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ISO 9001 requires different types of information to be documented; however, not all information
needs to be documented as separate documents. It is flexible so that the organization to decide on
the size of the documentation and the level of details documented. For example, small companies
can have documented procedures that will be included in the QMS manual.
How to structure your QMS documentation
The international standard ISO 10013:2001 Guidelines for quality management system
documentation gives directions for effective dimensioning of the QMS documentation, as well as
an overview of recommended contents and structure of the different QMS document types. The
following recommendations take into consideration the ISO 10013 guidelines.
1) Quality manual. The manual should fit your organization. The structure and the content of
the manual can vary depending on the size of the organization, the complexity of operations, and
the competence of the personnel. Small organizations can document the entire QMS in one
manual. On the other side, large international organizations may have several different quality
manuals. Generally, the manual includes the QMS scope, exclusions from the standard,
references to relevant documents, and the business process model. The quality policy and the
objectives can be part of the manual as well.
The quality manual should include most of following elements: title and table of contents; scope
of the QMS; exclusions from ISO 9001, versioning information and approval; quality policy and
objectives; QMS description, the business process model of the organization; definition of
responsibilities for all personnel; references to relevant documents and relevant appendices.
More information on how to document an effective quality manual can be found in this
article: Writing a short Quality Manual.
2) Quality policy. A policy represents a declarative statement by an organization. A Quality
policy should state the commitment of the organization to quality and continual improvement.
Usually, this policy is used for promotional purposes and should be displayed in the
organizations premises and posted on websites, so a clear and short quality policy is convenient
and is the general practice.
The Quality policy defines the quality objectives to which the organization strives. The quality
goals of organizations are defined by quantifying the quality objectives.
3) Quality procedures. Quality procedures can have different formats and structures. They can
be narrative, i.e., described through text; they can be more structured by using tables; they can be
more illustrative, i.e., flow charts; or they can be any combination of the above.
Quality procedures should include the following elements:
Scope to explain what aspects will be covered in the procedure, and which aspects will
not be covered;
Records that result from the activities described in the procedure should be defined and
listed;
Document control identification of changes, date of review, approval and version of the
document should be included in accordance with the established practice for document
control;
Description of activities this is the main section of the procedure; it relates all the other
elements of the procedure and describes what should be done, by whom and how, when and
where. In some cases, why should be clarified as well. Additionally, the inputs and the
outputs of the activities should be explained, including the needed resources.
4) Work instructions. Work instructions can be part of a procedure, or they can be referenced in
a procedure. Generally, work instructions have a similar structure to the procedures and cover the
same elements; however, the work instructions include details of activities that need to be
realized, focusing on the sequencing of the steps, tools, and methods to be used and required
accuracy.
Training of personnel and use of competent personnel can decrease the need for highly detailed
work instructions. More detail on this topic can be found in Using Competence, Training and
Awareness to Replace Documentation in your QMS.
Good QMS documentation is essential for an effective quality management system
Dimensioning the QMS documentation based on your organizational needs is essential for a
functional QMS. Moreover, properly structured documentation will make your operations much
easier, while incorrect documentation will bring you nothing but trouble.
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1. Check sheet
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.
3. Pareto chart
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