ISO & BIS

Submitted To : Prof. Tejal Shah

Submitted By : Dixita Patel (Pharma) Hiran Patel (IB) Jaan Patel (Pharma) Jyoti Patel (Agri)

ISO(International organization for standardization)

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 .

ISO ORGANIZATION

General Assembly

CouncilPolicy Development committes

Technical Management Board

Technical Advisory Group

Technical Committees

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.

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.

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

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.

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.

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.

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…

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

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.

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…

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.

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.

BIS

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.

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

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

OBJECTIVES

To safeguard public health

To promote consumer confidence To protect

consumer from hazardeous product

To provide quality asssurance

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

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.

AREAS FOR CERTIFICATION:

Areas for Certification

TextilesWood Products

Leather Products

Rubber & Plastic Cement

& Concrete

Machinery & Equipment

Agriculture & Food

Buliding Material

Pumping, Irrigation& Drainage Equipment

Testing Instrument

CERTIFICATION PROCESSA. GRANT OF LICENSE

ApplicationPreliminary Inspection

Testing of samples

Final results and evaluation

Grant of License

B. MONITORING/SURVEILLANCE

Licensee

Surprise Visits

Testing in Factory

Market Samples

Testing in Independent Labs

Complaint and Feedback Investigation

Review of performance

License

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.