Bsi bip 0115 2014

I m pl em en ti n g a n I SO 485 Qu a l i ty M a n a g em en t System for M ed i ca l D evi ces Im plem en ting an ISO 3485 Qu ality M an agem ent System for M edical Devices Ann Go o da ll, Ph D F i rst p u b l i sh e d in th e UK in 01 by B SI S t a n d a rd s 89 Lo n d o n © Th e Al l Li m i te d C h i s wi ck H i g h Ro a d W4 4AL B ri ti sh S ta n d a rd s I n s ti t u t i o n ri g h t s re s e rve d Act 8 , s yst e m no a cce p ts n o a n y fo rm wi th m a y n ot be re l i a n ce in ta ke n on o r b y a n y m e a n s – e l e ctro n i c, in d e ve l o p i n g i t s co n t e n ts made to u ch wi t h re sp o n si b i l i t y fo r th e to Th e ri g h t o f An n a s se rt e d and s u ch b y th e m we b s i te s i s , G ood a l l in in and ca u s e d , e xc e p t t o to be a cco rd a n ce t ce th e B SI all wri t i n g com p i l i n g a ri s i n g th e in a th e to o r wi l l in t h i s p u b l i ca ti o n , e xt e n t t h a t su ch wi t h a n yo n e G re a t B ri ta i n b y Le t te rp a rt Li m i te d , G re a t B ri ta i n b y B e rfo rts G ro u p , 8-0-5 80-685 95 -8 th a t o r a p p ro p ri a te a u t h o r o f th i s Wo rk h a s b e e n and o f th e C o p yri g h t , www l e t te rp a rt co m www b e rfo rt s co u k fo r t h i s b o o k i s a va i l a b l e or d o e s n o t g u a n te e British Library Cataloguing in Publication Data I SB N cl a i m i n g a d d re s s and a cc u t e a s th e se ct i o n s 7 Typ e s e t i n re co rd B SI l i a b i l i ty o r a ccu cy o f U R Ls fo r e xte rn a l re m a i n , i d e n ti fi e d a b o ve t h i s b o o k, P ri n te d A ca ta l o g u e p u b l i sh e r d i re ct l y o r i n d i re ct l y i n P a t e n t s Act 8 in P a te n ts re t ri e va l p h o t o co p yi n g , fro m co p yri g h t h o l d e rs , a t th e p e rsi s te n ce t h i rd - p a rty i n t e rn e t we b s i te s re fe rre d a n y co n t e n t o n D esi g n s a n d s to re d l a w e ve ry e ffo rt h a s b e e n g et i n C o p yri g h t , re p ro d u ce d , – wi th o u t p ri o r p e rm i ss i o n h a s been e xcl u d e d co p yri g h t sh o u l d has no u n d e r th e m a y be l i a b i l i t y fo r a n y l o ss o r d a m a g e co n n e ct i o n B SI in o r o th e rwi se Wh i l st e ve ry ca re Wh i l e E xce p t a s p e rm i t te d p a rt o f th i s p u b l i ca t i o n o r t n s m i t te d re co rd i n g 01 fro m th e B ri ti s h Li b ry D esi g n s Co n te n ts Ch a p te r – I n tro d u cti o n O vervi ew D efi n i ti on s Ch a p te r – I S O 485 Th e rel a ti on sh i p between I SO 001 a n d I SO 485 I SO /TR 49 69 B en efi ts of i m pl em en ti n g a certi fi ed I SO 485 q u a l i ty m a n a g em en t system 10 I SO 485 a n d reg u l a tory req u i rem en ts 10 Su m m a ry 12 Ch a p te r – G e tti n g sta rte d 13 Q u a l i ty m a n a g em en t system s 13 Pri n ci pl es of q u a l i ty m a n a g em en t 14 Process a pproa ch 17 Pl a n n i n g th e i m pl em en ta ti on 21 Ten -step i m pl em en ta ti on process 22 Key el em en ts of g etti n g sta rted 27 Su m m a ry 28 Ch a p te r – Q u a l i ty m a n a g e m e n t syste m : m e e ti n g th e re q u i re m e n ts o f Cl a u se s , , a n d o f I S O 485 29 Scope (Cl a u se ) 29 N orm a ti ve referen ces (Cl a u se ) 30 Term s a n d d efi n i ti on s (Cl a u se ) 30 Q u a l i ty m a n a g em en t system (Cl a u se 4) 31 Su m m a ry 45 Ch a p te r – M a n a g e m e n t re sp o n si b i l i ty: m e e ti n g th e re q u i re m e n ts o f Cl a u se o f I S O 485 47 M a n a g em en t com m i tm en t (Cl a u se ) 47 Cu stom er focu s (Cl a u se ) 49 Q u a l i ty pol i cy (Cl a u se ) 50 Pl a n n i n g (Cl a u se 4) 51 Respon si bi l i ty, a u th ori ty a n d com m u n i ca ti on (Cl a u se ) 53 M a n a g em en t revi ew (Cl a u se 6) 57 Su m m a ry 63 Implementing an ISO 3485 Quality Management System for Medical Devices v Ch a p te r – Re so u rce m a n a g e m e n t: m e e ti n g th e re q u i re m e n ts o f Cl a u se o f I S O 48 65 H u m a n resou rces (Cl a u se ) 65 I n fra stru ctu re (Cl a u se ) 69 Work en vi ron m en t (Cl a u se 4) 70 Su m m a ry 75 Ch a p te r – Pro d u ct re a l i za ti o n : m e e ti n g th e re q u i re m e n ts o f Cl a u se o f I S O 485 77 Pl a n n i n g of prod u ct rea l i za ti on (Cl a u se ) 77 Cu stom er-rel a ted processes (Cl a u se ) 83 D esi g n a n d d evel opm en t (Cl a u se ) 85 Pu rch a si n g (Cl a u se 4) 02 Prod u cti on a n d servi ce provi si on (Cl a u se ) 111 Con trol of m on i tori n g a n d m ea su ri n g d evi ces (Cl a u se 6) 34 Su m m a ry 36 Ch a p te r – M e a su re m e n t, a n a l ysi s a n d i m p ro ve m e n t: m e e ti n g th e re q u i re m e n ts o f Cl a u se o f I S O 485 39 G en era l req u i rem en ts (Cl a u se ) 39 M on i tori n g a n d m ea su rem en t (Cl a u se ) 41 Con trol of n on form i n g prod u ct (Cl a u se ) 54 An a l ysi s of d a ta (Cl a u se 4) 58 I m provem en t (Cl a u se ) 59 Su m m a ry 71 Ch a p te r – Ach i e vi n g a n d co n ti n u i n g to m a i n ta i n I S O 485 ce rti fi ca ti o n 73 Prepa ri n g for certi fi ca ti on to I SO 485 73 After th e certi fi ca te i s recei ved – m a i n ta i n i n g certi fi ca ti on 75 Th e fu tu re of I SO 485 76 Su m m a ry 79 Ap p e n d i x – B a ckg ro u n d a n d o ri g i n s o f I S O 485 : 003 81 Re fe re n ce s 83 Implementing an ISO 3485 Quality Management System for Medical Devices vi Ch a pter – I n trod u cti on Overview Medical devices — Quality management systems — Requirements for regulatory purposes i s n ow becom i n g th e Th e sta n d a rd I SO 485 , certi fi ca ti on sta n d a rd of ch oi ce for m ed i ca l d evi ce m a n u fa ctu rers Al l th e req u i rem en ts a re speci fi c to org a n i za ti on s th a t provi d e m ed i ca l d evi ces a n d d o n ot d epen d on th e si ze or type of th e org a n i za ti on I SO 485 su pports reg u l a tory com pl i a n ce i n severa l cou n tri es, i n cl u d i n g th e cou n tri es of th e E U (CE m a rki n g ) , Ca n a d a , Au stra l i a a n d Ta i wa n M ed i ca l d evi ces i n cl u d e a cti ve, n on -a cti ve, i m pl a n ta bl e a n d n on -i m pl a n ta bl e m ed i ca l d evi ces a n d i n vi tro d i a g n osti c m ed i ca l d evi ces Th e sta n d a rd ca n be u sed by org a n i za ti on s th a t d esi g n , prod u ce, i n sta l l a n d servi ce m ed i ca l d evi ces I t ca n be u sed by both i n tern a l a n d extern a l pa rti es to a ssess a n org a n i za ti on ’s q u a l i ty m a n a g em en t system Th e pu rpose of I SO 485 i s to provi d e q u a l i ty m a n a g em en t system req u i rem en ts th a t a re a ppl i ca bl e to th e m ed i ca l d evi ce i n d u stry, th a t a re i n terpreti ve a n d n ot prescri pti ve, a n d th a t wi l l serve a s a ba si s for reg u l a tory com pl i a n ce, tra ctu a l rel a ti on sh i ps a n d th i rd -pa rty certi fi ca ti on s Th i s book provi d es pra cti ca l g u i d a n ce for i m pl em en ti n g a q u a l i ty m a n a g em en t system th a t ca n be certi fi ed to I SO 485 a n d m a i n ta i n i n g on g oi n g certi fi ca ti on Th e a i m s of th i s book a re to: • • expl a i n th e scope a n d stru ctu re of I SO 485 ; si d er th e key a spects of th e i m pl em en ta ti on process, from th e perspecti ves of pl a n n i n g a n d i m pl em en ti n g th e req u i rem en ts; • expl a i n h ow to u n d ersta n d , i n terpret a n d a ppl y th e req u i rem en ts of th e sta n d a rd i n a n org a n i za ti on ; • si d er th e d evel opm en t of th e processes, pol i ci es, obj ecti ves a n d d ocu m en ta ti on a n d th e d evel opm en t of m ea su rem en t tech n i q u es; • si d er th e resou rces req u i red for i m pl em en ti n g a n d m a i n ta i n i n g a certi fi ed q u a l i ty m a n a g em en t system ; • si d er th e system s th a t a re req u i red to i m pl em en t a n I SO 485 q u a l i ty m a n a g em en t system ; Implementing an ISO 3485 Quality Management System for Medical Devices Ch a p te r • – In tro du ctio n expl a i n h ow to en su re th a t th e I SO 485 req u i rem en ts a re effecti vel y i m pl em en ted to a l l ow th e org a n i za ti on ’s q u a l i ty m a n a g em en t system to be certi fi ed ; • d i scu ss th e proposed fu tu re ch a n g es to I SO 485 I SO 485 i s a q u a l i ty m a n a g em en t system sta n d a rd for m ed i ca l d evi ces d esi g n ed speci fi ca l l y for reg u l a tory pu rposes Wh i l e i t i s ba sed on I SO 001 (th e sta n d a rd for q u a l i ty m a n a g em en t system s) , I SO 485 i s a sta n d -a l on e sta n d a rd I SO 485 h a s ei g h t cl a u ses: • Cl a u ses to cover th e scope, n orm a ti ve referen ces a n d term s a n d d efi n i ti on s; • Cl a u se ta i n s th e req u i rem en ts for th e q u a l i ty m a n a g em en t system ; • • • • Cl a u se d eta i l s th e req u i rem en ts for m a n a g em en t respon si bi l i ty; Cl a u se covers resou rce m a n a g em en t; Cl a u se d eta i l s th e req u i rem en ts for prod u ct rea l i za ti on ; Cl a u se ta i n s th e req u i rem en ts for m ea su rem en t, a n a l ysi s a n d i m provem en t Th e book i s org a n i zed i n th e ord er of th e cl a u ses i n th e sta n d a rd For ea ch cl a u se of th e sta n d a rd i t i n cl u d es d i scu ssi on on th e a pproa ch to be ta ken to i m pl em en t a n d m a i n ta i n th e req u i rem en ts of I SO 485 : • Ch a pter revi ews th e ben efi ts of u si n g I SO 485 a n d i ts u se for reg u l a tory com pl i a n ce; • Ch a pter l ooks a t th e process of pl a n n i n g th e i m pl em en ta ti on a n I SO 485 q u a l i ty m a n a g em en t system ; • Ch a pters to d i scu ss, from a pra cti ca l perspecti ve, h ow to i m pl em en t th e req u i rem en ts for Cl a u ses to of I SO 485 ; • Ch a pter d i scu sses th e process of h a vi n g a q u a l i ty m a n a g em en t system certi fi ed to I SO 485 by a th i rd -pa rty certi fi ca ti on bod y a n d th e i m porta n ce of en su ri n g th a t th e q u a l i ty m a n a g em en t system i s m a i n ta i n ed i n com pl i a n ce wi th I SO 485 ; i t a l so l ooks to th e fu tu re of I SO 485 Definitions Th e d efi n i ti on of a m ed i ca l d evi ce i s i n cl u d ed i n I SO 485 , Cl a u se I t sta tes th a t a m ed i ca l d evi ce i s: a n y in stru m e n t, in vitro re la te d a rticle , Im p le m e n tin g D e vice s a p p a tu s, im p le m e n t, re a g e n t o r ca lib to r, so ftwa re , in te n de d b y th e an ISO m a ch in e , a p p lia n ce , im p la n t, m a te ria l o r o th e r sim ila r o r m a n u fa ctu re r to be u se d, 3485 Q u a lity Ma n a g e m e n t Syste m a lo n e o r in fo r Me dica l Chapter – Achieving and continuing to maintain ISO 3485 certification Th ese ben efi ts cl ea rl y ou twei g h th e ba rri ers to certi fi ca ti on , su ch a s th e d i ffi cu l ty i n i d en ti fyi n g a n d crea ti n g n ew processes for th e q u a l i ty m a n a g em en t system , d evel opm en t of th e n ecessa ry d ocu m en ted proced u res a n d i n stru cti on s, a n d resi sta n ce by som e em pl oyees to ch a n g e (a n d process m ea su rem en ts) , th a t a re fou n d i n m ost org a n i za ti on s Factors to consider when selecting a certification body Wh en l ooki n g for a certi fi ca ti on bod y to certi fy a n org a n i za ti on ’s I SO 485 system , i t i s i m porta n t to ch eck h ow th a t certi fi ca ti on bod y i s i tsel f a ccred i ted I t m a y a l so be n ecessa ry to si d er wh ere th e m ed i ca l d evi ce i s reg i stered ; for exa m pl e, th e I SO 485 certi fi ca ti on m a y h a ve to be g i ven by a speci fi c reg i stra r, for Ca n a d a I n th e E U , for h i g h er-ri sk d evi ces, th ere a re ben efi ts to ch oosi n g a n org a n i za ti on th a t ca n a ct a s th e I SO certi fi ca ti on bod y a n d a l so th a t i s a n oti fi ed bod y for th a t type of m ed i ca l d evi ce Being ready for certification For a n org a n i za ti on to be rea d y for certi fi ca ti on i t m u st h a ve fu l l y i m pl em en ted a n I SO 485 q u a l i ty m a n a g em en t system a n d be u si n g th a t system Wh en th e q u a l i ty m a n a g em en t system i s bei n g a ssessed for certi fi ca ti on th e certi fi ca ti on bod y i s si d eri n g two a spects: Are a l l th e req u i rem en ts i n cl u d ed i n th e q u a l i ty m a n a g em en t system ? Th i s wi l l be fi rm ed by th e revi ew of th e system a s i t i s d ocu m en ted a n d by revi ew of th e i n tern a l a u d i ts a n d m a n a g em en t revi ews th a t h a ve ta ken pl a ce Th i s i s often ca l l ed a Sta g e a ssessm en t or D ocu m en t Revi ew Sta g e a ssessm en ts a re n orm a l l y d u cted a s a on e-d a y, on -si te revi ew, a l th ou g h i n certa i n ci rcu m sta n ces th ey m a y ta ke pl a ce by revi ewi n g th e d ocu m en ta ti on rem otel y; th e secon d sta g e of th e certi fi ca ti on process i s to fi rm th e effecti ven ess of th e processes th a t h a ve been pu t i n pl a ce to m eet th e req u i rem en ts of th e sta n d a rd D u ri n g th i s a ssessm en t th e org a n i za ti on m u st d em on stra te th e ti n u a l i m provem en t of th e q u a l i ty m a n a g em en t system Th i s i s Sta g e of th e a ssessm en t Th i s wi l l n orm a l l y req u i re m ore th a n on e d a y, even for th e sm a l l est org a n i za ti on , a s i t h a s to be en su red th a t a l l th e req u i rem en ts of th e q u a l i ty m a n a g em en t system h a ve been i m pl em en ted effecti vel y An org a n i za ti on n eed s to be su re th a t i t i s rea d y to d em on stra te both th ese a spects O ften org a n i za ti on s try to com pl ete th e process too q u i ckl y a n d d o n ot h a ve su ffi ci en t evi d en ce of th e worki n g of th e q u a l i ty m a n a g em en t system to be a bl e to d em on stra te i ts effecti ven ess Implementing an ISO 3485 Quality Management System for Medical Devices 74 After the certificate is received – maintaining certification Th e n u m ber of d a ys th a t th e a ssessm en t ta kes d epen d s on th e n u m ber of em pl oyees i n th e org a n i za ti on I f on l y on e pa rt of th e org a n i za ti on i s wi th i n th e scope of th e I SO 485 q u a l i ty m a n a g em en t system , th e n u m ber of em pl oyees wh o su pport th i s pa rt of th e org a n i za ti on wi l l be u sed a s th e ba si s for ca l cu l a ti n g th e n u m ber of d a ys th a t wi l l be req u i red for th e revi ew Th i s ti m e peri od i s ca l cu l a ted u si n g a d ocu m en t pu bl i sh ed by th e I n tern a ti on a l Accred i ta ti on Foru m (I AF) : I AF M a n d a tory D ocu m en t for th e Appl i ca ti on of I SO /I E C 02 i n M ed i ca l D evi ce Q u a l i ty M a n a g em en t System s (I SO 485 ) , I ssu e , Versi on Th e cu rren t versi on i s I AF M D : 01 , wh i ch wa s a ppl i ed from J u l y 01 O rg a n i za ti on s ca n en cou n ter severa l pi tfa l l s, wh i ch i n cl u d e th e fol l owi n g : • th ere i s i n su ffi ci en t a wa ren ess th rou g h ou t th e org a n i za ti on of th e I SO 485 q u a l i ty m a n a g em en t system a n d h ow i t rel a tes to i n d i vi d u a l s’ rol es, for exa m pl e, h ow th e q u a l i ty pol i cy rel a tes to th e a cti vi ti es i n a n i n d i vi d u a l ’s j ob rol e; • m a n a g em en t h a s n ot been su ffi ci en tl y i n vol ved to d em on stra te th a t i t i s ta ki n g i ts m a n a g em en t respon si bi l i ty seri ou sl y I t i s i m porta n t th a t m a n a g em en t ca n sh ow h ow i t h a s l ed th e org a n i za ti on i n i m pl em en ti n g a n d m a i n ta i n i n g th e I SO 485 q u a l i ty m a n a g em en t system ; • m a n a g em en t revi ews ca n n ot d em on stra te top m a n a g em en t’s i n vol vem en t i n th e q u a l i ty m a n a g em en t system , or ca n n ot fu l l y d em on stra te i t Th i s i n cl u d es m a i n ta i n i n g th e effecti ven ess of th e q u a l i ty m a n a g em en t system on ce i t h a s been i m pl em en ted ; • th ere h a s been i n su ffi ci en t tra i n i n g th rou g h ou t th e org a n i za ti on to u n d ersta n d wh a t i s req u i red to i m pl em en t a n d m a i n ta i n a n I SO 485 q u a l i ty m a n a g em en t system ; • th e req u i rem en ts, especi a l l y th ose i n Cl a u se a n d Cl a u se , h a ve n ot been rel a ted to th e prod u ct th a t th e org a n i za ti on i s m a n u fa ctu ri n g or to th e servi ces th a t i t i s d el i veri n g ; • i n tern a l a u d i ts th a t h a ve been perform ed h a ve n ot covered th e • th e a ppropri a te m etri cs a n d m ea su res h a ve n ot been pu t i n pl a ce for com pl ete q u a l i ty m a n a g em en t system ; th e a n a l ysi s of d a ta a n d th e feed ba ck l oop to d em on stra te m a i n ten a n ce of th e q u a l i ty m a n a g em en t system ’s effecti ven ess; • th e q u a l i ty m a n a g em en t system h a s becom e too com pl ex a n d l a cks fl exi bi l i ty I t d oes n ot n ecessa ri l y h a ve to be com pl ex to m eet th e req u i rem en ts of I SO 485 After the certificate is received – maintaining certification Wh en a n org a n i za ti on a ch i eves certi fi ca ti on to I SO 485 i t i s a m a j or a ch i evem en t th a t i s ca u se for cel ebra ti on Th i s, th ou g h , i s j u st th e sta rt of th e process Implementing an ISO 3485 Quality Management System for Medical Devices 75 Chapter – Achieving and continuing to maintain ISO 3485 certification Wh en th e cel ebra ti on s a re over i t i s i m porta n t for everyon e i n th e org a n i za ti on to rea l i ze th a t m a i n ta i n i n g th e effecti ven ess of th e q u a l i ty m a n a g em en t system i s j u st a s i m porta n t a s i m pl em en ti n g th e system Th i s i s n ot th e en d of th e process bu t th e beg i n n i n g of th e ti n u i n g process of m a i n ta i n i n g th e q u a l i ty m a n a g em en t system , a s pa rt of th e ti n u a l i m provem en t process Th i s i n cl u d es u n d ersta n d i n g th a t i t i s a ti n u ou s process th a t everyon e i s com m i tted to a n d i n vol ved i n , to en su re th a t th e req u i rem en ts of th e q u a l i ty m a n a g em en t system ti n u e to be m et A g a p a n a l ysi s i s often perform ed a s pa rt of i m pl em en ti n g a n I SO 485 q u a l i ty m a n a g em en t system I t i s u sefu l to m a i n ta i n th i s g a p a n a l ysi s a n d revi si t i t from ti m e to ti m e, to en su re th a t th e org a n i za ti on ’s q u a l i ty m a n a g em en t system h a s n ot m oved a wa y from th e req u i rem en ts of I SO 485 Th e g a p a n a l ysi s wi l l a l so be a u sefu l tool i f reg u l a tory req u i rem en ts or th e req u i rem en ts of I SO 485 a re ch a n g ed , a s i t wi l l provi d e a ba si s for com pl eti n g a g a p a n a l ysi s a g a i n st th e n ew or revi sed req u i rem en ts The future of ISO 3485 Th i s secti on ou tl i n es recen t d evel opm en ts i n resol vi n g h a rm on i za ti on i ssu es (E N I SO 485 : 01 ) , a n d d escri bes th e topi cs th a t a re bei n g revi ewed for fu rth er u pd a tes of th e sta n d a rd EN ISO 3485:201 As d i scu ssed i n Ch a pter , E N I SO 485 : 01 h a s been i ssu ed , wh i ch a d d resses cern s a bou t th e h a rm on i za ti on of va ri ou s E u ropea n sta n d a rd s to E U d i recti ves D u ri n g 01 , th e E u ropea n Com m i ssi on i sed a n obj ecti on to th e h a rm on i za ti on sta tu s, a n d th e i m pl i ed presu m pti on of form i ty, of a n u m ber of E u ropea n sta n d a rd s, i n cl u d i n g E N I SO 485 : 003 Ad d i ti on a l l y, Swed en i sed a form a l obj ecti on i n Febru a ry 01 to th e E u ropea n Com m i ssi on on th e l i n k between a d h eri n g to th e sta n d a rd a n d com pl yi n g wi th th e d i recti ves Ch a n g es were m a d e to restore fi d en ce a n d bri n g ba ck th e presu m pti on of form i ty i n d i ca ted by th e h a rm on i zed sta tu s of th e sta n d a rd E N I SO 485 : 01 wa s pu bl i sh ed i n Febru a ry 01 O n Au g u st 01 , th e sta n d a rd wa s h a rm on i zed a s expected to th ree m ed i ca l d evi ces d i recti ves: Cou n ci l D i recti ve 0/3 85 /E E C [th e Acti ve I m pl a n ta bl e M ed i ca l D evi ces D i recti ve (AI M D ) ] , Cou n ci l D i recti ve /42 /E E C [th e M ed i ca l D evi ces D i recti ve (M D D ) ] a n d D i recti ve 8/7 /E C [th e I n Vi tro D i a g n osti c M ed i ca l D evi ces D i recti ve (I VD D ) ] E N I SO 485 : 01 i s a ppl i ca bl e to m a n u fa ctu rers pl a ci n g m ed i ca l d evi ces th a t h a ve th e CE m a rk on th e Implementing an ISO 3485 Quality Management System for Medical Devices 76 The future of ISO 3485 m a rket Th e ch a n g es a re i n th e Foreword a n d An n exes ZA, ZB a n d ZC on l y; th ese a n n exes a d d fu rth er d eta i l s on th e l i n k between th e sta n d a rd a n d th e th ree m ed i ca l d evi ces d i recti ves m en ti on ed a bove I n th e rest of th e worl d I SO 485 : 003 rem a i n s th e a ppl i ca bl e sta n d a rd Th ere h a s been n o ch a n g e to th e req u i rem en ts (n orm a ti ve text) ; th e cl a u ses/req u i rem en ts of th e sta n d a rd a re exa ctl y th e sa m e a s th e 003 versi on D epen d i n g on th e org a n i za ti on ’s ci rcu m sta n ces, certi fi ca ti on bod i es m a y i ssu e certi fi ca tes to E N I SO 485 : 003 a n d /or to E N I SO 485 : 01 ISO 3485:2003 under review I SO 485 : 003 i s u n d er revi ew by I SO /Tech n i ca l Com m i ttee (TC) 0, Worki n g G rou p (WG ) a n d G H TF Stu d y G rou p A n u m ber of m eeti n g s h a ve been h el d si n ce sta rti n g th e revi ew i n 01 Th e pu rpose of th e revi si on i s to i m prove th e cl a ri ty a n d com pa ti bi l i ty of th e sta n d a rd wi th cu rren t reg u l a tory req u i rem en ts a n d expecta ti on s I n Apri l 01 , a J u sti fi ca ti on Stu d y a n d a n ew work i tem proposa l (N WI P) were a g reed a n d th e resu l ts were revi ewed i n O ctober 01 Th e a rea s for si d era ti on i n cl u d ed : • th e pu bl i ca ti on of D i recti ve 007 /47 /E C: o cl i n i ca l d a ta ; o post-m a rket su rvei l l a n ce; o softwa re a s a m ed i ca l d evi ce, i n cl u d i n g req u i rem en ts for va l i d a ti on ; • th e Swed i sh Com peten t Au th ori ty form a l obj ecti on to • th e E u ropea n Com m i ssi on obj ecti on s to severa l E N sta n d a rd s a n d I SO 485 : 003 ; th ei r h a rm on i za ti on sta tu ses, etc , i n cl u d i n g th e ten t a n d form a t of th e An n exes ZA, ZB a n d ZC; • th e poten ti a l i m pa ct of a n y revi si on to I SO 001 , a n d th e effect of th e h i g h –l evel stru ctu re for m a n a g em en t system sta n d a rd s proposa l by th e I SO Tech n i ca l M a n a g em en t B oa rd ; • scope revi si on , wi th a rei n forced focu s on th e q u a l i ty m a n a g em en t system n ot th e prod u ct or prod u ct l i fe cycl e, a n d org a n i za ti on to i n cl u d e m a n u fa ctu rer, re-processor, d i stri bu tor, etc • • • • expa n d i n g ri sk m a n a g em en t req u i rem en ts; provi d i n g g rea ter cl a ri ty; em erg i n g m a rkets; th e req u i rem en ts of oth er reg u l a tory reg i m es a n d g eog ph i ca l a rea s; • m a n a g em en t respon si bi l i ty, person n el com peten ce, etc I n a l l , d i fferen t topi cs/su bj ect a rea s were h i g h l i g h ted Implementing an ISO 3485 Quality Management System for Medical Devices 77 Chapter – Achieving and continuing to maintain ISO 3485 certification I SO 485 , rd ed i ti on worki n g d ft (WD ) wa s com pi l ed a t a m eeti n g of I SO /TC 0, WG h el d i n O ctober 01 Th i s WD h a s been i ssu ed for com m en t Th e com m en ts a n d oth er feed ba ck wi l l be revi ewed a t a m eeti n g sch ed u l ed for ea rl y M a rch 01 i n J a pa n Th e i n ten ti on i s to i ssu e a com m i ttee d ft (CD ) a n d sta rt th e I SO revi ew process Th e ta rg et d a te for th e pu bl i ca ti on of th e th i rd ed i ti on of I SO 485 i s l a te 01 Som e of th e i tem s th a t a re expected to be i n cl u d ed i n th e revi si on s a re: • ri sk m a n a g em en t, post-m a rket i n form a ti on , a d verse even t reporti n g a n d com pl a i n t h a n d l i n g ; • • su ppl y ch a i n i ssu es a n d ou tsou rci n g ; process va l i d a ti on a n d softwa re va l i d a ti on Wh en a n y ch a n g es a re m a d e to th e req u i rem en ts of I SO 485 : 003 i t wi l l be i m porta n t for th e org a n i za ti on to a ssess h ow th e ch a n g es a ffect i ts own q u a l i ty m a n a g em en t system O n e of th e wa ys to d o th i s i s to com pl ete a g a p a n a l ysi s a g a i n st th e revi sed req u i rem en ts Th i s h a s two ben efi ts: i t si d ers th e i m pa ct of a n y ch a n g es th a t h a ve been m a d e to th e req u i rem en ts; i t revi ews th e cu rren t q u a l i ty m a n a g em en t system a g a i n st th e revi sed req u i rem en ts, to ch eck th a t th ese req u i rem en ts a re m a i n ta i n ed i n th e exi sti n g q u a l i ty m a n a g em en t system , a s th i s i s i m porta n t to en su re th a t th e org a n i za ti on m eets reg u l a tory req u i rem en ts Th e FDA and ISO 3485 Th e FD A i n trod u ced a M ed i ca l D evi ce I SO 485: 003 Vol u n ta ry Au d i t Report Su bm i ssi on Pi l ot Prog m i n 01 for a ccepti n g I SO 485 reports I t sta rted on J u n e 01 I n th e prog m m e, th e a u d i t report i s to be su bm i tted to th e FD A wi th i n d a ys from th e l a st d a y of th e m ost recen t I SO 485 a u d i t Th e report su bm i tted wi l l h a ve to be si sten t wi th H ea l th Ca n a d a ’s Stu d y G u i d e G D 1 : G u i d a n ce on th e ten t of q u a l i ty m a n a g em en t system a u d i t reports Th i s stu d y g u i d e i s ba sed on th e work of Stu d y G rou p of th e G H TF, a n d , i n pa rti cu l a r, on th e tech n i ca l ten t of G H TF d ocu m en t G H TF/SG 4/N 3 R1 6: 007 G u i d el i n es for Reg u l a tory Au d i ti n g of Q u a l i ty M a n a g em en t System s of M ed i ca l D evi ce M a n u fa ctu rers – Pa rt : Reg u l a tory Au d i t Reports D eta i l s of th e prog m m e ca n be fou n d on th e FD A – Cen ter for D evi ces a n d Ra d i ol og i ca l H ea l th (CD RH ) websi te Implementing an ISO 3485 Quality Management System for Medical Devices 78 Summary Summary Th e p ro ce s s o f i m p l e m e n ti n g d em a n d i n g o r a re and p a rt o f t h e At th e en d o f th e p ro j e ct te a m , p ro ce s s th e m a n a g e m e n t s ys t e m been to i t Th i s wi l l re q u i re m e n ts a n d Th e ke ys t o s ys t e m • • • • • • a th a t wi l l i n d e p e n d e n t l y ce rti fi e d p ro ve a re and t i m e - co n s u m i n g m a i n ta i n i n g fo r t h o s e b u t th e s u p p o rt th e s u p p o rt th e th e 48 a re wi l l ca n l ea d i n g re wa rd s a re o rg a n i z a t i o n and I SO wh o h a ve o rg a n i z a ti o n in p ro j e ct, wo rth wh i l e a q u a l i ty b u s i n e s s p ro ce s s ; o rg a n i z a t i o n be th e wi l l i t wi l l h a ve m e e ti n g a h a ve ce rt i fi ca te cu s to m e r re g u l a to ry re q u i re m e n ts s u cce s s i n i m p l e m e n ti n g an I SO 48 q u a l i ty m a n a g e m e n t h a vi n g : d e fi n e d s e l e ct i ve co n fo rm i n g e ffe ct i ve → → → d oi n g a u d i ts → wri ti n g i m p l e m e n ta t i o n re s u l ts re co rd s a s e vi d e n ce i n te rn a l → q u a l i ty m a n a g e m e n t s ys te m d o cu m e n ta ti o n → s a yi n g i t; i t; d oi n g i t; i t we l l ; p ro vi n g ch e cki n g i t; i t Implementing an ISO 3485 Quality Management System for Medical Devices 79 Appen d i x – B a ckg rou n d a n d ori g i n s of I SO 485 : 003 I SO 485 : 9 wa s pu bl i sh ed i n 9 I t h a d been prepa red by I SO /TC WG Th i s wa s a l i g n ed wi th th e 9 versi on of I SO 001 I SO 001 : 000 wa s pu bl i sh ed i n D ecem ber 000, repl a ci n g th e I SO 001 : 9 seri es Th ere wa s a th ree-yea r tra n si ti on peri od before th e 9 versi on s [I SO 001 : 9 4, Q u a l i ty system s — M od el for q u a l i ty a ssu n ce i n d esi g n , d evel opm en t, prod u cti on , i n sta l l a ti on a n d servi ci n g (th e com pl ete m a n a g em en t system ) , I SO 002 : 9 4, Q u a l i ty system s — M od el for q u a l i ty a ssu n ce i n prod u cti on , i n sta l l a ti on a n d servi ci n g (th e excl u si on of d esi g n a n d d evel opm en t) , a n d I SO 003 : 9 4, Q u a l i ty system s — M od el for q u a l i ty a ssu n ce i n fi n a l i n specti on a n d test (th e excl u si on for d esi g n a n d d evel opm en t, a n d m a n u fa ctu ri n g ) ] were wi th d wn for th ose org a n i za ti on s th a t were a l rea d y certi fi ed to th e sta n d a rd s Th e I SO 485 : 9 sta n d a rd m a d e referen ce to I SO 001 th rou g h ou t; i t wa s n ot a sta n d -a l on e sta n d a rd , bu t, th er, provi d ed a d d i ti on a l req u i rem en ts for th e m ed i ca l d evi ce i n d u stry Th ere wa s a l so I SO 488: 9 6; i t wa s a l i g n ed to I SO 002 : 9 4, wh i ch focu sed on a l l th e q u a l i ty m a n a g em en t system a spects wi th th e excepti on of d esi g n a n d d evel opm en t D u ri n g Apri l 000, I SO 485 : 9 a n d I SO 488: 9 were a d opted a s E u ropea n sta n d a rd s a n d repl a ced th e th en exi sti n g , sector-speci fi c E u ropea n sta n d a rd s (i e E N 46001 , E N 46002 , E N 46003 ) Th e E u ropea n Com m i ssi on red i rected th e h a rm on i zed referen ces to th e E U m ed i ca l d evi ces d i recti ves to th e I SO seri es, a wa y from th e E u ropea n N orm s (E N s) Som e of th e ch a n g es th a t h a d been i n trod u ced wi th th e pu bl i ca ti on of I SO 001 : 000 (i n cl u d i n g th e red u cti on i n th e n u m ber of req u i red d ocu m en ted proced u res a n d th e i n cl u si on of cepts su ch a s cu stom er sa ti sfa cti on a n d ti n u a l i m provem en t) were n ot i n a l i g n m en t wi th th e reg u l a tory req u i rem en ts for m ed i ca l d evi ces Th e opti on of revi si n g I SO 485 a n d I SO 488 to bri n g th em i n a l i g n m en t wi th I SO 001 : 000 wa s si d ered bu t th ou g h t n ot to be a ppropri a te, so th e Tech n i ca l Com m i ttee d eci d ed th a t I SO 485 sh ou l d becom e a sta n d -a l on e Implementing an ISO 3485 Quality Management System for Medical Devices 81 Appendix – Background and origins of ISO 3485:2003 sta n d a rd Th i s m ea n t th a t org a n i za ti on s d i d n ot h a ve to h a ve certi fi ca ti on to I SO 001 a s wel l a s to I SO 485 a n d I SO 488 i n ord er to fu l fi l th e reg u l a tory req u i rem en ts As sta ted i n th e Foreword to E N I SO 485 : 003 : Th e text of th e I n tern a ti on a l Sta n d a rd I SO 485 : 003 h a s been prepa red by Tech n i ca l Com m i ttee I SO /TC “ Q u a l i ty m a n a g em en t a n d correspon d i n g g en era l a spects for m ed i ca l d evi ces, Worki n g G rou p ” Th e tra n sposi ti on i n to a E u ropea n Sta n d a rd h a s been m a n a g ed by th e CE N M a n a g em en t Cen tre (CM C) wi th th e a ssi sta n ce of th e CE N /CE N E LE C Co-ord i n a ti n g Worki n g G rou p on q u a l i ty su ppl em en ts for m ed i ca l d evi ces (E N I SO 485 : 003 , Foreword ) As sta ted i n th e Foreword to I SO 485 : 003 : [I SO 485 : 003 ] ca n cel s a n d repl a ces th e fi rst ed i ti on (I SO 485 : 9 6) … I t a l so ca n cel s a n d repl a ces I SO 488: 9 Th ose org a n i za ti on s wh i ch h a ve u sed I SO 488… m a y u se th i s I n tern a ti on a l Sta n d a rd by excl u d i n g certa i n req u i rem en ts i n a ccord a n ce wi th [of I SO 485 : 003 ] (I SO 485 : 003 , Foreword ) An n ex A of I SO 485 : 003 d eta i l s th e correspon d en ce between I SO 485 : 9 a n d I SO 485 : 003 Al th ou g h I SO 485 : 003 i s a sta n d -a l on e sta n d a rd , th e ‘cl a u ses or su bcl a u ses th a t a re q u oted d i rectl y… from I SO 001 : 000 a re i n n orm a l fon t’ (I SO 485 : 003 , Cl a u se ) Wh ere a d d i ti on a l req u i rem en ts h a ve been i n trod u ced , or th e cl a u se ch a n g ed , i n I SO 485: 003 , th i s i s sh own i n i ta l i cs; i n el ectron i c or col ou r-pri n ted versi on s of th e sta n d a rd th i s i s sh own i n bl u e i ta l i cs An n ex B of I SO 485 : 003 d eta i l s th e si m i l a ri ti es a n d d i fferen ces between th e req u i rem en ts of I SO 485 : 003 a n d I SO 001 : 000, a n d a l so g i ves a ti on a l e for th e ch a n g es th a t h a ve been m a d e for I SO 485 : 003 Th e rea son s for th e d i fferen ces a re provi d ed i n th e ta bl e i n th e a n n ex I SO 485 : 003 i s pu bl i sh ed by va ri ou s bod i es; ea ch bod y i s i d en ti fi ed by th e l etters pl a ced before th e m a i n i d en ti fi er ‘I SO 485 : 003 ’ For exa m pl e, i n th e U K th e sta n d a rd i s pu bl i sh ed by th e B ri ti sh Sta n d a rd s I n sti tu ti on (B SI ) ; th i s cou l d be d en oted by th e sta n d a rd bei n g i d en ti fi ed a s ‘B S I SO 485: 003 ’ H owever, a s i t i s a l so a E u ropea n sta n d a rd (a n E N ) , i t i s pu bl i sh ed a s ‘B S E N I SO 485 : 003 ’ Implementing an ISO 3485 Quality Management System for Medical Devices 82 R e fe re n ce s Standards EN 41 : 0 , In fo rm a tio n su p p lie d b y th e m a n ufa ctu re r o f m e dica l de vice s EN I SO 48 : 2 , Me dica l de vice s — Q u a lity m a n a ge m e n t syste m s — R e qu ire m e n ts fo r re g u la to ry p urp o se s I SO 9000: 000, Q u a lity m a n a ge m e n t syste m s — Fu n da m e n ta ls a n d vo ca b u la ry I SO 9000: 005 , Q u a lity m a n a ge m e n t syste m s — Fu n da m e n ta ls a n d vo ca b u la ry I SO 0 : 9 4, de ve lo p m e n t, Q u a lity syste m s — Mo de l fo r q u a lity a ssu n ce p ro du ctio n , in sta lla tio n I SO 9001 : 000, Q u a lity m a n a ge m e n t syste m s — R e q u ire m e n ts I SO 9001 : 008, Q u a lity m a n a ge m e n t syste m s — R e q u ire m e n ts I SO 0 : 9 4, Q u a lity syste m s — Mo de l fo r q u a lity a ssu n ce p ro du ctio n , I SO 0 : 9 4, in sp e ctio n I SO in sta lla tio n in Q u a lity syste m s — Mo de l fo r q u a lity a ssu n ce in fin a l a n d te st 89 -1 : 01 , Im p la n ts fo r su rg e ry — R e trie va l a n d a n a lysis o f 48 : 9 , 48 : 0 , R e trie va l a n d h a n dlin g Q u a lity syste m s — Me dica l de vice s — Pa rticula r re q u ire m e n ts fo r th e I SO de sig n , a n d se rvicin g su rg ica l im p la n ts — Pa rt : I SO in a n d se rvicin g a p p lica tio n o f ISO 9001 Me dica l de vice s — Q ua lity m a n a g e m e n t syste m s — R e qu ire m e n ts fo r re g u la to ry p urp o se s I SO 48 : 9 , Q u a lity syste m s — Me dica l de vice s — Pa rticula r re q u ire m e n ts fo r th e I SO 40 : 0 4, with g uida n ce Im p le m e n tin g D e vice s a p p lica tio n o f ISO 9002 En viro n m e n ta l m a n a g e m e n t syste m s — R e qu ire m e n ts fo r u se an ISO 3485 Q u a lity Ma n a g e m e n t Syste m fo r Me dica l 83 References I SO 49 : 007 , Medical devices — Application of risk management to medical devices I SO 52 -1 : 01 , Medical devices — Symbols to be used with medical device labels, labelling and information to be supplied — Part : General requirements Medical devices — Symbols to be used with medical device labels, labelling, and information to be supplied — Part 2: Symbol development, selection and validation I SO 52 -2 : 01 0, I SO 81 -1 : 009 , In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part : Terms, definitions and general requirements I SO 81 -2 : 009 , In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 2: In vitro diagnostic reagents for professional use I SO 81 -3 : 009 , In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 3: In vitro diagnostic instruments for professional use I SO 81 -4: 009 , In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 4: In vitro diagnostic reagents for self-testing I SO 81 -5 : 009 , In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 5: In vitro diagnostic instruments for self-testing I SO 901 : 01 , Guidelines for auditing management systems Medical devices — Quality management systems — Guidance on the application of ISO 3485:2003 I SO /TR 49 69 : 004, O H SAS 8001 , Occupational Health and Safety Management Other publications Ca n a d a , M ed i ca l D evi ces Reg u l a ti on s (SO R/9 8-2 82 ) Co-ord i n a ti on of N oti fi ed B od i es M ed i ca l D evi ces (N B -M E D ) on Cou n ci l D i recti ves 0/3 85 /E E C, /42 /E E C a n d 8/7 /E C (2 000) N B -M E D /2 /Rec1 , Post-M a rketi n g Su rvei l l a n ce (PM S) post m a rket/prod u cti on – M a rket su rvei l l a n ce; vi g i l a n ce, E ssen : Tech n i ca l Secreta ri a t N B -M E D Cou n ci l D i recti ve 0/3 85 /E E C of J u n e 9 on th e a pproxi m a ti on of th e l a ws of th e M em ber Sta tes rel a ti n g to a cti ve i m pl a n ta bl e m ed i ca l d evi ces, Implementing an ISO 3485 Quality Management System for Medical Devices 84 References O ffi ci a l J ou rn a l of th e E u ropea n U n i on (O J ) N o L 89 of J u l y 9 [Acti ve I m pl a n ta bl e M ed i ca l D evi ces D i recti ve (AI M D ) ] Cou n ci l D i recti ve /42 /E E C of J u n e 9 cern i n g m ed i ca l d evi ces, O J L 69 of J u l y 9 [M ed i ca l D evi ces D i recti ve (M M D ) ] D i recti ve 8/7 /E C of th e E u ropea n Pa rl i a m en t a n d of th e Cou n ci l of O ctober 98 on i n vi tro d i a g n osti c m ed i ca l d evi ces, O J L 3 of D ecem ber 9 8, pp –3 [I n Vi tro D i a g n osti c M ed i ca l D evi ces D i recti ve (I VD D ) ] D i recti ve 007 /47 /E C of th e E u ropea n Pa rl i a m en t a n d of th e Cou n ci l of Septem ber 007 a m en d i n g Cou n ci l D i recti ve 0/3 85 /E E C on th e a pproxi m a ti on of th e l a ws of th e M em ber Sta tes rel a ti n g to a cti ve i m pl a n ta bl e m ed i ca l d evi ces, Cou n ci l D i recti ve /42 /E E C cern i n g m ed i ca l d evi ces a n d D i recti ve 8/8/E C cern i n g th e pl a ci n g of bi oci d a l prod u cts on th e m a rket, O J L 47 of Septem ber 007 Th e G l oba l H a rm on i za ti on Ta sk Force (G H TF) Stu d y G rou p (2 005 ) G H TF/SG /N 47 R4: 005 , Revi ew of Cu rren t Req u i rem en ts on Postm a rket Su rvei 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