met, the standard is referred back to the originating TC/SC for reconsideration in light of the technical reasons submitted in support of the negative votes received. Stage 6: Publication stage Once a final draft International Standard has been approved, only minor editorial changes, if and where necessary, are introduced into the final text. The final text is sent to the ISO Central Secretariat which publishes the International Standard.

ISOs orientation is guided by a Strategic Plan approved for a five-year period by the ISO members. The ISO members, ultimate representatives of ISO for their own countries, are divided in three categories: member bodies (full members) correspondent members and subscriber members. Only member bodies have the right to vote.

There are a number of policy development committees to provide strategic guidance for the standards development work on cross-sectoral aspects. They are: 1. CASCO (conformity assessment); 2. COPOLCO (consumer policy), and 3. DEVCO (developing country matter) The Technical Management Board (TMB) reports to Council, and is itself responsible for the overall management of the technical work, including for a number of strategic and technical advisory groups. Member bodies are eligible for appointment/election to the TMB in accordance with a set of criteria established by the Council. Operations are managed by the Secretary-General (chief executive officer) who reports to the Council. The Secretary-General is based at the ISO Central Secretariat in Geneva (Switzerland) with a compact staff which provides administrative and technical support to the ISO members, coordinates the decentralized standards' development programme, and publishes the output. The ISO Central Secretariat also acts as the secretariat of the governing bodies, policy development committees and their subsidiary bodies