› ISO13485

Anyone have recommendations for disucssion groups or sites
particular to this subject standard for medical device
manufacturers? This standard will be an independent
breakout of ISO 9001 this year.

Thank you.
RF Rudnick

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Comments

forrestbreyfogle 8/23/2005

INITIAL POSTING: As previously written in the Quality in Health Care forum: "In our May issue we have an article on Six Sigma in Health Care: http://www.qualitydigest.com/currentmag/articles/05_article.shtml
The main thrust of the article is that while Six Sigma is making it into health care, it seems to be doing so only at administrative or operational levels, not patient care (e.g., diagnostics). Anyone care to comment on this?"

RESPONSE: I believe that the observation that you described is true. Obviously there are very large opportunities; however, it seems that the incentive for change is lacking.

Forrest Breyfogle
Six Sigma Forum Moderator
forrest@smartersolutions.com
www.smartersolutions.com
512-918-0280 X401

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