Tag: BS EN ISO 13485:2012

Correction issued to BS EN ISO 13485:2012 Edition for Medical devices. Quality management systems. Requirements for regulatory purposes

It seems like the 2012 of BS EN ISO 13485,”Medical devices. Quality management systems. Requirements for regulatory purposes,” was just released.  But a few corrections have been found so the consolidated BS EN ISO 13485:2012 with Corrigendum 1 is now available from Document Center Inc.  A Corrigendum is a technical correction sheet and the EN standards are released as interfiled reprints of the original document.

The CENELEC corrigendum is from July 2012, but the integration into the BS Edition is dated 9/30/2012.  There are two corrections:  the title was altered and Table ZC.3 (Relationship with Annex IV of Directive 98/79/EC) was updated.

If you bought your copy of the BS EN ISO 13485:2012 from Document Center Inc., we’ll provide you with a corrected copy for a modest printing fee.  If not, you’ll need to purchase the new copy in its entirety.  You can order the document on our website, www.document-center.com.   Otherwise, contact us by phone (650-591-7600), fax (650-591-7617) or email (info@document-center.com) for more information.

New BS EN ISO 13485 2012 Edition, Medical devices. Quality management systems. Requirements for regulatory purposes

BSI has just released the new 2012 edition for BS EN ISO 13485, “Medical devices. Quality management systems. Requirements for regulatory purposes,” and it’s available from Document Center Inc. now.

BS EN ISO 13485:2012 is a key standard to measure the quality of medical equipment, medical instruments and medical technology. This standard sets out the requirements for a quality management system and quality assurance systems relating to the design, development, production, installation and servicing of medical devices. BS EN ISO 13485 can be used by internal and external parties, including certification bodies which test an organization’s ability to meet both customer and regulatory requirements.

This edition is the UK implementation of EN ISO 13485:2012.  It is identical to ISO 13485:2003, incorporating the corrigendum from August 2009. It supersedes BS EN ISO 13485:2003, which will be withdrawn on August 31, 2012.

The document is now 86 pages in length, compared to the 72 pages of the 2003 Edition republished in 2010 with the 3 corrigenda interfiled.  Changes have been made to the foreword and especially to the annexes, which accounts for the additional material.

It is available from Document Center Inc. at our website, www.document-center.com.  Or contact us by phone (650-591-7600), fax (650-591-7617) or email (info@document-center.com).  It’s our 30th year in business — we’ve been supplying companies around the world with standards and services since 1982.  We’d love to help you with your standards requirements as well!