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implementation of quality management system

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I. Contents of implementation of quality management system


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Step 1: Commitment from Top Management
The top management of an organisation should be determined and committed to
implement aquality management system. No quality initiative within an organisation
can succeed without commitment from top management. Top management can
demonstrate to their clients that the organisation is committed to quality through the
certification and registration of the ISO 9000standard. Top management should thus
come to the realization that overall business efficiency would be improved by means of
a quality management system.
Step 2: Establishing an Implementation Team
People are responsible for the implementation of ISO 9000. An implementation team,
headed by a Service Provider and a Management Representative (MR), is to be
established. The Service Provider and MR is the coordinator and is responsible for
planning and overseeing the implementation of the quality management system. He is

thus the link between top management and the ISO 9000 registrar. All departments within
the organisation should be represented on the implementation team.
Step 3: Conducting ISO 9000 Awareness Programs
Conducting ISO 9000 awareness programs will inform all employees about the aim of
a quality management system. These include the advantages offered to customers and
employees, their respective responsibilities and roles within the system, and how
the quality management system operates. The benefits that an organisation hopes to
realize through a quality management system implementation should be emphasized
through ISO 9000 awareness programs.
Step 4: Providing Training
All personnel and all areas in an organisation are affected by a quality management
system. Training regarding the quality management system should thus be provided for
all employees. The quality management system implementation plan should make
provision for this training. All basic concepts of quality management systems and its
impact on the organisation should be covered.
Step 5: Conducting an Initial Status Survey
A quality management system conforming to the ISO 9000 standard should be created.
However, this does not preclude incorporating, adapting, or adding onto quality programs
that already exists. Thus, this step basically involves comparing an organizations
existing quality management system (if there is one) with the requirements of ISO
Step 6: Creating a Documented Implementation Plan
Once an organizations quality management system has been compared with the ISO
9001:2008 standard, a documented implementation plan is used to address any nonconformances. The documented implementation plan identifies and describes processes
in order to make the organizations current quality management system in full
compliance with the ISO 9000 standard.
Step 7: Developing a Quality Management System Documentation
Documentation is an area where non-conformance regarding quality management
systemsare very common. In order to avoid these non-conformities, documentation of
a quality management system should include the following:

o Documented statements of a quality policy and quality objectives;

o A quality manual;
o Documented procedures and records required by the standard of ISO 9001:2008;
o Documents needed to ensure effective planning, operation and control of its
Step 8: Control of Documents
In order to control quality management system documentation, a documented system
should be created. The creation, approval, distribution, revision, storage, and disposal of
various types of documentation are thus managed. Document control systems should be
as easy and simple to operate as possible. However, it should still be sufficient enough to
meet the requirements of ISO 9001:2008.
Step 9: Implementation
In large organizations, it is best to implement the quality management system being
documented as the documentation is developed. This is in stark contrast to smaller
organizations, where the quality management system is implemented throughout the
organisation all at once. During phased implementation, however, an evaluation can take
place regarding the effectiveness of the system in different areas.
Through management review and an internal quality audit, the implementation progress
is monitored to ensure that the quality management system is effective and thus
conforms to the IS0 9000 standard
Step 10: Internal Quality Audit
The effectiveness of the installed system should be checked regularly by means of an
internal quality audit. Below are some reasons for conducting an internal quality audit
into a quality management system:
o To ensure that the quality management system conforms to the quality
management system requirements established by your organization, as well as to
the requirements of the ISO 9001:2008 standard; and
o To ensure that the quality management system is implemented and maintained
in an effective manner

Step 11: Reviewing by Management

A management review should be conducted three to six months after quality
management system implementation took place. The reasons for conducting
management reviews are to ensure continuous effectiveness, adequacy, and suitability of
the quality management system.
Step 12: Pre-assessment Audit
Before applying for certification, a pre-assessment audit usually takes place. Certification
bodies provide a qualified but independent auditor to conduct this service. Some degree
of confidence is gained before application for certification if the pre-assessment audit
goes well
Step 13: Certification and Registration
A formal application for certification is made at a certification body as soon as
the quality management system has been operating for a few months and has stabilized.
An audit of the documents (known as an adequacy audit) is first carried out, and if it
conforms to the requirements of the quality standard, it is followed by an on-site audit. A
certificate is only awarded to the organisation if the certification body is satisfied with the
workings of the system. However, the certificate is valid for a period of three years only,
after which the certification body will carry out periodic surveillance audits.
Step 14: Continual Improvement
Although an organisation gained certification, it is important to note that it has to try and
improve the suitability and effectiveness of the quality management system on a
continuous basis.


III. Quality management tools

1. Check sheet

The check sheet is a form (document) used to collect data

in real time at the location where the data is generated.
The data it captures can be quantitative or qualitative.
When the information is quantitative, the check sheet is
sometimes called a tally sheet.
The defining characteristic of a check sheet is that data
are recorded by making marks ("checks") on it. A typical
check sheet is divided into regions, and marks made in
different regions have different significance. Data are
read by observing the location and number of marks on
the sheet.
Check sheets typically employ a heading that answers the
Five Ws:

Who filled out the check sheet

What was collected (what each check represents,
an identifying batch or lot number)
Where the collection took place (facility, room,
When the collection took place (hour, shift, day of
the week)
Why the data were collected

2. Control chart
Control charts, also known as Shewhart charts
(after Walter A. Shewhart) or process-behavior
charts, in statistical process control are tools used
to determine if a manufacturing or business
process is in a state of statistical control.
If analysis of the control chart indicates that the
process is currently under control (i.e., is stable,
with variation only coming from sources common
to the process), then no corrections or changes to
process control parameters are needed or desired.

In addition, data from the process can be used to

predict the future performance of the process. If
the chart indicates that the monitored process is
not in control, analysis of the chart can help
determine the sources of variation, as this will
result in degraded process performance.[1] A
process that is stable but operating outside of
desired (specification) limits (e.g., scrap rates
may be in statistical control but above desired
limits) needs to be improved through a deliberate
effort to understand the causes of current
performance and fundamentally improve the
The control chart is one of the seven basic tools of
quality control.[3] Typically control charts are
used for time-series data, though they can be used
for data that have logical comparability (i.e. you
want to compare samples that were taken all at
the same time, or the performance of different
individuals), however the type of chart used to do
this requires consideration.

3. Pareto chart

A Pareto chart, named after Vilfredo Pareto, is a type

of chart that contains both bars and a line graph, where
individual values are represented in descending order
by bars, and the cumulative total is represented by the
The left vertical axis is the frequency of occurrence,
but it can alternatively represent cost or another
important unit of measure. The right vertical axis is
the cumulative percentage of the total number of
occurrences, total cost, or total of the particular unit of
measure. Because the reasons are in decreasing order,
the cumulative function is a concave function. To take
the example above, in order to lower the amount of
late arrivals by 78%, it is sufficient to solve the first
three issues.
The purpose of the Pareto chart is to highlight the
most important among a (typically large) set of
factors. In quality control, it often represents the most
common sources of defects, the highest occurring type
of defect, or the most frequent reasons for customer
complaints, and so on. Wilkinson (2006) devised an
algorithm for producing statistically based acceptance
limits (similar to confidence intervals) for each bar in
the Pareto chart.

4. Scatter plot Method

A scatter plot, scatterplot, or scattergraph is a type of

mathematical diagram using Cartesian coordinates to
display values for two variables for a set of data.
The data is displayed as a collection of points, each
having the value of one variable determining the position
on the horizontal axis and the value of the other variable
determining the position on the vertical axis.[2] This kind
of plot is also called a scatter chart, scattergram, scatter
diagram,[3] or scatter graph.
A scatter plot is used when a variable exists that is under
the control of the experimenter. If a parameter exists that
is systematically incremented and/or decremented by the
other, it is called the control parameter or independent
variable and is customarily plotted along the horizontal
axis. The measured or dependent variable is customarily
plotted along the vertical axis. If no dependent variable
exists, either type of variable can be plotted on either axis
and a scatter plot will illustrate only the degree of
correlation (not causation) between two variables.
A scatter plot can suggest various kinds of correlations
between variables with a certain confidence interval. For
example, weight and height, weight would be on x axis
and height would be on the y axis. Correlations may be
positive (rising), negative (falling), or null (uncorrelated).
If the pattern of dots slopes from lower left to upper right,
it suggests a positive correlation between the variables
being studied. If the pattern of dots slopes from upper left
to lower right, it suggests a negative correlation. A line of
best fit (alternatively called 'trendline') can be drawn in
order to study the correlation between the variables. An
equation for the correlation between the variables can be
determined by established best-fit procedures. For a linear
correlation, the best-fit procedure is known as linear
regression and is guaranteed to generate a correct solution
in a finite time. No universal best-fit procedure is
guaranteed to generate a correct solution for arbitrary
relationships. A scatter plot is also very useful when we
wish to see how two comparable data sets agree with each

other. In this case, an identity line, i.e., a y=x line, or an

1:1 line, is often drawn as a reference. The more the two
data sets agree, the more the scatters tend to concentrate in
the vicinity of the identity line; if the two data sets are
numerically identical, the scatters fall on the identity line

5.Ishikawa diagram
Ishikawa diagrams (also called fishbone diagrams,
herringbone diagrams, cause-and-effect diagrams, or
Fishikawa) are causal diagrams created by Kaoru
Ishikawa (1968) that show the causes of a specific event.
[1][2] Common uses of the Ishikawa diagram are product
design and quality defect prevention, to identify potential
factors causing an overall effect. Each cause or reason for
imperfection is a source of variation. Causes are usually
grouped into major categories to identify these sources of
variation. The categories typically include
People: Anyone involved with the process
Methods: How the process is performed and the
specific requirements for doing it, such as policies,
procedures, rules, regulations and laws
Machines: Any equipment, computers, tools, etc.
required to accomplish the job
Materials: Raw materials, parts, pens, paper, etc.
used to produce the final product
Measurements: Data generated from the process
that are used to evaluate its quality
Environment: The conditions, such as location,
time, temperature, and culture in which the process

6. Histogram method

A histogram is a graphical representation of the

distribution of data. It is an estimate of the probability
distribution of a continuous variable (quantitative
variable) and was first introduced by Karl Pearson.[1] To
construct a histogram, the first step is to "bin" the range of
values -- that is, divide the entire range of values into a
series of small intervals -- and then count how many
values fall into each interval. A rectangle is drawn with
height proportional to the count and width equal to the bin
size, so that rectangles abut each other. A histogram may
also be normalized displaying relative frequencies. It then
shows the proportion of cases that fall into each of several
categories, with the sum of the heights equaling 1. The
bins are usually specified as consecutive, non-overlapping
intervals of a variable. The bins (intervals) must be
adjacent, and usually equal size.[2] The rectangles of a
histogram are drawn so that they touch each other to
indicate that the original variable is continuous.[3]

III. Other topics related to implementation of quality

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