UNIT 32 Quality Systems In It QUALITY

UNIT 32 Quality Systems In It
* A system by which an organization aims to reduce and eventually eliminate
nonconformance to specifications, standards, and customer expectations in the
most cost effective and efficient manner. * A quality management system (QMS)
can be expressed as the organizational structure, procedures, processes and
resources needed to implement quality management * A quality management system
is a management technique used to communicate to employees what is required to
produce the desired quality of products and services and to influence employee
actions to complete tasks according to the quality specifications
What Purpose Does a Quality Management System Serve?

✔ Establishes a vision for the employees.
✔ Sets standards for employees.
✔ Builds motivation within the company.
✔ Sets goals for employees.
✔Helps fight the resistance to change within organizations. ✔ Helps direct
the corporate culture.

Quality management is becoming increasingly important to the leadership and
management of all organisations. It is necessary to identify Quality Management
as a distinct discipline of management and lay down universally understood and
accepted rules for this discipline. Definition of Quality Management Principle:

“A quality management principle is a comprehensive and fundamental rule /
belief, for leading and operating an organisation, aimed at continually
improving performance over the long term by focusing on customers while
addressing the needs of all other stake holders”. The eight principles are

1. Customer-Focused Organisation
2. Leadership
3. Involvement of People
4. Process Approach
5. System Approach to Management
6. Continual Improvement
7. Factual Approach to Decision Making
8. Mutually Beneficial Supplier Relationships..
Principle 1 – Customer-Focused Organisation : “Organisations depend on
their customers and therefore should understand current and future customer
needs, meet customer requirements and strive to exceed customer
expectations”. Steps in application of this principle are

1. Understand customer needs and expectations for products, delivery, price,
dependability, etc. 2. Ensure a balanced approach among customers and other
stake holders (owners, people, suppliers, local communities and society at
large) needs and expectations. 3. Communicate these needs and expectations
throughout the organisation. 4. Measure customer satisfaction & act on
results, and 5. Manage customer relationships.

Principle 2 – Leadership : “Leaders establish unity of purpose and
direction of the organisation. They should create and maintain the internal
environment in which people can become fully involved in achieving the
organisation’s objectives.” Steps in application of this principle are

1. Be proactive and lead by example.HND Assignment Help
2. Understand and respond to changes in the external environment. 3. Consider
the needs of all stake holders including customers, owners, people, suppliers,
local communities and society at large. 4. Establish a clear vision of the
organisation’s future. 5. Establish shared values and ethical role models at
all levels of the organisation. 6. Build trust and eliminate fear.

7. Provide people with the required resources and freedom to act with
responsibility and accountability. 8. Inspire, encourage and recognise people’s
contributions. 9. Promote open and honest communication.

10. Educate, train and coach people.
11. Set challenging goals and targets, and
12. Implement a strategy to achieve these goals and targets. Principle 3 –
Involvement of People: “People at all levels are the essence of an
organisation and their full involvement enables their abilities to be used for
the organisation’s benefit”. Steps in application of this principle are

1. Accept ownership and responsibility to solve problems. 2. Actively seek
opportunities to make improvements, and enhance competencies, knowledge and
experience. 3. Freely share knowledge & experience in teams.

4. Focus on the creation of value for customers.
5. Be innovative in furthering the organisation’s objectives. 6. Improve the
way of representing the organisation to customers, local communities and
society at large. 7. Help people derive satisfaction from their work, and

8. Make people enthusiastic and proud to be part of the organisation. Principle
4 – Process Approach : “A desired result is achieved more efficiently when
related resources and activities are managed as a process.” Steps in
application of this principle are


Unit 4 – Personal  and professional development in health and social care

1. Define the process to achieve the desired result.
2. Identify and measure the inputs and outputs of the process. 3. Identify the
interfaces of the process with the functions of the organisation. 4. Evaluate
possible risks, consequences and impacts of processes on customers, suppliers
and other stake holders of the process. 5. Establish clear responsibility,
authority, and accountability for managing the process. 6. Identify internal
and external customers, suppliers and other stake holders of the process, and
7. When designing processes, consider process steps, activities, flows, control
measures, training needs, equipment, methods, information, materials and other
resources to achieve the desired result. Principle 5 – System Approach to
Management: “Identifying, understanding and managing a system of
interrelated processes for a given objective improves the organisation’s
effectiveness and efficiency.” Steps in application of this principle are

1. Define the system by identifying or developing the processes that affect a
given objective. 2. Structure the system to achieve the objective in the most
efficient way. 3. Understand the interdependencies among the processes of the
system. 4. Continually improve the system through measurement and evaluation,
and 5. Estimate the resource requirements and establish resource constraints
prior to action. Principle 6 – Continual Improvement: “Continual
improvement should be a permanent objective of the organisation.” Steps in
application of this principle are

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1. Make continual improvement of products, processes and systems an objective
for every individual in the organisation. 2. Apply the basic improvement
concepts of incremental improvement and breakthrough improvement. 3. Use
periodic assessments against established criteria of excellence to identify
areas for potential improvement. 4. Continually improve the efficiency and effectiveness
of all processes. 5. Promote prevention based activities.

6. Provide every member of the organisation with appropriate education and
training, on the methods and tools of continual improvement such as the
Plan-Do-Check-Act cycle , problem solving , process re-engineering, and process
innovation. 7. Establish measures and goals to guide and track improvements,and
8. Recognise improvements.

Principle 7 – Factual Approach to Decision Making: “Effective decisions
are based on the analysis of data and information.” Steps in application
of this principle are
1. Take measurements and collect data and information relevant to the
objective. 2. Ensure that the data and information are sufficiently accurate,
reliable and accessible. 3. Analyse the data and information using valid

4. Understand the value of appropriate statistical techniques, and 5. Make
decisions and take action based on the results of logical analysis balanced
with experience and intuition. Principle 8 – Mutually Beneficial Supplier
Relationships: “An organisation and its suppliers are interdependent, and
a mutually beneficial relationship enhances the ability of both to create
value.” Steps in application of this principle are

1. Identify and select key suppliers.
2. Establish supplier relationships that balance short-term gains with
long-term considerations for the organisation and society at large. 3. Create
clear and open communications.
4. Initiate joint development and improvement of products and processes. 5.
Jointly establish a clear understanding of customers’ needs. 6. Share
information and future plans, and
7. Recognise supplier improvements and achievements.

Quality standards
What is ISO?
ISO (International Organization for Standardization) is the world’s largest developer
of voluntary International Standards. International Standards give state of the
art specifications for products, services and good practice, helping to make
industry more efficient and effective. Developed through global consensus, they
help to break down barriers to international trade. Popular name for
International Organization For Standardization (IOS), a voluntary, non-treaty
federation of standards setting bodies of some 130 countries. Founded in
1946-47 in Geneva as a UN agency, it promotes development of standardization
and related activities to facilitate international trade in goods and services,
and cooperation on economic, intellectual, scientific, and technological
aspects. ISO covers standardization in all fields including computers and data
communications, but excluding electrical and electronic engineering (governed
by the International Electro-technical Commission or IEC) and
telecommunications (governed by International Telecommunications Union’s
Telecommunications Standards Sector or ITU-TSS).

NB: “Because ‘International Organization for Standardization’ would have
different acronyms in different languages (IOS in English, OIN in French for
Organisation internationale de normalisation), our founders decided to give it
the short form ISO. ISO is derived from the Greek isos, meaning equal. Whatever
the country, whatever the language, the short form of our name is always ISO.”

Popular standards
ISO 9000 – Quality management – Make sure your products and services meet
customers’ needs with this family of standards. ISO 14000 – Environmental
management – Improve your environmental performance with this family of
standards. ISO 3166 – Country codes – Avoid confusion when referring to
countries and their subdivisions with this standard. ISO 22000 – Food safety
management – Inspire confidence in your food products with this family of
standards. ISO 26000 – Social responsibility – Help your organization to
operate in a socially responsible way with this standard. ISO 50001 – Energy
management – Make energy savings and help make your organization more efficient
with this standard. ISO 31000 – Risk management – Manage risks that could be
negative for your company’s performance with this standard ISO 4217 – Currency
codes – Avoid confusion when referring to world currencies with this standard.
ISO 639 – Language codes – Describe languages in an internationally accepted
way with this standard Benefits of International Standards

Unit 4 – Personal  and professional development in health and social care

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International Standards bring technological, economic and societal benefits.
They help to harmonize technical specifications of products and services making
industry more efficient and breaking down barriers to international trade.
Conformity to International Standards helps reassure consumers that products
are safe, efficient and good for the environment. For business

International Standards are strategic tools and guidelines to help companies
tackle some of the most demanding challenges of modern business. They ensure
that business operations are as efficient as possible, increase productivity
and help companies access new markets. Benefits include:

* Cost savings – International Standards help optimise operations and therefore
improve the bottom line * Enhanced customer satisfaction – International
Standards help improve quality, enhance customer satisfaction and increase
sales * Access to new markets – International Standards help prevent trade
barriers and open up global markets * Increased market share – International
Standards help increase productivity and competitive advantage * Environmental
benefits – International Standards help reduce negative impacts on the
environment Businesses also benefit from taking part in the standard
development process. For Society

ISO has over 19 500 standards touching almost all aspects of daily life.
When products and services conform to International Standards consumers can
have confidence that they are safe, reliable and of good quality. For example,
ISO’s standards on road safety, toy safety and secure medical packaging are
just a selection of those that help make the world a safer place. For

ISO standards draw on international expertise and experience and are therefore
a vital resource for governments when developing regulations. National
governments can make ISO standards a regulatory requirement (remember ISO
standards themselves are voluntary). This has a number of benefits: * Expert
opinion – ISO standards are developed by experts. By integrating an ISO
standard into national regulation, governments can benefit from the opinion of
experts without having to call on their services directly. * Opening up world
trade – ISO standards are international and adopted by many governments. By
integrating ISO standards into national regulation, governments help to ensure
that requirements for imports and exports are the same the world over,
therefore facilitating the movement of goods, services and technologies from
country to country.


As commitment to provide quality, many business organisation put much effort to
pursue with ISO certification. However, many camponies facing problems in
applying ISO system in the company and these had created challenges in
progressing to certify. * Budget – Common constraint facing by
one organisation is budget. Either it is a limited budget,
unwillingness to spend on ISO matters or even consider a big
problem for a small business organisation. Realizing that they
required to be certified by have limitation in spending much money on it. High
cost of consultancy fees including consultant’s travelling expenses that
normally include in the costing will be the burden to the orgsanisation. *
Consultant – Many companies hire and rely on external consultant with less of
involvement in setting up the ISO system. Unfortunately, they may discover that
the consultant does not understand the organisation’s business or process,
resulting in a documented system that little or no merit to organisation.
Although there are many excellent consultant out there, a company’s limited
financial resources may become a deciding factor between choosing a consultant
who is cheap or consultant who is capable. This may result in problem in
maintaining the ISO system after certification and cause wasting of money as
product quality still cannot be consistently produce even the ISO system is
already in place. * Time – Distruptions of consultant’s onsite visit to daily
operation due to tight scheduling to match with consultant’s own scehdule.

* Increased Customer Satisfaction
Because ISO 9000 is dedicated to the boosting the quality of your final
product, successful implementation of the program should increase your customer
satisfaction. A product of a high quality is less likely to malfunction or
cease working, which could cause irate purchasers. High-quality products last
for a long time, and happy customers will spread the word about your business.
Tracking customer response will give you a way to tinker your ISO 9000 efforts
as you take advantage of what you have learned. * Third party assessment

The biggest advantage of ISO certification is the perspective of a third party
assessment. Frequently, companies underestimate problems or just ignore them
because they are too painful. The third party audit ensures that the quality
management is properly calibrated against the rest of the industry. * Executive
management exposure

Theories and concept of human development and behavior

Executive management tends to listen to recommendations and not their own
departments. ISO audits have a way of percolating to the highest levels of
the organization. This enables systemic problems that may be concealed to be
brought out to the appropriate levels of a company. Of course, this is a doubl
eedged sword as attention may be unnecessary, but it is nonetheless an
advantage for executive management to be involved in their quality system. *

ISO certification is also the most common type of certification. This makes it
easier to implement new systems, hire personnel, and understand changes. Some
of the more obtuse quality paradigms like Baldridge or TQM require specialized
training or knowledge that substantially ups the ante for those organizations
considering an alternative.

* Does not guarantee better quality
ISO certification definitely does not automatically lead to better quality
product. While it does encourage operations to think in terms of systems, it
does not require them to be good. This is definitely a problem with newer
certified companies and those with purchased quality systems. * Focus on

For anyone that has worked with ISO certified companies, this is definitely a
truth. ISO certification becomes a target, an end point, a stop on the road to
quality. In reality, continuously improving the systems would lead to better
quality, but for ISO certified companies, all too often the focus is on the
next audit.

How do companies get ISO?
One of the strengths of ISO standards is that they are created by the people
that need them. Industry experts drive all aspects of the standard development
process, from deciding whether a new standard is needed to defining all the
technical content. Getting involved in this process can bring significant
advantages to your business. For example by: * Giving early access to
information that could shape the market in the future * Giving your company a voice
in the development of standards * Helping to keep market access open.

Getting involved in standards development brings your concerns and needs to
bear on a process that will affect you in the future. Organizations and
companies often want to get certified to ISO’s management system standards (for
example ISO 9001 or ISO 14001) although certification is not a requirement. The
best reason for wanting to implement these standards is to improve the
efficiency and effectiveness of company operations. A company may decide to
seek certification for many reasons, as certification may: * be a contractual
or regulatory requirement

* be necessary to meet customer preferences
* fall within the context of a risk management programme, and * help motivate
staff by setting a clear goal for the development of its management system. ISO
does not perform certification
ISO develops International Standards, including management system standards
such as ISO 9001, ISO 14001 and ISO 31000. However, it is not involved in the
certification to any of the standards it develops. Certification is performed
by external certification bodies, which are largely private. Therefore a
company or organization cannot be certified by ISO. ISO does not perform

ISO develops International Standards, including management system standards
such as ISO 9001, ISO 14001 and ISO 31000. However, it is not involved in the
certification to any of the standards it develops. Certification is performed
by external certification bodies, which are largely private. Therefore a
company or organization cannot be certified by ISO. When a company or
organization is certified to an ISO standard they will receive a certificate
from the certification body. Even though the name of the ISO standard appears
on this certificate, it is not ISO that has issued it. Although ISO does not
perform certification, its Committee on Conformity Assessment (CASCO) has
produced a number of standards that relate to the certification process. The
voluntary criteria contained in these publications are an international
consensus on good practice relating to certification. Companies and
organizations usually operate their certification activities in accordance with
these international standards Process of acquiring ISO

1. Write documentation.


Unit 4 – Personal  and professional development in health and social care
You’ll need a written quality manual, certain written procedures, and probably
some forms. Some records will have to be kept. Your documentation
will have to meet the requirements of the ISO quality standard. It will
also have to fit your company’s quality goals. Your quality documentation
says what you do, how you do it, and provides proof that you do it. You
must be able to demonstrate that you are continuously improving your quality
system as well as your product or service, and your customers’ satisfaction. 2.

All of your people will require some training. The amount of training is
dependent on each individual’s responsibilities. 3. Practice and
live with your quality system for a few months. Undoubtedly you
will find that some changes need to be made. Keep records in accordance
with your quality system. After a few months your quality system
and your people should be ready for the registration audit. 4. Get audited.

The number of auditors needed, and the time involved to conduct a registration
audit will vary according to the size and complexity of your company.
During an ISO audit, the auditor(s) will examine your records and will talk
with your people. It is very important that your staff is properly trained
and that your records are in order. Auditors write up problems as
“nonconformances”. Nonconformances can be “major” or “minor”.
Auditors can also write up “observations”. A major nonconformance will
cause you not to get certified to the ISO standard. Minor nonconformances
may or may not prevent your certification, it all depends on the number and
severity of your nonconformances. Auditors have a fair amount of
discretion in what they write up, and whether or not you will get certified on
your first try. Observations will not cause you to lose your certification,
they are usually suggestions by the auditor for how you might be able to make
improvements to your quality system.


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