Basics of quality management

Quality management ensures that an organization, product or service is consistent. It has four main components:
quality planning, quality assurance, quality control and quality improvement.[1] Quality management is focused not only
on product and service quality, but also on the means to achieve it.

ISO 9000 is defined as a set of international standards on quality management and quality assurance developed to help
companies effectively document the quality system elements needed to maintain an efficient quality system. They are not
specific to any one industry and can be applied to organizations of any size.ISO 9000 can help a company satisfy its
customers, meet regulatory requirements, and achieve continual improvement. It should be considered to be a first step or
the base level of a quality system.

background

ISO 9000 was first published in 1987 by the International Organization for Standardization (ISO), a specialized international
agency for standardization composed of the national standards bodies of more than 160 countries. It was based on the BS
5750 series of standards from BSI that were proposed to ISO in 1979.

Reasons for use

The global adoption of ISO 9001 may be attributable to a number of factors. In the early days, the ISO 9001 (9002 and 9003)
requirements were intended to be used by procuring organizations, as the basis of contractual arrangements with their
suppliers.

ISO 9000 series Quality Management Principles

The ISO 9000 series are based on seven quality management principles
The seven quality management principles are:

Principle 1 – Customer focus

Organizations depend on their customers and therefore should understand current and future customer needs, should
meet customer requirements and strive to exceed customer expectations.

Principle 2 – Leadership

Leaders establish unity of purpose and direction of the organization. They should create and maintain the internal
environment in which people can become fully involved in achieving the organization's objectives.

Principle 3 – Engagement of people

People at all levels are the essence of an organization and their full involvement enables their abilities to be used for
the organization's benefit.

Principle 4 – Process approach

A desired result is achieved more efficiently when activities and related resources are managed as a process.

Principle 5 – Improvement

Improvement of the organization's overall performance should be a permanent objective of the organization.

Principle 6 – Evidence-based decision making

Effective decisions are based on the analysis of data and information.

Principle 7 – Relationship management

An organization and its external providers (suppliers, contractors, service providers) are interdependent and a mutually
beneficial relationship enhances the ability of both to create value.

ISO 9001:2015 Quality management systems — Requirements is a document of approximately 30 pages which is available
from the national standards organization in each country. Only ISO 9001 is directly audited against for third party
assessment purposes.
Contents of ISO 9001:2015 are as follows:

 Section 1: Scope
 Section 2: Normative references
 Section 3: Terms and definitions
 Section 4: Context of the organization
 Section 5: Leadership
 Section 6: Planning
 Section 7: Support
 Section 8: Operation
 Section 9: Performance evaluation
 Section 10: Continual Improvement

Essentially, the layout of the standard is similar to the previous ISO 9001:2008 standard in that it follows the Plan, Do, Check,
Actcycle in a process-based approach but is now further encouraging this to have risk-based thinking (section 0.3.3 of the
introduction). The purpose of the quality objectives is to determine the conformity of the requirements (customers and
organizations), facilitate effective deployment and improve the quality management system.[34][35]
Before the certification body can issue or renew a certificate, the auditor must be satisfied that the company being assessed
has implemented the requirements of sections 4 to 10. Sections 1 to 3 are not directly audited against, but because they
provide context and definitions for the rest of the standard, not that of the organization, their contents must be taken into
account.
The standard no longer specifies that the organization shall issue and maintain documented procedures, however, ISO
9001:2015 requires the organization to document any other procedures required for its effective operation. The standard
also requires the organization to issue and communicate a documented quality policy, a quality management system scope,
and quality objectives. The standard no longer requires compliant organizations to issue a formal Quality Manual. The
standard does require retention of numerous records, as specified throughout the standard. New for the 2015 release is a
requirement for an organization to assess risks and opportunities (section 6.1) and to determine internal and external issues
relevant to its purpose and strategic direction (section 4.1). The organization must demonstrate how the standard's
requirements are being met, while the external auditor's role is to determine the quality management system's
effectiveness. More detailed interpretation and implementation examples are often sought by organizations seeking more
information in what can be a very technical area.

Certification[edit]

The International Organization for Standardization (ISO) does not certify organisations itself. Numerous certification bodies
exist, which audit organisations and, upon success, issue ISO 9001 compliance certificates. Although commonly referred to
as "ISO 9000" certification, the actual standard to which an organization's quality management system can be certified is ISO
9001:2015 (ISO 9001:2008 expired around September 2018). Many countries have formed accreditation bodies to authorize
("accredit") the certification bodies. 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 worldwide. Certification bodies themselves operate under another
quality standard, ISO/IEC 17021,[36] while accreditation bodies operate under ISO/IEC 17011.[37]

An organization applying for ISO 9001 certification is audited based on an extensive sample of its sites, functions, products,
services and processes. The auditor presents a list of problems (defined as "nonconformities", "observations", or
"opportunities for improvement") to management. If there are no major nonconformities, the certification body will issue a
certificate. Where major nonconformities are identified, the organization will present an improvement plan to the
certification body (e.g., corrective action reports showing how the problems will be resolved); once the certification body is
satisfied that the organization has carried out sufficient corrective action, it will issue a certificate. The certificate is limited
by a certain scope (e.g., production of golf balls) and will display the addresses to which the certificate refers.
An ISO 9001 certificate is not a once-and-for-all award but must be renewed at regular intervals recommended by the
certification body, usually once every three years. There are no grades of competence within ISO 9001: either a company is
certified (meaning that it is committed to the method and model of quality management described in the standard) or it is
not. In this respect, ISO 9001 certification contrasts with measurement-based quality systems.

Evolution of ISO 9000 standards[edit]

The ISO 9000 standard is continually being revised by standing technical committees and advisory groups, who receive
feedback from those professionals who are implementing the standard.
1987 version[edit]
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]
1994 version[edit]

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]
2000 version[edit]

ISO 9001:2000 replaced all three former standards of 1994 issue, ISO 9001, ISO 9002 and ISO 9003. Design and
development procedures were 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 front and centre the concept of process
management (the monitoring and optimisation of a company's tasks and activities, instead of just inspection of the final
product). The 2000 version also demanded involvement by upper executives in order to integrate quality into the business
system and avoid delegation of quality functions to junior administrators. Another goal was 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.
ISO 9000 Requirements include:

 Approve documents before distribution;

 Provide correct version of documents at points of use;
 Use your records to prove that requirements have been met; and
 Develop a procedure to control your records.
2008 version[edit]
ISO 9001:2008 in essence re-narrates ISO 9001:2000. The 2008 version only introduced clarifications to the existing
requirements of ISO 9001:2000 and some changes intended to improve consistency with ISO 14001:2004. There were no
new requirements. For example, in ISO 9001:2008, a quality management system being upgraded just needs to be checked
to see if it is following the clarifications introduced in the amended version.
ISO 9001 is supplemented directly by two other standards of the family:

 ISO 9000:2005 "Quality management systems. Fundamentals and vocabulary"

 ISO 9004:2009 "Managing for the sustained success of an organization. A quality management approach"

Other standards, like ISO 19011 and the ISO 10000 series, may also be used for specific parts of the quality system.

2015 version[edit]

In 2012, ISO TC 176 - responsible for ISO 9001 development - celebrated 25 years of implementing ISO 9001,[38] and
concluded that it was necessary to create a new QMS model for the next 25 years. They subsequently commenced the
official work on creating a revision of ISO 9001, starting with the new QM principles. This moment was considered by
important specialists in the field as "beginning of a new era in the development of quality management systems."[39] As a
result of the intensive work from this technical committee, the revised standard ISO 9001:2015 was published by ISO on 23
September 2015. The scope of the standard has not changed; however, the structure and core terms were modified to allow
the standard to integrate more easily with other international management systems standards.[40]
The new ISO 9001:2015 management system standard helps ensure that consumers get reliable, desired quality goods and
services. This further increases benefits for a business.[41]
The 2015 version is also less prescriptive than its predecessors and focuses on performance. This was achieved by combining
the process approach with risk-based thinking, and employing the Plan-Do-Check-Act cycle at all levels in the
organization.[42]
Some of the key changes include:

 High-Level Structure of 10 clauses is implemented. Now all new standards released by ISO will have this high-level
structure
 Greater emphasis on building a management system suited to each organization's particular needs
 A requirement that those at the top of an organization be involved and accountable, aligning quality with wider
business strategy
 Risk-based thinking throughout the standard makes the whole management system a preventive tool and
encourages continuous improvement
 Less prescriptive requirements for documentation: the organisation can now decide what documented
information it needs and what format it should be in
 Alignment with other key management system standards through the use of a common structure and core
text[43]
 Inclusion of Knowledge Management principles
 Quality Manual & Management representative (MR) are no longer mandatory

Auditing[edit]
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 is supposed to, to find out where it can improve, and to correct or
prevent identified problems. It is considered healthier for internal auditors to audit outside their usual management line, so
as to bring a degree of independence to their judgements.

Industry-specific interpretations[edit]
The ISO 9001 standard is generic; 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 (United States), professional soccer teams (Mexico), and city councils (UK)—have successfully implemented
ISO 9001:2000 systems.

 Over time, various industry sectors have wanted to standardise 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.PS 9000 * 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 16949:2009 is an interpretation agreed upon by major automotive manufacturers (American and
European manufacturers); the latest version is based on ISO 9001:2008. The emphasis on a process approach is stronger
than in ISO 9001:2008. ISO/TS 16949:2009 contains the full text of ISO 9001:2008 and automotive industry-specific
requirements. After the new edition of ISO 9001:2015 the ISO/TS 16949:2009 was also completely revised and reissued
by IATF (International Automotive Task Force) IATF 16949:2016 is now a stand-alone standard which doesn't include
the ISO 9001:2015 requirements but still refer to them and works as additional automotive specific requirement to ISO
9001.
 TL 9000 is the Telecom Quality Management and Measurement System Standard, an interpretation developed by
the telecom consortium, QuEST Forum. In 1998 QuEST Forum developed the TL 9000 Quality Management System to
meet the supply chain quality requirements of the worldwide telecommunications industry. The TL 9000 standard is
made up of two handbooks: the QMS Requirements Handbook, and the QMS Measurement Handbook. The current
versions of the Requirements and Measurements Handbooks are 5.0. Unlike ISO 9001 or other sector-specific standards,
TL 9000 includes standardized product and process measurements that must be reported into a central repository,
which allows organizations to benchmark their performance in key process areas against peer organizations. It is
important to note that TL 9000 R5.0 contains the full text of ISO 9001:2008.
 ISO 13485:2016 is the medical industry's equivalent of ISO 9001. ISO 13485:2016 is a stand-alone standard.
Because ISO 13485 is relevant to medical devices manufacturers (unlike ISO 9001, which is applicable to any industry),
and because of the differences between the two standards relating to continual improvement, compliance with ISO
13485 does not necessarily mean compliance with ISO 9001 (and vice versa).
 ISO/IEC 90003:2014 provides guidelines for the application of ISO 9001 to computer software.

 ISO/TS 29001 is quality management system requirements for the design, development, production, installation,
and service of products for the petroleum, petrochemical, and natural gas industries. It is equivalent to API Spec Q1
without the Monogram annex.
 ISO 22000 Food Safety Management Systems.

Effectiveness[edit]
The debate on the effectiveness of ISO 9000 commonly centres on the following questions:

1. Are the quality principles in ISO 9001 of value?

2. Does it help to implement an ISO 9001-compliant quality management system?
3. Does it help to obtain ISO 9001 certification?
The effectiveness of the ISO system being implemented depends on a number of factors, the most significant of which are:

1. Commitment of senior management to monitor, control, and improve quality. Organizations that implement an
ISO system without this desire and commitment often take the cheapest road to get a certificate on the wall and
ignore problem areas uncovered in the audits.
2. How well the ISO system integrates into current business practices. Many organizations that implement ISO try to
make their system fit into a cookie-cutter quality manual instead of creating a manual that documents existing
practices and only adds new processes to meet the ISO standard when necessary.
3. How well the ISO system focuses on improving the customer experience. The broadest definition of quality is
"Whatever the customer perceives good quality to be." This means that a company doesn't necessarily have to
make a product that never fails; some customers will have a higher tolerance for product failures if they always
receive shipments on-time or have a positive experience in some other dimension of customer service. An ISO
system should take into account all areas of the customer experience and the industry expectations, and seek to
improve them on a continual basis. This means taking into account all processes that deal with the three
stakeholders (customers, suppliers, and organization); only then will a company be able to sustain improvements
in the customer's experience.
4. How well the auditor finds and communicates areas of improvement. While ISO auditors may not provide
consulting to the clients they audit, there is the potential for auditors to point out areas of improvement. Many
auditors simply rely on submitting reports that indicate compliance or non-compliance with the appropriate
section of the standard; however, to most executives, this is like speaking a foreign language. Auditors that can
clearly identify and communicate areas for improvement in language and terms executive management
understands facilitate action on improvement initiatives by the companies they audit. When management doesn't
understand why they were non-compliant and the business implications associated with non-compliance, they
simply ignore the reports and focus on what they do understand.
Advantages[edit]
Proper quality management can improve business, often having a positive effect on investment, market share, sales growth,
sales margins, competitive advantage, and avoidance of litigation.[44] The quality principles in ISO 9000:2000 are also sound,
according to Wade [45] and Barnes, who says that "ISO 9000 guidelines provide a comprehensive model for quality
management systems that can make any company competitive".[46] Sroufe and Curkovic, (2008) found benefits ranging
from registration required to remain part of a supply base, better documentation, to cost benefits, and improved
involvement and communication with management.[44] According to ISO[47] the 2015 version of the standard brings the
following benefits:

1. By assessing their context, organizations can define who is affected by their work and what they expect. This
enables clearly stated business objectives and the identification of new business opportunities.
2. Organizations can identify and address the risks associated with their organization.
3. By putting customers first, organizations can make sure they consistently meet customer needs and enhance
customer satisfaction. This can lead to more repeat customers, new clients and increased business for the
organization.
 4. Organizations work in a more efficient way as all their processes are aligned and understood by everyone. This
increases productivity and efficiency, bringing internal costs down.
5. Organizations will meet necessary statutory and regulatory requirements.
6. Organizations can expand into new markets, as some sectors and clients require ISO 9001 before doing business.
Criticisms of ISO 9001 certification[edit]
A common criticism of ISO 9000 and 9001 is the amount of money, time, and paperwork required for a complete
implementation, and later when needed; ISO 9001 certification.[7] Dalgleish cites the "inordinate and often unnecessary
paperwork burden" of ISO, and says that "quality managers feel that ISO's overhead and paperwork are excessive and
extremely inefficient".[48] The level of minimum documentation for a minimum scope organization has been greatly
reduced, going from ISO 9001:2000 to ISO 9001:2008 to ISO 9001:2015.[citation needed]
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".[46] Wilson suggests that ISO
standards "elevate inspection of the correct procedures over broader aspects of quality", and therefore, "the workplace
becomes oppressive and quality is not improved".[8]
One study showing reasons for not adopting this standard include the risks and uncertainty of not knowing if there are direct
relationships to improved quality, and what kind and how many resources will be needed. Additional risks include how
much certification will cost, increased bureaucratic processes and risk of poor company image if the certification process
fails.[44] According to John Seddon, ISO 9001 promotes specification, control, and procedures rather
than understanding and improvement.[9] 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".[45] In short, Wade argues that 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.[9] Certifications are in fact often based on customer contractual requirements rather than a desire to actually
improve quality.[46][49] "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.[49] Certification by an independent
auditor is often seen as the problem area, and according to Barnes, "has become a vehicle to increase consulting
services".[46]
Dalgleish argues that while "quality has a positive effect on return on investment, market share, sales growth, better sales
margins and competitive advantage," "taking a quality approach is unrelated to ISO 9000 registration."[50] In fact, ISO itself
advises that ISO 9001 can be implemented without certification, simply for the quality benefits that can be achieved.[51]

Abrahamson argues that fashionable management discourse such as Quality Circles tends to follow a lifecycle in the form
of a bell curve, possibly indicating a management fad.[52]

Pickrell argues[citation needed] that ISO systems merely gauge whether the processes are being followed. It does not gauge
how good the processes are or whether the correct parameters are being measured and controlled to ensure quality.
Furthermore, when unique technical solutions are involved in the creation of a new part, ISO does not validate the
robustness of the technical solution which is a key part of advanced quality planning. It is not unheard of for an ISO-certified
plant to display poor quality performance due to poor process selection and/or poor technical solutions.
Evolution[edit]
Quality management is a recent phenomenon but important for an organization. Civilizations that supported the arts and
crafts allowed clients to choose goods meeting higher quality standards rather than normal goods. In societies where arts
and crafts are the responsibility of master craftsmen or artists, these masters would lead their studios and train and
supervise others. The importance of craftsmen 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 was also important in bringing process and quality management practices into operation in his assembly lines. In
Germany, Karl 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 II. 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 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. These 14 points include key
concepts such as:

 Break down barriers between departments

 Management should learn their responsibilities, and take on leadership
 Supervision should be to help people and machines and gadgets to do a better job
 Improve constantly and forever the system of production and service
 Institute a vigorous program 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 high levels of quality in products from the 1970s onward. Many of
the methods not only provide techniques but also have associated quality culture (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 China and India, as well
internationalization of trade and competition. These countries, among many others, have raised their own standards of
quality in order to meet international standards and customer demands.[2][3] The ISO 9000 series of standards are
probably the best known International standards for quality management.

Customer satisfaction is the backbone of Quality Management. Setting up a million dollar company without taking care of
needs of customer will ultimately decrease its revenue.

There is a huge number of books available on quality management. Some themes have become more significant
including quality culture, the importance of knowledge management, and the role of leadership in promoting and achieving
high quality. Disciplines like systems thinking are bringing more holistic approaches to quality so that people, process and
products are considered together rather than independent factors in quality management.
The influence of quality thinking has spread to non-traditional applications outside of walls of manufacturing, extending into
service sectors and into areas such as sales, marketing and customer service.[4]

Principles[edit]
The International Standard for Quality management (ISO 9001:2015) adopts a number of management principles, that can
be used by top management to guide their organizations towards improved performance.
Customer focus[edit]

The primary focus of quality management is to meet customer requirements and to strive to exceed customer expectations.

Rationale
Sustained success is achieved when an organization attracts and retains the confidence of customers and other interested
parties on whom it depends. Every aspect of customer interaction provides an opportunity to create more value for the
customer. Understanding current and future needs of customers and other interested parties contributes to sustained
success of an organization [5]

Leadership[edit]
Leaders at all levels establish unity of purpose and direction and create conditions in which people are engaged in achieving
the organization’s quality objectives. Leadership has to take up the necessary changes required for quality improvement and
encourage a sense of quality throughout organisation. Rationale
Creation of unity of purpose and direction and engagement of people enable an organization to align its strategies, policies,
processes and resources to achieve its objectives [6]

Engagement of people[edit]

Competent, empowered and engaged people at all levels throughout the organization are essential to enhance its capability
to create and deliver value.
Rationale
To manage an organization effectively and efficiently, it is important to involve all people at all levels and to respect them as
individuals. Recognition, empowerment and enhancement of competence facilitate the engagement of people in achieving
the organization’s quality objectives.[7]

Process approach[edit]
Consistent and predictable results are achieved more effectively and efficiently when activities are understood and managed
as interrelated processes that function as a coherent system.
Rationale
The quality management system consists of interrelated processes. Understanding how results are produced by this system
enables an organization to optimize the system and its performance.[8]
Improvement[edit]
Successful organizations have an ongoing focus on improvement.
'Rationale'
Improvement is essential for an organization to maintain current levels of performance, to react to changes in its internal
and external conditions and to create new opportunities.[9]
Evidence based decision making[edit]
Further information: decision making

Decisions based on the analysis and evaluation of data and information are more likely to produce desired results.
Rationale

Decision making can be a complex process, and it always involves some uncertainty. It often involves multiple types and
sources of inputs, as well as their interpretation, which can be subjective. It is important to
understand cause-and-effect relationships and potential unintended consequences. Facts, evidence and data
analysis lead to greater objectivity and confidence in decision making.[10]

Relationship management[edit]
Further information: Relationship management

For sustained success, an organization manages its relationships with interested parties, such as suppliers, retailers.

'Rationale'
Interested parties influence the performance of an organizations and industry. Sustained success is more likely to be
achieved when the organization manages relationships with all of its interested parties to optimize their impact on its
performance. Relationship management with its supplier and partner networks is of particular importance.[11]
Criticism[edit]

The social scientist Bettina Warzecha (2017)[12] describes the central concepts of Quality Management (QM), such as e.g.
process orientation, controllability, and zero defects as modern myths. She demonstrates that zero-error processes and the
associated illusion of controllability involve the epistemological problem of self-referentiality. The emphasis on the
processes in QM also ignores the artificiality and thus arbitrariness of the difference between structure and process. Above
all, the complexity of management cannot be reduced to standardized (mathematical) procedures. According to her, the
risks and negative side effects of QM are usually greater than the benefits (see also brand eins, 2010).[13]

Quality improvement and more[edit]

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 9004:2008 — guidelines for performance improvement.

2. ISO 9001:2015 - a certified quality management system (QMS) for organisations

who want to prove their ability to consistently provide products and services
that meet the needs of their customers and other relevant stakeholders.[15]
 3. ISO 15504-4: 2005 — information technology — process assessment — Part 4:
Guidance on use for process improvement and process capability
determination.
4. QFD — quality function deployment, also known as the house of quality
approach.
5. Kaizen — 改善, Japanese for change for the better; the common English term
is continuous improvement.

6. 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.
7. Six Sigma — 6σ, Six Sigma combines established methods such as statistical
process control, design of experiments and failure mode and effects analysis
(FMEA) in an overall framework.

8. PDCA — plan, do, check, act cycle for quality control purposes. (Six
Sigma's DMAIC method (define, measure, analyze, improve, control) may be
viewed as a particular implementation of this.)
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
optimizing the workflows and processes within an organisation.
16. OQRM — Object-oriented Quality and Risk Management, a model for quality
and risk management.[16]
17. Top Down & Bottom Up Approaches—Leadership approaches to change[17]
Proponents of each approach have sought to improve them as well as apply them for small, medium and large gains. Simple
one is Process Approach, which forms the basis of ISO 9001:2008 Quality Management System standard, duly driven from
the 'Eight principles of Quality management', process approach being one of them. Thareja[18] writes about the mechanism
and benefits: "The process (proficiency) may be limited in words, but not in its applicability. While it fulfills the criteria of
all-round gains: in terms of the competencies augmented by the participants; the organisation seeks newer directions to the
business success, the individual brand image of both the people and the organisation, in turn, goes up. The competencies
which were hitherto rated as being smaller, are better recognized and now acclaimed to be more potent and
fruitful".[19] The more complex Quality improvement tools are tailored for 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 have 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 (that is '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.

Quality standards[edit]
ISO standards[edit]

The International Organization for Standardization (ISO) created the Quality Management System (QMS)[20] standards in
1987. They 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 are reviewed every few years by the International Organization for Standardization. The version in 1994 was
called the ISO 9000:1994 series; consisting of the ISO 9001:1994, 9002:1994 and 9003:1994 versions.

The last major revision was in the year 2000 and the series was called ISO 9000:2000 series. The ISO 9002 and 9003
standards were integrated into one single certifiable standard: ISO 9001:2000. After December 2003, organizations holding
ISO 9002 or 9003 standards had to complete a transition to the new standard.
ISO released a minor revision, ISO 9001:2008 on 14 October 2008. It contains no new requirements. Many of the changes
were to improve consistency in grammar, facilitating translation of the standard into other languages for use by over
950,000 certified organization in the 175 countries (as at Dec 2007) that use the standard.

The ISO 9004:2009 document gives guidelines for performance improvement over and above the basic standard (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, not the product or service itself. ISO 9000 standards do not certify the quality of the product or service.

In 2005 the International Organization for Standardization released a 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 also released standards for other industries. For example, Technical Standard TS 16949 defines requirements in
addition to those in ISO 9001:2008 specifically for the automotive industry.

ISO has a number of standards that support quality management. One group describes processes (including ISO/IEC
12207 and ISO/IEC 15288) and another describes process assessment and improvement ISO 15504.

CMMI and IDEAL methods[edit]

The Software Engineering Institute has its own process assessment and improvement methods, called CMMI (Capability
Maturity Model Integration) and IDEAL respectively.
Capability Maturity Model Integration (CMMI) is a process improvement training and appraisal program and service
administered and marketed by Carnegie Mellon University and required by many DOD and U.S. Government contracts,
especially in software development. Carnegie Mellon University claims CMMI can be used to guide process improvement
across a project, division, or an entire organization. Under the CMMI methodology, processes are rated according to their
maturity levels, which are defined as: Initial, Managed, Defined, Quantitatively Managed, Optimizing. Currently supported is
CMMI Version 1.3. CMMI is registered in the U.S. Patent and Trademark Office by Carnegie Mellon University.
Three constellations of CMMI are:

 Product and service development (CMMI for Development)

 Service establishment, management, and delivery (CMMI for Services)
 Product and service acquisition (CMMI for Acquisition).
CMMI Version 1.3 was released on November 1, 2010. This release is noteworthy because
it updates all three CMMI models (CMMI for Development, CMMI for Services, and CMMI
for Acquisition) to make them consistent and to improve their high maturity practices.
The CMMI Product Team has reviewed more than 1,150 change requests for the models
and 850 for the appraisal method.
As part of its mission to transition mature technology to the software community, the SEI
has transferred CMMI-related products and activities to the CMMI Institute, a
 100%-controlled subsidiary of Carnegie Innovations, Carnegie Mellon University’s
technology commercialization enterprise.[21]

Quality management software[edit]

Quality Management Software is a category of technologies used by organizations to
manage the delivery of high quality products. Solutions range in functionality, however,
with the use of automation capabilities they typically have components for managing
internal and external risk, compliance, and the quality of processes and products.
Pre-configured and industry-specific solutions are available and generally require
integration with existing IT architecture applications such as ERP, SCM, CRM, and PLM.

Quality Management Software Functionalities

 Non-Conformances/Corrective and Preventive Action

 Compliance/Audit Management
 Supplier Quality Management
 Risk Management
 Statistical Process Control
 Failure Mode and Effects Analysis
 Complaint Handling
 Advanced Product Quality Planning
 Environment, Health, and Safety
 Hazard Analysis & Critical Control Points
 Production Part Approval Process
Enterprise Quality Management Software

 The intersection of technology and quality management software prompted the emergence
of a new software category: Enterprise Quality Management Software (EQMS). EQMS is a
platform for cross-functional communication and collaboration that centralizes,
standardizes, and streamlines quality management data from across the value chain. The
software breaks down functional silos created by traditionally implemented standalone
and targeted solutions. Supporting the proliferation and accessibility of information
across supply chain activities, design, production, distribution, and service, it provides a
holistic viewpoint for managing the quality of products and processes.

4. job Analysis is a primary tool to collect job-related data. The process results in collecting and recording two data sets
including job description and job specification. Any job vacancy can not be filled until and unless HR manager has
these two sets of data. It is necessary to define them accurately in order to fit the right person at the right place and
at the right time. This helps both employer and employee understand what exactly needs to be delivered and how.

Both job description and job specification are essential parts of job analysis information. Writing them clearly and
accurately helps organization and workers cope with many challenges while onboard.Though preparing job description and
job specification are not legal requirements yet play a vital role in getting the desired outcome. These data sets help in
determining the necessity, worth and scope of a specific job.

Job Description Job description includes basic job-related data that is useful to advertise a specific job and attract a pool of talent. It
includes information such as job title, job location, reporting to and of employees, job summary, nature and objectives of a job,
tasks and duties to be performed, working conditions, machines, tools and equipments to be used by a prospective worker and
hazards involved in it.

Purpose of Job Description

 The main purpose of job description is to collect job-related data in order to advertise for a particular job. It helps in
attracting, targeting, recruiting and selecting the right candidate for the right job.

 It is done to determine what needs to be delivered in a particular job. It clarifies what employees are supposed to do
if selected for that particular job opening.

 It gives recruiting staff a clear view what kind of candidate is required by a particular department or division to
perform a specific task or job.
  It also clarifies who will report to whom.

Job Specification

Also known as employee specifications, a job specification is a written statement of educational qualifications, specific qualities,
level of experience, physical, emotional, technical and communication skills required to perform a job, responsibilities involved in a
job and other unusual sensory demands. It also includes general health, mental health, intelligence, aptitude, memory, judgment,
leadership skills, emotional ability, adaptability, flexibility, values and ethics, manners and creativity, etc.

Purpose of Job Specification

 Described on the basis of job description, job specification helps candidates analyze whether are eligible to apply for
a particular job vacancy or not.

 It helps recruiting team of an organization understand what level of qualifications, qualities and set of characteristics
should be present in a candidate to make him or her eligible for the job opening.

 Job Specification gives detailed information about any job including job responsibilities, desired technical and
physical skills, conversational ability and much more.

 It helps in selecting the most appropriate candidate for a particular job.

Job description and job specification are two integral parts of job analysis. They define a job fully and guide both employer and
employee on how to go about the whole process of recruitment and selection. Both data sets are extremely relevant for creating a
right fit between job and talent, evaluate performance and analyze training needs and measuring the worth of a particular job.

General and Specific Purpose of Job Description

Job description is all about collecting and recording basic job-related data that includes job title, job location, job summary, job
duties, reporting information, working conditions, tools, machines and equipments to be used and hazards and risks involved in it.
A job description may or may not have specific purpose. It depends on what HR managers want to determine and what is the
objective of conducting the process of job analysis.

Job Description is a summary of job analysis findings that helps managers determine what an employee is supposed to do when
onboard. The purpose of job description depends on the level of details the job findings include. Job description carried for general
purpose typically involves job identification (title, designation, location) and a statement of duties and functions of a prospective or
existing employee. A specifically carried job description includes detailed information about the kind of job, how it is supposed to
be performed and what is expected to be delivered. Let’s discuss the general and specific purpose of conducting a job description
process.

General Purpose of Job Description General purpose job descriptions are used by organizations to find the very basic information
about a particular job opening. Though data includes worker’s duties but does not contain sub tasks, performance standards and
basis for evaluating jobs and establishing right compensation packages.

Advantages

The main benefit of general purpose job description is that it does not consume much time and quickly provides basic information
to managers. It does not require much human efforts and is very easy and convenient to carry out. Additionally, a job analyst does
not have to conduct deep research to gather the required details.

Disadvantages

The main disadvantage of general purpose job description is that it does not provide managers with full-fledged information about
job context and sub tasks. Sometimes, a manager may fail to extract correct information from such small amount of data.

Specific Purpose of Job Description

Specific purpose job description includes detailed information about job responsibilities of an employee. It also covers sub tasks,
essential functions and detailed job duties. It involves huge amount of details such as what an employee needs to do, how it is to
be done and what are the performance standards, etc.
 Advantages

The main benefit of specific purpose job description is that it offers ample information to evaluate job performance and determine
training needs of employees. It serves as a basis for all other HR processes including recruitment and selection, performance
appraisal, compensation decision and many more.

Disadvantages

Though it assists managers in decision making process but it has its own limitations. The process, however, may take very long and
consume lots of human efforts. Since, it involves collecting detailed information; the biased nature of job analyst can cause severe
problems. The data collected may not be 100 percent genuine.

Performance Evaluation

Section 9.1: Monitoring, Measurement, Analysis and Evaluation

As noted elsewhere, the standard emphasizes both a process approach, and the need to utilize a review or checking

phase (from the Plan>Do>Check>Act approach.) The standard mandates determining what data needs to be collected,

how that data is collected and interpreted, and what results should be acted upon from a variety of inputs at various

points in the quality management process.

These results must in turn be verified (audited), and they must be subject to management’s direct review.

This process also must itself be evaluated for effectiveness.

Section 9.1.2: Customer Satisfaction

ISO 9001:2015 standard states that organizations are required to meet both stated and intended needs of their

customers. Data on the degree of customer satisfaction needs to be collected, analyzed and monitored to ensure

customer expectations are being met. Data collection methods include surveys, direct customer communication,

warranty activity and sales channel reports. The data collected can include measures around on time delivery,

product/service quality, or order accuracy. The standard also wants the organization to identify and manage

communication during the entire customer life cycle; this includes: how complaints will be addressed and solved and

how customer perception and satisfaction will be monitored and improved.

Section 9.1.3: Analysis and Evaluation

Data that reflects the performance of the QMS must be analyzed and evaluated to determine if improvements need

to be made. Examples of data to monitor and measure include customer satisfaction, nonconformities, effectiveness

of risk management and external provider performance.

Section 9.2: Internal Audit

In order to confirm that the QMS conforms to the ISO 9001:2015 standard and the organization’s standards internal

audits must be conducted at planned intervals. A formal internal audit program needs to be established which
defines the methods used, scope and frequency as well as assigning responsibility to objective and impartial auditors.

The results of internal audits are used to make corrections and improvementsto the QMS.

Section 9.3: Management Review

Data collected on QMS performance (i.e. customer input, internal audits, key quality performance indicators) and

determination of any support, changes, or improvementsmust be reviewed and discussed by top management at

planned intervals. Actions generated from the review must be recorded and implemented as they will be follow-up

on during the next management review.

Please note that certain text from the ISO 9001 standard is only used for instructional purposes. Standard Stores

recognizes and respects the International Organization for Standardization (ISO) copyright and intellectual property

guidelines.