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.