The ISO 13485 Medical Devices Standard has recently been updated, but only for the UK and the Rest of Europe.
The current International ISO Standard is ISO 13485:2003 (as of June 2012), but due to new European directives and legalisations changes, the European (including the UK) version of the standard has now been updated to BS EN ISO 13485:2012 – BS for British Standard, EN for European Standard and ISO for Internal Standard.
This update/revision affects only the Foreword and Annexes ZA, ZB, and ZC. The core text of the revised European standard remains identical to the International version of the standard.
The 2003 version of the standard is still a “current” document, but as of 31st August 2012 the ISO 13485:2003 standard will be replaced by the BS EN ISO 13485:2012 standard for those organizations based in Europe.
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Batalas offer ISO 13485 Internal Auditor Training Courses, ISO 13485 Lead Auditor Training Courses, and ISO 13485 Implementation Workshops.
