ISO

Professor Dr.
Moyassar I.A. aljoboury
QMS Consultant
Lecture axis
 The concept of Quality
 Quality Approaches
 The meaning of ISO
 The member of ISO
 ISO statistics
 ISO components
 The objectives
 Engage top management
 A process & Process approach
 Implementing ISO 9000 Quality Management System
 The risks of implementing QMS
 The certification process
The concept of Quality
 There are many opinions.
 That didn’t mean there are no agreements between the researcher.
 All of as talking about it and influenced by.
 Its not just a concept , not just a philosophy, not just a system, not
just a technique, not just a Process, not just a principle.
 There are product and service quality, process quality, procedures
quality, lecturer quality, organization quality, life quality, University
quality, and so on.
 The meaning decided by who is speaking.
Evolution of quality –Means & Focus
1980 1985 1990 1995
197
2000
5

Productivity Quality TQC/TQM

Total
Quality Quality
Circle

Quality
Employee
of
Involvement
Work life

Self Self
Directed Directed/Manage
Employees Teams d
Empowerme
Teams
nt

Operation Customers Innovations

7
 Quality
Approaches
1. A Quality Guru Approaches
a. Deming (PDCA Circle , Re-Action Chain,
fourteen golden points )
b. Juran (Juran quality trilogy , quality
improvement ten points ,
recommendations for timeless
problems ).
Continued

c. Crosby (Five Absolutes, fourteen points

for quality improvement, Quality Vaccine)
.
d. Feigenbaum (quality costs ideas,
customer oriented quality, quality based
competetion) .
 2. Contemporary Approaches

Company quality assurance systems

 ISO 9001-2008

 ISO 14001-2004
 ISO 18001-2007
ISO 9001:2008 specifies requirements for a quality management
system where an organization needs to

 Demonstrate its ability to consistently provide

product that meets customer and applicable
statutory and regulatory requirements, and
 Aims to enhance customer satisfaction through
the effective application of the system, including
processes for continual improvement of the
system and the assurance of conformity to
customer and applicable statutory and
regulatory requirements.
All requirements of ISO 9001:2008 are

 Generic and are intended to be applicable to all

organizations, regardless of type, size and product
provided.
 Where any requirement(s) of ISO 9001:2008 cannot be
applied due to the nature of an organization and its
product, this can be considered for exclusion.
 Where exclusions are made, claims of conformity to ISO
9001:2008 are not acceptable unless these exclusions are
limited to requirements within Clause 7, and such
exclusions do not affect the organization's ability, or
responsibility, to provide product that meets customer and
applicable statutory and regulatory requirements
Interoperability of standards
Standards, of course, are as international as the markets they serve
and currently the main producers of national standards in Western
Europe are:
 United Kingdom – British Standards Institution (BSI);

 Germany – Deutsch Institut fur Normung e.v. (DIN);

 France – Association Français de Normalisation (AFNOR).

Outside Europe the most widely used standards come from:

 America – American National Standards Institute (ANSI);

 Canada – Canadian Standards Association (CSA).

There are, of course, others (for example Japan and Saudi Arabia) but
Europe
and North America are the main two.
Members of ISO
 164 national standards bodies, comprising
 111 member bodies,
 49 correspondent members,
 4 subscriber members.

Technical committee structure

 3368 technical bodies, comprising
 224 technical committees,
 513 subcommittees,
 2544 working groups and
 87 ad hoc study groups.
Development of International Standards
Total at 31 December 2012

 19 573 International Standards and standards - type documents.

 These standards represented a total output of 832 685 pages in

English and French terminology is also often provided in other

languages
In 2012
 1280 International Standards and standards-type documents

published.
 This output represented a total of 77326 pages for 2012.
Data for Portfolio of ISO standards and Draft International
Standards by technical sector at the end of 2012
SECTOR Draft International Standards (DIS) Published ISO
and Final Draft International Deliverables in
Standards (FDIS) 2012

Engineering technologies 467 5355

Materials technologies 321 4543

Electronics, information technology and 313 3289
telecommunications

Transport and distribution of goods 260 2053

Generalities, infrastructures, sciences 303 1792
and services
Agriculture and food technology 75 1119
Health, safety and environment 89 802
Construction 57 461
Special technologies 11 159
Grand Total 1896 19573
components
 ISO 9000 series International standard for
generic quality assurance systems.
Concerned with
 continuous improvement through
preventative action. Elements are customer
 quality and regulatory requirements, and
efforts made to enhance customer
 satisfaction and achieve continuous
improvement.
 The International Organization for
Standardization (ISO) is a worldwide
federation of national standards bodies from
more than 145 countries, one from each
country.
 ISO is a non-governmental organization
established in 1947 and based in Geneva,
Switzerland. Its mission is to promote the
development of standardization and related
activities in the world with a view to facilitating
the international exchange of goods and
services, and to developing cooperation in the
spheres of intellectual, scientific, technological
and economic activity.
 ISO's work results in international
agreements which are published as
International Standards and other types of
ISO documents
 ANSI is the sole U.S. representative and
dues-paying member of the International
Organization for Standardization (ISO), and
as a founding member of the ISO, ANSI plays
an active role in its governance.
The focusing in the last version
The objectives are:
 Customer focus – actively reviewing customer needs
through dialogue; making customers aware of new
products and services; ensuring the organisation is
aware of customer needs; corrective action when the
service fails to meet expectations.
 Continual improvement – of products, services, working
environment, staff development, and management and
production processes.
 Reduced waste – a reduction in wasted products,
repeated or corrective work and unnecessary processes.
The main components are:
 The active and positive commitment of senior
management.
 Good two-way communication throughout the
organization that encourages a culture of initiative and
improvement.
 Simple, efficient monitoring systems that enable all
levels of management to identify bottlenecks and waste.
 Staff development that provides the correct level of
competence for each job, and provides staff with
opportunities to progress.
 Documentation that supports the above.
Fully engage top management to

 Define why you want to implement ISO 9001

 Define your mission, vision, and values in your
organization
 Define your organization’s stakeholders :
customers, suppliers, stockholders, employees,
society, etc.
 Define your quality policy, and
 Define and align organizational objectives and
related product/service quality objectives.
A process
A process approach
Implementing ISO 9000 Quality
Management System
 Implementation of ISO 9000 affects the entire
organization right from the start. If pursued
with total dedication, it results in 'cultural
transition' to an atmosphere of continuous
improvement.
The process of implementing ISO 9000
depends on:
 The sophistication of your existing quality
program,
 ƒ The size of your organization, and
 ƒ The complexity of your process
The 14 essential steps, briefly described below, are to be
followed through in order to implement ISO 9000 quality
management system successfully.
 Step 1: Top management commitment
 Step 2: Establish implementation team
 Step 3. Start ISO 9000 awareness programs
 Step 4: Provide Training
 Step 5. Conduct initial status survey
 Step 6: Create a documented implementation
plan
 Step 7. Develop quality management system
documentation
The steps (Con’t)

 Step 8: Document control

 Step 9. Implementation
 Step 10. Internal quality audit
 Step 11. Management review
 Step 12. Pre-assessment audit
 Step 13. Certification and registration
 Step 14: Continual Improvement
The risks of implementing QMS

 short-term increase in production costs during training

and implementation of the QMS.
 dissatisfaction of staff because of new methodology –
e.g. resistance to change and perceived risk of
‘exposure’;
 another set of rules and papers without actual results –
e.g. documents that reflect what management think is
happening, not what is happening;
 no improvement of the quality level in the final product –
additional bureaucratic effort with no gain.
 The risks of implementing and maintaining
a QMS are now well known. Although
they cannot necessarily be eliminated
they can be managed, and their impact
reduced.
Further Resources

Important sources for more information:

The official ISO web site
The ISO Standards Developers Information Site, which
provides a comprehensive library of procedural documents,
forms, guidance and training materials and other useful
information for the development of ISO Standards.
ISO Technical Committee Business Plans, which provide
information on the work programs of ISO standards
development committees, as well as market environments,
dynamics, and needs that shape the development of these
work programs and the resulting ISO standards. These
business plans are available to the general public for review
and comment.
Thanks for listening