Quality management system iso 9001

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I. Contents of quality management system iso 9001

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Why Quality Management Systems?
Successful organizations are driven by Quality because only quality-oriented organizations can sustain
and grow in the fierce competitive scenario prevailing today.
Establishment and implementation Quality Management Systems results in leaner, efficient and effective
organizations that are equipped to face challenges and harness opportunities in the global marketplace.
ISO 9001:2008
International Standards provide a reference framework, or a common technological language, between
suppliers and their customers which facilitates trade and the transfer of technology. ISO 9001: 2008 is
an international standard related to quality management systems, applicable to any organization from all
types of business sectors and activities.
ISO 9001:2008 is based on eight quality management principles, which are essentially aimed at
1.
2.
3.
4.
5.
6.

improving performance of an organization. These eight principles are:

Customer focus
Leadership
Involvement of People
Process Approach
Systems Approach to Management
Continual Improvement

7.
8.

Fact based Decision-making

Mutually Beneficial Supplier Relationship
Role of Top Management
ISO 9000 defines Top Management as a person or a group of people who direct(s) and control(s) an
organization at the highest level.
ISO 9001:2008 requires that the Top Management shall provide evidence of its commitment to the
development and implementation of quality management systems and continually improve its

effectiveness. Top Management has to:

establish and define quality policy, quality objectives
ensure availability of resources for implementation of quality management systems
ensure that customer requirements are determined and met with the aim of enhancing customer
satisfaction
Top Management responsibilities cannot be delegated.
Quality driven organizations with top management commitment reap the benefits of quality management
systems, for the benefit of the organization, customer, and society at large.

Why Choose Transpacific Certifications Limited for QMS Certification?

Transpacific Certifications Limited offers certification/registration services for Quality
Management Systems as per ISO 9001:2008, besides offering a range of other services like certification
of Environmental Management Systems as per ISO 14001:2004, Food Safety Management Systems
(including HACCP) as per ISO 22000:2005, Information Security Management Systems as per ISO
27001:2005, Occupational Health & Safety as per OHSAS 18001.
TCL is a fast growing certification body possessing highly skilled and experienced human
resources dedicated to provide quality services to our clients for achieving excellence in business. Our
clients, numbering more than 10,000 bear a testimony to this.
TCL has the distinction of being one of the few organizations accredited by JAS-ANZ for all
scopes of QMS, EMS, OHSAS, ISMS and FSMS in India, which means we can handle work of all
categories and diverse industry types.
TCL is also accredited with National Accreditation Board for Certification Bodies (NABCB) for
Quality Management Systems, ISO 9001:2008.
TCL is one of the very few certification bodies in India permitted to use logo of IAF Logo
(International Accreditation Forum Inc., World Association for Conformity Assessment) on the certificate
as per agreement signed with them through AB.
TCL has a global presence. We have offices in various countries like Bulgaria,
Egypt, Korea, Turkey, UK etc.
ISO 9001:2008 Registration Process : Our Methodology
At Transpacific Certifications Limited our methodology for ISO 9001:2008 registration/certification
consists of the following steps:

1.
2.
3.
4.
5.
6.
7.

Signing of Contract
Pre-audit (optional) to identify gap analysis of your current position against the standard
Stage I Audit Documentation Review
Stage II Audit Initial Certification Audit
Issuance of Certificate
Surveillance Audits to ensure maintenance of system and continual improvement
Re-certification through full audit after 3 years for continual assessment

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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 Quality management system iso

9001 (pdf download)
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