Origin Of ISO 9000 Standards

Origin Of ISO 9000 Standards
The story of ISO 9000 Standards is a story of standards, methods and regulation. The brief history that follows is in no way comprehensive but is intended to illustrate four things:
1. that ISO 9000 standards are an ancient concept that survived several millennia; that a means of verifying compliance often follows the setting of
standards;
2. that the formalizing of working practices is centuries old and seen as a
means to consistently meet standards;
3. that market regulation (relative to the standard of goods and services) has
been around for centuries for the protection of both craftsmen and
traders.
4. ISO 9000 is a symptom of practices that were around centuries before anyone coined the term quality management. It is in some respects a natural
progression that will continue to evolve. The story is told from a British
viewpoint.
ISO 9000 grew out of BS 5750, a standard published by the British Standards Institution (BSI) in 1979. Initially, it was used only in manufacturing industries. ISO 9000 is now employed across a variety of other types of businesses. It is a set of international standards of quality management systems. ISO 9000 has been accepted by more than 100 countries as their national quality assurance standard by the end of 1997.
The history of ISO 9000 Standards dates back to Mil-Q-9858a, the first quality standard for military procurement established in 1959 by the US. By 1962, NASA (National Aeronautics and Space Administration) developed its quality system requirements for suppliers. In 1965, NATO (North Atlantic Treaty Organization) accepted the AQAP (allied quality assurance procedures) specifications for the procurement of equipments.
During the 1970s, BSI published BS 9000 (the first UK standard for quality assurance) and BS 5179 (guidelines for quality assurance) norms. In 1979, it created BS 5750, a series of standards for use by manufacturing companies. They were enforced through assessments and audits. In 1988, ISO (International Standards Organization) adopted the BS 5750 standard without changes and published it globally under the name ISO 9000. The ISO adopted this standard with a view to create an international definition of the necessary characteristics of a quality system for all businesses, regardless of industry. In 1994, the ISO revised the ISO 9000 standard and published it globally.
In the beginning, ISO 9000 was implemented exclusively by large companies. But by mid-1990s, small and mid-sized companies began to increasingly implement these standards. In the United States, the total number of registrations increased from a little more than 2,200 in 1993 to more than 17,000 in 1998. Of these 17,000 registrations, almost 60 percent were held by businesses with annual sales of $100 million or less.

ISO 9000 family of standards and SMEs
The ISO 9000 quality management system is generic in nature and applicable to all companies, regardless of the type and size of the business, including small and medium enterprises (SMEs), and they are applicable to all categories of products, whether hardware, software, processed materials or services. ISO 9001:2008 specifies what is required to be done by an organization but does not indicate how it should be done, thus giving the enterprise a lot of flexibility to run its business.
It is simple to use, clear in language and easily understandable. The new standard is also appropriate for small companies, as it does not demand the type of paper bureaucracy needed for the implementation of the 1994 version. Only six documented procedures are now required and need for other procedures/documents can be decided by the company. Companies will, however, be required to provide objective evidence that the QMS has been effectively implemented. A small company may find it appropriate to include the description of its entire QMS within a single Quality Manual, including all the documented procedures required by the standard.
The process-based approach given in the new standard will tend to ensure that systems are documented and implemented in a manner that suits a SME’s own way of doing business. This approach makes it easier for SMEs to implement, instead of just taking over an artificial structure of QMS imposed from outside. It will also be easier for SMEs managed by their owners to demonstrate “top management commitment” towards QMS. Furthermore, in a SME, it is easier to ensure effective internal communication, better utilization of resources, people clearly understanding their roles and responsibilities, etc.
The new standard has included a provision for deciding on the applicability of
certain product realization processes included in section 7 of the standard. For example, if the SME has no responsibility for the design and development of the product it provides, the SME may say so, giving the reasoning behind it, in the Quality Manual; the certification body, being satisfied that this corresponds, would then award it certification to ISO 9001:2008. Similarly, other product realization processes such as purchasing, product identification and traceability, control of measuring devices may also be excluded if these are not applicable for the type of products or services being provided by the company.
It is also possible that SMEs may not have adequate in-house expertise or there may be other constraints to perform all processes on their own. In such cases, the new standard also permits the outsourcing of any of the QMS processes, providing the company has control over such processes. The nature of this control will depend on the nature of the outsourced or subcontracted processes and the risk involved. For example, the design and development process may be subcontracted to an expert or a specialized agency, inspection/verification of goods purchased may be subcontracted to an inspection agency, internal audit of QMS can be outsourced, etc. However, overall responsibility for ensuring control on all outsourced processes as per requirements of the standard would remain with the company’s management.

Scope Of The Quality Management System

Scope Of The Quality Management System
The ISO 9001 standard requires the quality manual to include the scope of the quality management system including details of justification for any exclusion. The standard addresses activities that may not be relevant or applicable to an organization. The permissible exclusions are explained in section 1.2 of ISO 9001. Here it states that the organization may only exclude requirements that neither affect the organization’s ability, nor its responsibility to provide product that meets customer and applicable regulatory requirements. The requirements for which exclusion is permitted are limited to those in section 7 of the standard.
Under ISO 9001:2008, it was possible for organizations to exclude functions and processes of their organization that may have been difficult to control or were not part of the order fulfilment cycle. Organizations that designed their own products but not for specific customers could escape bringing these operations into the management system. Marketing was omitted because it operated before placement of order. Accounting, Administration, Maintenance, Publicity, Public Relations and After Sales Support functions were often omitted because there were no requirements in the standard that specifically dealt with such activities. As there is no function in an organization that does not directly or indirectly serve the satisfaction of interested parties, it is unlikely that any function or process will now be excluded from the quality management system.
It is sensible to describe the scope of the quality management system so as to ensure effective communication. The scope of the quality management system is one area that generates a lot of misunderstanding particularly when dealing with auditors, consultants and customers. When you claim you have a management system that meets ISO 9001 it could imply that you design, develop, install and service the products you supply, when in fact you may only be a distributor. Why you need to justify specific exclusions is uncertain because it is more practical to justify inclusions.
The scope of the quality management system is the scope of the organization. There is no longer any reason to exclude locations, activities, functions or processes for which there is no requirement in the standard. The reason is because the ISO 9000 family now serves customer satisfaction and is not limited to quality assurance as were the 1994 versions of ISO 9001, ISO 9002 and ISO 9003.
It is not appropriate to address exclusions by inserting pages in the manual corresponding to the sections of the standard and adding justification if not within the scope of the management system – such as ‘We don’t do this!’.
It is much more appropriate to use an appendix as indicated previously in the manual contents list. By describing the nature of the business, you are establishing boundary conditions. If in doing so you do not mention that you design products, it will be interpreted that design is not applicable.
For exclusions relative to detail requirements, the Compliance Matrix may suffice but for an unambiguous solution, it is preferable to produce an exposition that addresses each requirement of the standard.

ISO 9000 Standards ..

What Is ISO 9000 Standards?
ISO 9000 is a set of interrelated ideas, principles and rules and could therefore be considered a system in the same way that we refer to the metric system or the imperial system of measurement. ISO 9000 is both an international standard and until year 2008, was a family of some 20 international standards. As a standard, ISO 9000 was divided into 4 parts with part 1 providing guidelines on the selection and use of the other standards in the family. The family of standards included requirements for quality assurance and guidelines on quality management. Some might argue that none
of these are in fact standards in the sense of being quantifiable. The critics argue that the standards are too open to interpretation to be standards anything that produces such a wide variation is surely an incapable process with one of its primary causes being a series of objectives that are not measurable. However, if we take a broader view of standards, any set of rules, rituals, requirements, quantities, targets or behaviours that have been agreed by a group of people could be deemed to be a standard. Therefore by this definition, ISO 9000 is a standard.

ISO 9001 Standard - ISO 9001:2008 Standards

What Is ISO 9000 Standards

What Is ISO 9000 Standards?

ISO 9000 is a set of interrelated ideas, principles and rules and could therefore be considered a system in the same way that we refer to the metric system or the imperial system of measurement. ISO 9000 is both an international standard and until year 2008, was a family of some 20 international standards. As a standard, ISO 9000 was divided into 4 parts with part 1 providing guidelines on the selection and use of the other standards in the family. The family of standards included requirements for quality assurance and guidelines on quality management. Some might argue that none
of these are in fact standards in the sense of being quantifiable. The critics argue that the standards are too open to interpretation to be standards anything that produces such a wide variation is surely an incapable process with one of its primary causes being a series of objectives that are not measurable. However, if we take a broader view of standards, any set of rules, rituals, requirements, quantities, targets or behaviours that have been agreed by a group of people could be deemed to be a standard. Therefore by this definition, ISO 9000 is a standard.

Origin Of ISO 9000 Standards Video

Origin Of ISO 9000 Standards

The story of ISO 9000 Standards is a story of standards, methods and regulation. The brief history that follows is in no way comprehensive but is intended to illustrate four things:
1. that ISO 9000 standards are an ancient concept that survived several millennia; that a means of verifying compliance often follows the setting of
standards;
2. that the formalizing of working practices is centuries old and seen as a
means to consistently meet standards;
3. that market regulation (relative to the standard of goods and services) has
been around for centuries for the protection of both craftsmen and
traders.
4. ISO 9000 is a symptom of practices that were around centuries before anyone coined the term quality management. It is in some respects a natural
progression that will continue to evolve. The story is told from a British
viewpoint.

ISO 9000 grew out of BS 5750, a standard published by the British Standards Institution (BSI) in 1979. Initially, it was used only in manufacturing industries. ISO 9000 is now employed across a variety of other types of businesses. It is a set of international standards of quality management systems. ISO 9000 has been accepted by more than 100 countries as their national quality assurance standard by the end of 1997.
The history of ISO 9000 Standards dates back to Mil-Q-9858a, the first quality standard for military procurement established in 1959 by the US. By 1962, NASA (National Aeronautics and Space Administration) developed its quality system requirements for suppliers. In 1965, NATO (North Atlantic Treaty Organization) accepted the AQAP (allied quality assurance procedures) specifications for the procurement of equipments.
During the 1970s, BSI published BS 9000 (the first UK standard for quality assurance) and BS 5179 (guidelines for quality assurance) norms. In 1979, it created BS 5750, a series of standards for use by manufacturing companies. They were enforced through assessments and audits. In 1988, ISO (International Standards Organization) adopted the BS 5750 standard without changes and published it globally under the name ISO 9000. The ISO adopted this standard with a view to create an international definition of the necessary characteristics of a quality system for all businesses, regardless of industry. In 1994, the ISO revised the ISO 9000 standard and published it globally.
In the beginning, ISO 9000 was implemented exclusively by large companies. But by mid-1990s, small and mid-sized companies began to increasingly implement these standards. In the United States, the total number of registrations increased from a little more than 2,200 in 1993 to more than 17,000 in 1998. Of these 17,000 registrations, almost 60 percent were held by businesses with annual sales of $100 million or less.

Commitment and Environmental Policy

An environmental policy is a statement of the organization’s overall aims and principles ofaction with respect to the environment, including compliance with all relevant stakeholders. As such, it should be written clearly and concisely to enable a
regulatory requirements. It is a key tool in communicating the environmental priorities of your organization to employees at all levels, as well as to external layperson to understand it, and should be made publicly available. It is up to the organization to decide on environmental priorities based on an initial environmental review, but these choices should be justified in the policy. To be truly effective the policy should regularly be reviewed and revised and incorporated into the organization’s overall corporate policy. The policy statement should set in writing a few achievable quantifiable priorities related to the environmental management system and the significant environmental effects found at the work-site. Furthermore, EMAS requires that the most signifcant environmental effects be mitigated within three years. Some form of improvement must also be accomplished from year-to-year by the organization and must be shown in the annual reports.

Although the formulation of policies and clear priorities is the most important step of
environmental management, this step is often neglected. Many top managers feel pressure to do something for the environment and thus embark on some form of ?Environmental activism?E often containing many isolated activities but no clear direction. For an organization to be a credible and efficient environmental performer and to reap the benefits of being an environmental leader in its markets, the rationale for investing in environmental management must be very clear.

To ensure an organization’s commitment towards a formulated environmental policy, it is
essential that top management is involved in the process of formulating the policy and of setting priorities. Therefore the first step is to get the commitment from the highest level of management. Based on this commitment the organization should then conduct an initial environmental review and draft an environmental policy. This draft should be discussed and approved by the board of directors. Finally, the approved environmental policy statement must be communicated internally and made available to the public.

As the environmental policy establishes an overall sense of direction and sets the principles
of action for an organization, it requires commitment from the highest level of management. Top management should be involved in the development and adoption of an environmental policy.

Getting the commitment from the highest level should be argued on the basis of costs and the implementation of an EMS increases shareholder value it is easier for top
benefits and their impact on shareholder value. If management to commit themselves to approving an environmental policy and to implementing an environmental management system. This commitment includes three basic policy statements:
Continuous improvement in environmental performance
Compliance with environmental regulations



Maintaining public relations regarding environmental issues of the organization, its activities, products and services.

The central focus of the policy should be a commitment to continuous improvement. This

means improvement in the EMS itself and a decrease in environmental impacts caused by an organization’s activities, products and services. It is important for businesses to show improvement over time, both in environmental performance and in organizational commitment to this path.

A commitment to comply with at least local environmental regulations is a minimum
requirement for all of the environmental standards. However, multinationals operating in various environments and facing different laws in each, should think about which laws to abide by and if it is feasible to adopt the same standard worldwide. Generally, laws in newly industrializing countries are lax as compared to industrialized countries. However, given the increase in interest in environmental issues in these industrializing countries and the possible impact of the ISO 14000 series, it may be sound practice to adopt the more stringent laws in worldwide operations, where it is feasible to do so. In addition, the adoption of high standards worldwide can yield other benefits, such as an improved public image or easier technology transfer between different sites.

Companies should guard against going overboard in fulfilling environmental policies. Limits
are in fact set on how far a company has to go to reduce its environmental impacts. Reductions do not have to exceed levels which can be achieved by economically viable application of the best available technology (BAT).

Measurement and Evaluation In ISO 14001:2004

After implementing the environmental policy, management needs to measure environmental that the data can be verified by an internal or external auditor.
interventions and their impact on the environment. This is done by building up an environmental effects register (environmental inventory). All equipment used for monitoring and measuring must be accurate and calibrated on a regular basis. To check the compliance status of an organization, additional information about regulations and other requirements is needed. A so called environmental regulations register?Eis often installed and maintained for this purpose. To obtain a better picture about the financial consequences of environmental protection, the accounting system should reflect environmental costs. Therefore, information about environmentally-induced costs and earnings needs to be collected. All this information should be recorded in such a manner.er
Environmental Performance Evaluation Accesses Environment Performance against environmental targets and objectives and against applicable environmental regulations. Responsibilities and authority need to be defined to deal with non-compliance within the EMS. This includes specifying the actions to be taken to correct an undesirable ituation and to prevent future non-compliance.
The analysis of environmental and economic performance leads to eco efficiency, the key component in sustainable business management.
The analysis of environmental and economic performance leads to eco
efficiency, the key component in sustainable business management. The recording of physical environmental data, environmental regulations and environmentally-induced financial information is necessary as a basis for effective decision making. Therefore, financial, legal and ecological data systems must be built up from scratch or adapted to the requirements of the EMS standard.

Basic QC and Six Sigma Tools

The 7 QC Tools
The Seven Quality Control tools (7QC tools) are graphical and statistical tools which are most often used in QC for continuous improvement. Since they are so widely utilized by almost every level of the company, they have been nicknamed the Magnificent Seven. They are applicable to improvements in all dimensions of the process performance triangle: variation of quality, cycle time and yield of productivity.
Each one of the 7QC tools had been used separately before 1960. However, in the early 1960s, they were gathered together by a small group of Japanese scientists lead by Kaoru Ishikawa, with the aim of providing the QC Circles with effective and easy-to-use tools. They are, in alphabetical order, cause-and-effect diagram, check sheet, control chart, histogram, Pareto chart, scatter diagram and stratification. In Six Sigma, they are extensively used in all phases of the improvement methodology – define, measure, analyze, improve and control.
(1) Cause-and-effect diagram
An effective tool as part of a problem-solving process is the cause-and-effect diagram, also known as the Ishikawa diagram (after its originator) or fishbone diagram. This technique is useful to trigger ideas and promote a balanced approach in group brainstorming sessions where individuals list the perceived sources (causes) with respect to outcomes (effect).
When constructing a cause-and-effect diagram, it is often appropriate to consider six main causes that can contribute to an outcome response (effect): so-called 5M1E (man, machine, material, method, measurement, and environment).
When preparing a cause-and-effect diagram, the first step is to agree on the specific wording of the effect and then to identify the main causes that can possibly produce the effect. The main causes can often be identified as any of 5M1E, which helps us to get started, but these are by no means exhaustive.
Using brainstorming techniques, each main cause is analyzed. The aim is to refine the list of causes in greater detail until the root causes of that particular main cause are established. The same procedure is then followed for each of the other main causes. The method is a main cause, the pressure and the temperature are the causes, and “the pressure is low” and “the temperature is too high” are the root causes.
(2) Check sheet
The check sheet is used for the specific data collection of any desired characteristics of a process or product that is to be improved. It is frequently used in the measure phase of the Six Sigma improvement methodology, DMAIC. For practical purposes, the check sheet is commonly formatted as a table. It is important that the check sheet is kept simple and that its design is aligned to the characteristics that are measured. Consideration should be given as to who should gather the data and what measurement intervals to apply. For example, Figure 4.2 shows a check sheet for defect items in an assembly process of automobile ratios.
(3) Control chart
(a) Introduction
The control chart is a very important tool in the “analyze, improve and control” phases of the Six Sigma improvement methodology. In the “analyze” phase, control charts are applied to judge if the process is predictable; in the “improve” phase, to identify evidence of special causes of variation so that they can be acted on; in the “control” phase, to verify that the performance of the process is under control.
The original concept of the control chart was proposed by Walter A. Shewhart in 1924 and the tool has been used extensively in industry since the Second World War, especially in Japan and the USA after about 1980. Control charts offer the study of variation and its source. They can give process monitoring and control, and can also give direction for improvements. They can separate special from common cause issues of a process. They can give early identification of special causes so that there can be timely resolution before many poor quality products are produced. Shewhart control charts track processes by plotting data over time in the form shown in Figure 4.3. This chart can track either variables or attribute process parameters. The types of variable charts are process mean (x), range (R), standard deviation (s), individual value (x) and moving range (Rs). The attribute types are fraction nonconforming (p), number of nonconforming items (np), number of nonconformities (c), and nonconformities per unit (u).
(4) Histogram
It is meaningful to present data in a form that visually illustrates the frequency of occurrence of values. In the analysis phase of the Six Sigma improvement methodology, histograms are commonly applied to learn about the distribution of the data within the results Ys and the causes Xs collected in the measure phase and they are also used to obtain an understanding of the potential for improvements.
(5) Pareto chart
The Pareto chart was introduced in the 1940s by Joseph M.Juran, who named it after the Italian economist and statistician Vilfredo Pareto, 1848–1923. It is applied to distinguish the “vital few from the trivial many” as Juran formulated the purpose of the Pareto chart. It is closely related to the so-called 80/20 rule – “80% of the problems stem from 20% of the causes,” or in Six Sigma terms “80% of the poor values in Y stem from 20% of the Xs.”
In the Six Sigma improvement methodology, the Pareto chart has two primary applications. One is for selecting appropriate improvement projects in the define phase. Here it offers a very objective basis for selection, based on, for example, frequency of occurrence, cost saving and improvement potential in process performance.
The other primary application is in the analyze phase for identifying the vital few causes (Xs) that will constitute the greatest improvement in Y if appropriate measures are taken.
A procedure to construct a Pareto chart is as follows:
1) Define the problem and process characteristics to use in the diagram.
2) Define the period of time for the diagram – for example, weekly, daily, or shift.
Quality improvements over time can later be made from the information determined within this step.
3) Obtain the total number of times each characteristic occurred.
4) Rank the characteristics according to the totals from
(6) Scatter diagram
The scatter plot is a useful way to discover the relationship between two factors, X and Y, i.e., the correlation. An important feature of the scatter plot is its visualization of the correlation pattern, through which the relationship can be determined. In the improve phase of the Six Sigma improvement methodology, one often searches the collected data for Xs that have a special influence on Y. Knowing the existence of such relationships, it is possible to identify input variables that
cause special variation of the result variable. It can then be determined how to set the input variables, if they are controllable, so that the process is improved. When several Xs may influence the values of Y, one scatter plot should be drawn for each combination of the Xs and Y.
(7) Stratification
Stratification is a tool used to split collected data into subgroups in order to determine if any of them contain special cause variation. Hence, data from different sources in a process can be separated and analyzed individually. Stratification is mainly used in the analyze phase to stratify data in the
search for special cause variation in the Six Sigma improvement methodology.
The most important decision in using stratification is to determine the criteria by which to stratify. Examples can be machines, material, suppliers, shifts, day and night, age groups and so on. It is common to stratify into two groups. If the number of observations is large enough, more detailed stratification is also possible.

TQM and Six Sigma

While Six Sigma is definitely succeeding in creating some impressive results and culture changes in some influential organizations, it is certainly not yet a widespread success. Total Quality Management (TQM) seems less visible in many businesses than it was in the early 1990s. However, many companies are still engaged in improvement efforts based on the principles and tools of TQM. It appears at least in Korea that Six Sigma is succeeding while TQM is losing its momentum.
One of the problems that plagued many of the early TQM initiatives was the preeminence placed on quality at the expense of all other aspects of the business. Some organizations experienced severe financial consequences in the rush to make quality “first among equals.” The disconnection between management systems designed to measure customer satisfaction and those designed to measure provider profitability often led to unwise investments in quality, which has been often practiced in TQM. Ronald Snee (1999) points out that although some people believe it is nothing new, Six Sigma is unique in its approach and deployment. He defines Six Sigma as a strategic business improvement approach that seeks to increase both customer satisfaction and an organization’s financial health. Snee goes on to claim that the following eight characteristics account for Six Sigma’s increasing bottom-line (net income or profit) success and popularity with executives.
• Bottom-line results expected and delivered
• Senior management leadership
• A disciplined approach (DMAIC)
• Rapid (3–6 months) project completion
• Clearly defined measures of success
• Infrastructure roles for Six Sigma practitioners and leadership
• Focus on customers and processes
• A sound statistical approach to improvement
Other quality initiatives including TQM have laid claim to a subset of these characteristics, but only Six Sigma attributes its success to the simultaneous application of all eight. Six Sigma is regarded as a vigorous rebirth of quality ideals and methods, as these are applied with even greater passion and commitment than often was the case in the past. Six Sigma is revealing a potential for success that goes beyond the levels of improvement achieved through the many TQM efforts. Some of the mistakes of yesterday’s TQM efforts certainly might be repeated in a Six Sigma initiative if we are not careful.
A review of some of the major TQM pitfalls, as well as hints on how the Six Sigma system can keep them from derailing our efforts is listed below.
1. Links to the business and bottom-line success:
In TQM, quality often was a “sidebar” activity, separated from the key issues of business strategy and performance. The link to the business and bottom-line success was undermined, despite the term “total” quality, since the effort actually was limited to product and manufacturing functions. Six Sigma emphasizes reduction of costs, thereby contributing to the bottom-line, and participation of three major areas: manufacturing, R&D and service parts.
2. Top-level management leadership:
In many TQM efforts, top-level management’s skepticism has been apparent, or their willingness to drive quality ideas has been weak. Passion for and belief in Six Sigma at the very summit of the business is unquestioned in companies like
Motorola, GE, Allied Signal (now Honeywell), LG and Samsung. In fact, top-level management involvement is the beginning of Six Sigma.
3. Clear and simple message:
The fuzziness of TQM started with the word “quality” itself. It is a familiar term with many shades of meaning. In many companies, Quality was an existing department with specific responsibilities for “quality control” or “quality assurance,” where the discipline tended to focus more on stabilizing rather than improving processes. Also TQM does not provide a clear goal at which to aim. The concept of Six Sigma is clear and simple. It is a business system for achieving and sustaining success through customer focus, process management and improvement, and the wise use of facts and data. A clear goal (3. 4 DPMO or 6s quality level) is the centerpiece of Six Sigma.
4. Effective training:
TQM training was ineffective in the sense that the training program was not so systematic. Six Sigma divides all the employees into five groups (WB, GB, BB, MBB and Champion), and it sets very demanding standards for learning, backing them up with the necessary investment in time and money to help people meet those standards.
5. Internal barriers:
TQM was a mostly “departmentalized” activity in many companies, and it seemed that TQM failed to break down internal barriers among departments. Six Sigma places priority on cross-functional process management, and cross-functional project teams are created, which eventually breaks down internal barriers.
6. Project team activities:
TQM utilized many “quality circles” of blue-collar operators and workers, and not many “task force teams” of white-collar engineers even if they are needed. Six Sigma demands a lot of project teams of BBs and GBs, and the project team activities are one of the major sources of bottom-line and top-line success.
3. Clear and simple message:
The fuzziness of TQM started with the word “quality” itself. It is a familiar term with many shades of meaning. In many companies, Quality was an existing department with specific responsibilities for “quality control” or “quality assurance,” where the discipline tended to focus more on stabilizing rather than improving processes. Also TQM does not provide a clear goal at which to aim. The concept of Six Sigma is clear and simple. It is a business system for achieving and sustaining success through customer focus, process management and improvement, and the wise use of facts and data. A clear goal (3. 4 DPMO or 6s quality level) is the centerpiece of Six Sigma.

4. Effective training:
TQM training was ineffective in the sense that the training program was not so systematic. Six Sigma divides all the employees into five groups (WB, GB, BB, MBB and Champion), and it sets very demanding standards for learning, backing them up with the necessary investment in time and money
to help people meet those standards.

5. Internal barriers:
TQM was a mostly “departmentalized” activity in many companies, and it seemed that TQM failed to break down internal barriers among departments. Six Sigma places priority on cross-functional process management, and cross-functional project teams are created, which eventually breaks down internal barriers.

6. Project team activities:
TQM utilized many “quality circles” of blue-collar operators and workers, and not many “task force teams” of white-collar engineers even if they are needed. Six Sigma demands a lot of project teams of BBs and GBs, and the project team activities are one of the major sources of bottom-line and top-line success.

ISO 9000 Series and Six Sigma

ISO (International Organization for Standardization) 9000 series standards were first published in 1987, revised in 1994, and re-revised in 2000 by the ISO. The 2000 revision, denoted by ISO 9000:2000, has attracted broad expectations in industry.
As of the year 2001, more than 300,000 organizations world-wide have been certified to the ISO 9000 series standards. It embodies a consistent pair of standards, ISO 9001:2000 and ISO 9004:2000, both of which have been significantly updated and modernized. The ISO 9001:2000 standard specifies requirements for a quality management system for which third-party certification is possible, whereas ISO 9004:2000 provides guide- lines for a comprehensive quality management system and performance improvement through Self-Assessment.
The origin and historical development of ISO 9000 and Six Sigma are very different. The genesis of ISO 9000 can be traced back to the standards that the British aviation industry and the U.S. Air Force developed in the 1920s to reduce the need for inspection by approving the conformance of suppliers’ product quality. These standards developed into requirements for suppliers’ quality assurance systems in a number of western countries in the 1970s. In 1987 they were amalgamated into the ISO 9000 series standards.
Independent of ISO 9000, the same year also saw the launch of Six Sigma at Motorola and the launch of Self-Assessment by means of the Malcolm Baldrige National Quality Award in USA. Both Six Sigma and Self-Assessment can be traced back to Walter A. Shewhart and his work on variation and continuous improvement in the 1920s. It was Japanese industry that pioneered a broad application of these ideas from the 1950s through to the 1970s. When variation and continuous improvement caught the attention of some of the American business leaders in the late 1980s, it took the form of the Malcolm Baldrige National Quality Award, on a national level, and of Six Sigma at Motorola.
Some people are wondering if the ISO 9000:2000 series standards make Six Sigma superfluous. They typically refer to clause 8 of ISO 9001: “Measurement, analysis, improvement.”
It requires that companies install procedures in operations for the measurement of processes and data analysis using statistical techniques with the demonstration of continuous improvement . They also partly refer to the ISO 9004:2000 standards that embody guidelines and criteria for Self-Assessment similar to the national quality awards.
The author firmly believes that Six Sigma is needed regardless of whether a company is compliant with the ISO 9000 series. The two initiatives are not mutually exclusive and the objectives in applying them are different. A Six Sigma program is applied in organizations based on its top-line and bottom-line rationales. The primary objective for applying the ISO 9000 series standards is to demonstrate the company’s capability to consistently provide conforming products and/or services. Therefore, the ISO 9000 series standard falls well short of making Six Sigma superfluous.
The ISO 9000 series standards have from their early days been regarded and practiced by industry as a minimum set of requirements for doing business. The new ISO 9000:2000 stan
dards do not represent a significant change to this perspective. Six Sigma on the other hand, aims at world-class performance, based on a pragmatic framework for continuous improvement.
The author believes that Six Sigma is superior in such important areas as rate of improvement, bottom-line and top-line results, customer satisfaction, and top-level management commitment. However, considering the stronghold of ISO 9000 in industry, Six Sigma and ISO 9000 are likely to be applied by the same organization, but for very different purposes.

Lean Manufacturing and Six Sigma

(1) What is lean manufacturing?
Currently there are two premier approaches to improving manufacturing operations. One is lean manufacturing (hereinafter referred to as “lean”) and the other is Six Sigma.
Lean evaluates the entire operation of a factory and restructures the manufacturing method to reduce wasteful activities like waiting, transportation, material hand-offs,inventory, and over-production. It reduces variation associated with manufacturing routings, material handling, storage, lack of communication, batch production and so forth. Six Sigma tools, on the other hand, commonly focus on specific part numbers and processes to reduce variation. The combination of the two approaches represents a formidable opponent to variation in that it includes both layout of the factory and a focus on specific part numbers and processes.
Lean and Six Sigma are promoted as different approaches and different thought processes. Yet, upon close inspection, both approaches attack the same enemy and behave like two links within a chain – that is, they are dependent on each other for success. They both battle variation, but from two different points of view. The integration of Lean and Six Sigma takes two powerful problem-solving techniques and bundles them into a powerful package. The two approaches should be viewed as complements to each other rather than as equiva
lents of or replacements for each other (Pyzdek, 2000). In practice, manufacturers that have widely adopted lean practices record performance metrics superior to those achieved by plants that have not adopted lean practices. Those practices cited as lean in a recent industrial survey (Jusko, 1999) include
• quick changeover techniques to reduce setup time;
• adoption of manufacturing cells in which equipment and workstations are arranged sequentially to facilitate small-lot, continuous-flow production;
• just-in-time (JIT) continuous-flow production techniques to reduce lot sizes, setup time, and cycle time; and,
• JIT supplier delivery in which parts and materials are delivered to the shop floor on a frequent and as-needed basis.
(2) Differences between Lean and Six Sigma
There are some differences between Lean and Six Sigma as noted below.
• Lean focuses on improving manufacturing operations in variation, quality and productivity. However, Six Sigma focuses not only on manufacturing operations, but also on all possible processes including R&D and service areas.
• Generally speaking, a Lean approach attacks variation differently than a Six Sigma system does (Denecke, 1998) as shown in Figure 5.4. Lean tackles the most common form of process noise by aligning the organization in such a way that it can begin working as a coherent whole instead of as separate units. Lean seeks to co-locate, in sequential order, all the processes required to produce a product. Instead of focusing on the part number, Lean focuses on product flow and on the operator. Setup time, machine maintenance and routing of processes are important measures in Lean. However, Six Sigma focuses on defective rates and costs of poor quality due to part variation and process variation based on measured data.
• The data-driven nature of Six Sigma problem-solving lends itself well to lean standardization and the physical rearrangement of the factory. Lean provides a solid foundation for Six Sigma problem-solving where the system is measured by deviation from and improvements to the standard.
• While Lean emphasizes standardization and productivity, Six Sigma can be more effective at tackling process noise and cost of poor quality.

Seven Steps for Six Sigma Introduction

When a company intends to introduce Six Sigma for its new management strategy, we would like to recommend the following seven-step procedures:
1. Top-level management commitment for Six Sigma is first and foremost. The CEO of the corporation or business unit should genuinely accept Six Sigma as the management strategy. Then organize a Six Sigma team and set up the long-term Six Sigma vision for the company.
2. Start Six Sigma education for Champions first. Then start the education for WBs, GBs, BBs and MBBs in sequence. Every employee of the company should take the WB education first and then some of the WBs receive the GB education, and finally some of the GBs receive the BB education. However, usually MBB education is practiced in professional organizations.
3. Choose the area in which Six Sigma will be first introduced.
4. Deploy CTQs for all processes concerned. The most important is the company’s deployment of big CTQy from the standpoint of customer satisfaction. Appoint BBs as full-time project leaders and ask them to solve some important CTQ problems.
5. Strengthen the infrastructure for Six Sigma, including measurement systems, statistical process control (SPC), knowledge management (KM), database management system (DBMS) and so on.
6. Designate a Six Sigma day each month, and have the progress of Six Sigma reviewed by top-level management.
7. Evaluate the company’s Six Sigma performance from the customers’ viewpoint, benchmark the best company in the world, and revise the Six Sigma roadmap if necessary. Go to step 1 for further improvement.
First of all, a handful or a group of several members should be appointed as a Six Sigma team to handle all kinds of Six Sigma tasks. The team is supposed to prepare proper education and the long-term Six Sigma vision for the company. We can say that this is the century of the 3Cs, which are Changing society, Customer satisfaction and Competition in quality. The Six Sigma vision should be well matched to these 3Cs. Most importantly, all employees in the company should agree to and respect this long-term vision.
Second, Six Sigma can begin from proper education for all classes of the company. The education should begin from the top managers, so called Champions. If Champions do not understand the real meaning of Six Sigma, there is no way for Six Sigma to proceed further in the company. After Champion’s education, GB BB MBB education should be completed in sequence.
Third, we can divide Six Sigma into three parts according to its characteristics. They are R&D Six Sigma, manufacturing Six Sigma, and Six Sigma for non-manufacturing areas. The R&D Six Sigma is often called DFSS (Design for Six Sigma). It is usually not wise to introduce Six Sigma to all areas at the same time. The CEO should decide the order of introduction to these three areas. It is common to introduce Six Sigma to manufacturing processes first, and then service areas and R&D areas. However, the order really depends on the current circumstances of the company.
Fourth, deploy CTQs for all processes concerned. These CTQs can be deployed by policy management or by management by objectives. Some important CTQs should be given to BBs to solve as project themes. In principle, the BBs who lead the project teams work as full-time workers until the projects are finished.

Useful Aids to Implement ISO 9001 Standards

Useful Aids To Implement ISO 9001 Standards
Many companies implement ISO 9001 without using all the available tools. As a result, some companies may not fully optimize their implementation. This issue could be manifested as confusion over terms, misunderstanding about requirements, and perplexity concerning intention.ISO, the International Organization for Standardization, based in Geneva Switzerland issues thousands of standards, but we limit our scope to ISO 9001:2008 and its immediate “family”.This includes ISO 9000:2005 and ISO 9004:20002. ISO 9001 is a general industry standard for quality management, but ISO also issues industry specific standards. Many of these standards, such as ISO 13485 for medical devices, are based on ISO 9001 and can also utilize these available tools.
In addition to the information discussed below, ISO also issues standards related to specific activities that may arises in a quality management system. The following lists these supporting documents.
Automotive ISO/TS 16949:2002Education IWA 2:2007Energy PC 242, ISO 50001Food safety ISO 22000:2005Information security ISO/IEC 27001:2005Health care IWA 1:2005Local government IWA 4:2005Medical devices ISO 13485:2003Petroleum and gas ISO 29001:2003Ship recycling ISO/PAS 30000:2008Supply chain security ISO 28000:2007

Process Approach In ISO 9001 Standards

Process Approach In ISO 9001 Standards
The process approach was introduced into ISO 9001 with the year 2000 version of the standards.Prior versions used an element approach. The document Guidance on the concept and use of the process approach for management systems describes to process approach and offers an implementation paradigm.1. Identification of processes of the organization1.1. Define the purpose of the organization1.2. Define the policies and objectives of the organization1.3. Determine the processes in the organization1.4. Determine the sequence of the processes1.5. Define process ownership1.6. Define process documentation2. Planning of a process2.1. Define the activities within the process2.2. Define the monitoring and measurement requirements2.3. Define the resources needed
2.4. Verify the process and its activities against its planned objectives3. Implementation and measurement of the process4. Analysis of the process5. Corrective action and improvement of the process ImplementationThis document explains the process used to evaluate changes to the 2008 version. In particular, it explains the revision process and illustrates the impact vs. benefit analysis used to evaluate potential changes.In addition to the guidance documents, ISO maintains a web site with “official interpretations” of ISO 9001. Currently, these interpretations only include ISO 9001:2000, but, because the changes to the 2008 version were limited, they are valuable.Consider a common question. An organization needs a documented procedure for preventive action (8.5.3), and must keep records of the results of preventive action (8.5.3.d). One of the interpretation requests asks, “Does sub-clause 8.5.3 a) require organizations to demonstrate, with objective evidence in the form of records, that they have undertaken actions to determine the existence of ‘potential nonconformities and their causes’?” The answer is “No”.Auditing PracticesThe ISO 9001 Auditing Practices Group maintains a website9 with guidance and information on auditing ISO 9001 quality management systems. It is an informal group of quality management system (QMS) experts, auditors, and practitioners drawn from the ISO Technical Committee 176 Quality Management and Quality Assurance (ISO/TC 176) and the International Accreditation Forum (IAF).The website, primarily aimed at QMS auditors, consultants, and quality practitioners, is an online source of papers and presentations on auditing a QMS and reflect the process based approach.The website contains almost forty guidance documents with practical advice ranging from “How to audit top management processes” to “The role and value of the audit checklist”.

Why Deploy Six Sigma?

Why Deploy Six Sigma in your organization?
Here are some reasons why we should be using Six Sigma to make process improvements:
a) It is a structured approach – if we follow the process, people will not forget any important steps along the way before they implement the solution.
b) It helps quantify the benefits and thus make it easier to sell the improvements to senior managers in the company.
c) It uses facts & data and the rigor of statistical testing to arrive at the right root cause instead of fixing symptoms or putting band-aids.
d) There is a greater likelihood of the solution being sustainable if we follow the Six Sigma process.
e) Six Sigma focuses of solving the right problems using the project selection matrix.
f) It has proven itself in a large number of deployments. Frankly, there is no better tool out there to make process improvements – especially when the root cause or the solution is not known.

Quality Planning

Whenever the term “product” is used within the ISO 9001 standard, it refers to both tangible goods and intangible services. The ISO 9001 standard is meant to be generic which means that it is suitable for all kinds of organization, whether commercial or otherwise. The purpose of the quality management system model that is being propagated by the standard is the fulfillment of customer requeirements and expectations in order to induce high levels of customer satisfaction. An unsatisfied customer is essentially a customer whose requirements or needs, and expectations of the level of services being granted upon him/her have not been met. We are all customers because we buy products all the time. So we know what it means to be a dissatisfied customer. The common reaction is to never to go back to that seller and look for other alternatives. A successful organization is one which understands what it takes to meet customer requirements in order to satisfy their needs and expectations. A specific process is thus necessary to resolve any customer complaint or dispute. This process should be geared towards satisfying the customer’s needs and expectations. The parameters of this process should be referenced from the terms of the sale and purchase. This is why it is necessary to review the customer’s requirements before committing to the sales contract. It is necessary that the customer understands what he/she is paying for and it is equally necessary for the organization to understand what it is supposed to deliver. When your organization has these processes in place, then the only thing to do next is to continually measure the effectiveness and subsequently take actions to continually improve the whole process.

ISO 9001 Standards Software

ISO 9001 Standards Software
Companies that need quality management systems realize that products like ISO 9001 software are important tools to insure their product safety, consistency and profitability. Using ISO 9001 software can help guarantee that any company can monitor productivity, customer satisfaction and product quality with reports that contain solid information.
This information is now vital to management in order for maximum efficiency in any industry. This is why ISO 9001 software is vital to any sized company. Continuous improvement means continuous profitability. Here are just a few reasons why:
o Companies increase sales because of better performance, quality, and delivery. This propels you ahead of your competition.
o ISO 9001 software helps retain employees and attract more highly qualified employees because they are assured of a controlled and consistent work environment.
o The experience of a more professional workplace boosts employee morale.
o Reduced operating costs dramatically increase your company’s productivity, leading to higher profitability.
o Customer satisfaction and higher profitability expand your market share and demand for your consistently higher product quality.
o When you’re compliant or certified to the appropriate standard, the businesses that work with you know that quality objectives, continuous improvement, and customer satisfaction are your goals.
Many companies require that their suppliers are ISO 9001 compliant; therefore, once you’re certified, your opportunities increase. ISO 9001 software has be utilized and has developed experience of helping manufacturing, service, and distribution organizations to be more efficient and more profitable through continuous improvement programs. We help you to implement the time-tested methods of continuous improvement to measure performance, analyze data, and apply the appropriate process changes. This includes using ISO 9001 software.
ISO 9001 software also offers a suite of modules to enable you to manage the document management and ISO 9001 Compliance Management process. These modules enable complete transparent system measurement with targeted action items ensuring all persons are notified of tasks and carry them out in a prompt and efficient manner. ISO 9001 software provides training in there software and also bring extensive experience in implementing the ISO 9001 software in various environments.

ISO 14001 And The Environment

The ISO 14000 family of International Standards on environmental management is a relative newcomer to ISO’s portfolio – but enviroment-related standardization is far from being a new departure for ISO.
In fact, ISO has two-pronged approach to meeting the needs of business, industry, governments, non-governmental organizations and consumers in the field of the environment.
On the one hand, it offers a wideranging portfolio of standardized sampling, testing and analytical methods to deal with specific environmental challenges. It has developed more than 350 International Standards (out of a total morethan 12000) for the monitoring of such aspects as the quality of air, water and soil. These standards are means of providing business and government with scientifically valid data on the environmental effects of economic activity.
They also serve in a number of countries as the technical basis for environmental regulations.
ISO is leading a strategic approach by developing environmental management system standards that can be implemented in any type of organization in either public or private sectors (companies, administration, public utilities). To spearhead this strategic approach, ISO establish a new technical commitee, ISO /TC 207, Environmental management, in
1993. This followed ISO’s successful pioneering experience in management system standardization with the ISO 9000 series for quality management.
ISO’s direct involvement in environmental management stemmed from an intensive consultation process, carried out within the framework of a Strategic Advisory Group on Environment (SAGE),set up in 1991, in which 20 countrie, 11 international organizations and more than 100 environmental experts participated in defining the basic requirements of a new approach to environment-related standards.
This pioneering work was consolidated with ISO’s commitment to support the objective of “sustainable development” dicussed at the United Nations Conference on Environment and Development in Rio de Janeiro in 1992.
Today, delegations of business and government experts from 55 countries have participate actively within TC 207,
and another 16 countries have observer status. These delegations are chosen by the national standars institute concerned and they are required to bring to TC 207 a national consensus on issue being addressed by the commitee.
This national consensus is derived from a process of consultation with interested parties.
From its beginning, it was recognized that ISO/TC 207 should have close cooperation with ISO/TC 176, Quality management and quality assurance, in the areas of management systems, auditing and related terminology. Active efforts are under way to ensure compatibility of ISO environmental management and quality management standards, for the benefit of all organizations wishing to implement them.