- The International Organization for Standardization (ISO) was established in 1947 to develop international standards across many areas. It has 157 member countries that work to develop standards to facilitate international trade and disseminate technological advances. - ISO standards contribute to more efficient, safer, and cleaner development, manufacturing, and supply of products and services. They make trade between countries easier and fairer. - Some key ISO standards include ISO 9000 for quality management systems and ISO 14000 for environmental management systems. ISO uses a six stage process to develop international standards through technical committees and member votes.

1. PREPARED BY
B SWATHY
FACULTY IN PHARMACEUTICS
UCPSC PALAMURU UNIVERSITY

2. INTRODUCTION
• International organization for standardization (ISO) was established in 23rd
february1947 in switzerland to develop common international standards in
many areas.
• It is the worlds largest developer and publisher of international standards,
with network of national standards institutes of 157 countries one member
per country.
• It is a non governmental organization that forms a bridge between public
private sectors.
• ISO standards contribute in making the development,manufacturing, supply
of products and services more efficient, safer and cleaner. Trade between
countries became easier and fairer.

3. Need of standards
• Makes the trade more reliable.
• Facilitate trade between countries fairer.
• Provides government with a technical base for health, safety, environmental
legislation and conformity.
• Share technological advances and good management practice.
• Disseminate innovation.
• Safegaurd customers and users in general of products and services.
• Makes life simpler by providing solutions to common problems.

4. ISO Benefits
• ISO standards provide technological,economic and societal benefits.
• For businesses, to develop the products that have wide international
acceptance in their sectors.
• For innovators of new technologies , on aspects like terminology,
compatability and safety speed up the dissemination of innovations and
their development into manufacturable and marketable products.
• For customers the world wide compatability of technology which is
achieved when products and services are based on international standards
gives them a broad choice of offers.
• For governments, ISO provide the technological and scientific bases
underpinning helath, safety and environmental legislation.
• For trade officials

5. ISO BENEFITS
• For developing countries
• For consumers conformity of products and services to international
standards provides assurance about their quality, safety and reliability.
• For everyone to contribute the quality of life in general by ensuring that the
transport, machinery and tools we use are safe.

6. Members of ISO
• Membership Of ISO is open to national standards institutes or similar
organizations most representative of standardization in their ountry.
• Full members known as Member Bodies, each have one vote, beside the
country's strength.
• Corresspondent members are usually organizations in countries which do
not yet have a fully developed national standards activity.
• Corresponent members do not take part in technical issues .
• Subscriber members are institutes from countries with very small
economies that neverthless wish to maintain contact with international
standardization.

7. ISO structure
• General Assembly: constituted by the officers and delegates nominated by
the member bodies.
• Correspondent and subscriber members may attend as observers.
• GA meet once a year, discuss about annual report, strategic plan with
financial implications and annual financial status report .

8. ISO STEPS FOR REGISTRATION
• An international standard is the result of an agreement between the member
bodies of ISO.
• International standards are developed by ISO technical committes (TC)and
sub committes (SC)by a six step process.
• Stage 1: Proposal Stage
• Stage 2: Preparatory Stage
• Stage 3: Committee stage
• Stage 4: Enquiry stage
• Stage 5: Approval stage
• Stage 6: Publication Stage

9. • PROPOSAL STAGE: A new work item proposal is submitted for vote by
the members of relevant TC or SC to determine the inclusion of the work
item in the programme.
• The proposal is accepted if a majority of P members of the TC /SC votes in
favour and if atleast 5 P members declare their commitment to participate
actively in project.
• Project leader will responsible for the work team .
• PREPARATORY STAGE: A working group of experts the chairman of
which is the project leader, is setup by the TC 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.
• The draft is forwarded to the working groups parent committee for the
consensus building phase.

10. ISO STEPS FOR REGISTRATION
• Committee Stage : The first draft is registered by the ISO central
secretariat and distributed for comments, and if required the P members
may vote.
• The draft is finalized as it clears all doubts and submitted as Draft
international standards(DIS).
• Enquiry stage: The DIS is circulated to all ISO members for voting and
gwithin a period of five months.
• It is approved as final DIS if 2/3rd majority favours.
• It is returned to TC if it is not approved for further study and Again DIS
should be prepared.
• Approval stage: FDIS is circulated to all ISOmembers by the secretary for a
final yes/no vote within a period of two months.
• If any technical document is received it is considered for future assistance .
• Publication stage: Final draft international standard has been approved and
sent to ISO cental secretariat which publishes the international standard.

11. ISO 9000 & ISO 14000
• These are mostly used standards by 610000 organizations.
• ISO 9000 has became an international reference for quality requirements.
• ISO 14000 enables organization to meet their environmental challenges.
• Both are known As Generic Management System Standards.
• Generic means that the same standard can be applied to any organization.
• Management system refers to the organization structure for managing its
processes and activities.

12. ISO 9000
• ISO 9000 has been published in GATT meeting at uruguay.
• It is the most important quality standard for thousand of companies as it
controls quality and reaches the expectation of customers with good
satisfaction.
• ISO first published its QA and QM stds in 1987 and revised in 1994.
• The purpose is to facilitate International business by providing single set of
stds that people can easily recognize and respect.
• ISO 9000 includes 9001,9002,9003,1001110013.
• ISO 9000 guidelines for selection and use.
• ISO 9002 Quality systems model for QA in design, development,
production and servicing.
• ISO 9003: QA in inspection and tests.
• ISO 10011 Auditing quality systems
• ISO 10012 quality in measuring equipments
• ISO 10013 Quality manuals

13. ISO 14000
• These stds are published in 1987 to assist organizations manage the
environmental effect of their business practices.
• It deals with how company manages the environment inside its facilities
and immediate outside environment.
• ISO call for analysis of entire product cycle from raw material to eventual
disposal.
• Give awareness of process and procedures that can effect the environment.
• ISO 14001 Environmental management systems
• ISO 14004 standard guidelines
• ISO 14010-015 auditing
• ISO 14020-024 labelling
• ISO 14031-032 evaluation
• ISO14040-043 life cycle assesment
• ISO14050 terms and definitions