ISO 9000 QUALITY

MANAGEMENT

BACKGROUND
ISO 9000 was first published in 1987 and was based on the BS S750
series of standards from BSI that were proposed to ISO in 1979.
However, its history can be traced back some twenty years before
that, to the publication of the united States Department of Defense
MIL-Q-9858 standard in 1959.
BSI has been certifying organizations for their quality management
systems since 1978. its first certification (FM 00001) is still extant
and held by Tarmac Limited, a successor to the original company
which held this certificate.
Today BSI claims to certify organizations at nearly 70,000 sites
globally.

ISO 9000 FAMILY

ISO 9001:2008 sets out the

requirements
of
a
quality
management system

ISO 9000:2005 covers the basic

concepts and language

ISO 9004:2009 focuses on how

to make a quality management
more efficient and effective

ISO
9011:2011
sets
out
guidance
on
internal
and
external
audits
of
quality
management systems.

ISO 9001
MANAGEMENT

FINANCE
55% achieved cost savings
=
Positive impact on the bottom line

OPERATION
75% boosted their operational
performance
=
Process efficiency
Reduced errors
Cost savings
Effective performance management
Business agility

Certified companies out perform the

market by more than 100%
=
Share price
Strategic alignment

ISO
9001
QUALIT
Y

PRODUCT DEVELOPMENT
Manufacturing cycles reduced by 48%
=
Increased speed market
Better quality products

SALES & MARKETING

71% acquired new customers and
retained existing clients
=
Market access
Product differentiation

SERVICES
75% improved their levels of
customer satisfaction and loyalty
=
Consumer confidence
Increased satisfaction

8 MANAGEMENT PRINCIPLES

8 MANAGEMENT PRINCIPLES
CUSTOMER FOCUS
-Understand current and future customer needs.
-Meet customer requirements and strive to exceed customer
expectations.

LEADERSHIP
-Leaders are responsible for defining the organizations goals and
objectives and maintain an environment where people can operate effectively

INVOLVEMENT OF PEOPLE
-Everyone in the organization is the key to its success and their full
involvement enables their skills to be used to the maximum benefit for
themselves and for you.

8 MANAGEMENT PRINCIPLES
PROCESS APPROACH
-When activities are seen, understood, managed and delivered
through clear business processes, your objectives are more likely to be
achieved.

SYSTEM APPROACH TO MANAGEMENT

-When you identify, understand and manage interrelated processes
as a system, it contributes to achieving your goals and objectives.

CONTINUAL INVOLVEMENT
-Continually improving your organization ensures that your
performance will increase and change over time to react to future
challenges.

8 MANAGEMENT PRINCIPLES
FACTUAL APPROACH TO DECISION MAKING
-Effective decisions are based on understanding real data and
information and this will help you make the right decisions.

MUTUALLY BENEFICIAL SUPPLIER RELATIONSHIPS

-Your suppliers can be key to your business and its important to
work closely with them in a mutually beneficial way to create value for
both organizations.

PROCESS APPROACH

GUIDANCE ON THE CONCEPT AND USE OF THE

PROCESS APPROACH FOR MANAGEMENT
SYSTEMS
PROCESS: DEFINITION
- a set of interrelated or interacting activities which
transforms inputs into outputs.
*These activities require allocation of resources such as
people and materials.
MAJOR ADVANTAGE: In the management and control
of the interactions between these processes and
interfaces between the functional hierarchies of the
organization.

PROCESS APPROACH
EFFECTIVENESS OF PROCESS
Ability to achieve desire results

INPUT
Requirements Specified
(includes resources)

Interrelated or
interacting activities
and control methods

OUTPUT
Requirements Satisfied
(Results of a process)

Monitoring and Measuring

EFFICIENCY OF PROCESS
Results achieved v. Resources used

TYPICAL TYPES OF PROCESSES

PROCESSES FOR THE MANAGEMENT OF AN
ORGANIZATION
These includes processes relating to:
strategic planning,
establishing policies,
setting objectives,
ensuring communication,
ensuring availability of resources for the other
organizations quality objectives and
for management reviews.

TYPICAL TYPES OF PROCESSES

PROCESSES FOR MANAGING RESOURCES
These includes all the processes that are necessary to
provide the resources needed for the organizations
quality objectives and desired outcomes.
REALIZATION PROCESSES
These includes all the processes that provide the
desired outcomes of the organization.

TYPICAL TYPES OF PROCESSES

MEASUREMENT, ANALYSIS AND IMPROVEMENT
PROCESSES
These includes the processes needed to measure and
gather data for performance analysis and improvement of
effectiveness and efficiency. They include:
Measuring
Monitoring
Auditing
Performance analysis
Improvement processes

UNDERSTANDING THE PROCESS APPROACH

The
process
approach
introduces
horizontal
management, crossing barriers between different
functional units and unifying their focus to the main
goals of the organization.
It also improves the management of process interfaces

UNDERSTANDING THE PROCESS APPROACH

UNDERSTANDING THE PROCESS APPROACH

UNDERSTANDING THE PROCESS APPROACH

IDENTIFICATION OF THE PROCESS OF THE ORGANIZATION

1) DEFINE THE PURPOSE OF THE ORGANIZATION.

2) DEFINE THE POLICIES AND OBJECTIVES OF THE ORGANIZATION.

3) DETERMINE THE PROCESSES IN THE ORGANIZATION.

4) DETERMINE THE SEQUENCE OF THE PROCESSES.

5) DEFINE PROCESS OWNERSHIP.

6) DEFINE PROCESS DOCUMENTATION.

PLANNING THE PROCESS

1) DEFINE THE ACTIVITIES WITHIN THE PROCESS.

2) DEFINE THE MONITORING AND MEASUREMENT REQUIREMENTS.

3) DEFINE THE RESOURCES NEEDED.

4) VERIFY THE PROCESS AGAINST ITS PLANNED OBJECTIVES.

IMPLEMENTATION AND MEASUREMENT OF

THE PROCESS
Implement the processes and their activities as planned.
The organization may develop a project for implementation that
includes, but is not limited to:

Communication

Awareness

Training

Change management

Management involvement

Applicable review

Apply the controls, and perform the monitoring and

measurements as planned.

ANALYSIS OF THE PROCESS

Analyze and evaluate process information obtained from
monitoring and measuring data, in order to quantify process
performance. Where appropriate, use statistical methods.
Compare the results of process performance information
with the defined requirements of the process, to confirm
process effectiveness and efficiency and to identify any need
for corrective action.
Identify process improvement opportunities based on
the results of the analysis of process information.
Report to top management and other relevant people
in the organization, on the performance of the process, as
appropriate.

ACT
-How to improve
next time?

PLAN
-What to do?
-How to do?

CHECK
-Did things
happen
according to
plan?

DO
-Do what was planned

PLAN-DO-CHECK-ACT (PDCA)

CORRECTIVE ACTION AND IMPROVEMENT

OF THE PROCESS
The Plan-Do-Check-Act (PDCA) methodology can be
a useful too to define, implement and control
corrective actions and improvements.

ACT

PLAN

-How to
improve
next time?

-What to do?
-How to do?

CHECK

DO

-Did things
happen
according
to plan?

-Do what was

planned

Plan Establish
the
objectives
and
processes necessary to deliver results in
accordance with customer, statutory and
regulatory
requirements
and
the
organizations policies.
Do

Implement the processes

Check Monitor and measure processes

and product against policies, objectives and
requirements for the product and report the
results
Act Take actions to continually improve

PLAN- MANAGEMENT RESPONSIBILITY

These individual requirements take managers through the following
activity:
CUSTOMER FOCUS through feedback surveys or talking to some
key customers
QUALITY POLICY- use information gathered to write quality policy
OBJECTIVES- establish measurable objectives to achieve aims of
the policy
PLAN THE SYSTEMeffective process

allocate

responsibilities

and

establish

REVIEW THE SYSTEM- review the operation of your system at

regular intervals and improve when necessary.

PLAN- RESOURCE MANAGEMENT

Resources are looked at in three ways:
PEOPLE decide the competence and skills needed; look
at your people and identify gaps in existing competence;
fill gaps by providing training and coaching or
encouraging self-learning; test its effectiveness
INFRASTRUCTURE- involves the facilities and equipment
you need to perform effectively. Start by determining and
providing what is needed and ensure you review regularly.
WORK ENVIRONMENT look at the condition under
which work is performed and ensure its being appropriate
to meet customers requirement.

DO- PRODUCT OR SERVICE REALIZATION

Typically, this involves defining the processes for:
SALES
DESIGN AND DEVELOPMENT
PURCHASING
PRODUCTION/ OPERATIONAL/ SERVICE
ACTIVITIES
DELIVERY

CHECK AND ACT- MEASUREMENT ANALYSIS

AND IMPROVEMENT
The standard provides you with set of requirements for
achieving this using tried and tested techniques.
CUSTOMER SATISFACTION involves monitoring of
customer perception.
INTERNAL AUDIT- conducting reviews of the system to
ensure it is according to plan.
MONITORING AND MEASUREMENT OF PRODUCTS
AND PROCESSES individual processes drive the system
and it is important that they are operating effectively and
efficiently; products should be measured and monitored.

CHECK AND ACT- MEASUREMENT ANALYSIS

AND IMPROVEMENT
CONTROL OF NON-CONFORMING
PRODUCTS/SERVICE if something goes wrong,
procedure should be in place to ensure the problem is
controlled and dealt with properly.
ANALYSIS OF DATA- use standard effectively to
produce data on how effective the system; use the
data to find improvements.
CONTINUAL IMPROVEMENT- use results of the
analysis to determine where improvements can be
made.

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SUMMARY OF ISO 9001:2008

SUMMARY OF ISO 9001:2008

The quality is a formal statement from management,
closely linked to the business and marketing plan and to
customer needs.
The quality policy is understood and followed at all
levels and by all employees. Each employee works
towards measurable objectives
The business makes decisions about quality system
based on recorded data.
The quality system is regularly audited
evaluated for conformance and effectiveness.

and

SUMMARY OF ISO 9001:2008

Records show how and where raw materials and products
were processed to allow products and problems to be traced to the
source.
The business determines customer requirements
documents to show how they have done so.

makes

The business has created systems for communicating with

customers about product information, enquires, contracts, orders,
feedback, and complaints.
When developing new products, the business plans the stages of
development, with appropriate testing at each stage. It tests
and documents whether the product meets design requirements,
regulatory requirements and user needs.

SUMMARY OF ISO 9001:2008

The business regularly reviews performance through
internal audits and meetings. The business determines
whether the quality system is working and what
improvements can be made. It has a documented procedure
for internal audits.
The business deals with past problems and potential
problems. It keeps records of these activities and the
resulting decisions, and monitors their effectiveness.
The business has documented procedures for dealing
with actual and potential nonconformances (problems
involving suppliers, customers, or internal problems).

SUMMARY OF ISO 9001:2008

The business:
1. Takes action to make sure no one uses a bad
product
2. Determines what to do with a bad product
3. Deals with the root cause of problems
4. Keeps records to use as a tool to improve the
system.

10 TIPS ON MAKING ISO 9001 EFFECTIVE

10 TIPS ON MAKING ISO 9001 EFFECTIVE

1. Top management commitment is vital if the system is to be
introduced successfully.
2. Review systems, policies, procedures and processes you have
in place at the moment. Compare it with what ISO 9000/1 asks
for.
3. Make sure you have good internal communication channels
and processes within the organization.
4. Give some thought to how departments work together.
5. Dont ignore the impact that introducing these systems will
have on your customers and suppliers

10 TIPS ON MAKING ISO 9001 EFFECTIVE

6. Clearly lay out a well-communicated plan of activities and
timescales.
7. The nature and complexity of your documentation will
depend on the nature and complexity of your organization.
8. Make the achievement of ISO 9000/1 engaging and fun.
9. Train your staff to carry out audits of the system.
10. If you feel you are doing something just for the sake of the
standard and it doesnt add any value to you as a
business- question whether it is necessary.

THANK YOU.

-END-