1. Setting up a quality management system
In this file, you can ref useful information about setting up a quality management system such as
setting up a quality management systemforms, tools for setting up a quality management system,
setting up a quality management systemstrategies … If you need more assistant for setting up a
quality management system, please leave your comment at the end of file.
Other useful material for setting up a quality management system:
• qualitymanagement123.com/23-free-ebooks-for-quality-management
• qualitymanagement123.com/185-free-quality-management-forms
• qualitymanagement123.com/free-98-ISO-9001-templates-and-forms
• qualitymanagement123.com/top-84-quality-management-KPIs
• qualitymanagement123.com/top-18-quality-management-job-descriptions
• qualitymanagement123.com/86-quality-management-interview-questions-and-answers
I. Contents of setting up a quality management system
==================
First send the person in your company who is in charge of your quality management system
(QMS) certification to a ISO 9001 fundamentals training course and an ISO 9001 internal
auditor course. Start by getting them educated in what needs to be done. A suitable one day
ISO 9001 introduction course from an ISO 9001 Certifying Body (like SAI Global in
Australia) is a good place to start. The ISO 9001 Internal Quality Auditor Course training is a
2-day course.
In the end your Quality Manager will also need to go to the introduction to ISO 9001 training
and do an Internal Quality Auditor Course as proof that they are trained and qualified to be a
ISO 9001 Quality Manager.
Once your own person is knowledgeable in the needs of ISO 9001 accreditation, understands
what comprises an ISO 9001 Quality System, and knows how to build one, it is very likely
that they can develop a complying ISO9001 quality system for you. They will take longer
than a ISO 9001 Consultant because it is their first ISO 9001 system, but they will be capable
of developing a compliant ISO 9001 QMS.
Whether you use an ISO Consultant to develop your QMS, or you use your own internal
resources, normally is a matter of what you consider to be the most cost effective decision.
ISO 9001 Consultants cost much more than an hourly rate employee, but will complete the
QMS much faster and it will be built correctly. Most importantly, a good ISO 9001
Consultant will build into your QMS system the expertise and knowledge they know about
world class business management systems. That is something that your employee can never
know and will never do for you.

2. I find that if a company is driven by money-conscious management they get their own people
to do their own QMS (and thus lose fortunes and countless successes in future). Those
companies driven by long term success who want to build a business that will last get the best
ISO 9001 Consultant that they can afford to build their QMS and happily pay the price.
Step 2 is to buy the ISO 9001 Standard and do a ‘gap analysis’ table top audit of your
business processes and documents (you can use our ISO 9001 tabletop audit matrix at ISO
9001 Compliance Table) and identify what is missing from your current business
management system.
Next you need to develop your document management framework, document numbering and
document controls so that your QMS complies with ISO 9001 requirements for managing
your business documents and records. Eventually you will need to update all your QMS
documents with the QMS document numbering so that you can populate the document
management framework and manage your paperwork.
I then write the Quality Manual (an example of the top QMS document from which all the
other QMS documents cascade is at Quality Manual Lead Document) and lastly backfill the
tables at the end of the Manual with the documents that you use in your business to achieve
the intent of each of the ISO 9001 clauses.
When you come across necessary processes and documents needed by ISO 9001 that you do
not yet have, you create them, you teach them to your people and you make them part of your
future business practices forevermore.
The costs for me to do the table top audit is at senior consultant hourly rates. Allow 16 hours
to do the tabletop review and provide you with a basic report.
If you want me to build the QMS I charge at senior consultant hourly rates to develop it. If I
have to build the system from the documents that you already have allow two to three weeks
to compile the framework, populate the framework with documents, develop new processes
and write missing documents. (For a small business like yours it should take less than two
weeks if you have a good business management system already, and up to three weeks if you
have an average business management system.)
To these costs you need to add the cost for the Certifying Body preliminary audit and full
accreditation audit, plus the certificate issuing costs. Once you are ISO 9001 accredited you
have an ongoing annual certification fee to pay the Certifying Body and an annual audit from
them to pay for too.
==================
III. Quality management tools
1. Check sheet

3. 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,
apparatus)
 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

4. 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
process.
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
line.
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

5. 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

6. 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
exactly.
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
operates
6. Histogram method

7. 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 Setting up a quality management system (pdf
download)
quality management systems
quality management courses
quality management tools
iso 9001 quality management system
quality management process
quality management system example
quality system management
quality management techniques
quality management standards
quality management policy
quality management strategy
quality management books