
ISO 9001:2008
The International Standards Organisation (ISO) has published the standard
ISO 9001:2008, the latest edition of the International Standard used by
organizations in 175 countries as the framework for their quality management
systems (QMS).
ISO 9001:2008, Quality management system - Requirements, is the fourth
edition of the standard first published in 1987.
ISO 9001:2008 contains no new requirements compared to the 2000 edition,
which it replaces. It provides clarifications to the existing requirements
of ISO 9001:2000 based on eight years' experience of implementing the
standard worldwide and introduces changes intended to improve consistency
with the environmental management system standard, ISO 14001:2004.
The ISO Technical Committee (ISO/TC 176) which is responsible for the
ISO 9000 family, unites expertise from 80 participating countries and
19 international or regional organizations, plus other technical committees.
The review of ISO 9001 resulting in the 2008 edition was carried out
by subcommittee SC 2 of ISO/TC 176.
The new standard contains no new requirements, but only changes.
Main changes in the updated standard:
0.1 General - now states, "The design & implementation of the
QMS is influenced by its business environment, changes in that environment,
or the risks associated with that environment."
6.3 Infrastructure - section c) now includes "information systems"
to supporting services.
7.2.1 Determination of requirements related to product - a new Note
has been added indicating that post delivery activities in some instances
include, "actions under warranty provisions, contractual obligations
such as maintenance services, and supplementary services such as recycling
or final disposition."
7.5.4 Customer property - the Note now states that "Customer property
can include intellectual property and personal data."
7.6 Control of monitoring and measuring equipment - a new Note has been
added stating, "Confirmation of the ability of computer software
to satisfy the intended application would typically include its verification
and configuration management to maintain its suitability for use."
Other changes are largely to aid translation and are unlikely to affect
your management system.
From 14 November 2009, that is one year after publication of
ISO 9001:2008, all accredited new certificates issued shall be to ISO
9001:2008.
From 14 November 2010, that is two years after publication of
ISO 9001:2008, any existing certificates issued to ISO 9001:2000 will
no longer be valid.
All changes to the new ISO 9001:2008 support LRQA's existing interpretation
and therefore any required changes to your management system should
be minimal.
ISO Secretary-General Alan Bryden commented: "The revised ISO 9001
results from a structured process giving weight to the needs of users
and to the likely impacts and benefits of the revisions. ISO 9001:2008
is therefore the outcome of a rigorous examination confirming its fitness
for use as the international benchmark for quality management."
ISO/TC 176/SC 2 has also developed an introduction and support package
of documents explaining what the differences are between ISO 9001:2008
and the year 2000 version, why and what they mean for users.
Certification to ISO 9001 is frequently used in both public and private
sectors to increase confidence in the products and services provided
by certified organizations, between partners in business-to-business
relations, in the selection of suppliers in supply chains and in the
right to tender for procurement contracts. Up to the end of December
2007, at least 951 486 ISO 9001:2000 certificates had been issued in
175 countries and economies.
ISO and the International Accreditation Forum (IAF) have agreed on an
implementation plan to ensure a smooth transition of accredited certification
to ISO 9001:2008.
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