Bsi bip 0115 2014

I m pl em en ti n g a n I SO 1 3 485 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 1 3485 Qu ality
M an agem ent System for M edical
Devices

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D esi g n s


Co n te n ts

Ch a p te r 1

– I n tro d u cti o n

1

O vervi ew

1

D efi n i ti on s

2

Ch a p te r 2 – I S O 1 3 485

7

Th e rel a ti on sh i p between I SO 9 001 a n d I SO 1 3 485

7

I SO /TR 1 49 69

9

B en efi ts of i m pl em en ti n g a certi fi ed I SO 1 3 485 q u a l i ty m a n a g em en t
system

10

I SO 1 3 485 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 3 – 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 4 – 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 1 , 2 , 3 a n d 4 o f I S O 1 3 485

29

Scope (Cl a u se 1 )

29

N orm a ti ve referen ces (Cl a u se 2 )

30

Term s a n d d efi n i ti on s (Cl a u se 3 )

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 5 – 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 5 o f I S O 1 3 485

47

M a n a g em en t com m i tm en t (Cl a u se 5 . 1 )

47

Cu stom er focu s (Cl a u se 5 . 2 )

49

Q u a l i ty pol i cy (Cl a u se 5 . 3 )

50

Pl a n n i n g (Cl a u se 5 . 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 5 . 5 )

53

M a n a g em en t revi ew (Cl a u se 5 . 6)

57

Su m m a ry

63

Implementing an ISO 1 3485 Quality Management System for Medical
Devices
v

Ch a p te r 6 – 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 6 o f I S O 1 3 48 5

65

H u m a n resou rces (Cl a u se 6. 2 )

65

I n fra stru ctu re (Cl a u se 6. 3 )

69

Work en vi ron m en t (Cl a u se 6. 4)

70

Su m m a ry

75

Ch a p te r 7 – 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 7 o f I S O 1 3 485

77

Pl a n n i n g of prod u ct rea l i za ti on (Cl a u se 7 . 1 )

77

Cu stom er-rel a ted processes (Cl a u se 7 . 2 )

83

D esi g n a n d d evel opm en t (Cl a u se 7 . 3 )

85

Pu rch a si n g (Cl a u se 7 . 4)

1 02

Prod u cti on a n d servi ce provi si on (Cl a u se 7 . 5 )

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 7 . 6)

1 34

Su m m a ry

1 36

Ch a p te r 8 – 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 8 o f I S O 1 3 485

1 39

G en era l req u i rem en ts (Cl a u se 8. 1 )

1 39

M on i tori n g a n d m ea su rem en t (Cl a u se 8. 2 )

1 41

Con trol of n on con form i n g prod u ct (Cl a u se 8. 3 )

1 54

An a l ysi s of d a ta (Cl a u se 8. 4)

1 58

I m provem en t (Cl a u se 8. 5 )

1 59

Su m m a ry

1 71

Ch a p te r 9 – 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 1 3 485
ce rti fi ca ti o n

1 73

Prepa ri n g for certi fi ca ti on to I SO 1 3 485

1 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

1 75

Th e fu tu re of I SO 1 3 485

1 76

Su m m a ry

1 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 1 3 485 : 2 003

1 81

Re fe re n ce s

1 83

Implementing an ISO 1 3485 Quality Management System for Medical
Devices

vi


Ch a pter 1 – 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 1 3 485 ,

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 1 3 485
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 1 3 485 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, con 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 1 3 485 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 1 3 485 ;
con 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 ;

•

con 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;

•

con 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 ;

•

con 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 1 3 485
q u a l i ty m a n a g em en t system ;

Implementing an ISO 1 3485 Quality Management System for Medical
Devices
1


Ch a p te r 1

•

– In tro du ctio n

expl a i n h ow to en su re th a t th e I SO 1 3 485 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 1 3 485 .

I SO 1 3 485 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 9 001 (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 1 3 485 i s a
sta n d -a l on e sta n d a rd .
I SO 1 3 485 h a s ei g h t cl a u ses:

•

Cl a u ses 1 to 3 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 4 con 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 5 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 6 covers resou rce m a n a g em en t;
Cl a u se 7 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 8 con 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 1 3 485 :

•

Ch a pter 2 revi ews th e ben efi ts of u si n g I SO 1 3 485 a n d i ts u se for
reg u l a tory com pl i a n ce;

•

Ch a pter 3 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 1 3 485 q u a l i ty m a n a g em en t system ;

•

Ch a pters 4 to 8 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 1 to 8 of I SO 1 3 485 ;

•

Ch a pter 9 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 1 3 485 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 1 3 485 ; i t a l so l ooks to th e fu tu re
of I SO 1 3 485 .

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 1 3 485 , Cl a u se 3 . 7 . 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 ,

2

Im p le m e n tin g

D e vice s

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so ftwa re ,

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ISO

m a ch in e ,

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1 3485 Q u a lity Ma n a g e m e n t Syste m

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fo r Me dica l

Definitions
combination, for human beings for one or more of the specific
purpose(s) of
•

d i a g n osi s, preven ti on , m on i tori n g , trea tm en t or a l l evi a ti on of
d i sea se,

•

d i a g n osi s, m on i tori n g , trea tm en t, a l l evi a ti on of or com pen sa ti on
for a n i n j u ry,

•

i n vesti g a ti on , repl a cem en t, m od i fi ca ti on , or su pport of th e
a n a tom y or of a ph ysi ol og i ca l process,

•
•
•
•

su pporti n g or su sta i n i n g l i fe,
con trol of con cepti on ,
d i si n fecti on of m ed i ca l d evi ces,
provi d i n g i n form a ti on for m ed i ca l pu rposes by m ea n s of i n vi tro
exa m i n a ti on of speci m en s d eri ved from th e h u m a n bod y,

and which does not achieve its primary intended action in or on the
human body by pharmacological, immunological or metabolic means,
but which may be assisted in its function by such means.
(I SO 1 3 485 , Cl a u se 3 . 7 )

Th ere a re a d d i ti on a l term s, a n d d efi n i ti on s of th ose term s, i n
I SO 9 000: 2 005 , wh i ch a re u sed th rou g h ou t I SO 1 3 485 ; i t i s a u sefu l
sta n d a rd for org a n i za ti on s i m pl em en ti n g I SO 1 3 485 .
I SO 9 000: 2 005 , Q u a l i ty m a n a g em en t system s — Fu n d a m en ta l s a n d
voca bu l a ry i s th e top-l evel q u a l i ty m a n a g em en t system sta n d a rd , wh i ch
sets ou t th e com m on term s a n d a pproa ch th a t a re u sed i n th e sta n d a rd s
rel a ti n g to q u a l i ty m a n a g em en t system s. Th rou g h ou t th i s book va ri ou s
term s wi l l be u sed , for wh i ch th e fol l owi n g d efi n i ti on s a re ta ken from
I SO 9 000: 2 005 , i n a d d i ti on to th e d efi n i ti on s i n I SO 1 3 485 . Th ese i n cl u d e:

•

quality
d eg ree to wh i ch a set of i n h eren t ch a ra cteri sti cs… fu l fi l s
req u i rem en ts…
N O TE 1 Th e term “ q u a l i ty” ca n be u sed wi th a d j ecti ves su ch a s poor, g ood or
excel l en t.

N O TE 2 “ I n h eren t” , a s opposed to “ a ssi g n ed ” , m ea n s exi sti n g i n som eth i n g ,
especi a l l y a s a perm a n en t ch a ra cteri sti c.
(I SO 9 000: 2 005, Cl a u se 3 . 1 . 1 )

•

requirement

n eed or expecta ti on th a t i s sta ted , g en era l l y i m pl i ed or obl i g a tory
N O TE 1 “ G en era l l y i m pl i ed ” m ea n s th a t i t i s cu stom or com m on pra cti ce for
th e org a n i za ti on … , i ts cu stom ers… a n d oth er i n terested pa rti es… , th a t th e
n eed or expecta ti on u n d er con si d era ti on i s i m pl i ed .

Implementing an ISO 1 3485 Quality Management System for Medical
Devices
3


Chapter 1 – Introduction
N O TE 2 A q u a l i fi er ca n be u sed to d en ote a speci fi c type of req u i rem en t, e. g .
prod u ct req u i rem en t, q u a l i ty m a n a g em en t req u i rem en t, cu stom er
req u i rem en t.

N O TE 3 A speci fi ed req u i rem en t i s on e th a t i s sta ted , for exa m pl e i n a
d ocu m en t. . . .
N O TE 4 Req u i rem en ts ca n be g en era ted by d i fferen t i n terested pa rti es… .
(I SO 9000: 2 005 , Cl a u se 3 . 1 . 2 )

•

m a n a g em en t

coord i n a ted a cti vi ti es to d i rect a n d con trol a n org a n i za ti on …
N O TE I n E n g l i sh , th e term “ m a n a g em en t” som eti m es refers to peopl e, i . e. a
person or g rou p of peopl e wi th a u th ori ty a n d respon si bi l i ty for th e con d u ct
a n d con trol of a n org a n i za ti on . Wh en “ m a n a g em en t” i s u sed i n th i s sen se, i t
sh ou l d a l wa ys be u sed wi th som e form of q u a l i fi er to a voi d con fu si on wi th
th e con cept “ m a n a g em en t” d efi n ed a bove. For exa m pl e, “ m a n a g em en t

sh a l l … ” i s d epreca ted wh erea s “ top m a n a g em en t… sh a l l … ” i s a ccepta bl e.
(I SO 9000: 2 005 , Cl a u se 3 . 2 . 6)

•

org a n i za ti on

g rou p of peopl e a n d fa ci l i ti es wi th a n a rra n g em en t of
respon si bi l i ti es, a u th ori ti es a n d rel a ti on sh i ps…
N O TE 1 Th e a rra n g em en t i s g en era l l y ord erl y.

N O TE 2 An org a n i za ti on ca n be pu bl i c or pri va te.
(I SO 9000: 2 005 , Cl a u se 3 . 3 . 1 )

E xa m pl es of org a n i za ti on s a re a m a n u fa ctu rer, d i stri bu tor, ‘Com pa n y,
corpora ti on , fi rm , en terpri se, i n sti tu ti on , ch a ri ty, sol e tra d er, [or]
a ssoci a ti on … ’ (I SO 9 000: 2 005 , Cl a u se 3 . 3 . 1 ) .

•

prod u ct [or servi ce]

resu l t of a process…
N O TE 1 Th ere a re fou r g en eri c prod u ct ca teg ori es, a s fol l ows:

•

servi ces (e. g . tra n sport) ;

•

softwa re (e. g . com pu ter prog ra m , d i cti on a ry) ;

•

h a rd wa re (e. g . en g i n e m ech a n i ca l pa rt) ;

•

processed m a teri a l s (e. g . l u bri ca n t) .

Implementing an ISO 1 3485 Quality Management System for Medical
Devices

4


Definitions
M a n y prod u cts com pri se el em en ts bel on g i n g to d i fferen t g en eri c
prod u ct ca teg ori es. Wh eth er th e prod u ct i s th en ca l l ed servi ce,
softwa re, h a rd wa re or processed m a teri a l d epen d s on th e d om i n a n t
el em en t. For exa m pl e, th e offered prod u ct “ a u tom obi l e” con si sts of
h a rd wa re (e. g . tyres) , processed m a teri a l s (e. g . fu el , cool i n g l i q u i d ) ,
softwa re (e. g . en g i n e con trol softwa re, d ri ver’s m a n u a l ) , a n d servi ce
(e. g . opera ti n g expl a n a ti on s g i ven by th e sa l esm a n ) .
N O TE 2 Servi ce i s th e resu l t of a t l ea st on e a cti vi ty n ecessa ri l y perform ed a t
th e i n terfa ce between th e su ppl i er… a n d cu stom er… a n d i s g en era l l y
i n ta n g i bl e. Provi si on of a servi ce ca n i n vol ve, for exa m pl e, th e fol l owi n g :

•

a n a cti vi ty perform ed on a cu stom er-su ppl i ed ta n g i bl e prod u ct (e. g .

a u tom obi l e to be repa i red ) ;

•

a n a cti vi ty perform ed on a cu stom er-su ppl i ed i n ta n g i bl e prod u ct (e. g . th e

i n com e sta tem en t n eed ed to prepa re a ta x retu rn ) ;

•

th e d el i very of a n i n ta n g i bl e prod u ct (e. g . th e d el i very of i n form a ti on i n

th e con text of kn owl ed g e tra n sm i ssi on ) ;

•

th e crea ti on of a m bi en ce for th e cu stom er (e. g . i n h otel s a n d resta u ra n ts) .

Softwa re con si sts of i n form a ti on a n d i s g en era l l y i n ta n g i bl e a n d ca n
be i n th e form of a pproa ch es, tra n sa cti on s or proced u res… .
H a rd wa re i s g en era l l y ta n g i bl e a n d i ts a m ou n t i s a cou n ta bl e
ch a ra cteri sti c [i . e. q u a n ti fi a bl e] … . Processed m a teri a l s a re g en era l l y
ta n g i bl e a n d th ei r a m ou n t i s a con ti n u ou s ch a ra cteri sti c [i . e.
q u a n ti fi a bl e] . H a rd wa re a n d processed m a teri a l s often a re referred
to a s g ood s.
N O TE 3 Q u a l i ty a ssu ra n ce… i s m a i n l y focu sed on i n ten d ed prod u ct.
(I SO 9 000: 2 005, Cl a u se 3 . 4. 2 )

•

supplier
org a n i za ti on … or person th a t provi d es a prod u ct…
E XAM PLE Prod u cer, d i stri bu tor, reta i l er or ven d or of a prod u ct, or
provi d er of a servi ce or i n form a ti on .
N O TE 1 A su ppl i er ca n be i n tern a l or extern a l to th e org a n i za ti on .

N O TE 2 I n a con tra ctu a l si tu a ti on , a su ppl i er i s som eti m es ca l l ed “ con tra ctor” .
(I SO 9 000: 2 005, Cl a u se 3 . 3 . 6)

An oth er u sefu l d ocu m en t for org a n i za ti on s i m pl em en ti n g I SO 1 3 485 i s a
tech n i ca l report pu bl i sh ed by th e I n tern a ti on a l O rg a n i za ti on for
Sta n d a rd i za ti on (I SO ) . Tech n i ca l report I SO /TR 1 49 69 : 2 004, M ed i ca l d evi ces
— Q u a l i ty m a n a g em en t system s — G u i d a n ce on th e a ppl i ca ti on of

Implementing an ISO 1 3485 Quality Management System for Medical
Devices
5


Chapter 1 – Introduction

I SO

1 3 48 5 : 2 0 0 3

i m p l e m e n ti n g

N o w th a t I S O
on

h o w to

h o w to

p ro vi d e s g u i d a n ce

and

m a i n ta i n i n g

1 3 48 5

pu t I SO

e n s u re

h a s been

1 3 48 5

th a t th e

an

to

h el p

I SO

m a n u fa ctu re rs i n

1 3 48 5

o u tl i n e d ,

th e

d e ve l o p i n g ,

q u a l i ty m a n a g e m e n t s ys te m .

fo l l o wi n g

ch a p t e rs wi l l

q u a l i ty m a n a g e m e n t s ys te m s i n to

re q u i re m e n ts co n ti n u e

to

be

p l a ce

fo cu s

and

m e t.

6
Implementing an ISO 1 3485 Quality Management System for Medical
Devices


C h a p te r 2

– I SO

Th i s ch a p te r d e s cri b e s th e
I SO

9001 ,

to g e t h e r wi th

1 3 48 5

b a ckg ro u n d

th e

u se

and

of I SO

re l a ti o n s h i p

1 3 48 5 : 2 0 0 3

of I SO

1 3 48 5

wi th

fo r re g u l a t o ry

p u rp o s e s .

Th e

ch a p t e r fo cu s e s o n :

•
•
•

I S O /TR 1 49 6 9 ;

th e

re l a ti o n s h i p

b e t we e n

I SO

b e n e fi ts o f i m p l e m e n ti n g

a

9001

and

ce rti fi e d

I SO

I SO

1 3 48 5 ;

1 3 48 5

q u a l i ty m a n a g e m e n t

s ys t e m ;

•

I SO

1 3 48 5

and

re g u l a to ry re q u i re m e n ts .

The relationship between ISO 9001 and ISO 1 3485
Th e

I SO

1 3 48 5

s ta n d a rd
sa m e

s t a n d a rd

bu t i s a

fo r m e d i ca l

s ta n d - a l o n e

a s o th e r s ta n d a rd s i n

d e vi ce s i s b a s e d

s ta n d a rd .

t h i s fa m i l y,

Th e

on

s tru ctu re

i n cl u d i n g

I SO

th e

I SO

of I SO

1 40 0 1

9 001

1 3 48 5

and

i s th e

O H S AS

1 8001 .

Th e

p a rti c u l a r re q u i re m e n ts fo r cu s to m e r s a ti s fa ct i o n

i m p ro ve m e n t h a ve
I SO

1 3 48 5

been

m o d i fi e d

p ro m o te s a ct i ve
o rg a n i z a ti o n

1 3 48 5

i s m e e ti n g

is a

to

co n t i n u i n g

m o s t o f th e

Th e

main

co n ti n u a l
I SO

9001 .

e ffe c ti ve n e s s o f th e

m e e t cu s t o m e r re q u i re m e n t s ;
to

i t a l so

wh e t h e r th e

cu s to m e r re q u i re m e n t s .

q u a l i ty m a n a g e m e n t s ys te m

and

and

re q u i re m e n ts i n

s ys te m s fo r cu s t o m e r fe e d b a ck re l a te d

fo r re g u l a to ry p u rp o s e s .

•

th e

re q u i re s p ro ce s s e s fo r e n s u ri n g

q u a l i ty m a n a g e m e n t s ys t e m

I SO

fro m

I SO

1 3 48 5

re q u i re m e n t s a re

d i ffe re n ce s b e twe e n

fo r m e d i ca l

h a s th e
th e

I SO

sa m e

d e vi ce s s p e ci fi ca l l y

fo rm a t a s I S O

9 001 : 2 000

sa m e .

9001

and

I SO

th a t re q u i re m e n ts fo r ‘ cu s to m e r s a ti s fa cti o n ’

1 3 48 5

a re

a re :

ch a n g e d

to

‘ cu s t o m e r fe e d b a ck’ ;

•

th a t re q u i re m e n ts fo r ‘ co n ti n u a l
‘ co n ti n u a l

•
•

i m p ro ve m e n t o f th e

i m p ro ve m e n t’

a re

ch a n g e d

to

q u a l i ty m a n a g e m e n t s ys te m ’ ;

th e

i n cre a s e d

re q u i re m e n ts fo r p ro ce d u re s ;

th e

i n cre a s e d

re q u i re m e n ts fo r re co rd s ;

Implementing an ISO 1 3485 Quality Management System for Medical
Devices
7


Chapter 2 – ISO 1 3485
•

th e i n cl u si on of speci fi c reg u l a tory topi cs rel a ted to m ed i ca l d evi ces,
i n cl u d i n g post-prod u cti on revi ew, a d vi sory n oti ces a n d a d verse
even ts.

‘Cu stom er sa ti sfa cti on ’ a n d ‘con ti n u a l i m provem en t’ a re n ot i n cl u d ed i n
I SO 1 3 485 beca u se th ese con cepts a re n ot a ppropri a te for reg u l a tory
pu rposes.
Th e m od i fi ca ti on th a t h a s rem oved ‘cu stom er sa ti sfa cti on ’ a n d ‘con ti n u a l
i m provem en t’ from I SO 1 3 485 : 2 003 m ea n s th a t con form a n ce wi th
I SO 1 3 485 : 2 003 d oes n ot provi d e con form i ty wi th I SO 9 001 : 2 008.
I n pra cti ce, a n I SO 1 3 485 : 2 003 sta n d a rd sta tes wh a t h a s to be d on e. Th e
q u a l i ty m a n a g em en t system sta n d a rd speci fi es th e processes th a t wi l l
m a i n ta i n com pl i a n ce to th e system a n d h ow th ey a re to be ca rri ed ou t.
Th e org a n i za ti on th en n eed s to h a ve i n tern a l a u d i ts 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 sta n d a rd a re bei n g
com pl eted a s i n ten d ed . Th i s i n cl u d es con form i n g to th e reg u l a tory
req u i rem en ts th a t h a ve been 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
sta n d a rd a n d th a t a re i n ten d ed to be fu l fi l l ed a s pa rt of i t. Th ere a re
system s to veri fy th a t th e processes a re bei n g m a n a g ed effecti vel y a n d to
en su re th a t th e org a n i za ti on i s fu l l y i n con trol of i ts a cti vi ti es. Th i s g i ves

th e cu stom ers of a n org a n i za ti on con fi d en ce i n th e q u a l i ty ca pa bi l i ti es of
th e org a n i za ti on .
Wh en a n org a n i za ti on h a s certi fi ca ti on to I SO 1 3 485 by a certi fi ca ti on
bod y th i s g i ves a n org a n i za ti on th e cred i bi l i ty of a n i n d epen d en t
a ssessm en t. Th i s certi fi ca te wi l l be revi ewed by cu stom ers, wh i ch cou l d
m ea n th a t th ey m i g h t n ot con si d er i t n ecessa ry to a u d i t th e org a n i za ti on
for th em sel ves. Th e n u m ber of a u d i ts th a t a n org a n i za ti on m u st h a ve
m a y th erefore be red u ced , a n d a u d i ts th a t a re req u i red m i g h t be l ess
ri g orou s th a n before. Th e certi fi ca te ca n be a referen ce for cu stom ers
a n d ca n sh ow con form i ty for reg u l a tory req u i rem en ts.
I SO 1 3 485 a ppl i es to org a n i za ti on s i n th e m ed i ca l d evi ce i n d u stry. Th i s
i n cl u d es org a n i za ti on s th a t d esi g n a n d d evel op d evi ces, m a n u fa ctu re
d evi ces, i n sta l l d evi ces, servi ce d evi ces a n d provi d e servi ces th a t a re
rel a ted to m ed i ca l d evi ces.
I SO 1 3 485 i n cl u d es d efi n i ti on s th a t a re speci fi c to th e m ed i ca l d evi ce
i n d u stry, i n cl u d i n g a d efi n i ti on of a m ed i ca l d evi ce (see Ch a pter 1 ) a n d
oth er term s th a t wi l l be u sed . ‘Th i s d efi n i ti on h a s been d evel oped by th e
G l oba l H a rm on i za ti on Ta sk Force (G H TF) ’ (I SO 1 3 485 : 2 003 , Cl a u se 3 . 7 ) .
Th e d efi n i ti on esta bl i sh es th a t to be a m ed i ca l d evi ce th e i n stru m en t or
th e i n vi tro rea g en t (for exa m pl e) m u st h a ve a m ed i ca l l y i n ten d ed
pu rpose.

8
Implementing an ISO 1 3485 Quality Management System for Medical
Devices


ISO/TR 1 4969

I SO/TR 1 4969

I SO /TR 1 49 69 i s a tech n i ca l report th a t i s i n ten d ed to provi d e g u i d a n ce
for th e a ppl i ca ti on of I SO 1 3 485 : 2 003 . I t i s a very u sefu l d ocu m en t for
a n y org a n i za ti on th a t i s i m pl em en ti n g or m a i n ta i n i n g a n I SO 1 3 485
q u a l i ty m a n a g em en t system . I t provi d es g u i d a n ce on h ow th e
req u i rem en ts of I SO 1 3 485 ca n be m et, a n d i s recom m en d ed rea d i n g for
th ose i n vol ved i n i m pl em en ti n g I SO 1 3 485 .
I SO /TR 1 49 69 : 2 004 sta tes th a t i t:
provi d es g u i d a n ce to a ssi st i n th e d evel opm en t, i m pl em en ta ti on a n d
m a i n ten a n ce of q u a l i ty m a n a g em en t system s th a t a i m to m eet th e
req u i rem en ts of I SO 1 3 485 for org a n i za ti on s th a t d esi g n a n d
d evel op, prod u ce, i n sta l l a n d servi ce m ed i ca l d evi ces, or th a t d esi g n ,
d evel op a n d provi d e rel a ted servi ces. I t provi d es g u i d a n ce rel a ted to
q u a l i ty m a n a g em en t system s for a wi d e va ri ety of m ed i ca l d evi ces
a n d rel a ted servi ces. Su ch 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.
(I SO /TR 1 4969 : 2 004, Cl a u se 0. 1 . 1 )

Th e g u i d a n ce i n I SO /TR 1 49 69: 2 004 h a s con si d ered req u i rem en ts a n d
g u i d a n ce from th e fol l owi n g org a n i za ti on s:

•
•
•

th e G l oba l H a rm on i za ti on Ta sk Force (G H TF) ;
th e I n tern a ti on a l O rg a n i za ti on for Sta n d a rd i za ti on (I SO ) ;
th e E u ropea n Com m i ttee for Sta n d a rd i za ti on (CE N ) a n d th e
E u ropea n Com m i ttee for E l ectrotech n i ca l Sta n d a rd i za ti on (CE N E LE C) ;
and

•

n a ti on a l reg u l a tory bod i es.

Com pa ti bi l i ty wi th oth er m a n a g em en t system s i s d i scu ssed i n Cl a u se 0. 4
of th e i n trod u cti on to I SO 1 3 485.
Con form i n g to th e req u i rem en ts of I SO 1 3 485 d oes n ot m ea n th a t th e
org a n i za ti on con form s to th e n a ti on a l or reg i on a l reg u l a tory
req u i rem en ts. I t i s th e respon si bi l i ty of th e org a n i za ti on to i d en ti fy a n d
esta bl i sh th e req u i rem en ts n eed ed to en su re com pl i a n ce wi th th e
reg u l a tory req u i rem en ts.
Th e rel a ti on sh i p between th e sta n d a rd s, g u i d a n ce a n d reg u l a ti on s
i n terrel a tes a n d overl a ps. Th e ba ckg rou n d a n d evol u ti on of I SO 1 3 485 i s
d escri bed i n th e Appen d i x.

Im plem en tin g
Devices

an

ISO

1 3485 Qua lity Ma na gem en t System

for Medica l
9


Chapter 2 – ISO 1 3485

Ben efits of im plem en tin g a certified ISO 1 3485
q u ality m an ag em en t system
Th ere a re m a n y g ood rea son s wh y a n org a n i za ti on m a y ch oose to
i m pl em en t a n I SO 1 3 485 q u a l i ty m a n a g em en t system a n d th en to certi fy
th a t q u a l i ty m a n a g em en t system to I SO 1 3 485 . Th ese i n cl u d e a q u a l i ty
m a n a g em en t system bei n g req u i red to m eet reg u l a tory req u i rem en ts
wh en reg i steri n g m ed i ca l d evi ces worl d wi d e.
I n i ti a l l y, q u a l i ty wa s very m u ch ba sed on q u a l i ty con trol , bu t wi th th e
d evel opm en t of q u a l i ty m a n a g em en t system s th e em ph a si s h a s m oved to
q u a l i ty a ssu ra n ce. Q u a l i ty con trol i s rea cti ve; exa m pl es of q u a l i ty con trol
a re con form i ty ch ecks a n d prod u ct testi n g to d etect d efects. Q u a l i ty
a ssu ra n ce i s preven ti ve; i t i s a proa cti ve a pproa ch to i d en ti fyi n g a n d
preven ti n g probl em s.
A wel l -i m pl em en ted I SO 1 3 485 -ba sed q u a l i ty m a n a g em en t system
su pports reg u l a tory com pl i a n ce a n d i m proves cu stom er con fi d en ce. I t
i m proves th e con si sten cy a n d sta bi l i ty of th e processes u sed by th e
org a n i za ti on . I t ca n red u ce wa ste a n d d efects, i m prove em pl oyee
m oti va ti on a n d pa rti ci pa ti on , a n d provi d e th e ba si s for m on i tori n g ,
m a n a g i n g or poten ti a l l y i m provi n g th e perform a n ce of su ppl i ers.
I n a d d i ti on , i t m i g h t h el p to i n crea se th e org a n i za ti on ’s com peti ti ve ed g e.
I t m a kes g ood bu si n ess sen se a n d form s a n excel l en t ba si s for a n effi ci en t
a n d effecti ve bu si n ess, to be certi fi ed a g a i n st I SO 1 3 485 .
Th ere a re m a n y ben efi ts to i m pl em en ti n g I SO 1 3 485 , wh i ch i n cl u d e:

•
•

th e en h a n ced repu ta ti on of th e org a n i za ti on ;
i t wi l l resu l t i n a n en g a g ed workforce wh o u n d ersta n d th ei r rol es i n

th e bu si n ess, a s i t i n trod u ces a stru ctu re for th e org a n i za ti on ;

•

i t h el ps wi th th e ten d er process to h a ve a n i n d epen d en tl y certi fi ed
q u a l i ty m a n a g em en t system ;

•

i t ca n be a n expecta ti on of cu stom ers, a n d be pa rt of cu stom er
req u i rem en ts worl d wi d e to h a ve certi fi ca ti on to a n i n tern a ti on a l l y
recog n i zed sta n d a rd ;

•
•

i t d ri ves i m provem en t i n th e q u a l i ty m a n a g em en t system ;

•

i t h el ps wi th m eeti n g reg u l a tory req u i rem en ts. For exa m pl e,

i t su pports a n y i n tern a l bu si n ess n eed to m ove forwa rd i n to a n ew
bu si n ess sector;

I SO 1 3 485 i s a h a rm on i zed sta n d a rd for E U m ed i ca l d evi ces d i recti ves.

ISO 1 3485 an d regu latory requ irem ents
I SO 1 3 485 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 ) , Au stra l i a , Ca n a d a a n d Ta i wa n .

Implementing an ISO 1 3485 Quality Management System for Medical
Devices

10


ISO 1 3485 and regulatory requirements
Va ri ou s reg u l a tors u se I SO 1 3 485 a s a ba si s for sh owi n g con form i ty to
th ei r reg u l a tory req u i rem en ts, a n d for com pl i a n ce wi th reg u l a ti on s,
i n cl u d i n g th ose i n force i n Ca n a d a , th e E u ropea n E con om i c Area a n d
Au stra l i a .
I n E u rope, a q u a l i ty m a n a g em en t system i s req u i red for CE m a rki n g of a
m ed i ca l d evi ce th a t i s pl a ced on th e m a rket i n th e E U . U n d er th e m ed i ca l
d evi ces d i recti ves, i n cl u d i n g Cou n ci l D i recti ve 9 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 ) ] a n d D i recti ve 9 8/7 9 /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 ) ] , I SO 1 3 485 : 2 003 i s a
h a rm on i zed sta n d a rd th a t ca n be u sed by org a n i za ti on s to sh ow
con form i ty of th ei r q u a l i ty m a n a g em en t system to th e req u i rem en ts of
th e d i recti ves. E N I SO 1 3 485 : 2 01 2 wa s h a rm on i zed for u se wi th th e E U
d i recti ves i n Au g u st 2 01 2 to repl a ce E N I SO 1 3 485 : 2 003 a s th e
h a rm on i zed sta n d a rd . E N I SO 1 3 485 : 2 01 2 provi d es a fra m ework to en a bl e
a m a n u fa ctu rer to m eet som e of th e q u a l i ty m a n a g em en t system
req u i rem en ts for a n E C D ecl a ra ti on of Con form i ty [An n ex 2 a n d An n ex 5
of th e AI M D ; An n ex I I , V a n d VI of Cou n ci l D i recti ve 9 3 /42 /E E C [th e
M ed i ca l D evi ces D i recti ve (M D D ) ] ; or An n ex I I I , I V a n d VI I of th e I VD D ] . As
th e E U h a rm on i zed sta n d a rd for 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 t i s a n essen ti a l tool th a t a l l ows m ed i ca l d evi ce m a n u fa ctu rers
to provi d e evi d en ce of com pl i a n ce to E U l eg i sl a ti on , ba sed on a sou n d
reg u l a tory i n terpreta ti on , th rou g h i ts i m pl em en ta ti on i n th ei r q u a l i ty

m a n a g em en t system .
I n Au stra l i a i t i s a reg u l a tory req u i rem en t th a t th e m a n u fa ctu rer’s q u a l i ty
m a n a g em en t system h a s to m eet th e req u i rem en ts of I SO 1 3 485: 2 003 .
I n Ca n a d a , I SO 1 3 485 : 2 003 certi fi ca ti on i s pa rt of th e req u i rem en ts of th e
M ed i ca l D evi ces Reg u l a ti on s. M a n u fa ctu rers of Cl a ss I I or h i g h er-cl a ss
m ed i ca l d evi ces h a ve to h a ve a n I SO 1 3 485 : 2 003 q u a l i ty m a n a g em en t
system th a t i s certi fi ed to th e Ca n a d i a n M ed i ca l D evi ces Con form i ty
Assessm en t System (CM D CAS) .
I n Ta i wa n th e G ood M a n u fa ctu ri n g Pra cti ce req u i rem en ts a re ba sed on
certi fi ca ti on to I SO 1 3 485: 2 003 .
I n J a pa n , I SO 1 3 485 : 2 003 i s a n opti on , n ot a req u i rem en t, bu t i t i s th e
ba si s of com pl i a n ce to th e reg u l a ti on s. J a pa n req u i res th e esta bl i sh m en t
of a q u a l i ty m a n a g em en t system th a t con form s to th e M i n i stry of H ea l th ,
La bor a n d Wel fa re (M H LW) M i n i steri a l O rd i n a n ce N o. 1 69 , 2 004, wh i ch i s
si m i l a r to I SO 1 3 485 .
I n th e U n i ted Sta tes th e m ed i ca l d evi ce org a n i za ti on s h a ve to esta bl i sh a
q u a l i ty m a n a g em en t system th a t m eets th e req u i rem en ts of th e Q u a l i ty
System (Q S) reg u l a ti on , Cod e of Fed era l Reg u l a ti on s Ti tl e 2 1 (2 1 CFR) pa rt
82 0 a s pu bl i sh ed i n th e Fed era l Reg i ster. I SO 1 3 485 i s a n opti on bu t i s n ot
a req u i rem en t. M a n y of th e req u i rem en ts i n th e Q S reg u l a ti on a re si m i l a r
to I SO 1 3 485 bu t th ere a re a d d i ti on a l req u i rem en ts th a t h a ve to be m et

Implementing an ISO 1 3485 Quality Management System for Medical
Devices
11


Chapter 2 – ISO 1 3485
for m ed i ca l d evi ces th a t a re sol d i n th e U n i ted Sta tes. Th e U n i ted Sta tes
Food a n d D ru g Ad m i n i stra ti on (FD A) h a s been co-opera ti n g cl osel y wi th

th e d evel opm en t of I SO 1 3 485 , i n a n a ttem pt to fu rth er a l i g n I SO 1 3 485
a n d Q S reg u l a ti on req u i rem en ts.
Wi th th e g rowi n g i n terest i n reg u l a ti on i n th e M i d d l e E a st, Asi a , Afri ca
a n d La ti n Am eri ca , m a n y m ore reg u l a tory req u i rem en ts a re a d d ed wh en
d oi n g bu si n ess i n th ese reg i on s. I SO 1 3 485 certi fi ca ti on i s a n excel l en t
tool to h a rm on i ze th e va ri ou s q u a l i ty m a n a g em en t system req u i rem en ts
from a l l th ese exi sti n g a n d d evel opi n g l eg i sl a ti on s, a s i t i s ea sy for
n a ti on a l reg u l a tors to a d d cou n try-speci fi c req u i rem en ts to th e g en era l
fra m ework provi d ed i n th e g l oba l sta n d a rd .

Summary
I n su m m a ry, wh en a n org a n i za ti on u ses I SO 1 3 485 a s th e ba si s for i ts
q u a l i ty m a n a g em en t system , th i s ca n su pport th e bu si n ess a n d en su re
th a t th e reg u l a tory req u i rem en ts i n th e i n ten d ed m a rkets for th e m ed i ca l
d evi ces wi l l be m et.

Implementing an ISO 1 3485 Quality Management System for Medical
Devices

12


C h a p te r 3

– G e t ti n g

Th i s ch a p te r d i s cu s s e s th e
th e

i m p l e m e n ta ti o n

Th e

fo cu s wi l l

•
•
•
•
•
•

be

of a n

s ta rte d

i s s u e s th a t s h o u l d
I SO

1 3 48 5

be

co n s i d e re d

wh e n

pl a n n i n g

q u a l i ty m a n a g e m e n t s ys te m .

on :

q u a l i ty m a n a g e m e n t s ys t e m s ;
p ri n ci p l e s o f q u a l i ty m a n a g e m e n t ;
a

p ro ce s s a p p ro a ch ;

pl a n n i n g

th e

a

i m p l e m e n ta ti o n

1 0 - s te p

i m p l e m e n ta ti o n ;

ke y e l e m e n t s o f g e t ti n g

Th i s ch a p te r co n s i d e rs th e
u n d e rt a ke n

b e fo re

an

m a n a g e m e n t s ys t e m
e xp l a i n s th e

p ro ce s s ;

s t a rte d .

pl a n n i n g

th a t m e e ts th e

q u a l i ty m a n a g e m e n t s ys te m s .

to

be

co n s i d e re d
and

ca n

i n i ti a l

s ta rt to

a cti vi ti e s t h a t h a ve

i m pl em en t a

re q u i re m e n t s o f I S O

p ri n ci p l e s o f q u a l i t y m a n a g e m e n t a n d

to

s ys t e m

o f th e

o rg a n i z a ti o n

wh e n

so m e

Th e

ch a p te r wi l l

i m p l em e n ti n g

t o o l s th a t ca n

be

an

u se d

I SO
to

th e

h el p

th e

be

1 3 48 5 .

I t a l so

p ro ce s s a p p ro a ch

i n cl u d e

1 3 48 5

to

q u a l i ty

i ssu e s th a t n e e d

q u a l i ty m a n a g e m e n t

i m p l e m e n ta ti o n .

Quality management systems
A q u a l i ty m a n a g e m e n t s ys t e m

sh o u l d

o b j e cti ve s o f t h e

th a t i t i s s u p p o rt i n g ;

o rg a n i z a ti o n

fra m e wo rk th a t e n a b l e s th e
th o s e

o b j e cti ve s .

m e e t th e
o f th e

o rg a n i z a t i o n ,
an

wo rks ;

o rg a n i z a ti o n

so

n eed s a n d
i t n e e d s to

o rg a n i z a ti o n .

b u si n e ss a n d

i m p l e m e n te d

in

i t sh o u l d

I t ca n

fo r m a n a g i n g
a

to

fl e xi b l e

a p p l i ca b l e
u se d

ch a n g e s to

and

sh o u l d

p a p e r,

a

to

ch e ckl i s t o r b o x- ti cki n g
to

th e

as a

th e

th e

sh ou l d

p ro vi d e

to

all

a

a ch i e ve m e n t o f
be

d e si g n e d

re p u ta ti o n

and

to

image

te a m s a n d

fra m e wo rk fo r i m p ro vi n g

th a t b u si n e ss.
th e

b u si n e ss

i t sh ou l d

wa y t h e

I t sh o u l d

be

o rg a n i z a ti o n

a l l o w fo r ch a n g e .

a

ce rti fi ca t i o n

th e

be

wa y t h a t i s b u i l t a ro u n d

be

wi t h

manage

be

A q u a l i ty m a n a g e m e n t s ys t e m

co n fo rm a n ce

to

e n h a n ce

s a ke

o f h a vi n g

a l i g n ed

q u a l i t y m a n a g e m e n t s ys te m

s ta ke h o l d e rs ’

a cti vi ti e s i n
th e

Th e

be

n o t j u st b e

s ta n d a rd .
a cti vi ti e s ;

re q u i re m e n ts o f th e

i m p l e m e n ted

I t sh ou l d
i t sh o u l d

s ta n d a rd

n ot be

be

all

m o re

th a t th e

fo r th e

a bou t

th a n

si m pl y

o rg a n i z a t i o n

i s i m p l e m e n ti n g .

Implementing an ISO 1 3485 Quality Management System for Medical
Devices
1 3


Chapter 3 – Getting started
Th ere a re ben efi ts to h a vi n g q u a l i ty m a n a g em en t system s for both l a rg e
a n d sm a l l org a n i za ti on s. An org a n i za ti on ca n i m pl em en t a q u a l i ty
m a n a g em en t system to i m prove i ts effi ci en cy a n d effecti ven ess, a n d to
m a n a g e th e wa y a cti vi ti es a re com pl eted ; th i s m ea n s th a t i ssu es a re

con si d ered a n d a cti vi ti es d o n ot g et l eft ou t. Th e q u a l i ty m a n a g em en t
system esta bl i sh es cl ea r l i n es of respon si bi l i ty: i t d escri bes wh a t h a s to be
d on e, wh en i t sh ou l d be d on e, h ow i t sh ou l d be d on e, a n d wh ere i t
sh ou l d be com pl eted . Th i s m ea n s th a t th ere i s a system a ti c a pproa ch ,
en su ri n g a con si sten t a pproa ch wi th ou t person n el a l l d oi n g th i n g s i n
th ei r own wa y.
I SO q u a l i ty m a n a g em en t system s sta n d a rd s m a ke th i s g ood m a n a g em en t
pra cti ce a va i l a bl e to org a n i za ti on s of a l l si zes i n a l l sectors.
Q u a l i ty m a n a g em en t system s con si st of com m on el em en ts th a t a re
expressed a s th e org a n i za ti on a l stru ctu re, processes, proced u res, work
i n stru cti on s a n d resou rces n eed ed to i m pl em en t q u a l i ty m a n a g em en t.
Th e q u a l i ty m a n a g em en t system l i n ks:

•
•
•
•

q u a l i ty pl a n n i n g – pol i ci es, obj ecti ves, processes, con trol s;
q u a l i ty a ssu ra n ce – proa cti ve;
q u a l i ty con trol – rea cti ve, d etecti on , con form i ty;
q u a l i ty i m provem en t – effecti ven ess, effi ci en cy, ca pa bi l i ty.

Th ese el em en ts a re l i n ked th rou g h pol i ci es of th e q u a l i ty m a n a g em en t
system , u si n g th e I SO 1 3 485 sta n d a rd a n d th e q u a l i ty m a n a g em en t
system pri n ci pl es to g i ve con si sten cy.
I SO 1 3 485 a n d I SO 9 001 a re from th e sa m e fa m i l y of I SO sta n d a rd s. Th e
ben efi t th a t i s g a i n ed from bei n g pa rt of a fa m i l y of sta n d a rd s i s th a t
th ey ca n be u sed a s pa rt of a n i n teg ra ted set. I SO 1 3 485 fol l ows th e sa m e
form a t a s I SO 9 001 : 2 000. O th er sta n d a rd s i n th e sa m e fa m i l y a re

I SO 1 4001 (for en vi ron m en ta l m a n a g em en t system s) a n d O H SAS 1 8001
(for h ea l th a n d sa fety m a n a g em en t system s) .

Principles of quality management
Th ere a re ei g h t pri n ci pl es of q u a l i ty m a n a g em en t.
Th ese a re th e sh a red el em en ts of org a n i za ti on a l stru ctu re, a u th ori ti es
a n d respon si bi l i ti es, m eth od s a n d processes, d a ta m a n a g em en t, resou rces,
tra i n i n g , m a i n ten a n ce, cu stom er req u i rem en ts, prod u ct q u a l i ty a n d
con ti n u ou s i m provem en t. Th ey a re th e ba si s of a n I SO 1 3 485 q u a l i ty
m a n a g em en t system . Th e l i st bel ow d i scu sses ea ch of th ese el em en ts a n d
h ow th ey a re pa rt of th e q u a l i ty m a n a g em en t system .

Implementing an ISO 1 3485 Quality Management System for Medical
Devices

14


Principles of quality management

1 . Cu sto m e r a n d

re g u l a to ry fo cu s

I t i s i m porta n t th a t th ere i s a n u n d ersta n d i n g of cu rren t a n d fu tu re
cu stom er n eed s so th a t th e org a n i za ti on ca n m eet i ts req u i rem en ts,
i n cl u d i n g en su ri n g th a t a l l kn own a ppl i ca bl e reg u l a ti on s a re a ppl i ed . I n
ord er to d o so, th e org a n i za ti on m u st kn ow th e req u i rem en ts of i ts
cu stom ers a n d u n d ersta n d th e reg u l a tory req u i rem en ts of th e m a rkets i n
th e cou n tri es wh ere th e prod u ct or servi ce i s to be sol d . Th i s m a y be a

ch a n g i n g en vi ron m en t.

2 . Le a d e rs h i p o n

p u rp o s e a n d

d i re cti o n

Lea d ers, by esta bl i sh i n g a com m on pu rpose a n d d i recti on for th e
org a n i za ti on , crea te a n d m a i n ta i n th e i n tern a l en vi ron m en t i n wh i ch
peopl e ca n becom e fu l l y i n vol ved i n a ch i evi n g th e org a n i za ti on ’s
obj ecti ves. I n I SO 1 3 485 , th e l ea d ersh i p i s referred to a s ‘top
m a n a g em en t’ – th i s bei n g th e sen i or m a n a g em en t of th e org a n i za ti on or
of th e si te th a t own s th e q u a l i ty m a n a g em en t system .

3 . I n vo l ve m e n t o f p e o p l e a t a l l l e ve l s

A key el em en t of a n y org a n i za ti on i s i ts peopl e. Th ei r fu l l i n vol vem en t
en a bl es best perform a n ce i n th e org a n i za ti on ; i t i s i m porta n t to i n vol ve
a l l th e peopl e i n th e org a n i za ti on i n i m pl em en ti n g a n d th en m a i n ta i n i n g
a q u a l i ty m a n a g em en t system .

4. Pro ce s s a p p ro a ch

to re s o u rce s a n d

a cti vi ti e s

E very org a n i za ti on u ses processes for d epl oyi n g i ts resou rces a n d
perform i n g th e a cti vi ti es for th e prod u ct or servi ce th a t i t i s su ppl yi n g .

I SO 1 3 485 a s a q u a l i ty m a n a g em en t sta n d a rd i s ba sed on a process
a pproa ch . Va ri ou s tool s ca n be u sed a s a ba si s for a process a pproa ch ; a n
a pproa ch th a t i s com m on l y u sed i s th e Pl a n –D o–Ch eck–Act (PD CA) cycl e.
Th i s wi l l be d escri bed i n m ore d eta i l l a ter i n th i s ch a pter.

5 . S yste m s a p p ro a ch

to m a n a g e m e n t

An i m porta n t el em en t to en su ri n g th e sm ooth ru n n i n g of a n y q u a l i ty
m a n a g em en t system i s i d en ti fyi n g , u n d ersta n d i n g a n d m a n a g i n g i ts
i n terrel a ted processes. Th i s con tri bu tes to th e org a n i za ti on ’s effecti ven ess
a n d effi ci en cy i n a ch i evi n g i ts obj ecti ves a n d red u ci n g overa l l process
ri sks.

Implementing an ISO 1 3485 Quality Management System for Medical
Devices
15


Chapter 3 – Getting started

6.

Fa ctu a l

a p p ro a ch

D e ci s i o n s b a s e d
a re

on

typ i ca l l y m o re

wa y.

M o n i to ri n g

o rg a n i z a ti o n
p ro d u ct a n d

to

to d e ci si o n

a n a l ys i s o f d a t a

e ffe cti ve

and

th a n

m e a s u ri n g

u n d e rs ta n d

s e rvi ce

b a se d

m a ki n g

and

o f p ro d u ct a n d

i t s a b i l i t y to

on

i n fo rm a t i o n

d e ci s i o n s th a t a re

th e

p ro c e s s e s wi l l

su p p l y a

fa cts a n d

– fa cts a n d

d a ta

d a ta

n o t s u p p o rt e d

s a fe

and

in

–
th i s

a l l ow a n

e ffe cti ve

th a t h a ve

been

d e te rm i n e d .

7.

M u tu a l l y b e n e fi ci a l

An

o rg a n i z a ti o n

p ro ce s s e s .

Wi th

h a s b e co m e
a bl e
on

to

i s re s p o n s i b l e

i n cre a s i n g

on e

o f th e

re ce i vi n g

cu s t o m e rs ’

ke ys to

th e

o rg a n i z a ti o n
H e n ce ,

p ri n ci p l e

h a s been

m u ch

i n d u s t ry h a s b e e n

m a n a g e m e n t s ys te m .
i m p ro ve m e n t.

a

wi l l

co n ti n u i n g

a bl e

o rd e r to

be

i s ve ry d e p e n d e n t

and

to

m a n a g em en t
In

o f th e

ri g h t q u a l i t y.

m e e t i t s o wn

wo rki n g

re l a t i o n s h i p s wi th

in

o b j e cti ve

th e

m e d i ca l

i m p ro ve m e n t o f t h e

t a ke

i s n o w ch a n g i n g

co n ti n u o u s e ffo rt,

Th i s i s i n

i m p ro ve

p l a ce .

i n d u s t ry a b o u t th e
Th e

th e
to

n eed

s ti m u l a te

cu s to m e r’s a n d

I SO

fo cu s o f t h e

p ro d u ct
th a t fo r s o m e

re g u l a t o ry

9 0 0 1 : 2 0 0 8 wh e re

p ro d u ct a n d

q u a l i ty

fo r p ro d u ct

b u t i t i s re co g n i z e d

th e

co n tra s t to

d e vi ce

e ffe cti ve n e s s o f th e

Th i s d o e s n o t n e g a te

re q u i re m e n t t o

I SO 9000 a n d

ri g h t t i m e

n ot be

on g oi n g

b a s i c p ro d u ct m a y n e e d

re q u i re m e n ts .

o rg a n i z a t i o n

m u t u a l l y b e n e fi ci a l

d i s cu s s i o n

Le g i s l a ti o n

i m p ro ve m e n t i n
p ro d u ct a

th e

i m p ro ve m e n t th a t ca n

on

o f i ts o u ts o u rce d

s u p p l y ch a i n

o f a n y q u a l i ty m a n a g e m e n t s ys te m .

I m p ro ve m e n t a s a n

e xte n t o f co n ti n u a l

co n tro l

s u cce s s o f a n y o rg a n i z a ti o n .

p ro d u ct o r s e rvi ce s a t t h e

n e ed s.

s u p p l i e rs i s a

Th e re

fo r e n s u ri n g

re g u l a to ry p re s s u re ,

s u p p l y i ts p ro d u ct o r s e rvi ce

Wi th o u t th i s ,

8.

s u p p l i e r re l a ti o n s h i p s

th e re

is a

p ro ce s s e s .

I S O 1 3 48 5 fa m i l y o f q u a l i ty m a n a g e m e n t

s ta n d a rd s

In

a d d i ti o n

and

I SO

to

1 3 48 5

o b j e ct i ve

th e
a re

e i g h t q u a l i ty m a n a g e m e n t p ri n ci p l e s ,
b o th

o f e n s u ri n g

b a se d

th a t a n

on

th e

P D C A cycl e .

o rg a n i z a t i o n

I SO

9001 : 2 008

Th e y s h a re

m e e ts cu s to m e r,

th e

p ri m a ry

s ta tu to ry a n d

re g u l a t o ry re q u i re m e n t s .

Th e

s ta n d a rd s e n co u ra g e

o rg a n i z a ti o n s to

q u a l i ty m a n a g e m e n t s ys te m s i n
is a

wi d e r e m p h a s i s o n

b e n e fi t i n g

th e

an

c o n ti n u a l

I SO

co n ti n u a l l y i m p ro ve

1 3 48 5

wa y.

i m p ro ve m e n t ,

In

I SO

wh i ch ,

in

a d d i ti o n

o rg a n i z a ti o n ’s q u a l i ty m a n a g e m e n t s ys t e m ,

b e n e fi t cu s to m e rs ,

s u p p l i e rs a n d

o t h e r i n te re s te d

p a rti e s ;

th e i r

9001 : 2 008

wi l l

th e re

to

a l so

th i s i s n o t

Implementing an ISO 1 3485 Quality Management System for Medical
Devices

1 6


Process approach
i n cl u d ed i n I SO 1 3 485 . Th e sta n d a rd s a l so a ssi st org a n i za ti on s to esta bl i sh
con trol s to d ea l wi th th e th rea ts, ri sks a n d opportu n i ti es th a t a re

en cou n tered i n m a i n ta i n i n g a q u a l i ty m a n a g em en t system a n d m eeti n g
cu stom er req u i rem en ts.

Process approach
I SO 1 3 485 i s ba sed on a process a pproa ch to q u a l i ty m a n a g em en t system
m a n a g em en t. I t su g g ests th e u se of a process a pproa ch for th e
d evel opm en t, i m pl em en ta ti on a n d i m provem en t of th e effecti ven ess of a
q u a l i ty m a n a g em en t system , wi th th e a i m of provi d i n g m ed i ca l d evi ces
th a t m eet cu stom er a n d reg u l a tory req u i rem en ts. Th e q u a l i ty
m a n a g em en t system sh ou l d be reg a rd ed a s a process wi th severa l
processes wi th i n i t.
A process i s d efi n ed a s a ‘set of i n terrel a ted or i n tera cti n g a cti vi ti es wh i ch
tra n sform s i n pu ts i n to ou tpu ts’ (I SO 9 000: 2 005 , Cl a u se 3 . 4. 1 ) . An y a cti vi ty
th a t recei ves i n pu ts a n d con verts th em to ou tpu ts i s con si d ered to be a
process. (See Fi g u re 1 . )
For a n org a n i za ti on to fu n cti on effi ci en tl y i t h a s to i d en ti fy a n d m a n a g e
n u m erou s l i n ked processes. Th e ou tpu t from on e process often form s th e
i n pu t to th e n ext process. Th i s a ppl i ca ti on of a system of processes i n a n
org a n i za ti on , u si n g th e i d en ti fi ca ti on a n d i n tera cti on of th ese processes,
i s ca l l ed th e process a pproa ch . A process a pproa ch i s d efi n ed a s th e
system a ti c i d en ti fi ca ti on a n d m a n a g em en t of th e l i n ka g es, com bi n a ti on
a n d i n tera cti on of a system of processes wi th i n a n org a n i za ti on .

Fig u re 1 – Th e elem ents of a process

Implementing an ISO 1 3485 Quality Management System for Medical
Devices
17