BIS and ISO presentation that might helpful to obtain little knowledge of that.

1. ISO & BIS
Submitted To : Prof. Tejal Shah
Submitted By : Dixita Patel (Pharma)
Hiran Patel (IB)
Jaan Patel (Pharma)
Jyoti Patel (Agri)

2. ISO
(International organization for
standardization)

3. WHAT IS ISO?
 ISO is an international agency consisting of
156 member countries including Kenya.
 ISO was formed in 1947 and is based in
Geneva, Switzerland .
 It develops international standards to
foster increased trade of products and
services.
 By July 2005, ISO had published over 15,000
standards .

4. ISO ORGANIZATION
General
Assembly
Council
Policy
Development
committes
Technical
Management
Board
Technical
Advisory
Group
Technical
Committees

5. ISO STANDARDS
 ISO International standards ensure that
products and services are safe, reliable and of
good quality.
 The International organization for
standardization is a worldwide federation of
national standard bodies.
 Working through technical committees, it has
developed and published over 18000 different
ISO standards that are used internationally for
subjects ranging from film speeds to wine glasses
to quality management systems.

6.  The official purpose for the issuance of ISO
standards is to facilitate world trade through
standardization.
 For business they are strategic tools that reduce
costs by minimizing wastes and errors, and
increasing productivity.
 They help companies to access new markets,
level the playing field for developing countries
and facilitate free and fair global trade.
 Founded on 23 feb1947, the organization
promotes worldwide proprietary, industrial and
commercial standards.

7. SOME POPULAR STANDARDS
 ISO 9001 – Quality management
 ISO 14001- Environmental management
 ISO 3166- Country codes
 ISO 26000- Social responsibility
 ISO 50001- Energy management
 ISO 31000- Risk management
 ISO 22000- Food safety management

8. STAGES FOR REGISTRATION
 Submit application to registrar.
 Stage 1: assessment of readiness
 Stage 2: assessment for registration audit
 Registration/certification awarded for 3years
 Surveillance audit
 Recertification audit at the end of 3rd year.

9. ISO 9001 AND 14001 STANDARDS
 ISO 9001 AND 14001 are the most popular
standards amongst all others.
 They are implemented by a more then a million
organizations in some 175 countries.
 ISO 9001 helps organizations to implement
quality management.
 ISO 14001 helps organizations to implement
environmental management.
 Both ISO 9001 and 14001 are generic standards.
 Generic means that the same standards can be
applied to any organization, large or small, in
any sector of activity, whether its a business
enterprise, or a government department.

10. ISO 9001 ( QUALITY
MANAGEMENT)
 Quality refers to all those features of a product or
service which are requires by the customer.
 Quality management means what the
organization does to ensure that its products or
services, satisfy the customers quality
requirements and comply with any regulations
applicable to those products or services.
 Quality management also means what the
organization does to enhance customer
satisfaction and achieve continual improvement
of its performance.

11. THE ISO 9000 FAMILY
 ISO 9001 is the standard that gives the
requirements for a quality management
system.
 ISO 9001:2008 is the latest, improved version.
 It is the only standard in the ISO 9000 family
that can be used for certification.
 There are 16 other standards in the family that
can help an organization on specific aspects such
as performance improvement, auditing,
training…

12. WHY ADOPT ISO 9000?
 To comply with customers who require ISO 9000
 To sell in the European Union market
 To compete in domestic markets
 To improve the quality system
 To minimize repetitive auditing by similar and
different customers
 To improve subcontractors’ performance

13. ISO 14001
 This is for environment management.
 Environment management means what the
organization does to minimize harmful effects on
the environment caused by its activities, to
conform to applicable regulatory requirements
and to achieve improvement of its environment
performance.
 ISO 14000 includes 21 other standards that can
help an organization specific aspects such as
auditing, environment labelling, life cycle
analysis, etc.

14. THE ISO 14000 FAMILY
 ISO 14001 is the standard that gives the
requirements for an environmental
management system.
 ISO 14001:2004 is the latest, improved version.
 It is the only standard in the ISO 14000 family
that can be used for certification.
 The ISO 14000 family includes 21 other
standards that can help an organization specific
aspects such as auditing, environmental
labelling, life cycle analysis…

15. BENEFITS OF ISO 9001 AND ISO 14001
 International, expert consensus on state-of-the-
art practices for quality and environmental
management.
 Common language for dealing with customers
and suppliers worldwide in B2B.
 Increase efficiency and effectiveness.
 Model for continual improvement.

16. BENEFITS OF ISO 9001 AND ISO
14001 (CONT.)
 Model for satisfying customers and other
stakeholders.
 Build quality into products and services from
design onwards.
 Address environmental concerns of customers
and public, and comply with government
regulations.
 Integrate with global economy.

17. BIS

18. INTRODUCTION
 The Product Certification Scheme of
BIS aims at providing Third Party Guarantee of
quality, safety and reliability.
 Standard Mark on a product is an assurance of
conformity.
 The conformity is ensured by regular surveillance
of the licensee's performance by surprise
inspections and testing of samples, drawn both
from the market and factory.

19.  The Bureau of Indian Standards, empowered
through an Act of the Indian Parliament, known
as the BIS Act, 1986, operates a product
certification scheme by which it grants licences to
manufacturers covering practically every
industrial discipline from Agriculture to Textiles
to Electronics.
 The certification allows the licensees to use the
popular ISI Mark, which has become
synonymous with Quality products for the Indian
and neighbouring markets over the last more
than 55 years

20. ABOUT BIS:
 BIS has set up eight laboratories in different
cities of India for testing samples of products
taken during preliminary and surveillance
operations.
 In addition, independent laboratories having
demonstrated ability and a quality system
complying with ISO/IEC Guide 17025:1999 have
been recognized for testing of samples.
 2500 products tested every year
 116 total laboratory
 Quality and standard products

21. OBJECTIVES
To
safeguard
public
health
To promote
consumer
confidence To protect
consumer from
hazardeous
product
To provide
quality
asssurance

22. ACTIVITIES
 Standards Formulation
 Certification
 Product
 Hallmarking of Gold Jewellery
 Quality Management System
 Environmental Management Systems
 Health and Safety Management System
 Hazard Analysis and Critical Control Points
 Imported Products
 Laboratory Management
 International Activities
BIS is a member of IO for ISO and IEC
Is a member in council board of IEC
 Training Services
 Consumer affairs and standards promotions

23. TYPES OF LICENCING
o The Government of India, on considerations of
public health and safety, security, infrastructure
requirements and mass consumption has
enforced mandatory certification on various
products through Orders issued from time to time
under various Acts. While BIS continues to grant
licences on application, the enforcement of
compulsory certification is done by the notified
authorities.
o Under separate arrangements with Statutory
agencies, some products have been placed under
special certification schemes of lot or batch
inspection carried out by BIS Inspecting officers.
E.g. Gas cylinders, regulators and valves.

24. AREAS FOR CERTIFICATION:
Areas for
Certification
Textiles
Wood
Products
Leather
Products
Rubber
& Plastic
Cement
&
Concrete
Machinery
&
Equipment
Agriculture
& Food
Buliding
Material
Pumping,
Irrigation&
Drainage
Equipment
Testing
Instrument

25. CERTIFICATION PROCESS
A. GRANT OF LICENSE
Application
Preliminary
Inspection
Testing of
samples
Final results
and evaluation
Grant of License

26. B. MONITORING/SURVEILLANCE
Licensee
Surprise
Visits
Testing in
Factory
Market
Samples
Testing in
Independent Labs
Complaint and Feedback
Investigation
Review of
performance
License

27. DIFFERENCE BETWEEN IOS & BIS
 ISO is the world’s largest developer of
international standards. Is a network of the
standards institute of 161 countries with a
central secretariat in Geneva, Switzerland that
co ordinates the system.
 BIS is the national standards body of India
resolves to be the leader in standardization
certification and quality in India.