108 FLEXOGRAPHY: PRINCIPLES & PRACTICES
T
he ISO 9000 system is not specif-
ic to flexo printing, instead it
specifies in very broad terms the
necessary components of a qual-
ity system. It details a list of stan-
dards that encompass the quality
function for all industries. ISO 9000 was orig-
inally published in 1987 by the International
Organization for Standardization in Geneva,
Switzerland and updated in 1994. It is sched-
uled for review every five years. The stan-
dards were written by an international group
of quality experts and practitioners including
those from the United States.
The registration function is performed by
an organization known as a registrar. These
are mostly private companies whose purpose
is to perform third-party audits and verify
that a company is in compliance with ISO
9000. These groups are registered with a
group known as the Registrar Accreditation
Board (RAB) in the U.S.A.
THE ISO 9000 SYSTEM
Actually, ISO 9000 is a series of five docu-
ments working together as a complete quali-
ty system. The documents and their content
are as follows:
ISO 9000. This is the basic set of guidelines
for the selection and use of management and
quality assurance standards. It is a statement
of purpose and a set of definitions that
serves as an advisory function. It suggests
whether to pursue ISO 9001, 9002, or 9003
registration.
ISO 9001, 9002 and 9003. These are the actu-
al standards to which a company becomes
registered. Each of the three differs in scope
and represents a different model quality sys-
tem depending on the type of business
involved. The most comprehensive is ISO
9001, covering 20 different components of a
quality system. These range from the respon-
sibility of management in setting quality policy
and defining quality responsibilities to such
areas as purchasing processes, training proce-
dures, and corrective action methodologies.
ISO 9002 is less comprehensive, omitting the
necessity of looking at design control
(research and development). ISO 9003 is pri-
marily for service type businesses. Table 26
shows the requirements of each of three stan-
dards and which items are not required as you
move from ISO 9001 to ISO 9003.
ISO 9004. This is a generic template of the
various elements of a quality management
and assurance system. It covers such items
as economics, quality in procurement, quali-
ty in marketing, and the use of statistical
methods. Essentially, ISO 9004 is a guideline
for implementing and auditing the total qual-
ity process.
The key to selecting the appropriate stan-
dard is to look at the type of business
involved. If it is a manufacturing-intensive
firm without extensive research and devel-
opment (design of the product), as are most
flexo printers, ISO 9002 is the appropriate
standard.
In order to become ISO 9000 certified, a
flexo company must do the following three
things:
1. Document what you do, especially if
there is an effect on product quality –
ISO 9000