iso_13485_iso_survey2014.xls

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The ISO Survey of Management SystemStandard Certifications (2004-2014)

ISO 14!" - Medica# devices - $ua#ity management systems - %e&uirements forregu#atory 'ur'oses

Overview - tables

Countries

Number of sitesWithdrawn certificates

Certificates - worldwide total - diagram

Regional share - diagram

World annual growth (in %) - diagram

Number of countries / economies - diagram

http://var/www/apps/conversion/tmp/scratch_2/














TOTAL

Africa

Central and South AmericaNorth America

Europe

Ea!t A!ia and "acific

Central and South A!ia

$iddle Ea!t

ear 2004

TOTAL ""

Africa 3

Central and South America %North America 3

Europe 28

Ea!t A!ia and "acific 12

Central and South A!ia %

$iddle Ea!t 1

1

2

3

%

5

#

(





ment systems - Requirements for regulator

200" 200/ 200

"0/" !02/ 12!"

3% 3( 5%

%1 10# 18%

1%8% 2%%% 2##2

2830 35(% (0%9

%35 125( 2359

133 3%1 392

108 2#( 285

200" 200/ 200

100* 100* 100*

0&(' 0&5' 0&%'

0&8' 1&3' 1&%'

29&3' 30&5' 20&5'

55&9' %%&5' 5%&3'

8&#' 15&(' 18&2'

2&#' %&2' 3&0'

2&1' 3&3' 2&2'

+nnua# gro



111* "!* /2*

1(' 9' %#'

(8' 159' (%'(5' #5' 9'

11#' 2#' 9('

25%' 189' 88'

(31' 15#' 15'

100' 1%(' ('

um,er of

200" 200/ 200

/ !1 !4

% # #

9 10 123 3 3

33 38 3(

13 1% 1%

3 5 (

2 5 5

*+ #1

,erman &

.tal $

China #

nited ingdom 1&

*wit0erland 1!

orea Re2ublic of 11

To' 10 countries for ISO 14!" certificates - 2014





uroses

200! 200 2010

124 1/42" 1!!4

#3 #8 10%

1#% 1#5 219

3033 3380 %0%0

(%#3 9008 1103%

19## 3119 2%80

259 2(# 501

28# %09 %5#

200! 200 2010

100* 100* 100*

0&5' 0&%' 0&#'

1&2' 1&0' 1&2'

22&9' 20&#' 21&5'

5#&%' 5%&8' 58&#'

1%&9' 19&0' 13&2'

2&0' 1&(' 2&('

2&2' 2&5' 2&%'

th a,so#ute num,ers



2* 24* 1"*

1(' 8' 53'

)11' 1' 33'1%' 11' 20'

#' 21' 22'

)1(' 59' )20'

)3%' (' 82'

0' %3' 11'

countries . economies

200! 200 2010

!! 0

# 5 8

13 13 123 3 3

39 %0 38

1% 15 15

# ( 8

( ( 9

#

'

'#

#'

'

"

$'





2011 2012 201

1!4 221 2"/""

15% 18# 1(0

2#% 320 38(

%522 %(19 5#(5

10515 12232 13203

2982 3328 %%#2

#9% 809 923

(18 (23 835

2011 2012 201

100* 100* 100*

0&8' 0&8' 0&8'

1&3' 1&%' 1&('

22&8' 21&1' 25&%'

53&0' 5%&8' 59&2'

15&0' 1%&9' 20&0'

3&5' 3&#' %&1'

3&#' 3&2' 3&('



"* 12* 1"*

%8' 21' )9'

21' 21' 21'12' %' 20'

)5' 1#' 8'

20' 12' 3%'

39' 1(' 1%'

5(' 1' 15'

2011 2012 201

" "

9 8 (

13 1% 133 3 3

%0 %0 39

15 1# 1#

# ( 8

9 9 9





2014

21

1#(

31#

#02#

12983

##3(

902

(#0

2014

100*

0&('

1&%'2(&0'

58&2'

29&('

%&0'

3&%'



!*

)2'

)18'#'

)2'

%9'

)2'

)9'

2014

"

(

123

%2

1#

(

8





ISO 13485 - !ertificates "orld"ide - gro"

ISO 13485 - &frica

ear 2004 200" 200/ 200 200! 200 2010 2011 2012 201 2014

Country 2 4 "4 / /! 104 1"4 1!/ 10 1/

Al*eria 3 3 2 % % % % # #

Central African +epu,lic ( (

E*-pt 5 # 22 33 %5 #5 #1 (% (5

Eritrea 1 1 1 1 1 1 1 2 2

/en-a 1 1 1 1

$alai 1$auritiu! 3

$orocco 2 1 2 2 2 3 % 5 % % #

South Africa 3 2 25 32 2# 2( %1 %2 59 82 (0

Sailand 2% 2% 1 10 2% 52 1

Tuni!ia 10 1 9 % 0 (

ISO 13485 - !entral ( Sout# &merica

ear 2004 200" 200/ 200 200! 200 2010 2011 2012 201 2014Country 2 41 10/ 1!4 1/4 1/" 21 2/4 20 ! 1/

Ar*entina 5 % 21 5# %% 35 3( (0 #0 #3 5(

.ar,ado! 1 1 1 1 1 1 1 1 2

.ermuda! 1 0

.oliia 1 1 1 1 1 1

.rail 5 % %0 (3 #2 #5 95 105 12( 158 11(

Chile 2 2 2 3 3 3 8 #

Colom,ia 2 1 2 2 10 20 %# ## 58

Co!ta +ica 1 % # % # ( 13 23 28 15

4ominican +epu,lic 1 2 2 % 3 % 5 9 9 12ondura! 1 1 1 1 1 1 1 1 1

Netherland! Antille! 3 2

"eru ( 9 9 ( 10 19 % ( 10 13

"uerto +ico 10 1# 2% 28 31 35 3( 3% 32 3# 31

Trinidad and To,a*o 2 2 1 1 % 3 0 1

:ru*ua- 3 5 2 3 % 3 % 1 # % 3

ISO 13485 - )ort# &merica



ISO 13485 - !ertificates "orld"ide - gro"t#

$acau China 10 18

ndone!ia 1 % # 5 8 ( ( 5 22 53 32

=apan 21 211 %38 %5# 393 %52 539 (33 (52 835 10(#

9 # 2( 2 18 3 1 2

/orea +epu,lic of 28 28 229 255 33 3%3 500 588 5(5 (39 11#9

$ala-!ia % 20 101 10( 122 15# 1(# 19% 228 28% 38(

$-anmar 1 1 1

Ne >ealand 2 2 ( ( 10 12 12 12 15 20 22"apua Ne 7uinea 1

"hilippine! 10 21 21 3 2 15 ( 8 1% 1% 28

Sin*apore 1( 50 %# %2 #9 102 12( 1%# 1#2 183 193

Thailand 3 % 32 2( 35 59 59 #9 (5 9% 118

@iet Nam 5 5 8 11 1% 1% 25 29 38

/orea 4emocratic "eopleB!+epu,lic



200/ 200 200! 200 2010 2011 2012"4 04 4/ 00! 1104 10"1" 1222

#8 1%0 158 1#0 13( 19( 128

5 # 3 5 5 # %

(5 (# (9 99 112 123 1%3

1 2 2 2 1 1

2 5 5 10 1( 3## 10 13 1# 15 1(

2 2 3 1 1

#5 221 199 131 183 1#% 195

( 5# (# 113 119 111 15#

( 2 3 3 5 9 9

20 188 31 8# 50 #( 10%

518 (09 (09 (88 8#5 1035 9%5

1#99 220% 2#51 3019 3291 3%38 %1%0

2# 31 32 %9 #1 50 (2

2( 3( 3# %5 58 #9 92

1 % % 5 5

8% 95 11# 121 155 159 193

3(# 1%82 1112 1109 1881 13%# 2052

3 1 1 8 1 5 3

2 % ( # 12 ( 1#

1 2 1 1 8 ( (

3 3 # ( 5 ( 8

1 1 2

2 3 1 1 % 2

2 2 2

55 %( 91 20# 285 33# 39#

2# 2% 2# 31 3# %5 32

(0 (# (# 1%% 158 15% 193

22 28 11 1( 2% 28 38

2 9 8 28 5# 109 9(

25 28 22 9% 11% (% 90



a

200/ 200 200! 200 2010 2011 2012

41 2 2" 2/ "01 /4 !0

8 3

1

188 222 19( 189 2(( 359 38#

1 1 % %

1 1 1 1 1 1 1

138 152 %9 (2 208 322 %0#

2 3 % % 2 3 312 % % # 5 5 8

2 % 3 %

200/ 200 200! 200 2010 2011 2012

2/ 2!" 2!/ 40 4"/ 1! 2

12 20 3% #1 (2 109 #5

2%% 255 233 330 359 585 #30

1 3 3 5 9 ( (

1 1 21 1 2

1 1 1 1 1% % ( ( 8 8 9

1 2 2 3 2

# 3 ( 3 3 3 5



Country 200 200! 200 2010 2011 2012 201 2014 Country 200 200! 200TOT+ "001 "1" / 4 102/ 121/4 1"!" 1!/41 TOT+ "001 "1" /Af*hani!tan 8 3 $alai

Al*eria 2 2 % % % % # # $ala-!ia %8 58

Andorra 1 $alta

Ar*entina %3 %2 3( %1 55 #( 18 21 $auritiu!

Au!tralia 5 32 %5 %% 51 55 (8 1%# $eico 23 2#

Au!tria 8 25 1( 10 2% 3% 195 280 $onaco

.ahrain 0 0 $ontene*ro 2 2

.an*lade!h 1 3 2 $orocco 2 2

.ar,ado! 1 0 2 $-anmar

.elaru! 2 2 2 2 % 2 % Nepal 1 1

.el*ium 21 (2 #1 #5 (8 11# 108 183 Netherland! 52 22

.ermuda! 1 0 Netherland! Ant&

.oliia 1 1 1 0 0 Ne >ealand ( 9

.o!nia and ere*oina 1 1 0 0 Nora- 5 12

.rail 38 29 %( (0 58 9( (1 (1 Oman

.ul*aria ( 11 30 2# 35 "ai!tan 2#

Cam,odia 1 2 2 2 1 5 "apua Ne 7uinea

Canada 2## 335 51( 3(( %25 %%8 5(# (59 "eru 8 (

Chile 2 2 % % % 2 # "hilippine! 2 1China 109( 350 %01 %(9 #98 915 19%1 "oland ## #%

on* /on* China 1# 18 2# 28 32 %# 3# 85 "ortu*al 5 2(

$acau China 2% "uerto +ico # #

Taipei Chine!e # %3 3#( %2( %#3 #09 290 %#3 atar 1

Colom,ia 1 15 1( 23 %1 (9 +omania 9 5

Co!ta +ica 3 2 2 2 1# % 10 +u!!ian 6ederation 20 21

Croatia 3 # 12 15 15 1# 10 12 San $arino

C-pru! 1 1 1 1 0 2 Saudi Ara,ia % #

Cech +epu,lic %( 18# 120 158 1%( 18% 2%# 2## Sene*al

4enmar 2# 5 28 32 51 22 1#% 1(% Ser,ia 1 1

4ominican +epu,lic 3 2 1 1 3 ( 3 12 Se-chelle! 1 2

E*-pt 5 1% 22 3% 3# %8 #9 (5 Sin*apore 1( 3(

Eritrea 1 1 1 1 1 1 2 2 Sloaia 21 20

E!tonia 3 # # ( ( 3 ( Sloenia 1

6inland 5( 2% (9 53 102 112 %0 2( South Africa 11 10

6rance 1% 18 1019 9(( 10#( 1#02 1518 2190 Spain 25 55

7erman- 15% 15%8 3(( #5 288% 282( 19(# 181% Sri Lana 1 1

7reece 1 12 2# 3% 5 #9 11# ## Sailand

ondura! 1 0 Seden 223 #9

un*ar- 35 35 %3 5% #2 90 88 89 Siterland 133 20#

celand 5 0 12 S-rian Ara, +epu,licndia 91 108 153 181 235 3%1 2(% 35% Thailand 1#

ISO 13485 - )um,er of sites covered ,y ISO 13485 certificates - single-site and multile-sitecertificates lus unsecified sites cumulated

The folloin* ta,le *ie! an idea of the num,er of !ite! coered ,- the certificate per countr-& t i! proided a! a rou*h indicator ) not all data !ource! re!ponded to

the reue!t for !uch fi*ure!&



ISO 13485 - .it#dra"n certificates

Country 200/ 200 200! 200 2010 2011 Country 200/ 200 200! 200 2010TOT+ !4 1!"" 1"4 222 !! 1/" TOT+ !4 1!"" 1"4 222 !!Al*eria 3 % $ala-!ia % 38 2 #0

Ar*entina 2 $eico 10 %

Au!tralia 1 38 38 1 3( $ontene*ro 2 2

Au!tria 3 % 3 2 $orocco 2 2

.elaru! % 2 Nepal 1 1

.el*ium 1 59 1 #1 1 2 Netherland! 1 %0 1% 18 2

.rail 15 2 8 Ne >ealand ( 11

.ul*aria 5 Nora-

Cam,odia 1 "ai!tan 29 1(Canada 113 21 1%% 11 25 "eru 3

China 10 89 195 10 103 "hilippine! 2 1 1

on* /on* China 1 12 13 1 "oland 18 2#

Taipei Chine!e ( 82 9 23# "ortu*al 1 5 13

Croatia 1 5 1 3 "uerto +ico 3 %

C-pru! 1 atar 1

Cech +epu,lic 5 1# 8 2 ( +omania 1 2

4enmar 2 1 +u!!ian 6ederation 1 #

4ominican +epu,lic 2 Saudi Ara,ia % #

E*-pt 5 22 2 Ser,ia 2 1

Eritrea 1 1 Se-chelle! 1 1E!tonia 1 1 1 Sin*apore 13 2 %9

6inland 1 1#0 2 1 % Sloaia 1 1

6rance 1% 1 1 291 ## Sloenia 2 1 1

7erman- 2 15 20 8 11 101 South Africa 1 10 10

7reece 1 3 2 # Spain 1# 1 3%

un*ar- 21 2 39 1 Sri Lana 1 1

ndia 1 11 20 3 22 Seden ( 5 # ( 1

ndone!ia 1 3 Siterland 9 9( 10 152 1

ran !lamic +epu,lic 1 2 31 Thailand 1 12 25

reland 2 23 ( 1( ( % Ture- % 11 9

!rael % 23 11 1% ( 15 :raine 2 1

tal- 2 11 15 :nited Ara, Emirate! 2 2

=apan 5 1%3 5 2% :nited /in*dom 9 3(0 19 %#0

/orea +epu,lic of ( 10( 21( 20 3(# :SA 332 1% 3%# 3

Liechten!tein 1 1 @iet Nam 2 3

Luem,our* 1 2

The folloin* ta,le *ie! an idea of ithdran certificate! per countr-& t i! proided a! a rou*h indicator ) not all data !ource! re!ponded to the reue!t for !uchfi*ure!&



0

5000

10000

15000

20000

25000

30000

23 41 106 184 164 165 219 264 320 387 316850 1,4842,444 2,662 3,033 3,380

4,040 4,522 4,719 5,675 6,026

54

108

267

285 286

409

456

718

723

835

760

2,830

3,574

7,0497,463

9,008

11,034 10,51512,232

13,203 12,983

1,257

1,966

3,119

2,480 2,982

3,328

4,462

6,637

341

392

276

501694

809

923

902

ISO 13485 !ertificates - "orld"ide total

$iddle Ea!t



Europe

North America

Central and South America

Africa



200% 2005 200# 200( 2008 2009 2010 2011 2012 2013 201%



200% 2005 200# 200( 2008 2009 2010 2011 2012 2013 201%

0'

10'

20'

30'

%0'

50'

#0'

(0'

80'

90'

100'

1 % 1% 0% 0% 0% 0 % 1% 1% 1% 1% 1%1 % 1% 1% 1% 1% 1 % 1% 1% 1% 2% 1%

3 5%

29% 30%

21% 23% 21%

2 1% 23% 21% 25% 27%

5 4%

56%

45%

54%

56%

55%

5 9% 53% 55% 59%

58%

5 %

9%

16% 18%

15% 19%

1 3%

15% 15% 20%

30%

% % !% % % % % "% !% "% !%!%

"%!% % % !%

!% "% "%"%

ISO 13485 - Regional s#are

$iddle Ea!t

Central andS out hA !ia

Ea!t A!iaand "aci fic

Euro pe

Nort hA merica

Central andS out hA merica

Africa





2005 200# 200( 2008 2009 2010 2011 2012 2013 201%

0'

10'

20'

30'

%0'

50'

#0'

(0'

80'

90'

100'

110'

120'

111%

5 8% 62%

2 %

24%

15%

5%

12% 15%

8%

ISO 13485 - .orld annual gro"t# /in 0



200% 2005 200# 200( 2008 2009 2010 2011 2012 2013 201%

0

20

%0

#0

80

100

120

3 4 6 6 6 5 8 9 8 7 7

4

9 10

12 13 13 12

13 14 13 12

3

3

3 3 3 3

3 3 3

3 3

2 8

33

38 37

39 40 38

40 40 39 421 2

13

14 14

14 15 15

15 16

16 16

4

3

5 7

6 7 8

6 7

8 7

1

2

5 5

7 7

9 9

9 9 8

ISO 13485 - )um,er of countries ( economies

$iddle Ea!t



Europe

North A merica

Central and South Ame rica

Africa

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