posted 24 November 1999 07:46 AM               

From: JackTQM@aol.com

To All,

Just for your early information...

At the 1999 Global Harmonization Task Force Meeting in Bethesda, Maryland the European attendees indicated that the EN46000 sereies of standards are in discussion to be "phased out" in favor of the "almost the same standard series" ISO13485/ISO13488.

In addition, the current ISO13485/ISO13488 are also not stand alone standards (just like EN 46001/EN 46002) and they are structured with heavy references to ISO 9001 and ISO 9002.

With the current changes afoot with ISO 9000:2000, including Customer Satisfaction and Continuous Improvement there are concerns from the government regulators regarding future references to ISO 9000:2000 in conjunction with Medical Device Quality Systems Standards (ISO13485/88 and EN46001/2). The government regulators indicated that they are not responsible nor do they want to be responsible for auditing compliance to customer satisfaction and continuous improvement standards requirements.

(IMHO) The bottom line is that we will see a "Stand Alone" Medical Device Quality System Standard in the near future without references to ISO 9000:2000 (how near is uncertain).