R RG Ohidy Jun 9, 2006 #1 Jun 9, 2006 #1 I have been looking for a cross reference table between Japans MHLW #169 and ISO 13485:2003. Any suggestions on where to look for such a table, or if someone has one they would like to share? Thanks, Rich
I have been looking for a cross reference table between Japans MHLW #169 and ISO 13485:2003. Any suggestions on where to look for such a table, or if someone has one they would like to share? Thanks, Rich
Marc Hunkered Down for the Duration with a Mask on... Staff member Admin Jun 9, 2006 #2 Jun 9, 2006 #2 What is the title of Japan's MHLW #169?
A Al Rosen Staff member Super Moderator Jun 9, 2006 #3 Jun 9, 2006 #3 Marc said: What is the title of Japan's MHLW #169? Click to expand... Ministerial Ordinance on Standards for Manufacturing Control and Quality Control for Medical Devices and In-vitro Diagnostic Reagents Click to expand... BTW, MHLW = Minister of Health Labour and Welfare Sorry, I don't have a cross reference, only an english translation that's posted in ISO13485:2003 vs. the Japanese PAL Ordinance No. 169 - Seeking Gap Analysis.
Marc said: What is the title of Japan's MHLW #169? Click to expand... Ministerial Ordinance on Standards for Manufacturing Control and Quality Control for Medical Devices and In-vitro Diagnostic Reagents Click to expand... BTW, MHLW = Minister of Health Labour and Welfare Sorry, I don't have a cross reference, only an english translation that's posted in ISO13485:2003 vs. the Japanese PAL Ordinance No. 169 - Seeking Gap Analysis.
R RG Ohidy Jun 9, 2006 #4 Jun 9, 2006 #4 Ok, thanks, but I already have the 169, was just wondering if anyone had put a matrix together. I'll see what I can do, and post one.
Ok, thanks, but I already have the 169, was just wondering if anyone had put a matrix together. I'll see what I can do, and post one.
A Al Rosen Staff member Super Moderator Jun 9, 2006 #5 Jun 9, 2006 #5 RG Ohidy said: Ok, thanks, but I already have the 169, was just wondering if anyone had put a matrix together. I'll see what I can do, and post one. Click to expand... Thanks!!
RG Ohidy said: Ok, thanks, but I already have the 169, was just wondering if anyone had put a matrix together. I'll see what I can do, and post one. Click to expand... Thanks!!
R RG Ohidy Jun 21, 2006 #6 Jun 21, 2006 #6 Here is a table I created. The table can be modified to include other standards/requirments, as well as listing procedures that apply to each. Rich Attachments MHLW #169 vs ISO 13485 2003.xls 32 KB Views: 1,284
Here is a table I created. The table can be modified to include other standards/requirments, as well as listing procedures that apply to each. Rich
U username Sep 15, 2006 #7 Sep 15, 2006 #7 Hi That was a great work! Do you happen to have an updated version of ISO 13485:2003 Vs. MHLW (Ministerial Ordinances on GQP & GMP) 2005? Thanks S
Hi That was a great work! Do you happen to have an updated version of ISO 13485:2003 Vs. MHLW (Ministerial Ordinances on GQP & GMP) 2005? Thanks S
M Mary Flynn Jul 6, 2008 #8 Jul 6, 2008 #8 Thank you so much for this matrix, you have saved me a lot of time.
Ajit Basrur Staff member Admin Jul 6, 2008 #9 Jul 6, 2008 #9 Mary Flynn said: Thank you so much for this matrix, you have saved me a lot of time. Click to expand... Welcome Mary - it was good to note that the matrix was useful to you. Hope to see your active participation in the cove
Mary Flynn said: Thank you so much for this matrix, you have saved me a lot of time. Click to expand... Welcome Mary - it was good to note that the matrix was useful to you. Hope to see your active participation in the cove
C CBAL08 May 28, 2015 #10 May 28, 2015 #10 Is the Matrix still valid after the changes as well which occured in November 2014?