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QMS Management 
 
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ISO & ISO 9000 STANDARDS
What is ISO?
ISO is the
 International Organization for Standardization
and has its headquarters at Geneva. It is made upof some 140 national standards institutes from countries large and small, industrialized and developing, inall regions of the world. ISO develops voluntary technical standards which contribute to making industrial production and supply more efficient, safer and cleaner, and to making trade between countries easier andfairer. ISO standards also serve to safeguard consumers and users in general of products and services - aswell as to making their lives simpler.
 How ISO works
?The work of preparing international standards is normally carried out through ISO technical committees.Each member national institute interested in a particular subject for which a technical committee has beenestablished has the right to be represented on that committee. International organizations, governmental andnon-governmental, in liaison with ISO, also take part in the work. Draft international standards adopted bytechnical committees are circulated to the member bodies for voting. Publication as an internationalstandard requires approval by at least 75% of the member bodies casting a vote.ISO standards are adopted by all countries as their national standards, with or without any changes.
What are ISO 9000 standards
?ISO 9000 series of standards are quality management system standards, and are among the most widelyknown and successful of the 13000 plus standards published by ISO since its inception in 1947. Thesestandards have become an international reference for quality requirements in business to business dealings.First edition of these standards were published in 1987. These were revised in 1994 and again in December 2000. While 1994 revision was restricted to some editorial changes and providing clarifications on somerequirements, year 2000 revision is very extensive.
General principles & concepts of ISO 9000 standards
ISO 9000 standards aresystems standardsSystems means way of working. If working is strictly as per specified systems, quality willalways be OK. Systems include procedures for working – what, when & how.ISO 9000 standards bringtransparency in workingEverything is in written form. What is not written, is not accepted. Write what you aredoing & then Do what you have written. Check & ensure that you are working as per written procedures. Correct any deficiencies observed and work as per corrected system.ISO 9000 standards work on checking andcontrolling deficiencies ateach stage, both inworking and in productquality
 Deficiencies in way of working 
– not following written procedures, not filling up forms,not recording what you have done,
 Deficiencies in product quality
– at incoming stage (raw materials), in-process stages(products at various stages of production), final product ,Products having any problem should be stopped at that stage and should not be used till problem is solved.Analyzing & correcting problems to avoid their repetitionProblem can be in any area. Problems are properly analyzed for possible reasons.Both short term and long term actions are decided and implemented to avoid repetition of the problem in future.ISO 9000 systems are person independentProcedures, specifications, work instructions, check list etc., are all in written form.Responsibility and authority of each person is clearly defined. Alternative arrangement for each function is also defined to make the system person independent.ISO 9000 systems areinternall
 
y auditedImplementation of ISO 9000 systems is periodically audited by company’s auditors todetermine its adequacy and effectiveness & to continually improve it.Provides completecustomer satisfactionCustomer satisfaction is defined for all areas such as, conformance to standards, delivery,after sales service and other related activities (both stated and implied).
315, Pragati Apartments, Punjabi Bagh Club Road, Paschim Puri, New Delhi – 110 063
 
QMS Management 
 
 Services
Consulting Services for Effective Management Systems
Phone:
25216144,
 
9810073862 
Website
: www.qmsservices.com
E Mail:
office@qmsservices.comISO 9001:2000 specifies requirements for a quality management system for any organization that needs todemonstrate its ability to consistently provide products that meet customer and applicable regulatoryrequirements and aims to enhance customer satisfaction. This standard has been organized in a user-friendly format with terms that are easily recognized by all business sectors. It is now the only standard inthe ISO 9000 family against whose requirements a quality management system can be certified by anexternal agency. The standard recognizes that the word "product" applies to services, processed material,hardware and software intended for, or required by the customer.There are five sections in the standard that specify activities that need to be considered when youimplement the system. The organization will need to describe the activities it uses to supply its productsand may exclude the parts of the Product Realization section that are not applicable to its operations. Therequirements in the other four sections – Quality management system, Management responsibility,Resource management, and Measurement, analysis & improvement– apply to all organizations and theorganization will be required to demonstrate how it applies them in the organization, and specify the samein its quality manual or other documentation.Together, the five sections of ISO 9001:2000 define what an organization should do consistently to provide products that meets customer and applicable regulatory requirements. In addition, organization will alsoseek to enhance customer satisfaction by improving its quality management system. ISO 9004:2000 can beused to extend the benefits obtained from ISO 9001:2000 to all parties that are interested in or affected byorganization’s business operations. Interested parties include organization’s employees, owners, suppliersand society in general. New ISO 9000 standards apply a process approach. Processes are recognized as consisting of one or morelinked activities that require resources and must be managed to achieve predetermined output. The outputof one process may directly form the input to the next process and the final product is often the result of anetwork or system of processes. The eight quality management principles provide the basis for continualimprovement of organizational performance.Typical goals of any organization may be :
Be more efficient and profitable
Produce products and services that consistently meet customer requirements
Achieve customer satisfaction
Increase market share
Maintain market share
Improve communications and morale in the organization
Reduce costs and liabilities
Increase confidence in the production system.Most new users of ISO 9000 standards obtain measurable benefits early in the process of deploying thestandard requirements in their operations. These initial benefits are generally due to improvements in their organization and internal communication. The benefits must be strengthened through effective internalauditing and management review of system performance. Like all systems, it either improves or becomesless effective. It does not remain static for long.When an organization adopts ISO 9001:2000, it must strive for the satisfaction of its customers and thecontinual improvement of the quality management system. Continual improvement is a process of increasing the effectiveness of the organization to fulfill its quality policy and quality objectives. ISO9001:2000 requires planning and managing the processes necessary for the continual improvement of thequality management system. It is recommended that the organization obtains data from various sources, both internal and external, to assess the appropriateness of its quality system goals. This information canalso be used to improve the performance of organization’s processes.315, Pragati Apartments, Punjabi Bagh Club Road, Paschim Puri, New Delhi – 110 063
 
QMS Management 
 
 Services
Consulting Services for Effective Management Systems
Phone:
25216144,
 
9810073862 
Website
: www.qmsservices.com
E Mail:
office@qmsservices.comSome organizations may expand their management systems by extending the ISO 9001:2000 structure toinclude the requirements of ISO 14001,
 Environmental management systems
. The structural andorganizational requirements of the two management systems have been designed to be compatible.
 Benefits of ISO 9000 standards
There are number of benefits associated with the revised quality management systems standards. The benefits are:
Applicability to all product categories, in all sectors and to all sizes of organizations
Simple to use, clear in language, readily translatable, and easily understandable
Significant reduction in the amount of required documentation
Connection of quality management systems to organizational processes
Provision of a natural move towards improved organizational performance
Greater orientation toward continual improvement and customer satisfaction
Compatibility with other management systems such as ISO 14000
Provision of a consistent basis to address the needs and interests of organizations in specificsectors (e.g. medical devices, telecommunications, automotive, etc)
The concept of the consistent pair - ISO 9001 covering the requirements and ISO 9004 for going beyond the requirements in order to further improve the performance of the organization
Consideration of the needs of and benefits to all interested parties.Customers and users will benefit by receiving the products that are:
conforming to the requirements
dependable and reliable
available when needed
maintainablePeople in the organization will benefit by:
 better working conditions
increased job satisfaction
improved health and safety
improved morale
improved stability of employmentOwners and investors will benefit by:
increased return on investment
improved operational results
increased market share
increased profitsSuppliers and partners will benefit by:
stability
growth
 partnership and mutual understandingSociety will benefit by:
fulfillment of legal and regulatory requirements315, Pragati Apartments, Punjabi Bagh Club Road, Paschim Puri, New Delhi – 110 063
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