2. 2
• ISO 900 is a set of standards for quality assurance
systems
• A quality assurance system may be defined as the;
organizational structure,
responsibilities,
procedures,
processes,
and resources for implementing quality
management.
• These systems cover a wide variety of activities
encompassing;
a product’s entire life cycle including planning,
controlling,
measuring,
testing and reporting,
and improving quality levels throughout the
development and manufacturing process.
BackgroundTheISO9000Standards
3. 3
1987 1994 1994 1996 2000 2014 2015
First
Published
Unmature model
Military
the U.S. Department of
Defense (DoD)
announced in a press
release that it will
accept ISO registration
Revised
Increased maturity
Global
Adoption
409,421 Certificates
ISO Technical
Committee
Review
Another season of review
Doubled In
Adoption
1,111,698
Certificates
2015
version
New QMS model for
next 20 years
initiated
After adopting the standards, a country typically permits only ISO registered companies to supply goods and services to
government agencies and public utilities. Telecommunications equipment and medical devices are examples of product
categories that must be supplied by ISO registered companies
Adoption of the Standard
From unpopular to go viral
4. 4
Approved, adopted, and
publicized globally
Strength
Rationalization, bigger market
infiltration
Opportunities
the amount of money, time,
and paperwork required for
registration
Weakness
The model may not cover all
aspects of current trend of
QMS
Threat
S W
O T
Third-party certification bodies provide independent confirmation that organizations meet the requirements of ISO 9001. Over
one million organizations worldwide are independently certified, making ISO 9001 one of the most widely used management
tools in the world today
S.W.O.T ANALYSIS GRAPHIC
Is ISO as good as we think it is?
5. 5
Resources
How does resources
result in an ultimate
QMS?
Processes
What processes are
necessary ? Is there a
need for rationalization
Procedures
What sequence of work
QMS will be most
beneficial?
organizational
structure
What sort of culture is
required
The ISOApproach to Quality Management System
Nexus of many elements
6. 6
“
”
While the goal of the quality assurance systems for manufacturing
organizations and research and development groups are similar–
minimizing variation–the challenges faced when crafting an
appropriate quality assurance system differ due to the nature of
activities conducted in each type of organization. Computer
software development has unique characteristics within research
and development and engineering disciplines, further challenging
the design of ISO-complaint quality assurance systems.