ISO Quality management systems - Requirements
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1 ISO Quality management systems - Requirements Overview Year TOTAL Africa / West Asia Central / South America North America Europe Far East Australia / New Zealand Regional share - in % Year TOTAL 100% 100% 100% 100% 100% 100% 100% 100% 100% 100% 100% 100% 100% 100% 100% 100% 100% 100% Africa / West Asia 2.7% 2.6% 2.7% 3.8% 3.9% 4.5% 5.0% 4.4% 3.9% 4.2% 4.0% 4.8% 6.2% 8.0% 8.3% 7.4% 7.3% 5.7% Central / South America 0.3% 0.7% 1.0% 1.1% 1.3% 1.9% 2.6% 2.4% 2.8% 2.4% 1.9% 2.6% 2.9% 3.3% 4.1% 4.1% 3.4% 3.7% North America 5.6% 7.0% 8.1% 10.4% 11.3% 12.3% 13.1% 10.5% 10.0% 9.6% 8.1% 7.6% 7.7% 6.8% 5.0% 4.9% 3.9% 3.3% Europe 81.1% 78.7% 72.7% 67.6% 64.3% 61.2% 55.4% 58.8% 52.8% 52.1% 48.7% 48.6% 48.7% 46.2% 45.3% 46.3% 47.0% 47.8% Far East 3.4% 4.4% 7.3% 11.3% 13.4% 13.9% 16.5% 17.9% 24.8% 26.4% 32.7% 33.5% 31.9% 33.5% 36.3% 36.3% 37.4% 38.6% Australia / New Zealand 6.8% 6.6% 8.3% 5.8% 5.8% 6.2% 7.4% 6.0% 5.6% 5.2% 4.6% 3.0% 2.5% 2.2% 0.9% 1.0% 1.0% 0.9% Annual growth - absolute numbers Year TOTAL Africa / West Asia Central / South America North America Europe Far East Australia / New Zealand Annual growth - in % Year TOTAL 51% 81% 28% 37% 22% 26% 33% 11% 10% -11% 33% 17% 16% 6% 3% 8% 4% Africa / West Asia 46% 82% 82% 41% 40% 42% 17% -2% 19% -15% 56% 54% 48% 10% -7% 6% -18% Central / South America 239% 157% 40% 74% 75% 72% 20% 33% -5% -32% 83% 32% 31% 34% 1% -8% 11% North America 88% 111% 64% 48% 33% 35% 7% 5% 6% -25% 24% 19% 3% -23% 1% -12% -13% Europe 47% 67% 19% 31% 16% 14% 42% 0% 9% -17% 32% 18% 10% 4% 6% 10% 6% Far East 95% 199% 99% 62% 27% 49% 45% 55% 17% 10% 36% 12% 22% 15% 3% 12% 8% Australia / New Zealand 45% 127% -10% 37% 29% 51% 8% 6% 1% -22% -12% -5% 3% -56% 15% 3% -5%
2 ISO Quality management systems - Requirements Number of countries / economies Year TOTAL Africa / West Asia Central / South America North America Europe Far East Australia / New Zealand Top 10 countries for ISO 9001 certificates Top 10 countries for ISO 9001 growth China China Italy Russian Federation Russian Federation Italy Spain Brazil Japan United Kingdom Germany Germany United Kingdom Czech Republic India Malaysia United States of America Korea, Republic of Korea, Republic of Indonesia 1048 Far East Kiribati ISO 9001 newcomers
3 ISO Environmental management systems - Requirements with guidance for use Overview Year TOTAL Africa / West Asia Central / South America North America Europe Far East Australia / New Zealand Regional share - in % Year TOTAL 100% 100% 100% 100% 100% 100% 100% 100% 100% 100% 100% 100% Africa / West Asia 2.4% 2.8% 2.5% 2.7% 3.1% 3.3% 3.6% 3.8% 3.6% 4.1% 3.9% 3.4% Central / South America 2.2% 2.4% 1.9% 2.9% 2.6% 3.3% 3.1% 3.4% 2.8% 2.5% 1.8% 2.6% North America 7.0% 7.3% 7.4% 8.2% 8.1% 7.4% 6.4% 6.0% 4.7% 3.8% 3.3% 2.5% Europe 51.8% 48.0% 49.2% 47.1% 47.6% 44.0% 43.0% 43.6% 42.1% 41.4% 40.0% 41.1% Far East 31.1% 34.5% 35.1% 35.9% 36.5% 39.7% 42.1% 41.6% 46.2% 47.6% 50.3% 49.8% Australia / New Zealand 5.5% 4.9% 3.9% 3.2% 2.2% 2.3% 1.8% 1.7% 0.6% 0.7% 0.7% 0.7% Annual growth - absolute numbers Year TOTAL Africa / West Asia Central / South America North America Europe Far East Australia / New Zealand Annual growth - in % Year TOTAL 63% 60% 36% 31% 39% 23% 15% 21% 22% 18% 12% Africa / West Asia 93% 42% 47% 48% 50% 33% 21% 16% 38% 15% -3% Central / South America 80% 22% 108% 19% 75% 15% 28% -2% 9% -16% 64% North America 72% 61% 50% 29% 29% 6% 8% -5% -1% 2% -14% Europe 51% 64% 30% 33% 29% 20% 17% 16% 20% 14% 16% Far East 81% 62% 39% 34% 51% 30% 14% 34% 26% 25% 11% Australia / New Zealand 44% 28% 10% -10% 49% -6% 10% -58% 41% 27% 1%
4 ISO Environmental management systems - Requirements with guidance for use Number of countries / economies Year TOTAL Africa / West Asia Central / South America North America Europe Far East Australia / New Zealand Top 10 countries for ISO certificates China Japan Spain Italy United Kingdom Korea, Republic of Romania Czech Republic Germany Sweden 4622 Top 10 countries for ISO growth China United Kingdom Italy Czech Republic Korea, Republic of Spain Brazil Romania Korea, Democratic People's Republic Colombia 466 ISO newcomers Central / South America Bahamas Far East Kiribati Lao People's Democratic Republic
5 ISO/TS 16949* - Quality management systems - Particular requirements for the application of ISO 9001 for automotive production and relevant service part organizations Overview Year TOTAL Africa / West Asia Central / South America North America Europe Far East Australia / New Zealand Regional share - in % Year TOTAL 100% 100% 100% 100% 100% 100% 100% Africa / West Asia 4.2% 9.2% 9.2% 9.0% 8.8% 9.5% 9.5% Central / South America 3.9% 4.3% 4.5% 3.9% 3.7% 3.6% 3.5% North America 45.1% 26.8% 18.7% 16.8% 15.0% 13.1% 11.9% Europe 32.1% 36.9% 31.9% 28.9% 27.4% 25.5% 24.2% Far East 13.1% 22.5% 35.2% 40.9% 44.6% 47.9% 50.6% Australia / New Zealand 1.6% 0.3% 0.5% 0.5% 0.5% 0.4% 0.4% Annual growth - absolute numbers Year TOTAL Africa / West Asia Central / South America North America Europe Far East Australia / New Zealand Annual growth - in % Year TOTAL 70% 64% 26% 12% 5% 7% Africa / West Asia 276% 64% 23% 10% 13% 7% Central / South America 86% 73% 9% 5% 2% 4% North America 1% 14% 13% 0% -8% -4% Europe 96% 42% 14% 6% -2% 1% Far East 192% 157% 46% 22% 13% 13% Australia / New Zealand -70% 158% 40% 4% -9% -5%
6 ISO/TS 16949* - Quality management systems - Particular requirements for the application of ISO 9001 for automotive production and relevant service part organizations Number of countries / economies Year TOTAL Africa / West Asia Central / South America North America Europe Far East Australia / New Zealand Top 10 countries for ISO/TS certificates China Korea, Republic of United States of America Germany India Japan Brazil Italy Thailand France 1033 Top 10 countries for ISO/TS growth China India Korea, Republic of Thailand 90 5 Brazil 61 6 Taipei, Chinese 57 7 Italy 48 8 Turkey 40 9 Czech Republic Russian Federation 24 Europe Belarus ISO/TS newcomers * Data provided by the International Automotive Task Force
7 ISO/IEC Information technology - Security techniques - Information security management systems - Requirements Overview Year TOTAL Africa / West Asia Central / South America North America Europe Far East Australia / New Zealand Regional share - in % Year TOTAL 100% 100% 100% 100% 100% Africa / West Asia 7.3% 7.8% 10.6% 12.0% 10.2% Central / South America 0.3% 0.5% 0.8% 0.8% 0.7% North America 1.4% 1.4% 2.3% 2.5% 2.1% Europe 18.4% 18.5% 23.5% 27.6% 30.7% Far East 71.6% 71.1% 62.1% 56.7% 55.7% Australia / New Zealand 1.0% 0.7% 0.7% 0.5% 0.6% Annual growth - absolute numbers Year TOTAL Africa / West Asia Central / South America North America Europe Far East Australia / New Zealand Annual growth - in % Year TOTAL 33% 20% 40% 21% Africa / West Asia 41% 64% 58% 2% Central / South America 111% 89% 38% 17% North America 42% 89% 52% 2% Europe 35% 52% 64% 35% Far East 32% 4% 28% 19% Australia / New Zealand -7% 20% -10% 45%
8 ISO/IEC Information technology - Security techniques - Information security management systems - Requirements Number of countries / economies Year TOTAL Africa / West Asia Central / South America North America Europe Far East Australia / New Zealand Top 10 countries for ISO/IEC certificates Japan India United Kingdom Taipei, Chinese China Spain Czech Republic Italy Germany Romania 350 Top 10 countries for ISO/IEC growth Japan China Czech Republic Spain United Kingdom Germany Taipei, Chinese 94 8 Italy 77 9 Bulgaria Romania 47 Central / South America El Salvador Guatemala Panama Far East Korea, Democratic People's Republic ISO/IEC newcomers
9 ISO Food safety management systems - Requirements for any organization in the food chain Overview Year TOTAL Africa / West Asia Central / South America North America Europe Far East Australia / New Zealand Regional share - in % Year TOTAL 100% 100% 100% 100% Africa / West Asia 12.7% 17.9% 15.6% 13.9% Central / South America 2.2% 3.0% 1.9% 2.2% North America 1.2% 0.6% 0.7% 1.0% Europe 66.5% 59.3% 43.6% 38.0% Far East 17.0% 18.7% 37.7% 44.4% Australia / New Zealand 0.3% 0.5% 0.5% 0.5% Annual growth - absolute numbers Year TOTAL Africa / West Asia Central / South America North America Europe Far East Australia / New Zealand Annual growth - in % Year TOTAL 99% 69% 34% Africa / West Asia 179% 48% 20% Central / South America 168% 4% 61% North America -2% 115% 76% Europe 77% 24% 17% Far East 118% 240% 58% Australia / New Zealand 242% 61% 39%
10 ISO Food safety management systems - Requirements for any organization in the food chain Number of countries / economies Year TOTAL Africa / West Asia Central / South America North America Europe Far East Australia / New Zealand Top 10 countries for ISO certificates China Greece Turkey India Taipei, Chinese Romania Poland Japan Spain Egypt 276 Top 10 countries for ISO growth China Japan Greece Egypt Taipei, Chinese Malaysia Italy Spain 95 9 Serbia Poland 80 ISO newcomers Africa / West Asia Botswana Côte D'Ivoire Madagascar Malawi Senegal Yemen Zambia Zimbabwe Central / South America Barbados Dominican Republic Netherlands Antilles Europe Azerbaijan Iceland Far East Brunei Darussalam Cambodia Lao People's Democratic Republic
11 ISO Medical devices - Quality management systems - Requirements for regulatory purposes Overview Year TOTAL Africa / West Asia Central / South America North America Europe Far East Australia / New Zealand Regional share - in % Year TOTAL 100% 100% 100% 100% 100% 100% 100% Africa / West Asia 4.1% 5.4% 8.0% 5.6% 4.6% 4.6% 5.6% Central / South America 1.0% 0.8% 1.3% 1.4% 1.2% 1.0% 1.2% North America 35.4% 29.3% 30.5% 20.5% 22.9% 20.6% 21.5% Europe 54.4% 55.9% 44.5% 54.3% 56.4% 54.8% 58.6% Far East 4.9% 7.9% 14.7% 17.7% 14.4% 18.5% 12.7% Australia / New Zealand 0.2% 0.7% 0.9% 0.5% 0.4% 0.5% 0.4% Annual growth - absolute numbers Year TOTAL Africa / West Asia Central / South America North America Europe Far East Australia / New Zealand Annual growth - in % Year TOTAL 111% 58% 62% 2% 24% 15% Africa / West Asia 181% 134% 13% -17% 24% 41% Central / South America 78% 159% 74% -11% 1% 33% North America 75% 65% 9% 14% 11% 20% Europe 116% 26% 97% 6% 21% 22% Far East 237% 197% 94% -17% 59% -21% Australia / New Zealand 517% 105% -18% -11% 44% 1%
12 ISO Medical devices - Quality management systems - Requirements for regulatory purposes Number of countries / economies Year TOTAL Africa / West Asia Central / South America North America Europe Far East Australia / New Zealand Top 10 countries for ISO certificates United States of America Germany Italy United Kingdom Switzerland France Japan China Korea, Republic of Canada 481 Top 10 countries for ISO growth Italy United States of America United Kingdom Germany Korea, Republic of Switzerland Pakistan India 88 9 Japan Netherlands 79 Africa / West Asia Afghanistan Central African Republic Kenya Lebanon Oman Tunisia Europe Malta ISO newcomers
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