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Types of quality management systems
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I. Contents of types of quality management systems
If you’ve ever held a child’s toy or operated a power tool, you’re probably familiar with ISO
certifications. They apply to everything from industrial and household products and services to
environmental regulations and much more. ISO also applies to management, particularly an
essential structure for any company: The Quality Management System.
This is the first of a 2-part article. Here we will briefly discuss the highlights of the ISO 9001
Quality Management System. Next month, we will follow up with examples of how Lean
Principles help make the entire process more efficient and effective.
Before we delve in the Quality Management System, here’s a little background
ISO is the International Organization for Standardization, and they’re the world’s largest
developer of international standards. As their website states, “ISO-International Standards
ensure that products and services are safe, reliable and of good quality.” Their video explains in
According the LaManna Alliance’s quality guru, Ed Klaczak of EJK Consulting Solutions, Inc,
one of the most important standards for businesses is the ISO 9001, which provides the standard
for a Quality Management System (QMS).
“The QMS is the glue to the entire business operation,” Klaczak said. “It covers every facet of
your organization, from sales to product development to operations. ”
Why is instituting an effective QMS so important? Two main reasons:
1. For the good of your organization. Using a Quality Management System ensures that you
have a quality-based approach to your entire operation.
As ISO states, “For business, (ISO Standards) are strategic tools that reduce costs by minimizing
waste and errors and increasing productivity.”
ISO 9001 outlines ‘best-practices’ for an organization. The standard tells you “WHAT” is
Your organization needs to determine “HOW” best to implement the ISO requirements for your
business. This can be relatively simple for a smaller, or start-up operation, but complex for a
multi-site, international corporation. Lean Operations tools and techniques can help your
organization implement systems/processes as efficiently as possible.
2. As an entry to new markets. Many Europe and Asia firms will not do business with your
company (as their supplier) unless you have an ISO 9001 certification. With this certification,
you can also gain access to additional customers.
It can be a marketing tool even for customers that don’t require an IS0 9001 certification from
their suppliers. The certification still serves as proof that you’re a quality-driven organization.
self-disciplining, continually improving, driving down costs, etc. When push comes to shove,
that may be a deciding factor in their purchasing decision.
Now let’s take a closer look at what constitutes a QMS.
The Eight Principles of a Quality Management System
These principles are the macro-level ideals that define your QMS. As you read through them,
you’ll understand why this is such an all-encompassing approach to quality.
After each principle, you’ll see examples of the types of questions that ISO requires you to
address within your QMS and prove (you’re walking the walk) during a certification audit.
1. Customer Satisfaction: How are you defining customer satisfaction? What metrics are you
using? Are critical performance indicators improving?
2. Leadership: How well is your leadership team defined? How do they operate – is it hands-
on firefighting, or do they take a results-oriented approach using a balanced scorecard?
3. Involvement of People: Is the organization autocratic, or does it take a bottom-up approach
and involve its people in innovating and improving?
4. Process Approach: How well are the company’s processes defined? Do written procedures
(Work Instructions) clearly reflect the process? Are they current? What’s the process to amend
5. Systems Approach: What is the organizational structure, and how efficient is it at improving
6. Continual Improvement: What is the company doing to improve? How does it react to
metrics and solve problems? Does the Management Team fully support CI initiatives with
adequate resources and tools?
7. Factual Approach to Decision-Making and Problem Solving: How does the company
solve problems? Is it organized and structured, or is it ad hoc?
8. Mutually Beneficial Supplier Relationships: How good are the suppliers for the company?
Remember, you’re only as strong as your weakest link. In the same respect, your product quality
is only as good as your worst supplier.
Auditing the Quality Management System (QMS)
Similar to Quality Assurance (QA) gates at the end of the production line prior to shipment, a
QMS audit tests the effectiveness of your operational systems, processes and procedures.
There are 2 types of Quality Management Systems audits. Internal audits are done by internal
employees (self-correcting) and are a critical ‘feedback’ component of any Continuous
External audits are independent and contractually administered by a 3rd party registrar. This is
the basis that ISO certifications are granted, if your company is compliant (no major
Management Review of the QMS
More important than the audit is what the organization does with the findings. The audit
provides the feedback. If the audit finds an issue, that means an “escaping defect” occurred.
There are numerous Quality Improvement tools to help facilitate the correction of the defect(s).
In addition, there should be a scheduled, recurring review by the Management Team to guarantee
that improvements are put in place and that they are proving to be effective.
No QMS is ‘perfect,’ but a healthy organization constantly works to improve itself.
Remember, an internal audit provides ‘up-close’ feedback and an external audit provides ‘an
outsiders opinion.’ Use this feedback to get better…in everything you do!
The Elements of the ISO 9001
The ISO 9001 details numerous requirements (elements) that an organization must meet to be in
compliance with the standards. (Recall this is the “WHAT” you have to do, not the “HOW.”)
There are four ISO 9001 sections that apply to each organization. You can download snapshots
of those images by clicking here.
I’ve provided an excerpt of part of those requirements below:
This is a sample of section 4, which details general requirements of the QMS. Section 4.2.3
looks at the Control of Documents. It asks how does a company maintain its documentation?
How does it keep things current?
Ed Klaczak pointed out that when we refer to “documentation,” we’re not talking about a dusty,
outdated, standard operating procedures manual that sits on the shelf. “That’s of no value to
anyone,” he said.
Documentation today might take the form of a computer terminal, where work instructions for a
job are listed whenever a new order is processed. The instructions might serve as effective
training for newcomers to a job, but they also help keep skilled workers updated on recent
changes to the work instructions (so they don’t keep building it the “old way”).
“A quality-driven company might have a system that shows pictures identifying a critical step in
the process or even video on how a sequence of steps needs to be completed. Anything that
guides the worker from not creating a defect” Klaczak explains. Where feasible, manual
processes can be semi-automated or fully-automated, it further eliminates the potential for a
defect(s) to occur.
Show You The Money
This is all great, but how does ISO 9001 look in action, and more importantly, how can it
translate into money for your bottom line? In our post next month, we’ll provide you with both
Subscribe to my blog so you’ll get the post, along with my other weekly posts on strategies built
for the bottom line.
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
Check sheets typically employ a heading that answers the
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. 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. 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
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. This kind
of plot is also called a scatter chart, scattergram, scatter
diagram, 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
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. 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. 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. The rectangles of a
histogram are drawn so that they touch each other to
indicate that the original variable is continuous.
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