This document discusses quality management standards including ISO 9000, ISO 9001, ISO 9004, and Total Quality Management (TQM). It explains that ISO standards provide guidelines for documenting quality management processes, while TQM focuses on employee involvement and product improvement. ISO and TQM approaches complement each other, with ISO helping to shift organizations' cultures to successfully implement TQM.

2. Saleability ofaproduct
delivery
quality
price
A function of a
cost, profitmargin
and marketsforces
Afunction of the
organization’s
efficiency and
effectiveness
Determined by the
extent to which a
product oraservice
successfully serves
the purposes of the
user duringusage

3. Quality
means
A degree
of
excellence Conformance
with
requirements
Delighting
customers
Fitness
for
purpose
Freedom from
defects
imperfections or
contamination
Fitness
for use
Totality of
characteristics of
entity thatbear on
its ability to satisfy
implied or stated
needs

4. In the context of ISO 9000,
concerned with the totality
quality is
of the
characteristics thatsatisfy needs.
Quality is defined as the degree to which a
set of inherent characteristics fulfill the
requirements.

5. Quality is separatinggood from bad
partswithout feedback to the
production process.
Final Inspection
Quality Developing duringthe
productionprocess
Inspection is shifted into the
production process,prevention,
processorientation
Quality isdefined,
planned, andsupervised
company-wide
Commitment to
management,
participation of
employees, step bystep
improvement
QualityControl
QualityAssurance
Quality Management

6. This is the processof checking that aproduct,
service, or system meets specifications and
that it fulfils its intended purpose.
Validation canbe expressedby the query,
“Are you building the right thing?”
Verification, on the other hand, by “Are you
building it right?”

7. Verification is aqualitycontrolprocessthat is
used to evaluate whether or not aproduct,
service,or system complies with regulations,
specifications or conditions imposed at the
start of adevelopment, scale-up or
production.
Often an internalprocess

8. Validation is aquality assurance process of
establishing evidence that provides ahigh
degree of assurancethat aproduct, service,
or system accomplishes its intended
requirements.
Thisoften involves acceptanceof fitness for
purpose with end usersand other product
stakeholders.

9. Interested Party SuccessCriteria
Owner Financial return
Employees Jobsatisfaction,pay and conditions and
quality ofleadership
Customers Quality of products and services
Community Contribution to the community –jobs,
support for other traders in the
community - care for the local
environment
Suppliers Satisfactory mutualtrading
Investors Value of shares
Government Compliance with legislation

10. Trading of
goods and
services with
Chinese and
Indian traders
Tradingthrough
customer-
supplier
relationship*
Due todamaged
reputation,
broken promises
etc., ISO9000
comesin
*Based on trust and confidence

11. International Organization for
Standardization (ISO)
ISOisGreekroot meaning equal
These standards are guidelines on how to
document the processes in specific industries.
The goal is consistency and aset of complete,
easy to followinstructions.
ISO guidelines is where the TQM process can
become abit overwhelming.

12. TQM
( Employee involvementand
Product improvement)
ISO
(certification
shows that an
organizationis
following well-
established
industry
standards)
* ISOis the processthat typically shifts an organization's culture to allow
successful TQMimplementation

13. ISO standards are just a Quality Management
System (QMS) with specific guidelines on how to
document the processes. ISO is not, however
, a
way togetaroundTotalQuality Management.
Since ISO is focused on consistency and record-
keeping, while TQM is focused on employee
involvement and product improvement, they go
hand in hand. Both are customer requirements
focused, but Total Quality Management is really
the drivingfactor.

14. ISO
9000
series ofstandards
Contains technical
specifications or
other precisecriteria
asguidelines
provides atriedand
tested framework
for products’
satisfactionof
customers’
expectation

15. ISO9000 is aset of five guideline standards
that define the requirements for an effective
quality managementsystem.Of the five, only
three are certification standards (ISO9001,
9002 and 9003); both ISO9000 and 9004 are
guidelines for the other three.

16. 1. ISO9001:2008
2. ISO9001:2000
3. ISO9000:2005
4. ISO9004:2000
5. Malcolm Baldrige NationalQualityAward
6. European foundation for Quality
Management’s EFQMExcellenceModel
7. CanadaAwards forExcellence
8. Alliance forPerformance Excellence

17. 9. CAPAQualitySystems
10. ISO14001
11. ISO 27001 and Information
Security
12. ISO17025Testing andCalibration
13. AS9100

18. Organization
International
Standardization’s ISO 9001:2008
for
series
describesstandards for aQMSaddressing the
principles and processes surrounding the
design, development and delivery of a
general product orservice.

19. Organizations can participate in a continuing
certification process to ISO 9001:2000 to
demonstrate their compliance with the
standard, which includes a requirement for
continual improvement of the QMS.

20. ISO 9000:2005 provides information on the
fundamentals and vocabulary used in quality
managementsystems.
ISO 9004:2000 provides guidance for
improvement methods
However, neither of these standards can be
used for certification purposes asthey only
provide the standards andnot requirements.

21. It is a competition to identify and recognize
top-quality U.S. companies. This model
addresses a broadly-based range of quality
criteria, including commercial success and
corporate leadership. Once an organization
has won the award it has to wait several years
before being eligible to apply again.

22. European foundation for
Management’s EFQM Excellence
Quality
Model
supports an award scheme similar to the
Malcolm Baldrige Award for European
companies

23. National Quality Institute presents the
Canada Awards for Excellence on an annual
basis to organizations that have displayed
outstanding performance in the areas of
Quality and Workplace Wellness, and have
met the institute’s criteria with documented
overall achievements andresults

24. for Performance Excellence is a
Alliance
network of state, local, and international
organizations that usethe Malcolm Baldrige
National Quality Award criteria and model at
the grassroots level
local organizations
to improve the
and
performance of
economies.

25. A CAPA Quality System is absolutely essential in
some format for a complete quality
management program. What it is called is not as
important as the fact that it absolutely must
exist within the quality program. A CAPAquality
system is a required part of ISO compliance, and
is a vital part of TQM practices. The corrective
action, preventive action program is the means
by which unforeseen issues are addressed,
remedied, andeliminated.

26. ISO 14001 is the most well-known standard in
the ISO 1400 family. Unlike many other quality
control standards, the ISO 14001 standard does
not have any exact measures. Achieving
certification is based upon meeting all three of
the components of the ISO 14001Environmental
Management Standards; minimizing how
business operations negatively impact the
environment, complying with the regulations
and laws outlined in the EMS and continual
improvement.

27. Information security is part of the world of
information technology and that is where ISO
27001 comes in. ISO 27001 plays an integral
part in the information security management
process. An information security
management process is a set of policies that
focuses on the need for information security
within the information technology area.

28. ISO 17025 provides a roadmap of the general
requirements needed by testing and calibration
laboratories to prove competency. ISO17025 is
not the only method of accreditation, but it does
provide a level of visibility that few other
programs offer because it is an internationally-
recognized standard. Companies who are
looking to contract out testing services very
often look for ISO17025 accreditation for this
very reason.

29. AS9100, the Aerospace Quality Management
System standard provides guidance for
suppliers, designers, and manufacturers alike,
and is now a several-part-series of standards
that cover inspection, maintenance, and the
requirements for aerospace suppliers and
distributors.

30. ISO Certify organizations
ISOdoes not certify organizations. Many
countries have formed accreditation bodies
to authorize certification bodies, which audit
organizations applying for ISO9000
compliancecertification.

31. ISO9000:2000
certification* ISO9001:2000
Certification
*commonly preferred and known; actual standards to which an
organization’s quality management can be certified with an ISO
9001:2000certification

32. Applyingorganizations is assessedbased on
an extensive sample of its sites, functions,
products, services, andprocesses
An ISOcertificate is not aonce-and-for-all
award, but must be renewed at regular
intervals recommendedby the certification
body, usually around three years.

33. Twotypes of auditing arerequired to become
registered to the standard.
1.ExternalAudit
• Auditing by external certification body
2. InternalAudit
• Audits by internal staff trained for this process

34. The aim is acontinual processof review and
assessment,to verify that the system is
working asit’s supposedt, find out where it
can improve and to correct or prevent
problems identified.

35. Createamore efficient, effective operation
Increasecustomersatisfaction andretention
3 Reduceaudits
Enhancemarketing
5 Improve employee motivation, awareness and morale
Promote internationaltrade
Increaseprofit
8 Reducewaste andincreasesproductivity
1
2
4
6
7

36. Principle 1: CustomerFocus
Principle 2:Leadership
Principle 3:Involvement of People
Principle 4:ProcessApproach
Principle 5:Systemapproach to management
Principle 6:Continual Improvement
Principle 7:Factualapproach to decision
making
Principle 8: Mutually beneficial supplier
relationship

37. Organizations depend on their customers
and therefore should understand current and
future customer needs, should meet
customer requirements and strive to exceed
customer expectations.

38. Leaders establish unity
of purpose and
direction of the
organization. They
should create and
maintain the internal
environment in which
people can becomefully
involved in achieving
the organization’s
objectives.

39. Peopleat all levelsare the essenceof an
organization and their full involvement
enablestheir abilities to be usedfor the
organization’s benefit.

40. A desiredresult is achievedmore efficiently
when activities and related resources are
managed asaprocess

41. Identifying, understanding, and
managing interrelateprocessesas
asystem contributes to the
organization’s effectiveness and
efficiency in achieving its
objectives

42. Continual improvement of the organization’s
overall performance should be apermanent
objective of the organization.

43. Effectivedecisions are basedon the analysis
of dataand information.

44. An organizationand
its suppliers are
interdependent and
amutually
beneficial
relationship
enhances theability
of both to create
value.