The recent
edition of the ISO 9001 standard ISO 9001: 2008, Quality Management
Systems Requirements, was officially published by (ISO) the International
Organization for Standardization on November 14, 2008. It is the fourth edition
of the ISO 9001 standard as it was first published in 1987.
ISO 9001:2008 is
a standard that offers a generic set of requirements for organizations wishing
to develop a quality management system (QMS). The ISO 9001:2008 standard
focuses on developing organizations business processes. It does not indicate
any requirements for product or service quality. Customers typically set
product and service quality requirements. However, the anticipation is that an
organization with an effective ISO 9001 based QMS will indeed get better its
ability to meet customer, legal and regulatory requirements.
This is the merely
QMS standard to which an organization may perhaps obtain formal third party
certification. Because requirements are generic and not specific, organizations
have flexibility in tailoring their QMS to fit their business, ethnicity and hazards.
ISO 9001
requirements set off contractual and applicable statutory and regulatory
requirements. Those implementing a QMS conforming to ISO 9001 must ensure that
the explicit requirements of their customers and relevant statutory and
regulatory agencies are met.
ISO 9001 lead auditor courses |
Concepts
of Quality Management System
ü
A Quality
Management System in its fundamental concept is fairly simple. It seeks to:
Recognize the external quality related requirements specified in Licenses to
Trade, principles, particular customer requirements, and the preferred
management system standard(s)
ü
Ensure that all rations have been documented
within the management system in the appropriate location in requisites of
defined explicit system requirements
ü
Confirm that
employees receive appropriate
training in the quality system requirements
ü
Outline
performance processes, wherever applicable, to the quality system requirements
ü
Produce records
or substantiation that system requirements have been met
ü
Measure, observe
and report the level of observance with these performance procedures
ü
Continually
monitor and analyze changes to the requirements and confirm that all changes
are reflected in changes to the specific requirements when necessary
ü
Implement the audit
and evaluate the system processes and correct them when required
ü
Comprise
processes that will assist persistently improve the quality system.
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