Understanding
the Quality Management System (QMS)
The system means “assembly of interacting
elements”
This concept can be explained through a
simple system “pen”.
Elements or components of a ball pen…
·
Barrel
·
Spring
·
Thrust device
· Ink chamber
Interactions in the “Pen” as a system
Elements are
interconnected in this assembly that enables interaction. While pressing
plunge, the interaction starts and refill ballpoint tip come outside and ready
for writing. If press again, due to the interaction of spring, the tip goes
inside the barrel. While writing, the ink flows from the refill, this is one
interaction.
Purpose of existence of system “pen”
·
The purpose of this pen is to “write”
information.
·
While writing, ink flow should be adequate
and consistent and should not be abnormal or inconsistent
QMS has the following
elements/components…
·
customers
·
regulatory bodies
·
staff/employees
·
suppliers/service
providers/bankers
·
top management
members/directors/share holders
·
society/public
·
facilities (shop
floor, machines, utilities, measuring equipments, computers communication
systems, etc.,)
·
departments/functions within the organization
·
standards/Data/Information/Act/Rules/Regulations
·
drawings/customer
standards/specifications/customer manuals
·
procedures, Work
instructions, control plans, process standards, Operational control plans,
policy documents, etc.
·
practices/processes/activities
within the organization that affect quality
·
formats
·
information/data,
·
measurable Targets/objectives
·
maintaining things
in an orderly manner (example 5s) and
·
other things that
affect quality of the product/service
“ISO 9001:2015” and
“Quality Management System (QMS)” are the same. ISO 9001:2015 is a number given
to a standard. The title of this standard is “Quality Management
Systems-Requirements”. If we implement
ISO 9001:2015 requirements effectively, it means that we implement a Quality
Management System (QMS) effectively.
QMS covers all the
aspects (elements) of an organization that affect the quality of the
product/service it supplies.
There are always an
integration and interaction between these elements. This interaction is called,
“Process” within the QMS.
Example of interaction:
A purchase order is issued from the customer. This purchase order requirements
are transferred to the production function for further execution. The transformation
of purchase order requirements to production function is called “interaction”. This interaction is also called a “process”.
To limit the scope,
in QMS, we bother the interactions that affect “quality” and not other aspects
like interactions with the environment, interactions with human safety, etc. We
can use separate ISO standards for these management systems. For environment
management system (EMS) we can implement ISO 14001 and for human safety or
occupational health and safety management system (OHSMS) we can implement ISO
45001.
If we understand the
components of QMS and its interaction, we can easily understand the concept
called “Process”. The process is a very critical/important aspect of QMS.
Controlling the “process” is a critical factor to control the “quality” of
product/service.
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Definition of Quality Management System (QMS) as per ISO
9000:2015
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Contact
S.GIRIDHARA
Chief Consultant/CEO
Mobile : +919442248124, +916381889582
email : 607014@gmail.com
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