The ISO Survey of Management System Standard Certifications (2004-2014)

The ISO Survey of Management System
Standard Certifications (2004-2014)

ISO 13485 - Medical devices - Quality management systems - Requirements for
regulatory purposes
Overview - tables
Countries
Number of sites
Withdrawn certificates
Certificates - worldwide total - diagram
Regional share - diagram
World annual growth (in %) - diagram
Number of countries / economies - diagram
ISO 13485 - Medical devices - Quality management systems

Overview
Year
2004
TOTAL
2403
Africa
Central and South America
North America
Europe
East Asia and Pacific
Central and South Asia
Middle East
29
23
850
1,308
123
16
54
Regional share - in %
Year
2004
TOTAL
100%
Africa
North America
Europe
Middle East
1.2%
1.0%
35.4%
54.4%
5.1%
0.7%
2.2%
Year
2004
TOTAL
Africa
North America
Europe
Middle East
Year
TOTAL
Africa
North America
Europe
Middle East
Year
2004
TOTAL
55
Africa
North America
Europe
Middle East
3
4
3
28
12
4
1
Top 10 countrie
1
2
3
4
5
6
7
8
9
10
Top 10 countr
1
2
3
4
5
6
7
8
9
10
management systems - Requirements for regulatory purposes
2005
2006
2007
5065
8026
12985
34
41
1,484
2,830
37
106
2,444
3,574
54
184
2,662
7,049
435
133
108
1,257
341
267
2,359
392
285
2005
2006
2007
100%
100%
100%
0.7%
0.8%
29.3%
55.9%
8.6%
2.6%
2.1%
0.5%
1.3%
30.5%
44.5%
15.7%
4.2%
3.3%
0.4%
1.4%
20.5%
54.3%
18.2%
3.0%
2.2%
Annual growth - absolute num

2005
2006
2007
2662
2961
4959
5
18
634
1,522
312
117
54
3
65
960
744
822
208
159
17
78
218
3,475
1,102
51
18
Annual growth - in %
2005
2006
2007
111%
58%
62%
17%
78%
75%
116%
254%
731%
100%
9%
159%
65%
26%
189%
156%
147%
46%
74%
9%
97%
88%
15%
7%
Number of countries / econom

2005
2006
2007
67
81
84
4
9
3
33
13
3
2
6
10
3
38
14
5
5
6
12
3
37
14
7
5
Top 10 countries for ISO 13485 certificates - 2014

USA
Germany
Italy
China
United Kingdom
Switzerland
Korea, Republic of
Japan
France
5175
2890
2695
2559
1890
1304
1169
1076
1059
Taipei, Chinese
764
Top 10 countries for ISO 13485 growth - 2014

CHINA
ITALY
KOREA, REPUBLIC OF
SWITZERLAND
JAPAN
CANADA
USA
SPAIN
MALAYSIA
UNITED KINGDOM
1229
571
430
319
241
218
140
109
103
78
ulatory purposes
2008
2009
2010
13234
16425
18834
63
164
3,033
7,463
68
165
3,380
9,008
104
219
4,040
11,034
1,966
259
286
3,119
276
409
2,480
501
456
2008
2009
2010
100%
100%
100%
0.5%
1.2%
22.9%
56.4%
14.9%
2.0%
2.2%
0.4%
1.0%
20.6%
54.8%
19.0%
1.7%
2.5%
0.6%
1.2%
21.5%
58.6%
13.2%
2.7%
2.4%
2008
2009
2010
249
3191
2409
9
-20
371
414
-393
-133
1
5
1
347
1,545
1,153
17
123
36
54
660
2,026
-639
225
47
2009
2010
al growth - absolute numbers
Annual growth - in %
2008
2%
24%
15%
17%
-11%
14%
6%
-17%
-34%
0%
8%
1%
11%
21%
59%
7%
43%
53%
33%
20%
22%
-20%
82%
11%
2008
2009
2010
88
90
93
6
13
3
39
14
6
7
5
13
3
40
15
7
7
8
12
3
38
15
8
9
ber of countries / economies
014
5175
2890
2695
2559
1890
1304
1169
1076
1059
764
4
1229
571
430
319
241
218
140
109
103
78
2011
2012
2013
19849
22317
25655
154
264
4,522
10,515
186
320
4,719
12,232
170
387
5,675
13,203
2,982
694
718
3,328
809
723
4,462
923
835
2011
2012
2013
100%
100%
100%
0.8%
1.3%
22.8%
53.0%
15.0%
3.5%
3.6%
0.8%
1.4%
21.1%
54.8%
14.9%
3.6%
3.2%
0.8%
1.7%
25.4%
59.2%
20.0%
4.1%
3.7%
2011
2012
2013
1015
2468
3338
50
45
482
-519
502
193
262
32
56
197
1,717
346
115
5
-16
67
956
971
1,134
114
112
2011
2012
2013
5%
12%
15%
48%
21%
12%
-5%
20%
39%
57%
21%
21%
4%
16%
12%
17%
1%
-9%
21%
20%
8%
34%
14%
15%
2011
2012
2013
95
97
95
9
13
3
40
15
6
9
8
14
3
40
16
7
9
7
13
3
39
16
8
9
2014
27791
167
316
6,026
12,983
6,637
902
760
2014
100%
0.7%
1.4%
27.0%
58.2%
29.7%
4.0%
3.4%
2014
2136
-3
-71
351
-220
2,175
-21
-75
2014
8%
-2%
-18%
6%
-2%
49%
-2%
-9%
2014
95
7
12
3
42
16
7
8
ISO 13485 - Certificates worldwide - growth from end of 2004 to end of 2014
ISO 13485 - Africa
Year
Country
Algeria
Central African Republic
Egypt
Eritrea
Kenya
Malawi
Mauritius
Morocco
South Africa
Swaziland
Tunisia
ISO 13485 - Europe
2004
2005
2006
2007
2008
2009
2010
2011
2012
2013
2014
29
34
37
3
54
3
63
2
68
4
154
4
186
4
170
6
167
6
5
1
6
1
22
1
33
1
104
4
7
45
1
1
65
1
1
61
1
1
74
2
1
75
2
1
2
3
24
1
2
24
2
25
1
2
32
10
2
26
3
27
10
4
41
1
3
5
42
24
9
4
59
52
4
4
82
1
0
6
70
7
Year
Country
Andorra
Austria
Belarus
Belgium
Bosnia and Herzegovina
Bulgaria
Croatia
Cyprus
Czech Republic
Denmark
Estonia
Finland
ISO 13485 - Central / South America

Year
Country
Argentina
Barbados
Bermudas
Bolivia
Brazil
Chile
Colombia
Costa Rica
Dominican Republic
Honduras
Netherlands Antilles
Peru
Puerto Rico
Trinidad and Tobago
Uruguay
France
2004
2005
2006
2007
2008
2009
2010
2011
2012
2013
2014
23
5
41
4
106
21
1
184
56
1
164
44
1
165
35
1
219
37
1
264
70
1
316
57
2
40
73
2
1
6
2
1
1
62
2
2
4
4
1
1
65
2
2
6
3
1
1
95
3
10
7
4
1
320
60
1
1
1
127
3
46
23
9
1
2005
1308
2830
46
71
13
12
2
1
2
1
18
10
2
54
19
2
144
153
177
5
15
2
19
824
5
12
1
33
69
1
Georgia
10
19
105
3
20
13
5
1
3
4
387
63
1
0
1
158
8
66
28
9
1
2
10
13
Germany
Greece
Hungary
Iceland
Ireland
Italy
Latvia
Liechtenstein
Lithuania
Luxembourg
Malta
Monaco
Montenegro
16
24
28
31
35
37
34
32
36
31
Netherlands
15
31
2
2
2
3
1
4
1
3
4
1
3
6
0
4
1
3
Norway
Poland
Portugal
12
21
1
10
25
20
2
1
1
1
10
2004
4
2
1
1
117
6
58
15
12
2
2
1
Romania
ISO 13485 - North America

Year
Country
Canada
Mexico
USA
Russian Federation*
2004
2005
2006
2007
2008
2009
2010
2011
2012
2013
2014
San Marino Republic of
850
57
23
770
1484
146
28
1310
2444
306
25
2113
2662
408
68
2186
3033
443
67
2523
3380
453
93
2834
4040
481
108
3451
4522
562
130
3830
4719
503
142
4074
5675
508
132
5035
6026
726
125
5175
Serbia
Serbia and Montenegro
Slovakia
Slovenia
Spain
ISO 13485 - East Asia and Pacific

Year
Country
Sweden
2004
2005
2006
2007
2008
2009
2010
2011
2012
2013
2014
123
435
1257
2359
1966
3119
2480
2982
3328
4462
6637
68
2
509
32
83
2
633
42
82
2
759
44
111
2
1330
57
157
5
2559
87
410
450
571
690
764
Australia
Cambodia
China
Hong Kong, China
35
69
55
45
14
3
21
15
228
30
1329
20
1122
26
67
1
1498
32
Taipei, Chinese
16
15
35
42
66
362
Switzerland
The former Yugoslav Republic
of Macedonia
Turkey
Ukraine
United Kingdom
*The figures include certificates accredited by
national accredited bodies not members of the
IAF.
4
2
1
3
3
2
3
4
67
85
161
367
12
21
548
973
ISO 13485 - Certificates worldwide - growth from end of 2004 to end of 2014
Macau, China
Indonesia
10
ISO/TS 13485 - Central and South Asia
18
Year
2004
2005
16
133
India
Kazakhstan
Nepal
17
Pakistan
Seychelles
4
2
114
2
2004
2005
54
108
1
107
22
53
32
Japan
21
211
438
456
393
452
539
733
752
835
1076
Country
Korea, Democratic People's

Republic
Korea, Republic of
28
9
28
229
6
255
27
33
2
343
18
500
3
588
1
575
2
739
1169
Afghanistan
Bangladesh
20
101
107
122
156
176
194
10
12
12
12
228
1
15
284
1
20
387
1
22
Malaysia
Myanmar
New Zealand
Papua New Guinea
Philippines
10
21
21
15
14
14
1
28
Singapore
Thailand
17
3
50
4
46
32
42
27
69
35
102
59
127
59
146
69
162
75
183
94
193
118
11
14
14
25
29
38
Viet Nam
Sri Lanka
Tajikistan
Usbekistan
ISO/TS 13485 - Middle East

Year
Country
Iran, Islamic Republic of
Israel
Jordan
Lebanon
Oman
Qatar
Saudi Arabia
Syrian Arab Republic
United Arab Emirates
54
014
2006
2007
2008
2009
2010
2011
2012
3574
7049
7463
9008
11034
10515
12232
68
5
75
1
2
158
3
79
2
5
10
197
6
123
1
17
15
128
4
143
199
76
3
160
5
99
2
10
13
3
131
113
3
137
5
112
1
2
65
7
7
140
6
76
2
5
6
2
221
56
2
20
188
31
86
518
709
709
699
26
27
2204
31
37
84
376
3
2
1
3
164
111
9
36
17
1
195
156
9
50
67
104
788
865
1035
945
95
1482
1
4
2
3
2651
32
36
1
116
1112
1
7
1
6
3019
49
45
4
121
1109
8
6
1
7
1
2
3438
50
69
5
159
1346
5
7
7
7
1
4
4140
72
92
5
193
2052
3
16
7
8
2
2
3
2
3291
61
58
4
155
1881
1
12
8
5
1
1
55
47
91
206
285
336
396
26
70
22
24
76
28
26
76
11
31
144
17
36
158
24
45
154
28
32
193
38
16
1
183
119
5
28
56
109
97
25
28
22
94
114
74
90
10
11
30
32
47
9
6
22
6
23
5
66
8
43
11
24
13
50
17
29
40
57
78
98
124
161
177
231
239
284
254
315
266
446
608
728
836
985
695
843
55
2
648
52
6
589
2
16
5
901
1
83
6
1330
86
2
1880
1
101
5
1615
3
86
9
1573
014
nd South Asia
2006
2007
2008
2009
2010
2011
2012
341
392
259
276
501
694
809
3
1
188
222
197
189
1
1
277
1
1
359
4
1
386
4
1
138
2
152
3
49
4
72
4
208
2
322
3
406
3
12
2006
2007
2008
2009
2010
2011
2012
267
12
244
1
285
20
255
3
286
34
233
3
409
61
330
5
1
7
1
7
1
7
2
3
456
72
359
9
1
1
1
8
2
3
718
109
585
7
1
1
1
8
3
3
723
65
630
7
2
2
1
9
2
5
ast
ISO 13485 - Number of sites covered by ISO 13485 certificates - single-site and multiple-site
certificates, plus unspecified sites, cumulated
The following table gives an idea of the number of sites covered by the certificate per country. It is provided as a rough indicator - not all data sources responded to
the request for such figures.
Country
TOTAL
Afghanistan
Algeria
Andorra
Argentina
Australia
Austria
Bahrain
Bangladesh
Barbados
Belarus
Belgium
Bermudas
Bolivia
Bosnia and Herzegovina
Brazil
Bulgaria
Cambodia
Canada
Chile
China
Hong Kong, China
Macau, China
Taipei, Chinese
Colombia
Costa Rica
Croatia
Cyprus
Czech Republic
Denmark
Dominican Republic
Egypt
Eritrea
Estonia
Finland
France
Germany
Greece
Honduras
Hungary
Iceland
India
Indonesia
Iran, Islamic Republic of
Ireland
Israel
2007
2008
2009
2010
2011
2012
5001
5159
6733
9437
170296
121643
8
2
43
5
8
42
32
25
37
45
17
41
44
10
55
51
24
21
2
72
2
61
1
38
29
266
2
1097
16
335
2
1
1
47
7
1
517
43
3
3
1
47
26
3
5
1
2
6
367
1
2
12
57
14
154
1
186
5
2
14
1
3
24
18
1548
12
35
91
2
77
228
18
350
26
2
65
2
78
1
70
2
377
4
401
28
120
28
1
22
1
6
79
1019
377
26
15
1
158
32
1
34
1
6
53
977
65
34
463
17
2
15
1
147
51
3
36
1
7
102
1067
2884
5
35
43
54
62
108
4
153
3
28
65
205
181
3
38
21
187
235
3
40
98
380
14
200
427
15
1
58
11
2
425
4
479
32
2013
2014
175985 189641
3
4
6
6
1
67
18
21
55
78
146
34
195
280
0
0
1
3
2
1
0
2
4
2
4
116
108
183
1
0
0
0
0
0
97
71
71
30
26
35
2
1
5
448
576
759
4
2
6
698
915
1941
46
36
85
24
609
290
463
23
41
79
16
4
10
16
10
12
1
0
2
184
246
266
22
164
174
7
3
12
48
69
75
1
2
2
7
3
7
112
40
27
1602
1518
2190
2827
1976
1814
69
116
66
1
0
90
88
89
5
0
12
341
274
354
20
7
31
17
63
89
170
70
121
453
431
270
Country
TOTAL
Malawi
Malaysia
Malta
Mauritius
Mexico
Monaco
Montenegro
Morocco
Myanmar
Nepal
Netherlands
Netherlands Ant.
New Zealand
Norway
Oman
Pakistan
Papua New Guinea
Peru
Philippines
Poland
Portugal
Puerto Rico
Qatar
Romania
Russian Federation
San Marino
Saudi Arabia
Senegal
Serbia
Seychelles
Singapore
Slovakia
Slovenia
South Africa
Spain
Sri Lanka
Swaziland
Sweden
Switzerland
Syrian Arab Republic
Thailand
The
former Yugoslav
Republic of Macedonia
Trinidad and Tobago
Tunisia
Turkey
2007
2008
2009
5001
5159
6733
48
58
80
23
26
28
2
2
2
2
2
3
1
52
1
22
1
22
7
5
9
12
11
22
26
29
9
20
7
1
64
27
6
1
5
21
9
14
145
16
7
1
27
73
1
1
17
21
11
25
1
1
2
37
20
1
10
55
1
1
2
60
65
1
12
81
3
223
133
69
206
88
189
1
29
8
2
66
5
6
16
2
2
1
36
83
ISO 13485 - Withdrawn certificates

The following table gives an idea of withdrawn certificates per country. It is provided as a rough indicator - not all data sources responded to the request for such
figures.
Country
TOTAL
Algeria
Argentina
Australia
Austria
Belarus
Belgium
Brazil
Bulgaria
Cambodia
Canada
China
Hong Kong, China
Taipei, Chinese
Croatia
Cyprus
Czech Republic
Denmark
Dominican Republic
Egypt
Eritrea
Estonia
Finland
France
Germany
Greece
Hungary
India
Indonesia
Iran, Islamic Republic
Ireland
Israel
Italy
Japan
Korea, Republic of
Liechtenstein
Luxembourg
2006
2007
2008
2009
2010
2011
84
1855
154
2223
788
1675
10
1
38
3
4
59
113
89
12
7
21
1
14
2
1
5
2
2
5
1
1
160
15
1
21
11
1
2
4
23
23
5
7
143
107
1
1
16
1
38
4
2
61
15
5
1
144
195
13
82
5
8
22
1
1
2
1
20
2
7
11
1
8
3
39
20
3
1
17
14
2
217
1
2
Country
2
1
3
37
2
1
2
2
8
11
10
1
9
1
25
103
236
3
2
1
1
291
11
2
3
4
66
101
6
1
22
2
7
7
11
5
20
31
4
15
15
24
376
TOTAL
Malaysia
Mexico
Montenegro
Morocco
Nepal
Netherlands
New Zealand
Norway
Pakistan
Peru
Philippines
Poland
Portugal
Puerto Rico
Qatar
Romania
Russian Federation
Saudi Arabia
Serbia
Seychelles
Singapore
Slovakia
Slovenia
South Africa
Spain
Sri Lanka
Sweden
Switzerland
Thailand
Turkey
Ukraine
United Arab Emirates
United Kingdom
USA
Viet Nam
2006
84
2007
4
1855
38
10
2
2
1
40
7
2
18
5
3
2008
154
2009
2
14
1
1
4
2
1
13
1
2
1
7
9
1
2
1
10
16
1
5
97
12
4
2
2
370
332
2
1
6
10
19
14
2223
60
4
2
2
1
18
11
29
3
1
26
13
4
1
2
6
6
1
1
49
1
1
10
34
1
7
152
25
11
1
2
460
346
3
2010
788
21
1
176
3
9
2
1
1
1
4
13
14
95
5
35
ISO 13485 Certificates - worldwide total

30,000
760
902
Middle East
835
923
25,000

6,637
723
809
20,000
456
501
409
276
15,000
Africa
3,328
2,982
286
1,966
267
341
1,257
5,000
108
54
850
23
2004
12,983
11,034
10,515
4,040
4,522
4,719
5,675
6,026
9,008
7,049
7,463
3,574
2,830
1,484
41
2005
13,203
12,232
10,000
North America
3,119
285
392
2,480
718
694
4,462
Europe
2,444
2,662
3,033
3,380
106
184
164
165
219
264
320
387
316
2006
2007
2008
2009
2010
2011
2012
2013
2014
5,000
108
54
850
23
2004
3,574
2,830
1,484
41
2005
4,040
4,522
4,719
5,675
6,026
2,444
2,662
3,033
3,380
106
184
164
165
219
264
320
387
316
2006
2007
2008
2009
2010
2011
2012
2013
2014
I
SO
1 0
0 %
2
%
5
2
%
3
%
3
%
4
%
2
%
3
%
9
%
9 0 %
13485
2
%
2
%
R
e gi
o na
l
2
%
2
%
2
%
3
%
s
ha r
e
4
3
%
%
3
%
4
%
4
%
4
%
3
%
4
%
M
1
5
%
1
6
%
1
8
%
1
9
%
3
%
9
%
d d l e
i
C
e
1
5
1
5
%
5
3
5
5
%
2
0
%
8 0 %
3
0
%
n t
r
a
E a
s
E u
r
o p
e
N
o r
t
C
e
4
%
6 0 %
5
6
%
4
5
%
5 0 %
5
6
%
5
4
%
5
5
%
5
9
%
5
8
%
4 0 %
3 0 %
2 0 %
5
%
2
9
%
3
0
%
2
1
%
1 0 %
0 %
1
1
%
%
2 0 0 4
1
%
1
%
2 0 0 5
1
%
0
%
2 0 0 6
1
%
0
%
2 0 0 7
2
3
%
1
%
0
%
2 0 0 8
2
1
%
1
%
0
%
2 0 0 9
1
%
1
%
1
%
2 0 1 0
2
3
1
%
1
%
2 0 1 1
2
1
%
1
%
1
%
2 0 1 2
2
5
%
2
%
1
%
2 0 1 3
2
7
%
1
%
1
%
2 0 1 4
E a
s
l
As
h A
n t
r
a
Afr
i c
7 0 %
n d S
i a
m e
a
n d
r
i c
n d S
o
u t
P
a
h A
s
i a
i fi c
a
o
u t
h A
m e
r
i c
I
SO
13485
Wo
rl
d
a
nnua l
gro
wt h
(
i
n
% )
1
2 0
%
1
1 0
%
1
1
1
%
1
0 0
%
9
0 %
8
0 %
7
0 %
5
6
0 %
8
%
6
2
%
5
0 %
4
0 %
3
0 %
2
4
%
2
0 %
1
5
%
1
2
%
1
5
%
8
%
1
0 %
2
5
%
0
%
2
0 0
5
2 0
0 6
2 0 0
7
2 0
0 8
2 0 0
9
2
0 1 0
2 0
1 1
2
0 1
2
2 0
1 3
2
0 1
4
I
SO
13485
N
um be
r
o
f
co
unt r
i e
s
e
co
no m
i
e s
1 2 0
i d d l e
Ce n
1 0 0
8
0
5
5
2
3
6
0
1
4
1
5
7
1
4
1
4
3
8
3
7
1
4
1
5
1
5
3
9
4
0
3
8
9
6
9
7
1
5
1
6
4
0
4
0
9
8
1
6
8
7
1
6
1
3
4
0
3
9
4
2
3
3
2
2
0
3
3
4
3
2
0 0
4
9
4
2
0 0 5
3
1
0
6
2 0
0 6
3
1
2
6
2 0 0
7
3
1
3
6
2
0 0
8
3
1
3
5
2 0
0 9
3
1
2
8
2 0
1 0
3
1
3
9
2 0 1
1
3
1
4
8
2
0 1 2
3
1
3
7
2 0
1 3
3
1
2
7
2 0
1 4
t
r
a
E a s
E u r
o p e
N
o r
t
h
Ce n
Afr
As
E a s
l
a n d
i a
t
r
a
i c
So u t
h
a n d
me r
a n d
i c
a c
As
i a
i fi c
So u t
h
Am e
r
i c

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ISO 13485 - Medical devices - Quality management systems

management systems - Requirements for regulatory purposes

Annual growth - absolute num

Number of countries / econom

Top 10 countries for ISO 13485 certificates - 2014

Top 10 countries for ISO 13485 growth - 2014

al growth - absolute numbers

ber of countries / economies

ISO 13485 - Europe

ISO 13485 - Central / South America

ISO 13485 - North America

San Marino Republic of

ISO 13485 - East Asia and Pacific

ISO/TS 13485 - Central and South Asia

Korea, Democratic People's

ISO/TS 13485 - Middle East

ISO 13485 - Withdrawn certificates

ISO 13485 Certificates - worldwide total

Central and South Asia

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