The current International ISO standard is ISO 13485:2003,
however because of new European directives and legalizations changes, the European
version of the quality has currently been updated to ISO 13485:2012 – SB for
British standard, linear unit for European normal and ISO for Internal normal.
This update/revision affects solely the Foreword and
Annexes ZA, ZB, and ZC. The core text of the revised European normal remains
just like the International version of the quality.
The 2003 version of the quality remains a “current”
document, however as of thirty first August 2012 the ISO 13485:2003 normal are
going to be replaced by the SB linear unit ISO 13485:2012 normal for those
organizations based mostly in Europe.
Very useful blog. At the point when manufacturers are ensured to ISO 13485 they bring certainty and confirmation to their customers, stakeholders and themselves. Being affirmed makes a set of institutionalized methods to help produce sheltered, quality items. It additionally encourages a proactive danger administration framework to identify and avoid item surrenders. thanks a lot~ Anne at majakel medical
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