Monthly Archives: January 2011

ISO 9001:2008 :Measurement and Monitoring of Processes and products

Posted on January 30, 2011 by isotrainer

What to write inside your ISO 9001:2008 :Measurement and Monitoring of Processes and products procedures.You can always refer below example which can be use up inside your company procedures. Procedural Policy 1. The organization shall apply suitable method and measure … Continue reading →

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BS EN ISO 13485 MEDICAL DEVICES – QUALITY MANAGEMENT SYSTEMS – REQUIREMENTS FOR REGULATORY PURPOSES

Posted on January 27, 2011 by isotrainer

BS EN ISO 13485 MEDICAL DEVICES – QUALITY MANAGEMENT SYSTEMS – REQUIREMENTS FOR REGULATORY PURPOSES Latest Version 2003 COR 2010 31/01/2010 (DD/MM/YYYY) Language ENGLISH Publisher BSI Referenced Standards 90/385/EEC COUNCIL DIRECTIVE OF 20 JUNE 1990 ON THE APPROXIMATION OF THE … Continue reading →

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Irish Standard I.S. EN 868-5:2009

Posted on January 26, 2011 by isotrainer

Irish Standard I.S. EN 868-5:2009 is for title Packaging for terminally sterilized medical devices – Part 5: Sealable pouches and reels of porous materials and plastic film construction – Requirements and test methods. EN 868 consists of the following parts, … Continue reading →

Posted in Medical Device Standard | Tagged , , , , | 10 Comments