ISO Certification - ISO Certification for medical industry

ISO Certification

What is ISO? Established in 1947 as a non-governmental organization, ISO (International Organization for Standardization) is the world's largest publisher of standards in 157 countries.

What are some ISO standards for medical industry?

There are various ISO standards that can be implemented for a medical industry. Here are some ISO standards for medical industries:

IWA 1:2001 --- Quality management systems - Guidelines for process improvements in health service organizations

ISO/IEC Guide 63:1999 --- Guide to the development and inclusion of safety aspects in International Standards for medical devices

ISO/TR 11991:1995 --- Guidance on airway management during laser surgery of upper airway

ISO/ASTM 51939:2002 --- Practice for blood irradiation dosimetry

ISO 13485:1996 --- Quality systems- Medical devices- Particular requirements for the application of ISO 9001

ISO 13485:2003 --- Medical devices- Quality management systems- Requirements for regulatory purposes

ISO 13488:1996 --- Quality systems- Medical devices- Particular requirements for the application of ISO 9002

Advantages of ISO Certification

Here are some basic advantages ISO Certification

All your processes are evaluated, standardized and explained to the personnel
Training new employees is made much easier
Problems are detected more quickly and solutions/results are improved
Improved customer satisfaction
Better perception of your company
Efficient use of resources
Improved participation and cooperation of employees
Better understanding of customer needs