UNIT -I (ISO 9000 &14000)

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IS0 9000& ISO 1400

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www.iso.org International Organization for Standardization Dr.J.BelsenDavid MPharm,PhD., Associate Professor

WHAT IS ISO ?:

7/3/2013 2 WHAT IS ISO ? It is INTERNATIONAL ORGANIZATION FOR STANDARDIZATION WHAT IS ISO ?

WHAT IS ISO?:

3 WHAT IS ISO? ISO is the International Organization for Standardization It is a World wide Federation of National Standards Bodies (ISO Member Bodies) ISO

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4 ISO brings Quality to the Quality Management System of an organization- QMS ISO is an action Guide to the concept of Management by Objective (MBO) ISO is a Management system that stresses on “ SAY WHAT YOU DO and DO WHAT YOU SAY” ISO is an absolute Energy saver which avoids Confusion , Mess , chaos , Tensions , Desperation in any enterprise. ISO is a MANAGEMENT ROUTE MAP with clear Guide lines on Directions , Distances, Mile Stones , Stations and their importance. ISO implementation is an INVESTMENT with clear Projections and not at all an EXPENSE.

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5 Top Management ISO Steering Committee Department Heads Complete Company Staff IQA (Internal Quality Audit)Team Trainers and Training Team Management review Committee Consultants The MAIN Groups for ISO Implementation in an Organization

Objectives of Steering Committee:

6 Conducting the ISO Implementation in full Approval of BUSINESS PROCESS PLAN Reporting to TOP MANAGEMENT Selection of QMR and related management. Co ordination with the Consultant and Feedback Objectives of Steering Committee

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7 Total Team work Total Understanding of ISO and its Need . Chain Link system implementation in each department . Effective IQA system and Practice Training on ISO to all staff Top Management’s Total involvement. Pride In Doing things – Management by Objective. KEY TO SUCCESS in ISO IMPLEMENTATION

ISO 9001 and ISO 14001 (in brief):

ISO 9001 and ISO 14001 (in brief) ISO 9001 and ISO 14001 are among ISO's most well known standards ever. They are implemented by more than a million organizations in some 175 countries . ISO 9001 helps organizations to implement quality management . ISO 14001 helps organizations to implement environmental management .

Quality management :

Quality management ISO 9001 is for quality management . Quality refers to all those features of a product (or service) which are required by the customer. Quality management means what the organization does to ensure that its products or services satisfy the customer's 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.

Environmental management:

Environmental management ISO 14001 is for environmental management . This 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 continual improvement of its environmental performance .

Management systems :

Management systems Management system means what the organization does to manage its processes, or activities in order that its products or services meet the organization’s objectives , such as satisfying the customer's quality requirements , complying to regulations , or meeting environmental objectives To be really efficient and effective , the organization can manage its way of doing things by systemizing it. Nothing important is left out. Everyone is clear about who is responsible for doing what, when, how, why and where.

Management systems (cont.):

Management systems (cont.) Management system standards provide the organization with an international, state-of-the-art model to follow. Large organizations with complicated processes could not function well without management systems. Companies in such fields as aerospace, automobiles, defence, or health care devices have been operating management systems for years. The ISO 9001 and ISO 14001 management system standards now make these successful practices available for all organizations .

Processes, not products :

Processes, not products Both ISO 9001 and ISO 14001 concern the way an organization goes about its work. They are not product standards . They are not service standards . They are process standards . They can be used by product manufacturers and service providers. Processes affect final products or services. ISO 9001 gives the requirements for what the organization must do to manage processes affecting quality of its products and services. ISO 14001 gives the requirements for what the organization must do to manage processes affecting the impact of its activities on the environment .

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Certification and registration Certification is known in some countries as registration. It means that an independent, external body has audited an organization's management system and verified that it conforms to the requirements specified in the standard (ISO 9001 or ISO 14001). ISO does not carry out certification and does not issue or approve certificates, Accreditation Accreditation is like certification of the certification body. It means the formal approval by a specialized body - an accreditation body - that a certification body is competent to carry out ISO 9001:2008 or ISO 14001:2004 certification in specified business sectors. Certificates issued by accredited certification bodies - and known as accredited certificates - may be perceived on the market as having increased credibility.

Certification not a requirement:

Certification not a requirement Certification is not a requirement of ISO 9001 or ISO 14001. The organization can implement and benefit from an ISO 9001 or ISO 14001 system without having it certified. The organization can implement them for the internal benefits without spending money on a certification programme.

Certification is a business decision:

Certification is a business decision Certification is a decision to be taken for business reasons : if it is a contractual, regulatory, or market requirement , if it meets customer preferences it is part of a risk management programme , or if it will motivate staff by setting a clear goal.

ISO does not certify:

ISO does not certify ISO does not carry out ISO 9001 or ISO 14001 certification. ISO does not issue certificates. ISO does not accredit, approve or control certification bodies. ISO develops standards and guides to encourage good practice in accreditation and certification. ISO 9001:2008 is the latest, improved version. It is the only standard in the ISO 9000 that can be used for certification . ( There are 16 other standards that help an organization on specific aspects like performance improvement, auditing, training…) ISO 14001:2004 is the latest, improved version. It is the only standard in the ISO 14000, that can be used for certification .

The ISO Survey :

The ISO Survey The worldwide total of certificates to ISO 9001:2001 at the end of 2007 was 951 486. This was increase of 6 % over 2006 when the total was 896 929 certificates. Certificates had been issued in 175 countries compared to 170 the previous year.

The ISO Survey (cont…):

The ISO Survey (cont…) The worldwide total of ISO 14001 certificates at the end of 2007 was 154 572. This was an increase of 21 % over 2006 when the total was 128 211. Certificates had been issued in 148 countries compared to 140 the year before.

Benefits of ISO 9001 and ISO 14001:

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. Increase efficiency and effectiveness . Model for continual improvement . 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 .

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Sustainable business Unifying base for industry sectors Qualify suppliers for global supply chains Technical support for regulations Transfer of good practice to developing countries Tools for new economic players Regional integration Facilitate rise of services More information ISO 9000/ISO 14000 section on ISO Web site www.iso.org ISO Management Systems magazine www.iso.org/ims IMS Alerts free electronic newsletter www.iso.org/imsalerts

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