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STATISTICAL QUALITY IMPROVEMENT(SQQS 3063

Quality Management System (QMS):International Organization for

Standardization (ISO)

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Quality Management System (QMS)

• QMS is a system that outlines the policies and procedures necessary to improve and control the various processes that will ultimately lead to improved business performance.

• ISO 9000 standards have been adopted worldwide as the mainframe of QMS and have undergone significant development over the years.

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The 8 QMS Principles 1. Customer focus– Organization depends on their customers and

therefore should understand current and future customer needs, should meet customer requirements and strive to exceed customer expectations.

2. Leadership Leaders establish unity of purpose and direction of the

organization. They should create and maintain the internal environment in which people can become fully involved in achieving the organization’s objectives.

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3. Involvement of people– People at all levels are the essence of an

organization and their full involvement enables their abilities to be used for the organization’s benefit

4. Process approach A desired result is achieved more efficiently

when related resources and activities are managed as a process.

The 8 QMS Principles

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5. System approach to management– Identifying, understanding and managing interrelated

processes as a system contributes to the organization’s effectiveness and efficiency in achieving its objectives.

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6. Continual improvement Continual improvement of the organization’s overall

performance should be a permanent objective of the organization.

The 8 QMS Principles

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7. Factual approach to decision making– Effective decisions are based on the logical analysis of

data and information.

8. Mutually beneficial supplier relationship An organization and its supplier are interdependent and a mutually beneficial relationship enhances the ability of both to create value.

The 8 QMS Principles

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What do 8 QMS Principles do?• Provide direct benefits towards organization purpose

and goal• Contribute in managing benefits, costs and risks.• Impact on organization performance seen through:– Customer loyalty, increase in market share,boost confidence, competitive advantage, etc.

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ISO - why standard is important?

• Standards ensure desirable characteristics of products and services such as quality, environmental friendliness, safety, reliability, efficiency - and at an economical cost.

• When products and services meet our expectations, we tend to forget about standard. However, when standards are absent, we soon notice. We soon care when products turn out to be of poor quality, do not fit, are incompatible with equipment that we already have, are unreliable or dangerous.

• When products, systems, machinery and devices work well and safely, it is often because they meet standards

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What standards do?

• make the development, manufacturing and supply of products and services more efficient, safer and cleaner

• facilitate trade between countries and make it fairer• provide governments with a technical base for health, safety

and environmental legislation, and conformity assessment• share technological advances and good management practice• disseminate innovation• safeguard consumers, and users in general, of products and

services• make life simpler by providing solutions to common problems

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ISO IN GENERAL….

Aim is to help organizations be more effectiveand efficient

• Effective = Achieving the planned results • Efficient = Optimizing use of resources

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Who will benefit?• For businesses, the widespread adoption of International Standards

means that suppliers can develop and offer products and services meeting specifications that have wide international acceptance in their sectors. Therefore, businesses using International Standards can compete on many more markets around the world.

• For innovators of new technologies, International Standards on aspects like terminology, compatibility and safety speed up the dissemination of innovations and their development into manufacturable and marketable products.

• For customers, the worldwide compatibility of technology which is achieved when products and services are based on International Standards gives them a broad choice of offers. They also benefit from the effects of competition among suppliers.

• For governments, International Standards provide the technological and scientific bases, underpinning health, safety and environmental legislation.

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• For trade officials, International Standards create "a level playing field" for all competitors on those markets. The existence of divergent national or regional standards can create technical barriers to trade. International Standards are the technical means by which political trade agreements can be put into practice.

• For developing countries, International Standards that represent an international consensus on the state of the art are an important source of technological know-how. By defining the characteristics that products and services will be expected to meet on export markets, International Standards give developing countries a basis for making the right decisions when investing their scarce resources and thus avoid wasting them.

• For consumers, conformity of products and services to International Standards provides assurance about their quality, safety and reliability.

• For everyone, International Standards contribute to the quality of life in general by ensuring that the transport, machinery and tools we use are safe.

• For the planet we inhabit, International Standards on air, water and soil quality, on emissions of gases and radiation and environmental aspects of products can contribute to efforts to preserve the environment.

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Non Governmental Organization

• ISO standards are technical agreements which provide the framework for compatible technology worldwide. They are designed to be globally relevant - useful everywhere in the world.

• ISO standards are useful everywhere in the world.• ISO standards are voluntary. As a non-

governmental organization, ISO has no legal authority to enforce the implementation of its standards.

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Scope of ISO work

• ISO's work programme ranges from standards for traditional activities, such as agriculture and construction, through mechanical engineering, manufacturing and distribution, to transport, medical devices, information and communication technologies, and to standards for good management practice and for services.

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Examples of the benefits standards provide

• solves the repair and maintenance problems caused by a lack of standardization that were once a major headache for manufacturers and product users.

• Without the standardized dimensions of freight containers, international trade would be slower and more expensive.

• Consensus on grades of various materials gives a common reference for suppliers and clients in business dealings.

• Without the international agreement contained in ISO standards on metric quantities and units, shopping and trade would be haphazard, science would be unscientific and technological development would be handicapped.

• Agreement on test methods allows meaningful comparisons of products, or plays an important part in controlling pollution - whether by noise, vibration or emissions.

• Safety standards for machinery protect people at work, at play, at sea... and at the dentist's.

• Standardized documents speed up the transit of goods, or identify sensitive or dangerous cargoes that may be handled by people speaking different languages.

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ISO….• guides and standards for conformity assessment

represent an international consensus on best practice. • Their use contributes to the consistency of conformity

assessment worldwide and so facilitates trade.• "Conformity assessment" means checking that

products, materials, services, systems, processes or people measure up to the specifications of a relevant standard or specification.

• products require testing for conformity with specifications or compliance with safety, or other regulations before they can be put on many markets.

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What "international standardization" means

• When the large majority of products or services in a particular business or industry sector conform to International Standards, a state of industry-wide standardization exists.

• The economic stakeholders concerned agree on specifications and criteria to be applied consistently in the classification of materials, in the manufacture and supply of products, in testing and analysis, in terminology and in the provision of services.

• In this way, International Standards provide a reference framework, or a common technological language, between suppliers and their customers. This facilitates trade and the transfer of technology

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ISO 9000:2000 Family

• ISO 9000 – Describes fundamentals – Specifies the terminology & definition

• ISO 9001 – Specifies requirements

• ISO 9004 – Provides guidance to implementation

• Processes for continual improvement• Clarifies satisfaction measures

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ISO 9001 and ISO 14001

• ISO 9001 (quality) and ISO 14001 (environment) are "generic management system standards“.

• “Generic” means that the same standard can be applied to any organization, large or small, whatever its product or service, in any sector of activity, and whether it is a business enterprise, a public administration, or a government department.

• ISO 9001 contains a generic set of requirements for implementing a quality management system and ISO 14001 for an environmental management system.

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What is ISO 9000?

• ISO 9000 is a generic name given to a family of standards developed to provide a framework (guidelines) around which a quality management system can effectively be implemented.

• represents an international consensus on good quality management practices.

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How the model works?

ISO 9000 lays down what requirements your quality system must meet, but does not dictate how they should be met in any particular organization. This leaves great scope and flexibility for implementation in different business sectors and business cultures, as well as in different national cultures.

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• 2011 survey from the British Assessment Bureau showing 44% of their certified clients had won new business.

• Implementing ISO 9000 showed that certified organizations achieved superior return on assets compared to otherwise similar organizations without certification, led to superior operational and financial performance.

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3 Models of ISO 9000:1987 for quality management systems

• ISO 9001:1987 Model for quality assurance in design, development, production, installation, and servicing was for companies and organizations whose activities included the creation of new products.

• ISO 9002:1987 Model for quality assurance in production, installation, and servicing had basically the same material as ISO 9001 but without covering the creation of new products.

• ISO 9003:1987 Model for quality assurance in final inspection and test covered only the final inspection of finished product, with no concern for how the product was produced.

• ISO 9000:1987 was also influenced by existing U.S. and other Defense Standards, and so was well-suited to manufacturing. The emphasis tended to be placed on conformance with procedures rather than the overall process of management—which was likely the actual intent.

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ISO 9000:1994 (1994 version)

• Emphasized quality assurance via preventive actions, instead of just checking final product, and continued to require evidence of compliance with documented procedures.

• As with the first edition, the down-side was that companies tended to implement its requirements by creating shelf-loads of procedure manuals, and becoming burdened with an ISO bureaucracy. In some companies, adapting and improving processes could actually be hampered by the quality system.

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ISO 9001:2000

• combines the three standards 9001, 9002, and 9003 into one, called 9001. • Design and development procedures are required only if a company does

in fact engage in the creation of new products. • The 2000 version sought to make a radical change in thinking by actually

placing the concept of process management front and center ("Process management" was the monitoring and optimizing of a company's tasks and activities, instead of just inspecting the final product).

• The 2000 version also demands involvement by upper executives, in order to integrate quality into the business system and avoid delegation of quality functions to junior administrators. Another goal is to improve effectiveness via process performance metrics — numerical measurement of the effectiveness of tasks and activities. Expectations of continual process improvement and tracking customer satisfaction were made explicit.

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ISO 9001:2008

• Certification ISO 9001:2008 only introduces clarifications to the existing requirements of ISO 9001:2000 and some changes intended to improve consistency with ISO 14001:2004 (ISO 14001-Environmental management standards)

• There are no new requirements. • E.g: A quality management system being

upgraded just needs to be checked to see if it is following the clarifications introduced in the amended version

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Why an organization should implement ISO 9000?

• Without satisfied customers, an organization is in peril! To keep customers satisfied, the organization needs to meet their requirements.

• The ISO 9001:2008 standard provides a tried and tested framework for taking a systematic approach to managing the organization's processes so that they consistently turn out product that satisfies customers' expectations.

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• To check that it works:

1) The standard requires the organization itself to audit its ISO 9001:2008-based quality system to verify that it is managing its processes effectively - or, to put it another way, to check that it is fully in control of its activities.

2) In addition, the organization may invite its clients to audit the quality system in order to give them confidence that the organization is capable of delivering products or services that will meet their requirements.

3) Lastly, the organization may engage the services of an independent quality system certification body to obtain an ISO 9001:2008 certificate of conformity. This last option has proved extremely popular in the market-place because of the perceived credibility of an independent assessment.

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Advantages of ISO 9000

• A proper quality management improves business, often having a positive effect on investment, market share, sales growth, sales margins, competitive advantage, and avoidance of litigation. Some of the advantages:

• Create a more efficient, effective operation• Increase customer satisfaction and retention• Reduce audits• Enhance marketing• Improve employee motivation, awareness, and morale• Promote international trade• Increase profit• Reduce waste and increase productivity.

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Problems with ISO 9000• A common criticism of ISO 9001 is the amount of money, time and

paperwork required for registration.• not in any way an indication that products produced using its certified

systems are any good. A company can intend to produce a poor quality product and providing it does so consistently and with the proper documentation can put an ISO 9001 stamp on it.

• promotes specification, control, and procedures rather than understanding and improvement.

• effective as a guideline, but that promoting it as a standard helps to mislead companies into thinking that certification means better quality.

• reliance on the specifications of ISO 9001 does not guarantee a successful quality system.

• Another problem reported is the competition among the numerous certifying bodies, leading to a softer approach to the defects noticed in the operation of the Quality System of a firm

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ISO 9000 vs TQM

• ISO-9000 is a set of standards and focuses on documents. It ignores human element. On the contrary, TQM features on developing human elements.

• It is important to note that TQM and ISO 9000 Standard are not in opposition. One is supporting the other. The ISO-9000 standard establishes the principles for a management system which will improve a company’s performance. It provides basic building block for moving towards TQM. TQM is a much bigger concept than ISO. It is a way of life or an approach, which is peculated so that a company is better, managed.

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ISO 9000Focus on:• Certification• Product conforms to specification• Audits and check• Key processes• Quality system• External Trust• Visibility of capability prior to delivery• Maintenance of what is documented• An assurance to external customers that a quality system is

being pursued.

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TQM

Focus on:• Customer delight and satisfaction• Total organization including ‘invisible’ and visible resources• Total Quality Management• Internal and External Trust• Leadership• Internal Customer• Human Factor• Flexibility and change Management• Top management commitment• Continuous improvement

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• Although Total Quality Management (TQM) came on the scene first as a method for companies to improve profits and repeat business, complying to the ISO 9000 standards is the first thing a company should consider to improve the way it does business.