Quality 

in business, engineering and manufacturing has a pragmatic interpretation as the non-

inferiority or superiority of something. Quality is a perceptual, conditional and somewhat subjective attribute and may

be understood differently by different people. Consumers may focus on the specification quality of a product/service,

or how it compares to competitors in the marketplace. Producers might measure the conformance quality, or degree to

which the product/service was produced correctly.

Numerous definitions and methodologies have been created to assist in managing the quality-affecting aspects of

business operations. Many different techniques and concepts have evolved to improve product or service quality. There

are two common quality-related functions within a business. One is quality assurance which is the prevention of defects,

such as by the deployment of a quality management system and preventative activities like FMEA. The other is quality

control which is the detection of defects, most commonly associated with testing which takes place within a quality

management system typically referred to as verification and validation.

Quality control is a process by which entities review the quality of all factors involved in production. This

approach places an emphasis on three aspects: [citation needed]

1. Elements such as controls, job management, defined and well managed processes [1][2], performance
and integrity criteria, and identification of records

2. Competence, such as knowledge, skills, experience, and qualifications

3. Soft elements, such as personnel integrity, confidence, organizational culture, motivation, team

spirit, and quality relationships.

The quality of the outputs is at risk if any of these three aspects is deficient in any way.

Quality control emphasizes testing of products to uncover defects, and reporting to management who make

the decision to allow or deny the release, whereas quality assurance attempts to improve and stabilize

production, and associated processes, to avoid, or at least minimize, issues that led to the defects in the
first place.

“Total Quality Management is a systematic

managerial transformation designed to
address the needs and opportunities of all
organizations as they try to cope with the
increasing change, complexity and tension
within their environments.”
How can quality be improved?
Traditional: norms, training, job aids,
supervision, material and equipment
QA: team work, process analysis,
monitoring of data, client focus, coaching
Collaborative: common problem, change
package, sharing
experiences, positive competition, best practices,
rapid spread
Carrying out interventions correctly according
to pre-established standards and procedures,
with an aim of satisfying the customers of the
health system and maximizing results without
generating health risks or unnecessary costs.

What is Quality Assurance?

􀂄 All of the activities that make it possible to
define standards, to measure and improve
the performance of services and health
providers so that care is as effective as
possible.
Quality Assurance
􀂄 Define Quality
(Standards, norms,
guidelines)
􀂄 Measure Quality
(The variation in standards)
􀂄 Improve Quality
(Comply with norms)
􀂄 One cannot measure that
which one has not defined
􀂄 One cannot improve that
which one has not
measured

Model for Quality Improvement

What are we trying to
accomplish?
How will we know that a
change is an improvement?
What changes can we make that
will result in improvement?
Act Plan
Study Do

World Quality Day 2010

World Quality Day 2010 'Out of the Crisis' focuses on what a fit organisation looks like and
the role that quality management professionals play in facilitating fitness.
The CQI regions will be hosting Loxham Lecture events on this topic during the week 8-12
November 2010.
ISO9000 Quality Standard
ISO900 is an internationally recognized standard of quality, and includes guidelines to accomplish
the ISO9000 quality standard. Organizations can be optionally audited to earn ISO9000
certification.

ISO 9000 is rapidly becoming the most

popular quality standard in the world.
Thousands of organizations have already
adopted this important standard, and many
more are in the process of doing so.
ISO 9000 applies to all types of organizations. It doesn't matter what size they are or what they
do. It can help both product and service oriented organizations achieve standards of quality
that are recognized and respected throughout the world.

Here's how it works. You decide that you need to develop a quality system that meets the
ISO 9000 standards. You choose to follow this path because you feel the need to control the
quality of your products and services, to reduce the costs associated with poor quality, or to
become more competitive. Or, you choose this path simply because your customers expect
you to do so or because a regulatory body has made it mandatory.

You then develop a quality system that

meets the quality requirements specified
by one of the following three standards:
ISO 9001, ISO 9002, or ISO 9003. In the
course of doing so, you also consider ISO's
many guidelines. These guidelines include
ISO 9000, ISO 9004, ISO 10011, and ISO 10013.

Once your quality system has been

developed and implemented, you carry
out an internal audit to make sure your
system is working properly.

Then you invite an accredited

external auditor (registrar) to evaluate the effectiveness of your quality system. If your auditors
like what they see, they will certify that your quality system has met all of ISO's requirements.
They will then issue an official certificate to you and they will record your achievement in their
registry. You can then announce to the world that the quality of your products and services is
managed, controlled, and assured by a registered ISO 9000 quality system.

Various Perspectives
ISO 9001-2000: What to expect (article about new standards and how to implement them)
ISO 9000 Translated into Plain English
ISO homepage, English, with graphics
Welcome to ISO Easy!
FAQ-ISO9000
Basics of ISO 9001 Tutorial
Sections of this document include: general observations;
measur, measurement and more measurement; other
improvements;ISO9000:2000 a predjudiced view; and conclusion.

The Draft International Standard (DIS) for ISO 9001:2000 was released in
late November 1999. Reaction to this latest revision will no doubt vary and
will likely depend on how one approaches the document. A casual, non-
critical reading of the DIS will probably leave most readers with an overall
feeling of satisfaction vis-à-vis the standard. Indeed, people may even
comment that the 9001, 9000 and 9004 standards read better and are
clearer than previous editions (1987 and 1994). However, upon closer
examination, a more careful and critical reading will no doubt reveal that
this latest revision was prepared in haste and is still in need of major
editing. Indeed, the DIS is still replete with repetitions (and hence
redundancies), as well as vaguely phrased or inelegant sentences. Editing
these sentences and removing persistent redundancies would produce a
more elegant, concise and thus, clearer DIS.

General observations

What is interesting to note about the DIS is that, on first impression, only
minor changes seemed to have been introduced; a word changed here and
there, a few paragraphs renumbered or, a few sentences slightly
rephrased.  However, when one compares the CD 2 document to the DIS,
one notices that the nature of some of these changes is more significant
than at first thought.  For example, one notable change inserted to the DIS
addresses the need for documented procedures.  The CD 2 draft document
hardly made any references to the need to establish documented
procedures.  This apparent omission is now “corrected” in the DIS.  Indeed,
the phrase, “A documented procedure shall be established . .” is now
referenced six times!  One wonders who recommended the change.

The six specific references to “establishing documented procedures” are

found in the following paragraphs:

5.5.6 Control of documents; 5.5.7 Control of quality records; 8.2.2 Internal

audit; 8.3 Control of nonconformity; 8.5.2  Corrective action; and
8.5.3 Preventive action

In addition, references to the need for documentation are also stated in

paragraphs 7.1 and 5.4.2. Paragraph 7.1  Planning of realization
processes currently states: “Planning of the realization processes shall be
consistent with the other requirements of the organization’s quality
management system and shall be documented in a form suitable for the
organization’s method of operation.”

Paragraph 5.4.2 Quality planning, states that:  “The output of the planning

shall be documented.”  These last two examples (7.2 and 5.4.2) could also
be cited as an example of redundancy (7.1 partly repeats what is already
stated in 5.4.2); and obfuscation.  Indeed, who has ever heard
of “realization processes.”  Still, having coined a new term, the standard
does define product realization as “that sequence of processes and sub-
processes required to achieve the product.”  Government bureaucrats
could not have written a better sentence.

Should there be any doubts as to the nature of documentation, the DIS

currently states that:
“The organization shall establish, document, implement, maintain and
continually improve a quality management system in accordance with the
requirements of this International Standard.” (4.1)

“The quality management system documentation shall include:

a) documented procedures required in this International Standard;

b) documents required by the organization to ensure the effective operation

and control of its processes.” (4.2)

Procedures and documents are still very much alive and well in ISO
9001:2000.  So are redundancies which were so noticeable in the CD 2
document.  A review of the DIS revealed nine cases of redundancy and/or
repetition.  Examples of repetition would include sentences that repeat or
nearly duplicate (using different words) a point made in an earlier (or later)
paragraph or sometime, in the same paragraph.

Despite these flaws which may be corrected in the next DIS, one must
recognize that the specific reference to “establishing and maintaining
documented procedures,” so prevalent in the 1987 and 1994 versions, has
now been significantly reduced.

Measure, Measurement and More Measures

One of the major additions, one could even say, improvements to the ISO
9001:2000 standard is paragraph 8 entitled: Measurement, analysis and
improvement.  This paragraph now requires that an organization measures
and monitors customer satisfaction, the effectiveness of the quality
management system (via the internal audit process), processes and
products.  Whether or not people will understand the difference between
measurement and monitoring remains to be seen.

Since the ISO 9001:2000 will require organizations to collect much data,
one should not be surprised to learn that all these data will have to be
analyzed (8.4 Analysis of data) to assess customer satisfaction,
conformance to requirements, characteristics of processes, products (and
their trends) and suppliers (performance?).  The DIS is not always clear or
direct as to what is meant.  For example, with respect to the last
requirement (suppliers), the DIS currently reads (8.4):  “The organization
shall analyze this data (sic) to provide information on:  d)  suppliers.”  What
type of information is not stated.  However paragraph 7.4.1 does state that
that  “The organization shall evaluate and select suppliers based on their
ability to supply product in accordance with the organization’s
requirements.”  This last example indicates that the standard still needs to
be edited (“this data” should read “these data”), and moreover, readers will
occasionally have to cross-reference two or more paragraphs to
better understand the intent of a sentence or paragraph.

Other improvements

The new standard has tightened up previous requirements and clarified

others. For example, quality objectives must not only be measurable but
also “consistent with the quality policy.”  Management reviews must not
only include specific inputs (e.g., results of audits, customer feedback,
process performance, status of preventive and corrective actions, follow-up
actions, etc.), but must also contain specific outputs.  Management minutes
for example must now include actions related to: a) improvement of the
quality management system and its processes, b) improvement of product
related to customer requirements and resources needed (supposedly to
achieve these improvements.)

It is no longer sufficient to assess training needs and conduct training.  An

organization will have to evaluate the effectiveness of the training
provided.  The old design control paragraph (4.4 in ISO 9001:1994) has
now been renamed design and/or development.  Although the paragraphs
reads much the same as the old 4.4 Design control, a few requirements
have been added.  For example, one notes that evidence of design and/or
development validation must now be recorded.

9001:2000 A prejudiced point of view

In an article entitled “The Art of Creating Standards,” the authors (all

members of the US TC 176 committee), make several interesting claims
regarding the ISO 9000:2000 series of standards.  They state that  “As
clarity and simplification are pursued, words and paragraphs are
added. Also adding to the standards’ length is the need to make crystal
clear requirements that were always intended but previously were not
explicitly stated.”  Although it is true that certain sections (and/or
paragraphs) of the the ISO 9001:2000 are now clearer, it is also true that
the standard is longer because it introduces new requirements and  repeats
many requirements often using imprecise sentences.  We are then told that
the standard needs to be longer because requirements that “were always
intended” must now be made crystal clear.  But who would lay claim to
these intended requirements?  Is it some mythical customer or perhaps
some registrars, consultants, members of the TC 176 committee or a
combination of all four!  No one knows, we are simply told that such
requirements were always implied but, we are never told why they were
implied nor are we told why these implied requirements would necessarily
benefit a company.  These assertions are posited as obvious truth to be
recognized by anyone with the proper experience and knowledge.

The authors then proceed to assure the reader that “Compliance with ISO
9001 should not add any extra cost but may expose requirements that
should have been already considered but were not adequately
addressed.”  This statement, bordering on arrogance, is even more
remarkable because it clearly demonstrates that the authors are clearly
detached from the economic realities of everyday businesses. The logic is
rather simple:  these additional requirements (which were supposedly
implied in the first place), are not really additional requirements because
companies should have adequately addressed them in the first place.  We
still do not know who has the authority to decide what is adequate and what
is not adequate implementation. What is clearly implied by the authors’
statement is that organizations throughout the world have obviously
misunderstood the intent of ISO 9001 requirements which would explain
why clarifications are needed to correct these deficiencies. As far as the
authors are concerned, the cost of properly addressing these requirements
is not really a cost because these requirements were not adequately
addressed in the first place!  Confused? Don’t be because ISO 9001:2000
or perhaps, a future revision, will surely prescribe the best remedy to all
your woes.

You can rest assured that the new ISO 9001:2000 will cost more to
implement.  Naturally, the cost will vary and, it is also true that for some
companies which already have a system that complies with the new list of
requirements listed in 9001:2000, the cost will be negligible.  Nonetheless,
for many other companies, there will be a cost associated with the need to
align their quality management system with the new requirements.

Conclusion

Once the DISs (9000, 9001 and 9004) are edited, as we all hope they will
be, will they provide the reader with a better set of standards which will be
easier to interpret and implement?  The authors of “The Art of Creating
Standards” are, as can be expected, optimistic in their answer.  “The
authors believe,” they conclude, “that ISO 9001:2000 and ISO 9004:2000
will prove to be even more useful and valuable to organizations than their
predecessors.”   Based on this statement, one can assume that the authors
believe that the new standards will be better than their predecessors.  Is
that necessarily true and, more importantly, will it be easier to interpret and
implement ISO 9001:2000?  There is little doubt that the new standards are
better written.  The definition of terms provided by ISO 9000:2000 as well
as the prose of 9001 and 9004:2000, are an improvement over previous
releases. One would hope that one of the advantages of these
improvements is that fewer books on ISO 9000 will be published. However,
this is not likely to happen because ISO 9001:2000 will not necessarily be
easier to interpret and thus, implement. The Plan Do Check Act (PDCA)
structure implied in ISO 9001, although useful as a methodology, renders
the structure of ISO 9001 ponderous, and at times, difficult to interpret.  For
example, one likely source of confusion will be paragraphs 8.2.3
Measurement and monitoring of processes and 8.2.4 Measurement and
monitoring of products.  Since the effectiveness of a process has
traditionally been assessed by measuring product conformance, one is
curious to see how organizations will “monitor processes.”  Other examples
could be cited.

 Consequently, although ISO 9001:2000 will probably read better (and

perhaps, even be more useful and valuable to some), it will not be easier to
implement particularly, for first time implementers.  It will be more
demanding simply because the standard now places more demands on
organizations.  And that is why more books and thousands of pages of
advice and opinions on ISO 9001:2000 will be published even before the
standards are officially released. The more things change, the more they
remain the same.

  ISO 31000 2009 Risk Management Standard

ISO 9001 2008 Quality Management Standard
ISO 9004 2009 Quality Management Standard
ISO 28000 2007 Supply Chain Security Standard
OHSAS 18001 2007 OH&S Management Standard
 AS9100C Aerospace Quality Management Standard
ISO 14001 2004 Environmental Management Standard
ISO 13485 2003 Medical Device Quality Standard
ISO 22000 2005 Food Safety Management Standard
ISO 27001 2005 Information Security Management Standard
ISO 27002 2005 Information Security Management Standard
ISO 90003 2004 Software Quality Management Standard