What is TQM ?

A management approach for an organization

centered on quality based on the participation of all its
members and aiming at customer satisfaction and
benefits to all members of the organization and to society. It
is being practiced to improve the competitiveness,
effectiveness and flexibility of the whole organization.
 Other definition of TQM is that it is a customer driven
approach in operating an organization by combining the
talents of labor and management, working cooperatively to
improve the quality and productivity through teamwork and
fact based methodologies.

 It is not short term commitment or a one time effort and

this must be a long term commitment and many experts
say that it takes 5-10years to embed TQM within the
underlying foundations of an organization.

 TQM is a way of thinking and working to achieve

continuous improvement through employee involvement
and a focus on customer. Doing the right thing, right the
first time, all the time; always striving for improvement and
always satisfying the customer.
 Other definitions of Total
Quality Management includes :
• A philosophy for conducting business.
• A new fundamental way of thinking.
• A change in the old way of thinking.
• An unending focus on customer
satisfaction.
•A commitment to an attitude of continuous
improvement.
 Total Quality Management is defined as a
continuous effort by management to upgrade
and improve the processes and systems to
ensure superior quality products. Every
organization has to take care of its
customers. Their feedbacks are essential.
Total Quality management creates processes
and systems based on customer feedbacks
and various researches which eventually help
in the development of organization.
 Managers play an important role in Total Quality
Management:
Initiating and implementing total quality
management programs require great amount of
planning and research. Managers need to get trained
in various TQM practices before implementing the
same. There are costs involved with the entire
process of total quality management. It is the
manager’s responsibility to allocate budgets for TQM
at the beginning of every financial year. Remember,
you can’t crib later on. Read a lot about total Quality
management.
 One need to be convinced first why quality is such an
important parameter in every business. If you yourself are
not convinced, it would be very difficult for you to
convince other departments for implementing TQM.
Know who your customers are? Understand your target
market carefully. Go out, meet customers and find out as
to what all they expect from your brand. Customer
feedbacks play an important role in formulating strategies
for total quality management. As a manager; you need to
work closely with the senior management, human
resource professionals to develop foolproof
implementation strategies. Remember, a manager has to
act as a bridge between the senior management and the
entire workforce.
 The role of a manager
is :
1. To act as a facilitator at the workplace. It
is your duty to assist employees in
implementing TQM.
2. As a manager, it is your responsibility to
select and appoint right individuals who
can work as line managers and take
charge of the entire project. The
employees, you select ought to be
reliable and diligent and should be
capable enough to handle a crucial
project like total quality management.
3. It is the manager’s responsibility to assign
resources for total quality management, allocate
time for various training programs and appreciate
employees who come up with various
improvement ideas and strategies which would
help the organization deliver superior quality
products.

4. Further train your subordinates to ensure smooth

implementation of TQM without any obstacles.

5. A manager must communicate the benefits of total

quality management to all other members of the
organization. Call employees on a common
platform and address the benefits and importance
of total quality management.
6. Make them understand how successful
implementation of total quality management
programs would yield high quality products which
would not only benefit the organization but also
the employees associated with the same. Why do
we always think of outsourcing trainers? Why
can’t we train employees on our own? Believe me,
as a manager if you train your employees, the
results would be better rather than an unknown
face coming and loading them with information.
Do not forget, a trainer needs to be prepared for
every question. Do your homework carefully.
 Remember, a manager is always a strong
source of inspiration for other employees.
You need to practice total quality
management yourself before expecting
others to believe in the same. Customer
feedbacks should be carefully monitored and
taken into consideration while formulating
company’s major strategies. Provide
frequent reports to staff members
highlighting scope of improvement.
 Today, most managers agree that the
main reason to pursue quality
is to satisfy customers. The American
National Standards Institute ( ANSI ) and
the American Society for Quality ( ASQ )
define quality as “ the totality of

features and characteristics of a product

or service that bears on its ability
to satisfy given needs.”
 In highly competitive
markets, merely satisfying customer
needs will not achieve success. To
beat the competition, organization
often must exceed customer
expectations. Thus one of the most
popular definitions of quality is
meeting or exceeding customer
expectations.
 The Three ( 3 ) Paradigms of TQM :

● Total - Involves the entire organization ,

supply chain and or product life cycle .

● Quality - a dynamic state associated

with products, services, people processes and
environment that meets or exceeds expectations.

● Management – the system of managing

with steps like Plan, Organize, control, lead and
staff
 The Four ( 4 ) Cornerstones Of Total
Quality Management

1.Total Customer Satisfaction

2. Continuous Quality
Improvement ( Kaizen ) / Innovation

3. Teamwork

4. People Empowerment
A model for organization excellence
•No two organizations have the same TQM
implementation. There is no recipe for organization
success, however, there are a number of great TQM
models that organizations can use. These include
the Deming Application Prize, the Malcolm Baldrige
Criteria for Performance Excellence, the European
Foundation for Quality Management, and the ISO
quality management standards. Any organization
that wants to improve its performance would be well
served by selecting one of these models and
conducting a self-assessment.
•The simplest model of TQM is shown in the
diagram above. The model begins with
understanding customer needs. TQM
organizations have processes that
continuously collect, analyze, and act on
customer information. Activities are often
extended to understanding competitor's
customers. Developing an intimate
understanding of customer needs allows
TQM organizations to predict future
customer behavior.
• TQM organizations integrate
customer knowledge with other
information and use the planning process
to orchestrate action throughout the
organization to manage day to day
activities and achieve future goals. Plans
are reviewed at periodic intervals and
adjusted as necessary. The planning
process is the glue that holds together all
TQM activity.
•
TQM organizations understand that
customers will only be satisfied if they
consistently receive products and
services that meet their needs, are
delivered when expected, and are priced
for value. TQM organizations use the
techniques of process management to
develop cost controlled processes that
are stable and capable of meeting
customer expectations.
The final element of the TQM model is total
participation. TQM organizations understand that
all work is performed through people. This begins
with leadership. In TQM organizations, top
management takes personal responsibility for
implementing, nurturing, and refining all TQM
activities. They make sure people are properly
trained, capable, and actively participate in
achieving organizational success. Management and
employees work together to create an empowered
environment where people are valued.
•TQM organizations also understand that
exceptional performance today may be
unacceptable performance in the future so
they use the concepts of process
improvement to achieve both
breakthrough gains and incremental
continuous improvement. Process
improvement is even applied to the TQM
system itself!

•All of the TQM model's elements work

together to achieve results.
Implications of Quality

1. Company reputation
Perception of new products
Employment practices
Supplier relations
2. Product Liability
Reduce Risk
3. Global Implications
Improved Ability to compete
SELF CHECK NO. 1
1. Choose a product of any type that maybe known to the group. Discuss
the characteristics or attributes of this product that makes it highly
acceptable to you.
______________________________
______________________________
______________________________
______________________________
______________________________
______________________________
______________________________
______________________________
2. Recall any hospitality industry / establishment with which you are familiar or
one that you may have visited before. What are experiences that helped you
define “service quality” ?
______________________________
______________________________
______________________________
______________________________
______________________________
______________________________
______________________________
______________________________
 The Concepts of Quality

People define quality in many ways. Some

think of quality as superiority
or excellence, others view it as a lack of
manufacturing or service defects, still
others think of quality as related to product
features or price. A study that asked
managers of 86 firms in the eastern United
States to define quality produced
several dozen different responses,
including
1. perfection
2. consistency
3. eliminating waste
4. speed of delivery
5. compliance with policies and
procedures
6. providing a good, usable product
7. doing it right the first time
8. delighting or pleasing customers
9. total customer service and satisfaction.
 EVOLUTION OF QUALITY

1970’s : Conform to Product Requirements

1980’s : Conform to Customer Expectations

1990’s : Exceed Customer Expectations

 Quality in Products
Manufactured products have several quality
dimensions including the following :
1. Performance – a product’s primary operating
characteristics.
2. Features – the “ bells and whistles” of a product.
3. Reliability – the probability of a product’s
surviving over a specified period of time under
stated conditions of use.
4. Conformance - the degree to which physical
and performance characteristics of a product
match pre established standards.
5. Durability – the amount of use one gets from
a product before it physically deteriorates or
until replacement is preferable .
6. Serviceability – the ability to repair a product
quickly and easily.
7. Aesthetics – how a product looks, feels,
sounds, tastes or smells.
8. Perceived Quality – subjective assessment
resulting from image, advertising or brand
name.
Quality control in manufacturing is
usually based on conformance,
specifically, conformance to
specifications. Specifications are
targets and tolerances determined by
designers of products and services.
Targets are the ideal values for which
production strives;
Tolerances are acceptable deviations
from these ideal values.
 QUALITY IN SERVICES
Service can be defined as “ any primary or
complementary activity that does not directly
produce a physical product – that is the non
goods part of the transaction between buyer
( customer ) and seller ( provider ). Service
organization include Hotel and restaurant,
health, legal, engineering and other
professional services; educational
institutions ; financial services ; retailers;
transportation and public utilities.
 DIMENSIONS OF SERVICE QUALITY:
1. Time : how much time must a customer wait ?
2. Timeliness : Will a service be performed when promised ?
3. Completeness : Are all items in the order included ?
4. Courtesy : Do front line employees greet each customer
cheerfully ?
5. Consistency : Are services delivered in the same passion
for every customer and every time for the same customer ?
6. Accessibility and convenience : Is the service easy to
obtain ?
7. Accuracy : Is the service performed right the first time ?
8. Responsiveness : Can service personnel react quickly and
resolve unexpected problems ?
Many service organizations have well developed
quality assurance systems. Most of them,
however are based on manufacturing analogies
and tend to be more product oriented than service
oriented. Many of the key dimensions of product
quality apply to services. For example, “ on time
arrival “ for an airline is measure of service
performance ; frequent flyer awards and “
business class” sections represents features. A
typical hotel’s quality assurance system
focuses on technical specifications such as
properly made up rooms.
SERVICE AUDIT
Choose any work unit in the University. Using the 8 dimensions of
Service, rate each work unit using the below scale.

Work Unit / Department : _________________________________

Service Parameters Excellent Above Average Poor Observation/

( 4) Average (2) (1) Remarks
(3)

Time

Timeliness

Completeness

Courtesy

Consistency

Accessibility &
Convenience

Accuracy

Responsiveness
SERVICE AUDIT
Choose any work unit outside the University. Using the 8 dimensions of
Service, rate each work unit using the below scale.

Work Unit / Department : _________________________________

Service Parameters Excellent Above Average Poor Observation/

( 4) Average (2) (1) Remarks
(3)

Time

Timeliness

Completeness

Courtesy

Consistency

Accessibility &
Convenience

Accuracy

Responsiveness
Did you know that ????
Philippine Quality Award
The PQA sets a standard of excellence to help
Filipino organizations achieve world-class
performance and serves as a ―template‖ for
competitiveness based on the concepts of Total
Quality Management (TQM).

The highest national recognition for exemplary

organizational performance of private and public
organizations in the country

It is a national quality award comparable with

the Malcolm Baldrige National Quality Award
(MBNQA) of the US and those in Europe and
Asia.
PQA CriteriaAwardees are evaluated on:

1.Leadership
2.Strategic Planning
3. Customer & Market Focus
4. Measurement Analysis, and Knowledge
Management
5. Human Resource Focus
6. Process Management Organizational
7.Performance Results
REPUBLIC ACT No 9013 (Philippine
Quality Award Act)

AN ACT ESTABLISHING THE

PHILIPPINE QUALITY AWARD IN ORDER
TO ENCOURAGE ORGANIZATIONS IN
BOTH THE PRIVATE AND PUBLIC
SECTORS TO ATTAIN EXCELLENCE IN
QUALITY IN THE PRODUCTION AND/OR
DELIVERY OF THEIR GOODS AND
SERVICES.
Republic Act 9013, also known as the
Philippine Quality Award Act. The PQA
sets a standard of excellence to help Filipino
organizations achieve world-class
performance and serves as a "template" for
competitiveness based on the principles of
Total Quality Management (TQM). It is a
national quality award comparable with the
Malcolm Baldridge National Quality Award
(MBNQA ) of the US and those in Europe and
Asia.
Section 7 , states The Philippine Quality Award for
Performance Excellence. - The Philippine Quality
Award shall be conferred annually to qualified
organizations in the private and public sectors which
have demonstrated the highest level of performance
excellence. The organization should have
demonstrated management excellence by the
purposefulness with which it continues to improve
and build upon outstanding results and excellent
systems. It should serve as a national and global
model.
 ( 1) Recognition for Mastery in Quality
Management
The organization should have
demonstrated, through its practices and
achievements, superior results clearly
linked to robust management systems. It
should exhibit practices, which other
organizations can learn from and should
serve as role model for other
organizations in the Philippines.
 (2) Recognition for Proficiency in
Quality Management
The organization should have
demonstrated, through implementation of
quality and productivity management
principles, significant progress in building
sound and notable processes. It should
have a documented and solid approach to
system-Ievel quality and productivity
management and has been implementing
quality and productivity improvement plans
and procedures.
 (3) Recognition for Commitment to
Quality Management

The organization should have

demonstrated its serious commitment to
improvement in order to achieve quality
excellence. It should have planted the
seeds of quality and productivity and is
working towards reaping long term
benefits of its efforts.
QUIZZ

1. What is Quality (explain in your own understanding)

2. What are the 3 paradigm of TQM and explain each.
3. Give at least 1 responsibility of Manager in TQM.
4. Give at least 2 quality dimension of a product and explain
each.
5. Define SERVICE.
VERTCAL MANAGEMENT
vs.
QUALITY MANAGEMENT
SYSTEM
 Vertical Management

Inputs
Administration/Management

Marketing

Research and Devt.

Purchasing

Production
Outputs
Companies in the past have been vertically managed with very
little inter-action between the different departments. A
classic example – especially from the standpoint of
communication and training -- would be the automobile
assembly line. Employees are trained for one job, that is the
only job they perform. There is little cross training and no one
cares what talent an employee has other than what is
necessary to perform the designated job.

In this diagram, each component operates in a bubble with

little or no communication. Only the essential information is
passed on so that the product or service can be produced.
Information flows in straight lines from one unit to another.
Vertical Management Style
Focus on end product
Customer satisfaction only relevant to
complaints
Communication on a “need to know”
basis
Improvement on an “as needed” basis
Responsibility not established until
something goes wrong!
 ISO 9000 QM System
Continuous Improvement of the
QMS
Management
Responsibility Customers
Customers

Measurement,
Resource
Analysis and
Managemen
t
Improvement Satisfaction

Requirements Product
Product
Realization
Input Output
 Quality Management Style
Focus on the entire system
Customer is main concern
Communication at all levels
Continuous Improvement
Responsibility assigned
 Why Implement a QMS?

 Ensure Customer Satisfaction

 Improve Quality System
 Enhance Control of Resources
 Improve Suppliers
Performance
QUALITY MANAGEMENT SYSTEM
A quality management system (QMS) is
defined as a formalized system that
documents processes, procedures, and
responsibilities for achieving quality
policies and objectives. A QMS helps
coordinate and direct an organization’s
activities to meet customer and
regulatory requirements and improve its
effectiveness and efficiency on a
continuous basis.
What is a QMS?
The short answer:
Say what you do (documentation)
Do what you say (implementation)
Prove what you do (records)
Review and improve (continuous improvement)
 QMS Definitions
A Quality Management System is:
System for managing the quality of an
organization
Includes everything in the organization
that relates to quality:
Products and services
Processes
Operations
Customer Satisfaction
QMS Description
As required by ISO 9000:
The Quality System is well documented,
implemented, understood, maintained and
continually improved
Emphasis is placed on problem prevention
rather than inspection
Quality planning is required
The PROCESS APPROACH to management is
encouraged
Quality management systems serve
many purposes, including:
Improving processes
Reducing waste
Lowering costs
Facilitating and identifying training
opportunities
Engaging staff
Setting organization-wide direction
BENEFITS OF QUALITY MANAGEMENT
SYSTEMS
 Meeting the customer’s requirements, which
helps to instill confidence in the organization, in
turn leading to more customers, more sales, and
more repeat business

 Meeting the organization's requirements,

which ensures compliance with regulations and
provision of products and services in the most
cost- and resource-efficient manner, creating room
for expansion, growth, and profit
These benefits offer additional
advantages, such as helping to
communicate a readiness to produce
consistent results, preventing mistakes,
reducing costs, ensuring that processes
are defined and controlled, and
continually improving the organization's
offerings.
According to Peter Drucker, one way to measure
Quality and performance is using the ISO standards
International Standard Organization (ISO)
based in Switzerland – ensures to the
customers a basic standard of service performance.
The International Organization for
Standardization. Founded in 1947 by a
group of delegates from 25 countries,
the 67 original technical committees
of ISO came together with a unified
goal of ensuring products and services
are safe, reliable, and of good quality.
The very first ISO standard, called
“ISO/R 1:1951” – was first published in
1951 to set a standard reference
temperature for industrial length
measurements. Today, that standard
still exists (after many updates) as ISO
1:2002.
Over the decades following, ISO created
committees and published standards for
everything from units of measure to freight
containers and environmental quality. It was not
until 1987 that ISO 9001 – one of the most
recognizable standards today – was published as
ISO’s first quality management standard. The
environmental standard ISO 14001 followed not
long after in 1996, and ISO has only increased its
output of new guidance since, branching out into
fields such as information security, social
responsibility, energy management, and even
corporate integrity.
Having celebrated its 70th anniversary in
2017, ISO stands as a strong player in
international industries. Today, with
22,401 International Standards covering
all aspects of business and technology,
and members from 161 countries, ISO has
its eye on the future of quality and safety
certification.
 ISO 9000 Family of Standards
Standard / Title
Document
ISO Quality management systems - Fundamentals and
9000:2015 vocabulary
ISO Quality management systems - Requirements
9001:2015
ISO Quality management -- Quality of an organization --
9004:2018 Guidance to achieve sustained success
ISO Quality management - customer satisfaction - Guidelines for
10002:2018 complaint handling in organizations
ISO Quality management - customer satisfaction - Guidelines for
10003:2018 dispute resolution external to organizations
ISO Quality management - customer satisfaction - Guidelines for
10004:2018 monitoring and measuring
ISO Quality management - Guidelines for quality plans
10005:2018
ISO Quality management - Guidelines for quality in project
10006:2017 management
ISO Quality management - Guidelines for configuration
10007:2017 management
ISO Quality management - Customer satisfaction - Guidelines
10008:2013 for business-to-consumer electronic commerce transactions
ISO
10014:2006/ Guidelines for realizing financial and economic benefits
Cor 1:2007
ISO
Quality management - Guidelines for training
10015:1999
ISO Guidelines on people involvement and competence
10018:2012
ISO
19011:2018 Guidelines for auditing management systems
ISO Quality management systems - Guidelines for the
22006:2009 application of ISO 9001:2008 to crop production

ISO/IEC TR 90006:2013
ISO 15378:2011
ISO 13485:2016
API Specification Q1 : 9th ed : 2013
AS9100: Rev C / BS EN 9100
AS9101: Rev D /BS EN 9101
IS 15700:2005
Information technology - Guidelines for the
application of ISO 9001:2008 to IT service
management and its integration with ISO/IEC
20000-1:2011
Primary packaging materials for medicinal
products - Particular requirements for the
application of ISO 9001:2008, with reference
to Good Manufacturing Practice (GMP)
Medical devices - Quality management
systems - Requirements for regulatory
purposes
Specification for Quality Management System
Requirements for Manufacturing
Organizations for the Petroleum and Natural
Gas Industry
Quality Management Systems - Requirements
for Aviation, Space and Defense Organizations
Deployment Support Materials
Quality Management Systems Audit
Requirements for Aviation, Space, and
Defense Organizations
Quality management systems - Requirements
for service quality by public service
organizations
ISO 14001:2015 Environmental management systems
- Requirements with guidance for use
Environmental management systems
ISO 14004:2016 - General guidelines on
implementation
Environmental management systems
-Guidelines for the phased
ISO 14005:2010 implementation of an environmental
management system, including the
use of environmental performance
evaluation
Environmental management systems
ISO 14006:2011 - Guidelines for incorporating
ecodesign
Environmental management -
ISO 14015:2001 Environment assessment of sites and
organizations (EASO)
Environmental management -
ISO 14031:2013 Environmental performance
evaluation - Guidelines
ISO 9001 is defined as the international
standard that specifies requirements for a
quality management system (QMS).
Organizations use the standard to
demonstrate the ability to consistently
provide products and services that meet
customer and regulatory requirements.
ISO 9001 is an outline for a Quality
Management System
A set of coordinated activities to direct and control an
organization in order to continually improve the
effectiveness and efficiency of its performance.
 When you build your Quality Management
System based on ISO 9001:2015, you will be
managing your organization as a system of
interrelated processes.
ISO 9001:2015, the international standard
specifying requirements for quality management
systems, is the most prominent approach to quality
management systems.
While some use the term "QMS" to describe the
ISO 9001 standard or the group of documents
detailing the QMS, it actually refers to the entirety of
the system. The documents only serve to describe
the system.
What is ISO 9001

ISO 9001  is the world’s most popular and most

commonly used standard for quality management
systems.

A standard is not a law, but an agreement or best

practice that an organization can apply voluntarily. A
standard reflects a good level of professionalism. A
quality management system is a tool with which an
organization can determine how it can meet the
requirements of its customers and the other
interested parties that are involved in its activities.
What are the benefits of ISO 9001?

An ISO 9001 quality management system:

shows that you provide products and services

of consistent quality;

shows that you provide products and services

that meet the customer’s requirements, comply
with the law and legislation, and meet the
organization’s own requirements;

can help you streamline your business

processes and continuously improve them.
There are two additional benefits:

 ISO 9001 helps you increase customer

satisfaction;

 ISO 9001 is positive for your image: you show

that you comply with internationally
recognised quality standards. This is often a
requirement for customers and suppliers to do
business with you.
What does the ISO 9001 standard specify?

The most recent ISO 9001:2015 standard is

constructed around seven quality management
principles:
1. customer focus;
2. leadership;
3. engagement of people;
4. process approach;
5. improvement;
6. evidence-based decision making;
7. relationship management.

ISO 9001:2015 describes for each part which requirements

your products, services and organisation have to meet in
order to enjoy the above benefits.
Who determines, checks and manages ISO
9001?

ISO 9001 is managed by the International Organization for

Standardisation (ISO) in Geneva, Switzerland. ISO is an
independent membership organization and the world’s
largest developer of voluntary international standards. ISO
9001:2015 was developed by the ISO / TC 176 / SC 2 – Quality
Systems Technical Committee.

However, ISO does not provide certification or conformity

assessment. This is performed by accredited certification
bodies. These are establishments that evaluate an
organization’s management system and certify them with
respect to the published standards.
I understand that the previous version of ISO 9001 dates
from 2008 and that there is now a new version

A new version of ISO 9001 appears about every seven

years.
It was first issued in 1987: at that time, you had to
describe in detail what your business did. What applied
in the 1994 version, was ‘say what you do and do what
you say’. In the 2000 version, you had to focus on proper
processes in order to continually improve and thereby
increase your customer satisfaction. There was nothing
added in 2008, but it was more precise about the
interpretation of the standard. ISO 9001:2015 was
published on 23 September 2015.
Do organisations have to move over from
ISO 9001:2008 to ISO 9001:2015
immediately?

No. There is a transitional period of three years

after the publication of each new version of
ISO 9001, during which organizations can
adapt their quality management to match the
latest version. Organizations must therefore
implement the new ISO 9001:2015 standard
before 23 September 2018 in order to continue
complying with ISO 9001.
What are the main differences
between ISO 9001:2008 and ISO
9001:2015?

ISO 9001:2015 HAS TEN CLAUSES

INSTEAD OF EIGHT
The following table shows the relationship of the
ISO 9001:2008 clauses to those in the new ISO
9001:2015.
ISO 9001:2008 ISO 9001:2015
0. Introduction 0. Introduction
1. Scope 1. Scope
2. Normative reference 2. Normative reference
3. Terms and definitions 3. Terms and definitions
4. Quality management system 4. Context of the organisation
5. Leadership
5. Management responsibility
6. Planning
6. Resource management 7. Support
7. Product realisation 8. Operation

8. Measurement, analysis and 9. Performance evaluation

improvement 10. Improvement

The first three clauses in ISO 9001:2015 are largely the same as those in ISO 9001:2008,
but there are considerable differences between ISO 9001:2008 and ISO 9001:2015 from
the fourth clause onwards. The last seven clauses are now arranged according to the
PDCA cycle (Plan, Do, Check, Act). The following figure shows this.
Clauses 4, 5, 6 and 7 of ISO 9001:2015 come under PLAN, clause 8 comes
under DO, clause 9 comes under CHECK and clause 10 is covered by ACT.
With this new arrangement, the new ISO 9001:2015 strives to give
additional momentum to the continuous and systematic improvement of
processes within organisations.
ISO 9001:2015 HAS A HIGH LEVEL
STRUCTURE (HLS)

As a result of the new arrangement in ten clauses, ISO

9001:2015 now has the same unambiguous structure as
all standardised management systems, known as a ‘High
Level Structure’ (HLS).

The core elements of ISO 9001, ISO 14001, ISO 22000,

OHSAS 18001, etc. are therefore all the same from now
on. This has made the integration of various
management systems much simpler. If, for example, an
organization wishes to implement ISO 14001 in addition
to ISO 9001, the parts that cover the same topic can
easily be seen in the standards.
 CORE ELEMENT OF ISO 9001

Improve Customer Focus. ...

Enhance Leadership Involvement. ...
Improve Engagement of People. ...
Adopt a Process-Based Approach. ...
Enable People and Process
Improvement.
ISO 9001:2015 PUTS MORE FOCUS
ON INPUT AND OUTPUT

There is more emphasis in ISO 9001:2015 on

measuring and properly assessing the input
and output of processes. According to ISO
9001:2015, you must closely monitor which
articles, information and specifications are
involved in the production process. You must
also clearly check whether good articles come
out of the production process.
RISK-BASED THINKING IS AT THE CORE
OF ISO 9001:2015

Risk-based thinking has a very important place in ISO 9001:2015.

You are now strongly encouraged as an organisation to use risk
analysis in order to decide for yourself which challenges you see in
the management of your business processes.

Formal risk analysis, familiar to many organisations via FMEA or

HACCP techniques, is now standard for everyone. To emphasise
their dominance, the concept of ’risk’ occurs forty-eight times in
ISO 9001:2015, compared with only three times in ISO 9001:2008.

The addition of risk-based thinking has made the ‘preventive

measures’ of ISO 9001:2008 redundant. These preventive
measures no longer appear in ISO 9001:2015.
CONTEXT OF THE ORGANIZATION
IMPORTANT IN ISO 9001:2015
ISO 9001:2015 requires an organization to construct
its quality management system from now on from
the specific context within which it is active. This
means, among other things, that, as an
organization, you have to take into account the
needs and expectations of interested parties and
that you evaluate and deal with internal and
external strategic questions. You have to show that,
as an organization, you understand and respond to
the expectations of all the parties concerned.
ISO 9001:2015 AND THE ENGAGEMENT OF
INTERESTED PARTIES
In ISO 9001:2008, customers were often named as being the only
interested party. This concept has been extended in ISO 9001:2015.
Suppliers, personnel, shareholders, legislative bodies, society, internal
customers, etc. are now included as interested parties, in addition to
customers.

As an organization, you have to be aware of the importance of these

interested parties’ (changing) requirements and standards, and
anticipate them in the features of your products and services.

This has always been part of the standard in another form, however.
Therefore, it is not expected that organizations will have to implement
major changes in this respect. You cannot make or deliver a good
product without knowing the requirements and expectations of
customers and interested parties in any case. This is the basis of a
quality management system.