The ISO
9001:2008 is an international standard on quality management system
(QMS) that promotes a systematic approach towards the management of
product quality. It was first published by the
International Organization
for Standardization (ISO) in 1987 and later revised in 1994 and
2000. In 2008, it went through another revision in order
to accommodate current needs. Hence, it is now referred to as ISO
9001:2008. Read about the
ISO 9001:2008 revisions here.
The
history behind the ISO 9001 of standard can be traced to
the USA - during World War II. From the USA, the concept of quality
assurance spread to Europe via NATO where it evolved
into the Allied Quality Assurance Publication (AQAP).
This series of documents discussed everything from
production efficiency to selection of suppliers.
lThe
AQAP series were adopted by the UK Ministry of Defense
for the British Armed
Forces. This series had a trickle down
effect as organizations began to require quality
assurance programs from their suppliers. The problem was
that there was much diversity in the requirements for
different organizations.
l The
diversity issue was addressed by the British Standard BS
5750 which was based on the AQAP series and was introduced in
1979.
l
The
BS 5750 standard was considered so effective that it was
adopted almost without change by ISO in 1987 as ISO 9000.
Did you know that
the internet that we know today also originated from the
US military application?
In the ISO 9001
context, the term "product" refers to both tangible and intangible
products. It is applicable to all kinds of organization, whether
public, private or non-governmental, etc. but it is most adopted by
commercial and governmental organizations. The standard contains
eight sections or clauses. They are:
Clause 1 Scope
Clause 2 Normative reference
Clause 3 Terms and definitions
Clause 4 Quality management system
Clause 5 Management responsibility
Clause 6 Resource management
Clause 7 Product realization
Clause 8 Measurement, analysis and improvement
This
is a pictorial representation of the ISO 9001 standard. The
ISO 9001 model is about generating continual improvements in terms
of delivering delivering customer needs and enhancing their
satisfaction.
The
ISO 9001
is used by organizations in 175 countries as the framework for their quality
management systems (QMS). Look at the results of the ISO
Survey 2007:
Eight Quality Management Principles
The
ISO 9001 model is based on the Eight Quality Management Principles.
From these principles, tangible benefits are derived.
These principles are known as the Eight Quality
Management Principles. It is crucial that the QMS that you
establish and implement demonstrate these principles in action. One
key to better understanding of the requirements of ISO 9001 is to
understand these underlying principles, and inn the operation of the
quality management system, these principles must be adhered to,
without fail:
Customer focus ~ Organizations depend on
their customers and therefore should understand current and
future customer needs, should meet customer requirements and
strive to exceed customer expectations.
Leadership ~ Leaders establish unity of
purpose and direction of the organization. They should create
and maintain the internal environment in which people can become
fully involved in achieving the organization's objectives.
Involvement of people ~ People at all
levels are the essence of an organization and their full
involvement enables their abilities to be used for the
organization's benefit.
Process approach ~ A desired result is
achieved more efficiently when activities and related resources
are managed as a process.
Systems approach to management ~
Identifying, understanding and managing interrelated processes
as a system contributes to the organization's effectiveness and
efficiency in achieving its objectives.
Continual improvement ~ Continual
improvement of the organization's overall performance should be
a permanent objective of the organization.
Factual approach to decision making ~
Effective decisions are based on the analysis of data and
information.
Mutually beneficial supplier
relationships ~ An organization and its suppliers are
interdependent and a mutually beneficial relationship enhances
the ability of both to create value.
ISO 9001 Certification
Did you know that
certification of your quality management
system is not a requirement of ISO
9001:2008? Certifying your quality
management system means having an accredited
Certification Body or Registrar verify that
your quality management system is in
conformance with the requirements of ISO
9001:2008. Proof of this independent
verification is presented in a form of a
certificate, thus an "ISO 9001 Certificate".
However,
there is a bit of confusion with regards to
the related terms. In the context of
ISO 9001:2008, “certification”
refers to the issuing of written assurance
(the certificate) by an independent external
body that it has audited a management system
and verified that it conforms to the
requirements specified in the standard,
while
“registration” means that the
auditing body then records the certification
in its client register. So, the
organization’s management system has been
both certified and registered.
Therefore, the difference between the two
terms is not significant and both are
acceptable for general use.
“Certification” is the term most widely used
worldwide, although
registration is
often
preferred in North America, and the
two are used interchangeably. On the
contrary, using
“accreditation”
as an interchangeable alternative for
certification or registration is a mistake,
because it
means something
different. Accreditation
refers to the
formal recognition by a specialized
body – an accreditation body –
that a
certification body is competent to
carry out ISO 9001 certification in
specified business sectors.
In
any audit, your organization must provide
evidence of the effective implementation of
the QMS. Clause 3.8.1 of ISO 9000:2005
defines “objective evidence” as
“data
supporting the existence or variety of
something” and notes that
“objective
evidence may be obtained through
observation, measurement, test, or other
means.”
Objective evidence does not necessarily
depend on the existence of documented
procedures, records or other documents,
except where specifically mentioned in ISO
9001:2008. In some cases, (for example, in
clause 7.1(d)
Planning of
product realization, and clause 8.2.4
Monitoring
and measurement of product), it is up
to the organization to determine what
records are necessary in order to provide
this objective evidence.
Before you go for the ISO 9001 certification
by an independent Certification Body, you
must be able to demonstrate that you have
already established, documented,
implemented, maintained and improved your
quality management system as per the ISO
9001 standard. Quality records must
have been generated for at least 3 to 6
months before you go for that certification
process.
You have to appoint an ISO 9001 Registrar to
certify your QMS. Self-declaration of
conformance is possible but it is without
merit. The best practice approach is
to have an independent auditor to verify
your QMS conformance to ISO 9001
requirements. You may choose to
certify your QMS if,
it is a contractual or
regulatory requirement;
it is a market
requirement or to meet customer preferences; or
it increases
internal and external values.
Normally, the audit process comprises of two stages. Stage 1
represents the documentation audit. Here the auditors will
assess for adequacy of your QMS based on your documentation.
The objective is to assess if you QMS is in conformance to ISO 9001
requirements. If there is any deficiency, you will be asked to
review the documented quality management system.
Stage 2 is the physical audit. The auditors will interview
relevant personnel, make observations of your process performance
and inspect your records in order to verify that you have
implemented what you planned to do. If they find any
non-conformances, don't panic. Make corrective actions and
re-audit. You will be given ample time to make the corrective
actions- the time frame is negotiable with the auditors.
Audit methodologies include interviews with relevant personnel at
all levels, inspection of records and processes, and observations of
work activities and the work environment. Ensure that everyone
is aware of the role they play within the quality management system,
quality records are in order and the procedures are observed.
Remember, an audit's purpose is to verify your quality management
system's conformance to specified requirements and its effectiveness
in achieving its objectives.
Criteria for Choosing a
Certification Body
Besides the financial
aspect of selecting your Registrar/Certification Body, here are
the vital criteria:
Establish
whether the certification body has auditors with
experience in the organization's sector of activity;
Establish
whether the certification body implements, or is
migrating to ISO/IEC
17021:2006,Conformity assessment
– Requirements for bodies providing audit and
certification of management systems
;
Another point to
clarify is whether or not the certification body has
been accredited and, if so, by whom.
Accreditation, in simple terms, means that a
certification body has been officially approved as
competent to carry out certification in specified
business sectors by a national accreditation body.
