ISO 13485
ISO 13485 is an International Organization for Standardization (ISO) standard, published in 2003, that represents the requirements for a comprehensive quality management system for the design and manufacture of medical devices. This standard supersedes earlier documents such as EN 46001 and EN 46002 (both 1997), the ISO 13485 published in 1996 and ISO 13488 (also 1996).
Though it is tailored to the industry's quality system expectations and regulatory requirements, an organization does not need to be actively manufacturing medical devices or their components to seek certification to this standard, in contrast to the automotive sector's ISO/TS 16949, where only firms with an active request for quotation, or on the bid list, of an International Automotive Task Force supply chain manufacturer can seek registration.
While it remains a stand-alone document, ISO 13485 is generally harmonized with ISO 9001. A principal difference, however, is that ISO 9001 requires the organization to demonstrate continual improvement, whereas ISO 13485 requires only that the certified organization demonstrate the quality system is effectively implemented and maintained. Additionally, the ISO 9001 requirements regarding customer satisfaction are absent from the medical device standard.
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Heads Will Roll
by: Yeah Yeah YeahsOff with your head
Dance 'til you're dead
Heads will roll, heads will roll
Heads will roll on the floor
Glitter on the wet streets
Silver over everything
The river's all wet
You're all cold
Dripping with alchemy
Shiver stop shivering
The glitter's all wet
You're all chrome
The men cry out, the girls cry out
The men cry out, the girls cry out
The men cry out, oh no
The men cry out, the girls cry out
The men cry out, the girls cry out
The men cry out, oh no
Oh, oh, oh, oh
Off, off with your head
Dance, dance 'til you're dead
Heads will roll, heads will roll
Heads will roll on the floor
Looking glass, take the past
Shut your eyes, you realize
Looking glass, take the past
Shut your eyes, you realize
Glitter on the wet streets
Silver over everything
The glitter's all wet
You're all chrome, you're all chrome
Oh, oh, oh
Off, off, off with your head
Dance, dance, dance 'til you're dead
Off, off, off with your head
Dance, dance, dance 'til you're dead
Off, off, off with your head
Dance, dance, dance 'til you're dead
Off, off, off with your head
Dance, dance, dance 'til you're dead
Off, off, off with your head
Dance, dance, dance 'til you're dead
Off, off, off with your head
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