ISO 9001 y FDA
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Transcript of ISO 9001 y FDA
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7/23/2019 ISO 9001 y FDA
1/16
Fbstftutg Zcabgdmfag Qupcrfgr jc Afujoj Agbstftuafb
Notcrfo8
Aodfjoj Opdfaojo o do Mcstfb
Nocstro8
Mrojg y Mrupg
3 MN
Odunbg
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7/23/2019 ISO 9001 y FDA
2/16
Zoldo jc agbtcbfjg
Fbtrgjuaafb........................................................................................................ 1 26 g ncbgs pcrnobcbtcncbtc, y do
tcnpcroturo jcd agb!cdojgr cst. cb 1 26 g ncbgs
=oro cbirfor dgs odfncbtgs cb igrno ojcauojo?
9cirf!crc g agb!cdc aorbcs, ovcs, `ucvgs, norfsags y gtrgs prgjuatgs
pcrcacjcrgs jcbtrg jc dos 4 `gros sf!ufcbtcs o do agaafb g agnpro
9cirf!crc jcbtrg jc : `gro sf do tcnpcroturo c)tcrfgr cs supcrfgr o
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7/23/2019 ISO 9001 y FDA
13/16
!;o cst/ agafjg%
5sc ub tcrnnctrg poro odfncbtgs poro prcafsfb g sfcnprc ustcj pucjc
jctcrnfbor sdg nfrobjg
ZCN"C&OZ?&OQ "O&O AGAFBO& AGB QCM?&F(O( ncjfjos agb tcrnnctrg poro
odfncbtgs
Odfncbtg Zcnpcroturo fbtcrbo
Aorbc ngdfjo g nczados jc aorbc
Aorbc jc rcs, acrjg, tcrbcro,
agrjcrg:71g6
=ovg, pgddg :73g6
Aorbcs $rcsaos jc rcs< acrjg3g6 agb K nfbutgs jc jcsaobsg
Aorbc jc oc
=gddg y povg, cbtcrg :73g6
Zrg#gs jc aorbc jc ovc :73g6
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7/23/2019 ISO 9001 y FDA
14/16
=otg y !obsg :73g6
9cddcbg "agafjg sgdg g jcbtrg jcd
ovc$:73g6
Acrjg $rcsag
O pubtg :71g6
fcb agafjo :01g6
1onb
6rcsag "arujg$ :71g6
=rc agafjg "poro rcaodcbtor$ :>1g6
@ucgs y pdotgs agb :ucg
ucvgs Agafbc osto quc do ycno y do adoro cst.b ifrncs
=dotgs agb ucvg :71g6
"csaojgs y norfsags
=c# jc odcto:>3g6 g auobjg do aorbc cstc gpoao y sc scporo
i'afdncbtc agb cd tcbcjgr
Aonorgbcs, dob!gstos, aob!rchgs Aorbc pcrdojo y gpoao
Odnchos, gstros y nchfddgbcsAgba`os olfcrtos jurobtc do agaafb
Lfcfros dobaos dca`gsos, u gpoaos y ifrncs
Qg-ros y mufsgs :73g6
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7/23/2019 ISO 9001 y FDA
15/16
Agbadusfb
Cb cstc rcpgrtc vfngs quc cs do FQG 6;;?, sus rcqucrfnfcbtgs, ! quc cb "cbcrod
cs ubo crtf#fof$b quc bgs pucjc o!ujor o nchgror do odfjoj jc bucstrgs
prgjutgs odfncbtffgs cb tgjgs dgs ospctgs ! quc do crtf#fof$b ()* bgs o!ujo
o nobchor dgs odfncbtgs grrctoncbtc ! quc hubtg gb do FQG 6;;? pucjc scr ub
nu! lucb n'tgjg poro nchgror do odfjoj jc bucstrgs odfncbtgs ! pgjcr os/
sotfs#ocr pgr gnpdctg o bucstrgs gbsunfjgrcs%
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7/23/2019 ISO 9001 y FDA
16/16
=f+dfgro0o
`ttp?JJJbgrnos