Iso 9001 quality management systems requirements

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I. Contents of iso 9001 quality management systems

requirements
==================
SO 9001: 2008 is a standard which specifies the requirements for a quality management system
(QMS) where an organisation (1) needs to demonstrate its ability to consistently provide product
that meets customer and applicable regulatory requirements, and (2) aims to enhance customer
satisfaction through the effective application of the system. This includes processes for continual
improvement of the system and the assurance of conformity and applicable regulatory
requirements.
ISO 9001 is by far the worlds most established quality framework, currently being used by
around 897,000 organisations in 170 countries worldwide. It sets the standard not only for
quality management systems, but management systems in general. ISO 9001 helps all kinds of
organizations succeed through improved customer satisfaction, staff motivation and continual
improvement.
As an ISO 9001 certified organisation you will have implemented quality management system
requirements for all areas of the business including:

Facilities

People

Training

Services

Equipment

Continual Assessment

Achieving ISO 9001 standards is the first step of a process of continual improvement that will
provide your organisation with the necessary management tools to improve working practices
throughout the entire organisation.

UKAS accreditation

You will need to appoint a person to help you to carry out the internal assessments, assist in
writing up the Quality Manual and procedures, and help you with getting certified.

Benefits of ISO 9001

An ISO 9001 certificate will provide maximum benefit to your organisation if it approaches ISO
9001 implementation in a practical way. This will ensure that the quality management systems
that are adopted, work to improve the business and are not just a set of procedures that your
employees will find hard to manage.

By adopting an approach that starts out to implement more efficient working practices and
focuses on the organisations business objectives, you will achieve a system that will help and
support your staff, and improve customer satisfaction.
Whether you use an external assessor or allocate an internal resource to carry out the initial
assessments, you will need to ensure that they have buy-in from senior management to ensure all
areas of the organisation are aware of the importance of the ISO accreditation process.
ISO 9001 certification is not just suitable for large organisations but also small businesses that
will benefit from adopting efficient quality management systems that will save time and cost,
improve efficiency and ultimately improve customer relationships.
Some of the benefits to your organisation:

Provides senior management with an efficient management process

Sets out areas of responsibility across the organisation

Mandatory if you want to tender for some public sector work

Communicates a positive message to staff and customers

Identifies and encourages more efficient and time saving processes

Highlights deficiencies

Reduces your costs

Provides continuous assessment and improvement

Marketing opportunities

Some of the benefits to your customers:

Improved quality and service

Delivery on time

Right first time attitude

Fewer returned products and complaints

Independent audit demonstrates commitment to quality

ISO 9001 auditor

When you are satisfied that your entire organisation is working within the guidelines of the
quality management system, it is time to call in an ISO 9001 auditor. The audit can be done by a
number of Certification bodies, however it is important to note that not all ISO 9001 auditing
organisations are UKAS accredited.
If you do not use a UKAS accredited auditor your certification could end up being worthless.
==================

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,
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
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
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
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
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 Iso 9001 quality management

systems requirements (pdf download)
quality management systems
quality management courses
quality management tools
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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