Many industry standards
are based on the ISO 9001 standard and can be integrated into
a single management system that meets all the standards applicable
to your organization. Other ISO standards addressing different
topics can be implemented as stand alone systems or integrated
into a single management system that meets all the standards
applicable to your organization. Either way, Prism’s suite
of products and services can help you address any or all of the
following standards:
AS9100 for the aerospace industry adds requirements
to ISO 9001, especially in the areas of design control, purchasing,
production, inspection and others.
ISO 17025 for laboratory quality management,
is based on ISO 9001 but adds requirements for traceability and
other laboratory oriented requirements.
ISO 18001 for employee health and safety, which
is often combined with ISO 14001 for
environmental management for companies interested in managing
all elements of their operations according to international
standards.
ISO 13485 for quality management for medical
device manufacturers. ISO 13485 is based on ISO
9001, but
adds requirements related to regulatory compliance for medical
devices and excludes some ISO 9001 requirements. ISO 13485
is the international version of the Good Manufacturing Practices
(GMPs) administered by the US Food and Drug Administration (FDA)
for many years.
ISO 22000 for food safety management to ensure
food is safe at the time of human consumption. ISO 22000
is the international version of the Hazard Analysis and Critical
Control Point (HACCP) program administered by the US Food and
Drug Administration (FDA) for many years.
ISO 28000 is
the international standard for a security management system including
the security of an organization’s
supply chain. This standard provides structure and linkage
to Business Continuity Planning and Management methods in
use around the world.
TS 16949 / QS 9000 for the automotive industry
adds requirements to ISO 9001, with an emphasis on statistical
analysis, APQP, FMEA, PPAP and others. |
