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International Organization for Standardization


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ISO-9000 & 14000

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Submitted by alok kr vishwakarma bipin katiyar dept. of pharmaceutics PSIT,Kanpur

History of ISO-9000 : 

History of ISO-9000 History of ISO 9000 ISO 9000 is a series of quality management systems standards created by the International Organization for Standardization (ISO), a federation of 132 national standards bodies. The ISO 9000 quality management systems (QMS) Standards are not specific to products or services, but apply to the processes that create them. The Standards are generic in nature so that they can be used by both manufacturing and service industries. First released in 1987 and revised in a limited manner in 1994, they underwent a major revision in 2000. The approval Standard, ISO 9001:2000, uses a simple process-based structure, which fits easily the process management structure of most businesses.

What is an ISO? : 

What is an ISO? ISO 9000 is an international standard for operating a business in a manner that provide quality assurance for goods and services. The international organization for standardization (ISO) has formulated standarded for quality certification, it is known as “ISO 9000 series certification”

ISO 9000 series certification : 

ISO 9000 series certification The ISO-9000 series is made up of 5 parts:- ISO 9000 ISO 9001 ISO 9002 ISO 9003 ISO 9004. The guidelines for the certification are given in the ISO 9000 & ISO 9004. ISO 9001,ISO 9002 $ ISO 9003 are the categories for which companies may apply for certification.

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ISO 9001 certificate was awarded to organization/ industry which comply with all the 20 clauses. Industries having design, production and delivery (including inspection, handling, storage, preservation and services) went for this certification. ISO 9002 certificate was awarded to organization/industry which has in its fold the production operation & delivery (including inspection, handling, storage & services). ISO 9003 certificate was awarded to organization/industry which carried out only the last function. All marketing agencies & services fall under this category.

Elements of ISO 9001,9002,9003 standards : 

Elements of ISO 9001,9002,9003 standards

Indian Equivalance of ISO 9000 : 

Indian Equivalance of ISO 9000 Bureau of India standard(National Standard Body of India) has adopted ISO 9000series of standard in its IS -14000 series of standards.

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ISO-9004 guideline for establishing quality management system

How to apply for ISO-9000 registration? : 

How to apply for ISO-9000 registration? Acquaint the management with nation Prepare the workman for the change Selection of the model Study the model Prepare the checklist Formulate the quality policy Identify support required Procedure needed equipment and make them operational Write quality manual Prepare the work instruction Get approved Make audit checklist Self audit Conduct audit Apply for trial audit Implement recommendation Apply for registration

Firm & consultants for ISO-9000 registration : 

Firm & consultants for ISO-9000 registration Bureau of Indian standard (BIS) ,New Delhi Confederation of Indian industry, New Delhi Bureau of veritas quality international ltd., Mumbai National centre for quality management, Mumbai Quality management international, New Delhi National productivity council, New Delhi Department of electronics, Govt. of India New Delhi

Limitation from implementation of ISO-9000 QS : 

Limitation from implementation of ISO-9000 QS It does not guarantee business success Implementation can take more than two years Implementation is time consuming and team members must devote full attention to the process The drive for quality must come from the company chief executive officer unless there is close involvement and commitment from seniour management It is essential to have people who understand what is actually happening “on the ground”

Advantages : 

Advantages Helps to identify problem areas, possible solution and provide consistency Identify a product champion & closer to the top the better so that any argument or resistance can be quickly addressed Train every member of staff in quality awareness it ensure that the ISO-9001 quality management system become way of life Give team members operational support to fulfill day to day functions Give responsibility and accountability to the junior ranks Simplify the document procedure Keep the system relevant

ISO-14001Environmental management system : 

ISO-14001Environmental management system All kinds of organization are concerned to achieve and demonstrate healthy environment performance by controlling the impact of their activities, product or services on the environment , the development of economic policies and other measure to bring up environmental protection This international standard shares common management system principles with the ISO-9000 series of quality system standard The overall aim of this international standard is to support environmental protection and prevention of population in balance

ISO-14000 series certification : 

ISO-14000 series certification In ISO-14000 is a series of generic standard developed by ISO to provide industries and other organization with a system for managing environmental impact ISO-14000 consists of -specification standard -guidance standard ISO-14000 addresses six distinct but related subjects. They are 1.Environmental management system (EMS) 2.Environmental auditing (EA) 3.Environmental performance evaluation (EPE) 4.Environmental labelling (EL) 5.Life cycle assessment (LCA) 6.Environmental aspects in product standard (EAPS) THESE can be grouped as product oriented or process oriented standards as in the following figure:

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ISO-14000 PROCESS ORIENTED STANDARDS PRODUCT ORIENTED STANDARDS LCA EL EAPS EMS EPE EA FIG:- ISO 14000 STANDARD Government is imposing that all the industries which are energy intensive and highly polluting must get ISO 14000 certification

Standards ISO-14000 : 

Standards ISO-14000 1.Process standard ISO14001-EMS (Specification with guidance for use) ISO14004-EMS(GENERAL guidelines, system and supporting techniques) ISO14010-Guidelines for environmental auditing (general principles of environmental auditing) ISO14011-Guidelines for environmental auditing (audit procedure) ISO14031-Evaluation of environmental performance

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2.Product standard ISO14020-environmental labelling (general principle) ISO14024-environmental labelling (guide for certification procedures) ISO14040-environmental management –LCA (principles & guidelines) ISO14042-environmental management –LCA (life cycle impact assessment) ISO14060-guide for inclusion or environmental aspects in product standard

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Organizational commitment environmental management Adoption of environmental policy Review/audit of environmental policy Revision of environmental policy Implementation of environmental training programme Allocation of environmental responsibilities Setting of environmental objectives and targets Development of action plan to achieve environmental objectives and targets Operational control Audit of performance in relation to targets Audit of effectiveness of the management programme Review of the management system Corrective action Report environmental performance internally & externally

Field of application : 

Field of application Implement ,maintain & improve an EMS . Seek certification/registration of its EMS by an external organization. Make a self determining & self declaration of conformance with this international standard.

Advantages : 

Advantages Meeting & anticipating environmental requirements Reducing uncertainty Meeting customer requirements Improving public image Improving profitability Meeting customer requirements Improving public image Improving profitability by minimizing waste and reducing energy and resource consumption The development of EMS ensures commitment environment Green consumerism Market force

Structure of ISO-14001 : 

Structure of ISO-14001 Environmental policy planning Implementation & operation Management review Checking & corrective action plan act check do Deming cycle

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