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Quality assurance, or QA for short, is the set of planned and systematic actions

necessary to provide appropriate confidence that a product or service will satisfy the
requirements for quality.

Contents
[hide]

• 1 History
o 1.1 Early efforts to control the quality of production
o 1.2 Wartime production
o 1.3 Postwar
• 2 Quality assurance activities
o 2.1 Failure testing
o 2.2 Statistical control
o 2.3 Total quality control
o 2.4 ISO 17025
• 3 Company quality
• 4 Using Contractors and/or consultants
• 5 Academic resources
• 6 See also
• 7 References

• 8 External links

[edit] History
[edit] Early efforts to control the quality of production

When the first specialized craftsmen arose manufacturing tools for others, the principle of
quality was simple: "let the buyer beware" (caveat emptor).

Early civil engineering projects needed to be built from specifications in order to ensure
the four sides of the base of the Great Pyramid of Giza will be perpendicular to within 3.5
arcseconds.

During the Middle Ages, guilds took the responsibility of quality control upon
themselves.

Royal governments purchasing material were interested in quality control as customers.


For this reason , King John of England appointed a certain William Wrotham to report
about the construction and repair of ships. Some centuries later, but also in England,
Samuel Pepys, Secretary to the Admiralty, appointed multiple such overseers.
Prior to the extensive division of labor and mechanization resulting from the Industrial
Revolution, it was possible for workers to control the quality of their own products.
Working conditions then were more conducive to professional pride.

The Industrial Revolution led to a system in which large groups of people performing a
similar type of work were grouped together under the supervision of a foreman who was
appointed to control the quality of work manufactured.

[edit] Wartime production

During World War I, the manufacturing process became more complex, and the
introduction of large numbers of workers being supervised by a foreman designated to
ensure the quality of the work, which was being produced. This period also introduced
mass production and piecework, which created problems as workmen could now earn
more money by the production of extra products, which in turn led to bad workmanship
being passed on to the assembly lines.

Due to the large amount of bad workmanship being produced, the first full time
inspectors were introduced into the large-scale modern factory. These full time inspectors
were the real beginning of inspection quality control, and this was the beginning the large
inspection organizations of the 1920s and 1930s, which were separately organised from
production and big enough to be headed by superintendents.

The systematic approach to quality started in industrial manufacture during the 1930s,
mostly in the USA, when some attention was given to the cost of scrap and rework. With
the impact of mass production, which was required during the Second World War, it
became necessary to introduce a more appropriate form of quality control which can be
identified as Statistical Quality Control, or SQC. Some of the initial work for SQC is
credited to Walter A. Shewhart of Bell Labs, starting with his famous one-page
memorandum of 1924.

This system came about with the realisation that quality cannot be fully inspected into a
important batch of items . By extending the inspection phase and making inspection
organizations more efficient, it provides inspectors with control tools such as sampling
and control charts.

SQC had a significant contribution in that it provided a sampling inspection system


where 100 per cent inspection was not practicable. This type of inspection however did
lead to a lack of attention to the engineering activities for producinq quality.

For example, if you have a basic sampling scheme with an acceptance level of 4%, what
happens is you have a ratio of 96% products released onto the market with 4% defective
items – this obviously is a fair risk if you are ensured that unfortunate buyers will not
complain.

[edit] Postwar
After World War II, the United States continued to apply the concepts of inspection and
sampling to remove defective product from production lines. However, there were many
individuals trying to lead U.S. industries towards a more comprehensive approach to
quality. Excluding the U.S., many countries' manufacturing capabilities were destroyed
during the war. This placed American business in a position where advances in the
collaborative approaches to quality were essentially ignored.

After World War II, the U.S. sent General Douglas MacArthur to oversee the re-building
of Japan. During this time, General MacArthur involved two key individuals in the
development of modern quality concepts: W. Edwards Deming and Joseph Juran. Both
individuals promoted the collaborative concepts of quality to Japanese business and
technical groups, and these groups utilized these concepts in the redevelopment of the
Japanese economy.

[edit] Quality assurance activities


Quality assurance applies to all forms of products and services. This introduced the rules:
"fit for purpose" and "do it right the first time". It includes the regulation of the quality of
raw materials, assemblies, products and components; services related to production; and
management, production, and inspection processes.

One of the most widely used paradigms for QA management is the PDCA (Plan-Do-
Check-Act) approach, also known as the Shewhart cycle.

[edit] Failure testing

A valuable process to perform on a whole consumer product is failure testing, the


operation of a product until it fails, often under stresses such as increasing vibration,
temperature and humidity. This exposes many unanticipated weaknesses in a product,
and the data is used to drive engineering and manufacturing process improvements. Often
quite simple changes can dramatically improve product service, such as changing to
mould-resistant paint or adding lock-washer placement to the training for new assembly
personnel.

[edit] Statistical control

Many organizations use statistical process control to bring the organization to Six Sigma
levels of quality, in other words, so that the likelihood of an unexpected failure is
confined to six standard deviations on the normal distribution. This probability is less
than four one-millionths. Items controlled often include clerical tasks such as order-entry
as well as conventional manufacturing tasks.

Traditional statistical process controls in manufacturing operations usually proceed by


randomly sampling and testing a fraction of the output. Variances of critical tolerances
are continuously tracked, and manufacturing processes are corrected before bad parts can
be produced.
[edit] Total quality control

Deep Analysis of quality assurance practices and premisses used about them is the most
necessary inspection control of all in cases where, despite statistical quality control
techniques or quality improvements implemented, sales decrease.

The major problem which leads to a decrease in sales was that the specifications did not
include the most important factor, “What the specifications have to state in order to
satisfy the customer requirments ?”.

The major characteristics, ignored during the search to improve manufacture and overall
business performance were:

• Reliability
• Maintainability
• Safety

As the most important factor had been ignored, a few refinements had to be introduced:

1. Marketing had to carry out their work properly and define the customer’s
specifications.
2. Specifications had to be defined to conform to these requirements.
3. Conformance to specifications i.e. drawings, standards and other relevant
documents, were introduced during manufacturing, planning and control.
4. Management had to confirm all operators are equal to the work imposed on them
and holidays, celebrations and disputes did not affect any of the quality levels.
5. Inspections and tests were carried out, and all components and materials, bought
in or otherwise, conformed to the specifications, and the measuring equipment
was accurate, this is the responsibility of the QA/QC department.
6. Any complaints received from the customers were satisfactorily dealt with in a
timely manner.
7. Feedback from the user/customer is used to review designs.
8. Consistent data recording and assessment and documentation integrity.
9. Product and/or process change management and notification.

If the original specification does not reflect the correct quality requirements, quality
cannot be implemented into the product.

For instance, all parameters for a pressure vessel should include not only the material and
dimensions but operating, environmental, safety, reliability and maintainability
requirements.

To conclude, the above forms the basis from which the philosophy of Quality Assurance
has evolved, and the achievement of quality or the “fitness-for-purpose” is “Quality
Awareness” throughout the company.
[edit] ISO 17025

ISO 17025 is an international standard that specifies the general requirements for the
competence to carry out tests and or calibrations. There are 15 management requirements
and 10 technical requirements. These requirements outline what a laboratory must do to
become accredited. Management system refers to the organization's structure for
managing its processes or activities that transform inputs of resources into a product or
service which meets the organization's objectives, such as satisfying the customer's
quality requirements, complying with regulations, or meeting environmental objectives.

For software development organization, CMMI (Capability Maturity Model Integration)


standards are widely used to measure the Quality Assurance. These CMMI standards can
be divided in to 5 steps, which a software development company can achieve by
performing different quality improvement activities within the organization.

[edit] Company quality


During the 1980s, the concept of “company quality” with the focus on management and
people came to the fore. It was realised that, if all departments approached quality with
an open mind, success was possible if the management led the quality improvement
process.

The company-wide quality approach places an emphasis on four aspects :-

1. Elements such as controls, job management, adequate processes, performance and


integrity criteria and identification of records
2. Competence such as knowledge, skills, experience, qualifications
3. Soft elements, such as personnel integrity, confidence, organizational culture,
motivation, team spirit and quality relationships.
4. Infrastructure (as it enhances or limits functionality)

The quality of the outputs is at risk if any of these aspects is deficient in any way.

The approach to quality management given here is therefore not limited to the
manufacturing theatre only but can be applied to any business or non-business activity:

• Design work
• Administrative services
• Consulting
• Banking
• Insurance
• Computer software
• Retailing
• Transportation
• open source development
• education
It comprises a quality improvement process, which is generic in the sense it can be
applied to any of these activities and it establishes a behaviour pattern, which supports
the achievement of quality.

This in turn is supported by quality management practices which can include a number of
business systems and which are usually specific to the activities of the business unit
concerned.

In manufacturing and construction activities, these business practices can be equated to


the models for quality assurance defined by the International Standards contained in the
ISO 9000 series and the specified Specifications for quality systems.

Still, in the system of Company Quality, the work being carried out was shop floor
inspection which did not reveal the major quality problems. This led to quality assurance
or total quality control, which has come into being recently.

[edit] Using Contractors and/or consultants


It has become customary to use consultants and contractors when introducing new quality
practices and methodologies as in some instances the relevant skill-set and experience
might not be available within the organisation. In addition, when new initiatives and
improvements are required to boost the current quality system, or perhaps improve upon
current manufacturing systems, the use of temporary consultants becomes a viable
solution when allocating valuable resources.

There are various types of consultants and contractors available in the market; most will
have the skills needed to facilitate improvement activities such as Quality Management
Systems (QMS) Auditing and procedural documentation writing. But the higher end
consultants have knowledge and experience for implementing and improving
manufacturing processes by using the latest cutting edge improvement activities such as
Six Sigma, Measurement Systems Analysis (MSA), Failure Mode and Effects Analysis
(FMEA), Advance Product Quality Planning (APQP).

[edit] Academic resources


• Quality Assurance in Education, ISSN 0968-4883, Emerald Publishing Group
• Accreditation and Quality Assurance: Journal for Quality, Comparability and
Reliability in Chemical Measurement, ISSN: 1432-0517 (electronic) 0949-1775
(Paper), Springer

[edit] See also


• American Society for Quality
• Best practice
• CQE
• Data quality
• Data integrity
• GxP
• Quality control
• Quality management
• Software Testing
• Software quality assurance
• ISO 9000

covers all activities from design, development, production, installation, servicing and
documentation. This introduced the rules: "fit for purpose" and "do it right the first time".
It includes the regulation of the quality of raw materials, assemblies, products and
components; services related to production; and management, production, and inspection
processes.

One of the most widely used paradigms for QA management is the PDCA (Plan-Do-
Check-Act) approach, also known as the Shewhart cycle.

[edit] Failure testing

A valuable process to perform on a whole consumer product is failure testing, the


operation of a product until it fails, often under stresses such as increasing vibration,
temperature and humidity. This exposes many unanticipated weaknesses in a product,
and the data is used to drive engineering and manufacturing process improvements. Often
quite simple changes can dramatically improve product service, such as changing to
mold-resistant paint or adding lock-washer placement to the training for new assembly
personnel.

[edit] Statistical control

Many organizations use statistical process control to bring the organization to Six Sigma
levels of quality, in other words, so that the likelihood of an unexpected failure is
confined to six standard deviations on the normal distribution. This probability is less
than four one-millionths. Items controlled often include clerical tasks such as order-entry
as well as conventional manufacturing tasks.

Traditional statistical process controls in manufacturing operations usually proceed by


randomly sampling and testing a fraction of the output. Variances of critical tolerances
are continuously tracked, and manufacturing processes are corrected before bad parts can
be produced.

[edit] Company quality

During the 1980s, the concept of “company quality” with the focus on management and
people came to the fore. It was realised that, if all departments approached quality with
an open mind, success was possible if the management led the quality improvement
process.

The company-wide quality approach places an emphasis on three aspects :-

1. Elements such as controls, job management, adequate processes, performance and


integrity criteria and identification of records
2. Competence such as knowledge, skills, experience, qualifications
3. Soft elements, such as personnel integrity, confidence, organisational culture,
motivation, team spirit and quality relationships.

The quality of the outputs is at risk if any of these three aspects are deficient in any way.

The approach to quality management given here is therefore not limited to the
manufacturing theatre only but can be applied to any business activity:

• Design work
• Administrative services
• Consulting
• Banking
• Insurance
• Computer software
• Retailing
• Transportation

It comprises a quality improvement process, which is generic in the sense it can be


applied to any of these activities and it establishes a behaviour pattern, which supports
the achievement of quality.

This in turn is supported by quality management practices which can include a number of
business systems and which are usually specific to the activities of the business unit
concerned.

In manufacturing and construction activities, these business practices can be equated to


the models for quality assurance defined by the International Standards contained in the
ISO 9000 series and the specified Specifications for quality systems.

Still, in the system of Company Quality, the work being carried out was shop floor
inspection which did not control the major quality problems. This led to quality assurance
or total quality control, which has come into being recently.

[edit] Total quality control

Total Quality Control is the most necessary inspection control of all in cases where,
despite statistical quality control techniques or quality improvements implemented, sales
decrease.
The major problem which leads to a decrease in sales was that the specifications did not
include the most important factor, “What the customer required”.

The major characteristics, ignored during the search to improve manufacture and overall
business performance were:

• Reliability
• Maintainability
• Safety

As the most important factor had been ignored, a few refinements had to be introduced:

1. Marketing had to carry out their work properly and define the customer’s
specifications.
2. Specifications had to be defined to conform to these requirements.
3. Conformance to specifications i.e. drawings, standards and other relevant
documents, were introduced during manufacturing, planning and control.
4. Management had to confirm all operators are equal to the work imposed on them
and holidays, celebrations and disputes did not affect any of the quality levels.
5. Inspections and tests were carried out, and all components and materials, bought
in or otherwise, conformed to the specifications, and the measuring equipment
was accurate, this is the responsibility of the QA/QC department.
6. Any complaints received from the customers were satisfactorily dealt with in a
timely manner.
7. Feedback from the user/customer is used to review designs.
8. Consistent data recording and assessment and documentation integrity.
9. Product and/or process change management and notification.

If the original specification does not reflect the correct quality requirements, quality
cannot be inspected or manufactured into the product.

For instance, all parameters for a pressure vessel should include not only the material and
dimensions but operating, environmental, safety, reliability and maintainability
requirements.

To conclude, the above forms the basis from which the philosophy of Quality Assurance
has evolved, and the achievement of quality or the “fitness-for-purpose” is “Quality
Awareness” throughout the company.

[edit] See also


• American Society for Quality
• Bioburden
• Certified Quality Engineer
• Computerized system validation
• Contamination control
• EudraLex
• Evidence-based medicine
• Hoshin Kanri
• Hospital accreditation
• Industrial engineering
• Impulse excitation technique
• Kaizen
• List of production topics
• List of software engineering topics
• Manufacturing
• PIC/S
• Playtest
• Quality circle
• Quality Improvement Organizations
• Seven Tools of Quality
• Six Sigma
• Software quality & Software testing
• Test method
• Total Quality Management (TQM)
• Validation (drug manufacture)

Quality management is a method for ensuring that all the activities necessary to design,
develop and implement a product or service are effective and efficient with respect to the
system and its performance. Quality management can be considered to have three main
components: quality control, quality assurance and quality improvement. Quality
management is focused not only on product quality, but also the means to achieve it.
Quality management therefore uses quality assurance and control of processes as well as
products to achieve more consistent quality. Quality Management is all activities of the
overall management function that determine the quality policy, objectives and
responsibilities and implement them by means such as quality control and quality
improvements within a quality system.

Contents
[hide]

• 1 Quality management evolution


• 2 Quality improvement
• 3 Quality standards
• 4 Quality management terms
• 5 Academic resources
• 6 See also
• 7 External links
• 8 References

[edit] Quality management evolution


Quality management is not a recent phenomenon. Advanced civilizations that supported
the arts and crafts allowed clients to choose goods meeting higher quality standards than
normal goods. In societies where art and craft (and craftsmanship) were valued, one of
the responsibilities of a master craftsman (and similarly for artists) was to lead their
studio, train and supervise the work of their craftsmen and apprentices. The master
craftsman set standards, reviewed the work of others and ordered rework and revision as
necessary. One of the limitations of the craft approach was that relatively few goods
could be produced, on the other hand an advantage was that each item produced could be
individually shaped to suit the client. This craft based approach to quality and the
practices used were major inputs when quality management was created as a management
science.

During the industrial revolution, the importance of craftsmen was diminished as mass
production and repetitive work practices were instituted. The aim was to produce large
numbers of the same goods. The first proponent in the US for this approach was Eli
Whitney who proposed (interchangeable) parts manufacture for muskets, hence
producing the identical components and creating a musket assembly line. The next step
forward was promoted by several people including Frederick Winslow Taylor a
mechanical engineer who sought to improve industrial efficiency. He is sometimes called
"the father of scientific management." He was one of the intellectual leaders of the
Efficiency Movement and part of his approach laid a further foundation for quality
management, including aspects like standardization and adopting improved practices.
Henry Ford also was important in bringing process and quality management practices
into operation in his assembly lines. In Germany, Karl Friedrich Benz, often called the
inventor of the motor car, was pursuing similar assembly and production practices,
although real mass production was properly initiated in Volkswagen after world war two.
From this period onwards, north American companies focused predominantly upon
production against lower cost with increased efficiency.

Walter A. Shewhart made a major step in the evolution towards quality management by
creating a method for quality control for production, using statistical methods, first
proposed in 1924. This became the foundation for his ongoing work on statistical quality
control. W. Edwards Deming later applied statistical process control methods in the
United States during World War II, thereby successfully improving quality in the
manufacture of munitions and other strategically important products.

Quality leadership from a national perspective has changed over the past five to six
decades. After the second world war, Japan decided to make quality improvement a
national imperative as part of rebuilding their economy, and sought the help of Shewhart,
Deming and Juran, amongst others. W. Edwards Deming championed Shewhart's ideas in
Japan from 1950 onwards. He is probably best known for his management philosophy
establishing quality, productivity, and competitive position. He has formulated 14 points
of attention for managers, which are a high level abstraction of many of his deep insights.
They should be interpreted by learning and understanding the deeper insights and
include:

• Break down barriers between departments


• Management should learn their responsibilities, and take on leadership
• Improve constantly
• Institute a programme of education and self-improvement

In the 1950s and 1960s, Japanese goods were synonymous with cheapness and low
quality, but over time their quality initiatives began to be successful, with Japan
achieving very high levels of quality in products from the 1970s onward. For example,
Japanese cars regularly top the J.D. Power customer satisfaction ratings. In the 1980s
Deming was asked by Ford Motor Company to start a quality initiative after they realized
that they were falling behind Japanese manufacturers. A number of highly successful
quality initiatives have been invented by the Japanese (see for example on this page:
Taguchi, QFD, Toyota Production System. Many of the methods not only provide
techniques but also have associated quality culture aspects (i.e. people factors). These
methods are now adopted by the same western countries that decades earlier derided
Japanese methods.

Customers recognize that quality is an important attribute in products and services.


Suppliers recognize that quality can be an important differentiator between their own
offerings and those of competitors (quality differentiation is also called the quality gap).
In the past two decades this quality gap has been greatly reduced between competitive
products and services. This is partly due to the contracting (also called outsourcing) of
manufacture to countries like India and China, as well internationalization of trade and
competition. These countries amongst many others have raised their own standards of
quality in order to meet International standards and customer demands. The ISO 9000
series of standards are probably the best known International standards for quality
management.

[edit] Quality improvement


There are many methods for quality improvement. These cover product improvement,
process improvement and people based improvement. In the following list are methods of
quality management and techniques that incorporate and drive quality improvement.

1. ISO 9004:2000 - Guidelines for performance improvement.


2. ISO 15504-4: 2005 - Information technology -- Process assessment -- Part 4:
Guidance on use for process improvement and process capability determination.
3. QFD - Quality Function Deployment, also known as the House of Quality
approach.
4. Kaizen - 改善, Japanese for change for the better; the common English usage is
continual improvement.
5. Zero Defect Program - created by NEC Corporation of Japan, based upon
Statistical Process Control and one of the inputs for the inventors of Six Sigma.
6. Six Sigma - Six Sigma is based upon Statistical Process Control.
7. PDCA - Plan Do Check Act cycle for quality control purposes.
8. Six Sigma's DMAIC method (Design, Measure,Analyze, Improve, Control) for
more general improvement purposes.
9. Quality circle - a group (people oriented) approach to improvement.
10. Taguchi methods - statistical oriented methods including Quality robustness,
Quality loss function and Target specifications.
11. The Toyota Production System reworked in the west into Lean Manufacturing.
12. Kansei Engineering, an approach that focuses on capturing customer emotional
feedback about products to drive improvement.
13. TQM - Total Quality Management is a management strategy aimed at embedding
awareness of quality in all organizational processes. First promoted in Japan with
the Deming prize which was adopted and adapted in USA as the Malcolm
Baldrige National Quality Award and in Europe as the European Foundation for
Quality Management award (each with their own variations).
14. TRIZ meaning "Theory of inventive problem solving"
15. BPR - Business process reengineering, a management approach aiming at 'clean
slate' improvements (i.e. ignoring existing practices).

Proponents of each approach have sought to improve them as well as apply them to
enterprise types not originally targeted. For example, Six Sigma was designed for
manufacturing but has spread to service enterprises. Each of these approaches and
methods has met with success but also with failures. Some of the common differentiators
between success and failure include commitment, knowledge and expertise to guide
improvement, scope of change/improvement desired (Big Bang type changes tend to fail
more often compared to smaller changes) and adaption to enterprise cultures. For
example, quality circles do not work well in every enterprise (and are even discouraged
by some managers), and relatively few TQM participating enterprises have won the
national quality awards. There has been well publicized failures of BPR, as well as Six
Sigma. Enterprises therefore need to consider carefully which quality improvement
methods to adopt, and certainly should not adopt all those listed here. It is important not
to underestimate the people factors, such as culture, in selecting a quality improvement
approach. Any improvement (change) takes time to implement, gain acceptance and
stabilize as accepted practice. Improvement must allow pauses between implementing
new changes so that the change is stabilized and assessed as a real improvement, before
the next improvement is made (hence continual improvement, not continuous
improvement). Improvements that change the culture take longer as they have to
overcome greater resistance to change. It is easier and often more effective to work
within the existing cultural boundaries and make small improvements (i.e. Kaizen) than
to make major transformational changes. Use of Kaizen in Japan was a major reason for
the creation of Japanese industrial and economic strength. On the other hand,
transformational change works best when an enterprise faces a crisis and needs to make
major changes in order to survive. In Japan, the land of Kaizen, Carlos Ghosn led a
transformational change at Nissan Motor Company which was in a financial and
operational crisis. Well organized quality improvement programs take all these factors
into account when selecting the quality improvement methods.

[edit] Quality standards


The International Organization for Standardization (ISO) created the Quality
Management System (QMS) standards in 1987. These were the ISO 9000:1987 series of
standards comprising ISO 9001:1987, ISO 9002:1987 and ISO 9003:1987; which were
applicable in different types of industries, based on the type of activity or process:
designing, production or service delivery. The standards have been regularly reviewed
every few years by the International Organization for Standardization. The version in
1994 and was called the ISO 9000:1994 series; comprising of the ISO 9001:1994,
9002:1994 and 9003:1994 versions. The last revision was in the year 2000 and the series
was called ISO 9000:2000 series. However the ISO 9002 and 9003 standards were
integrated and one single certifiable standard was created under ISO 9001:2000. Since
December 2003, ISO 9002 and 9003 standards are not valid, and the organizations
previously holding these standards need to do a transition from the old to the new
standards. The ISO 9004:2000 document gives guidelines for performance improvement
over and above the basic standard (i.e. ISO 9001:2000). This standard provides a
measurement framework for improved quality management, similar to and based upon
the measurement framework for process assessment.

The Quality Management System standards created by ISO are meant to certify the
processes and the system of an organization and not the product or service itself. ISO
9000 standards do not certify the quality of the product or service.

Recently the International Organisation for Standardisation released a new standard, ISO
22000, meant for the food industry. This standard covers the values and principles of ISO
9000 and the HACCP standards. It gives one single integrated standard for the food
industry and is expected to become more popular in the coming years in such industry.

ISO has a number of standards that support quality management, one group describes
processes (including ISO 12207, ISO 15288)and another describes process assessment
and improvement ISO 15504. The Software Engineering Institute has its own process
assessment and improvement methods, called CMMi (Capability Maturity Model -
integrated) and IDEAL respectively.

[edit] Quality management terms


• Quality Improvement can be distinguished from Quality Control in that Quality
Improvement is the purposeful change of a process to improve the reliability of
achieving an outcome.
• Quality Control is the ongoing effort to maintain the integrity of a process to
maintain the reliability of achieving an outcome.
• Quality Assurance is the planned or systematic actions necessary to provide
enough confidence that a product or service will satisfy the given requirements for
quality.

[edit] Academic resources


• International Journal of Productivity and Quality Management, ISSN 1746-6474,
Inderscience
• International Journal of Quality & Reliability Management, ISSN: 0265-671X,
Emerald Publishing Group

[edit] See also


• Quality assurance
• Quality audit
• Quality control
• Quality management system
• ISO 15504
• Systems thinking - Applications
• Total Quality Management
• Hoshin Kanri
• Health care

From Wikipedia, the free encyclopedia

Jump to: navigation, search

ISO 9000 is a family of standards for quality management systems. ISO 9000 is
maintained by ISO, the International Organization for Standardization and is
administered by accreditation and certification bodies. Some of the requirements in ISO
9001 (which is one of the standards in the ISO 9000 family) include

• a set of procedures that cover all key processes in the business;


• monitoring processes to ensure they are effective;
• keeping adequate records;
• checking output for defects, with appropriate and corrective action where
necessary;
• regularly reviewing individual processes and the quality system itself for
effectiveness; and
• facilitating continual improvement

A company or organization that has been independently audited and certified to be in


conformance with ISO 9001 may publicly state that it is "ISO 9001 certified" or "ISO
9001 registered." Certification to an ISO 9000 standard does not guarantee the
compliance (and therefore the quality) of end products and services; rather, it certifies
that consistent business processes are being applied. Indeed, some companies enter the
ISO 9001 certification as a marketing tool.

Although the standards originated in manufacturing, they are now employed across a
wide range of other types of organizations. A "product", in ISO vocabulary, can mean a
physical object, or services, or software. In fact, according to ISO in 2004, "service
sectors now account by far for the highest number of ISO 9001:2000 certificates - about
31% of the total." [1]

Contents
[hide]

• 1 ISO 9000 family


• 2 Contents of ISO 9001
o 2.1 Summary of ISO 9001:2000 in informal language
• 3 History of ISO 9000
o 3.1 Pre ISO 9000
o 3.2 1987 version
o 3.3 1994 version
o 3.4 2000 version
o 3.5 Future version: 2008
o 3.6 Certification
• 4 Auditing
• 5 Industry-specific interpretations
• 6 Debate on the effectiveness of ISO 9000
o 6.1 Advantages
o 6.2 Problems
o 6.3 Summary
• 7 See also
• 8 Further reading
• 9 References

• 10 External links

[edit] ISO 9000 family


ISO 9000 includes the following standards:

• ISO 9000:2000, Quality management systems – Fundamentals and


vocabulary. Covers the basics of what quality management systems are and also
contains the core language of the ISO 9000 series of standards. A guidance
document, not used for certification purposes.
• ISO 9001:2000 Quality management systems – Requirements is intended for
use in any organization which designs, develops, manufactures, installs and/or
services any product or provides any form of service. It provides a number of
requirements which an organization needs to fulfill if it is to achieve customer
satisfaction through consistent products and services which meet customer
expectations. It includes a requirement for the continual (i.e. planned)
improvement of the Quality Management System, for which ISO 9004:2000
provides many hints.

This is the only implementation for which third-party auditors may grant certification. It
should be noted that certification is not described as any of the 'needs' of an organization
as a driver for using ISO 9001 (see ISO 9001:2000 section 1 'Scope') but does recognize
that it may be used for such a purpose (see ISO 9001:2000 section 0.1 'Introduction').

• ISO 9004:2000 Quality management systems - Guidelines for performance


improvements. covers continual improvement. This gives you advice on what
you could do to enhance a mature system. This standard very specifically states
that it is not intended as a guide to implementation.

There are many more standards in the ISO 9001 family (see "List of ISO 9000 standards"
from ISO), many of them not even carrying "ISO 900x" numbers. For example, some
standards in the 10,000 range are considered part of the 9000 family: ISO 10007:1995
discusses Configuration management, which for most organizations is just one element of
a complete management system. ISO notes: "The emphasis on certification tends to
overshadow the fact that there is an entire family of ISO 9000 standards ... Organizations
stand to obtain the greatest value when the standards in the new core series are used in an
integrated manner, both with each other and with the other standards making up the ISO
9000 family as a whole".

Note that the previous members of the ISO 9000 family, 9001, 9002 and 9003, have all
been integrated into 9001. In most cases, an organization claiming to be "ISO 9000
registered" is referring to ISO 9001.

[edit] Contents of ISO 9001


ISO 9001:2000 Quality management systems — Requirements is a document of
approximately 30 pages which is available from the national standards organization in
each country. Outline contents are as follows:

• Page iv: Foreword


• Pages v to vii: Section 0 Introduction
• Pages 1 to 14: Requirements
o Section 1: Scope
o Section 2: Normative Reference
o Section 3: Terms and definitions (specific to ISO 9001, not specified in
ISO 9000)'
• Pages 2 to 14
o Section 4: Quality Management System
o Section 5: Management Responsibility
o Section 6: Resource Management
o Section 7: Product Realization
o Section 8: Measurement, analysis and improvement

In effect, users need to address all sections 1 to 8, but only 4 to 8 need implementing
within a QMS.

• Pages 15 to 22: Tables of Correspondence between ISO 9001 and other standards
• Page 23: Bibliography

The standard specifies six compulsory documents:

• Control of Documents (4.2.3)


• Control of Records (4.2.4)
• Internal Audits (8.2.2)
• Control of Nonconforming Product / Service (8.3)
• Corrective Action (8.5.2)
• Preventive Action (8.5.3)

In addition to these, ISO 9001:2000 requires a Quality Policy and Quality Manual (which
may or may not include the above documents).

[edit] Summary of ISO 9001:2000 in informal language

• The quality policy is a formal statement from management, closely linked to the
business and marketing plan and to customer needs. The quality policy is
understood and followed at all levels and by all employees. Each employee needs
measurable objectives to work towards.
• Decisions about the quality system are made based on recorded data and the
system is regularly audited and evaluated for conformance and effectiveness.
• Records should show how and where raw materials and products were processed,
to allow products and problems to be traced to the source.
• You need a documented procedure to control quality documents in your company.
Everyone must have access to up-to-date documents and be aware of how to use
them.
• To maintain the quality system and produce conforming product, you need to
provide suitable infrastructure, resources, information, equipment, measuring and
monitoring devices, and environmental conditions.
• You need to map out all key processes in your company; control them by
monitoring, measurement and analysis; and ensure that product quality objectives
are met. If you can’t monitor a process by measurement, then make sure the
process is well enough defined that you can make adjustments if the product does
not meet user needs.
• For each product your company makes, you need to establish quality objectives;
plan processes; and document and measure results to use as a tool for
improvement. For each process, determine what kind of procedural
documentation is required (note: a “product” is hardware, software, services,
processed materials, or a combination of these).
• You need to determine key points where each process requires monitoring and
measurement, and ensure that all monitoring and measuring devices are properly
maintained and calibrated.
• You need to have clear requirements for purchased product.
• You need to determine customer requirements and create systems for
communicating with customers about product information, inquiries, contracts,
orders, feedback and complaints.
• When developing new products, you need to plan the stages of development, with
appropriate testing at each stage. You need to test and document whether the
product meets design requirements, regulatory requirements and user needs.
• You need to regularly review performance through internal audits and meetings.
Determine whether the quality system is working and what improvements can be
made. Deal with past problems and potential problems. Keep records of these
activities and the resulting decisions, and monitor their effectiveness (note: you
need a documented procedure for internal audits).
• You need documented procedures for dealing with actual and potential
nonconformances (problems involving suppliers or customers, or internal
problems). Make sure no one uses bad product, determine what to do with bad
product, deal with the root cause of the problem and keep records to use as a tool
to improve the system.

[edit] History of ISO 9000


[edit] Pre ISO 9000

During WWII, there were quality problems in many British industries such as munitions,
where bombs were exploding in factories during assembly. The adopted solution was to
require factories to document their manufacturing procedures and to prove by record-
keeping that the procedures were being followed. The name of the standard was BS 5750,
and it was known as a management standard because it specified not what to
manufacture, but how the manufacturing process was to be managed. According to
Seddon, "In 1987, the British Government persuaded the International Organization for
Standardization to adopt BS 5750 as an international standard. BS 5750 became ISO
9000." [2] [3]

[edit] 1987 version

ISO 9000:1987 had the same structure as the UK Standard BS 5750, with three 'models'
for quality management systems, the selection of which was based on the scope of
activities of the organization:
• 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 ("MIL
SPECS"), 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.[citation needed]

[edit] 1994 version

ISO 9000:1994 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 impeded by the quality system.[citation needed]

[edit] 2000 version

ISO 9001:2000 combines the three standards 9001, 9002, and 9003 into one, now 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.

[edit] Future version: 2008

TC 176, the ISO 9001 technical committee, has started its review on the next version of
ISO 9001, which will in all likelihood be termed the ISO 9001:2008 standard, assuming
its planned release date of 2008 is met. Early reports are that the standard will not be
substantially changed from its 2000 version.
As with the release of previous versions, organizations registered to ISO 9001 will be
given a substantial period to transition to the new version of the standard, assuming
changes are needed; organizations registered to 9001:1994 had until December of 2003 to
undergo upgrade audits.

[edit] Certification

ISO does not itself certify organizations. Many countries have formed accreditation
bodies to authorize certification bodies, which audit organizations applying for ISO 9001
compliance certification. Although commonly referred to as ISO 9000:2000 certification,
the actual standard to which an organization's quality management can be certified is ISO
9001:2000. Both the accreditation bodies and the certification bodies charge fees for their
services. The various accreditation bodies have mutual agreements with each other to
ensure that certificates issued by one of the Accredited Certification Bodies (CB) are
accepted world-wide.

The applying organization is assessed based on an extensive sample of its sites, functions,
products, services and processes; a list of problems ("action requests" or "non-
compliances") is made known to the management. If there are no major problems on this
list, the certification body will issue an ISO 9001 certificate for each geographical site it
has visited, once it receives a satisfactory improvement plan from the management
showing how any problems will be resolved.

An ISO certificate is not a once-and-for-all award, but must be renewed at regular


intervals recommended by the certification body, usually around three years. In contrast
to the Capability Maturity Model there are no grades of competence within ISO 9001.

[edit] Auditing
Two types of auditing are required to become registered to the standard: auditing by an
external certification body (external audit) and audits by internal staff trained for this
process (internal audits). The aim is a continual process of review and assessment, to
verify that the system is working as it's supposed to, find out where it can improve and to
correct or prevent problems identified. It is considered healthier for internal auditors to
audit outside their usual management line, so as to bring a degree of independence to
their judgments.

Under the 1994 standard, the auditing process could be adequately addressed by
performing "compliance auditing":

• Tell me what you do (describe the business process)


• Show me where it says that (reference the procedure manuals)
• Prove that that is what happened (exhibit evidence in documented records)

How this led to preventive actions was not clear.


The 2000 standard uses the process approach. While auditors perform similar functions,
they are expected to go beyond mere auditing for rote "compliance" by focusing on risk,
status and importance. This means they are expected to make more judgments on what is
effective, rather than merely adhering to what is formally prescribed. The difference from
the previous standard can be explained thus:

Under the 1994 version, the question was broadly "Are you doing what the
manual says you should be doing?", whereas under the 2000 version, the question
is more "Will this process help you achieve your stated objectives? Is it a good
process or is there a way to do it better?".

The ISO 19011 standard for auditing applies to ISO 9001 besides other management
systems like EMS ( ISO 14001), FSMS (ISO 22000) etc.

[edit] Industry-specific interpretations


The ISO 9001 standard is generalized and abstract. Its parts must be carefully interpreted,
to make sense within a particular organization. Developing software is not like making
cheese or offering counseling services; yet the ISO 9001 guidelines, because they are
business management guidelines, can be applied to each of these. Diverse organizations
—police departments (US), professional soccer teams (Mexico) and city councils (UK)—
have successfully implemented ISO 9001:2000 systems.

Over time, various industry sectors have wanted to standardize their interpretations of the
guidelines within their own marketplace. This is partly to ensure that their versions of
ISO 9000 have their specific requirements, but also to try and ensure that more
appropriately trained and experienced auditors are sent to assess them.

• The TickIT guidelines are an interpretation of ISO 9000 produced by the UK


Board of Trade to suit the processes of the information technology industry,
especially software development.
• AS 9000 is the Aerospace Basic Quality System Standard, an interpretation
developed by major aerospace manufacturers. The current version is AS 9100.
• PS 9000 is an application of the standard for Pharmaceutical Packaging Materials.
• QS 9000 is an interpretation agreed upon by major automotive manufacturers
(GM, Ford, Chrysler). It includes techniques such as FMEA and APQP. QS 9000
is now replaced by ISO/TS 16949.
• ISO/TS 16949:2002 is an interpretation agreed upon by major automotive
manufacturers (American and European manufacturers); the latest version is
based on ISO 9001:2000. The emphasis on a process approach is stronger than in
ISO 9001:2000. ISO/TS 16949:2002 contains the full text of ISO 9001:2000 and
automotive industry-specific requirements.
• TL 9000 is the Telecom Quality Management and Measurement System
Standard, an interpretation developed by the telecom consortium, QuEST Forum.
The current version is 4.0 and unlike ISO 9001 or the above sector standards, TL
9000 includes standardized product measurements that can be benchmarked.
• ISO 13485:2003 is the medical industry's equivalent of ISO 9001:2000. Whereas
the standards it replaces were interpretations of how to apply ISO 9001 and ISO
9002 to medical devices, ISO 13485:2003 is a stand-alone standard. Compliance
with ISO 13485 does not necessarily mean compliance with IS0 9001:2000.

[edit] Debate on the effectiveness of ISO 9000


The debate on the effectiveness of ISO 9000 commonly centers on the following
questions:

1. Are the quality principles in ISO 9000:2000 of value (note that the version date is
important: in the 2000 version ISO attempted to address many concerns and
criticisms of ISO 9000:1994)?
2. Does it help to implement an ISO 9001:2000 compliant quality management
system?
3. Does it help to obtain ISO 9001:2000 certification?

[edit] Advantages

It is widely acknowledged that proper quality management improves business, often


having a positive effect on investment, market share, sales growth, sales margins,
competitive advantage, and avoidance of litigation.[4][5] The quality principles in ISO
9000:2000 are also sound, according to Wade,[6] and Barnes, [5] who says "ISO 9000
guidelines provide a comprehensive model for quality management systems that can
make any company competitive." Barnes also cites a survey by Lloyd's Register Quality
Assurance which indicated that ISO 9000 increased net profit, and another by Deloitte-
Touche which reported that the costs of registration were recovered in three years.
According to the Providence Business News [7], implementing ISO often gives the
following advantages:

1. Create a more efficient, effective operation


2. Increase customer satisfaction and retention
3. Reduce audits
4. Enhance marketing
5. Improve employee motivation, awareness, and morale
6. Promote international trade
7. Increases profit
8. Reduce waste and increases productivity

However, a broad statistical study of 800 Spanish companies [8] found that ISO 9000
registration in itself creates little improvement because companies interested in it have
usually already made some type of commitment to quality management and were
performing just as well before registration.[4]

In today's service-sector driven economy, more and more companies are using ISO 9000
as a business tool. Through the use of properly stated quality objectives, customer
satisfaction surveys and a well-defined continual improvement program companies are
using ISO 9000 processes to increase their efficiency and profitability.

[edit] Problems

A common criticism of ISO 9001 is the amount of money, time and paperwork required
for registration.[9] According to Barnes, "Opponents claim that it is only for
documentation. Proponents believe that if a company has documented its quality systems,
then most of the paperwork has already been completed."[5]

According to Seddon, ISO 9001 promotes specification, control, and procedures rather
than understanding and improvement. [2] [3] Wade argues that ISO 9000 is effective as a
guideline, but that promoting it as a standard "helps to mislead companies into thinking
that certification means better quality, ... [undermining] the need for an organization to
set its own quality standards." [6] Paraphrased, Wade's argument is that total, blind
reliance on the specifications of ISO 9001 does not guarantee a successful quality system.

The standard is seen as especially prone to failure when a company is interested in


certification before quality.[2] Certifications are in fact often based on customer
contractual requirements rather than a desire to actually improve quality.[5][10] "If you just
want the certificate on the wall, chances are, you will create a paper system that doesn't
have much to do with the way you actually run your business," said ISO's Roger Frost.[10]
Certification by an independent auditor is often seen as the problem area, and according
to Barnes, "has become a vehicle to increase consulting services." [5] In fact, ISO itself
advises that ISO 9001 can be implemented without certification, simply for the quality
benefits that can be achieved. [11]

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.

[edit] Summary

A good overview for effective use of ISO 9000 is provided by Barnes: [5]

"Good business judgment is needed to determine its proper role for a company... Is
certification itself important to the marketing plans of the company? If not, do not rush to
certification... Even without certification, companies should utilize the ISO 9000 model
as a benchmark to assess the adequacy of its quality programs."

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