ISO Survey confirms boost in management systems (ISO 9001 Quality / 13485 Medical Devices / 22716 Cosmetics GMP)

‘The numbers are in. Getting certified to ISO management systems is on the rise.

The latest edition reveals a healthy growth across the board for all certifications at the end of 2012, exhibiting a worldwide total of 1 504 213 certificates across 191 countries. Overall, Asia comes up trumps once again in this year’s survey. Spurred by continued economic growth and important industrial and manufacturing production, China remains in the top 10 countries for six out of the seven standards covered in this survey.

ISO 9001 gives the requirements for quality management systems. Certification to the standard is used in global supply chains to provide assurance about suppliers’ ability to satisfy quality requirements and to enhance customer satisfaction in supplier-customer relationships.  Up to the end of December 2012, at least 1 101 272 certificates had been issued in 184 countries and economies, four more than in the previous year. The 2012 total represents an increase of 2 % (+21 625) over 2011.  The top three countries for the total number of certificates issued were China, Italy and Spain, while the top three for growth in the number of certificates in 2012 were Spain, China and Romania.

ISO 14001 which gives the requirements for environmental management systems, retains its global relevance for organizations wishing to operate in an environmentally sustainable manner.  Up to the end of December 2012, at least 285 844 ISO 14001:2004 certificates, a growth of 9 % (+ 23 887), had been issued in 167 countries, nine more than in the previous year. The top three countries for the total number of certificates issued were China, Japan and Italy, while the top three for growth in the number of certificates in 2012 were China, Spain and Italy.

ISO 13485 gives quality management requirements for the medical devices sector for regulatory purposes. Up to the end of December 2012, at least 22 237 ISO 13485:2003 certificates, a growth of 12 % (+2 388), had been issued in 97 countries and economies, two more than in the previous year. The top three countries for the total number of certificates issued were Germany, the USA and Italy, while the top three for growth in the number of certificates in 2012 were Italy, Germany and the USA. ‘

ISO 22716 gives the requirements for the manufacture of cosmetics according to GMP. As this standard is at its infancy stages, no data is available. Stay tuned however as it is becoming increasingly popular.

About CMS:

Compliance Management Solutions is a Melbourne based consultancy assisting organizations in obtaining and maintaining TGA (medicinal products and medical devices ISO 13485) | ISO 9001 (Quality) | Cosmetics GMP ISO 22716 | AS/NZS 4801 (OH&S) | ISO 14001 (Environmental) certification and registration.