| ISO (International organization for Standardization) | | | | tool available to you to meet the quality system |
| & CEN (European committee for standardsation) | | | | requirement and there are a number of really |
| are two main professional bodies for formulating | | | | compelling reasons to apply ISO 13485. |
| standards. Standards can be described as vertical or | | | | First, If you are in compliance with ISO 13485:2003, |
| horizontal, depending on how broad they are. A | | | | you are presumed to be in compliance with the |
| vertical standard is specific to a device and a | | | | quality system requirements of these directives. |
| horizontal standard applies to a wide range of | | | | Second why reinvent the wheel? ISO 13485 :2003 is |
| devices. Example of common horizontal standards are | | | | designed especially for medical device companies. |
| ISO 13485 and ISO 14971. An example of a vertical | | | | Third, ISO 13485:2003 is recognized worldwide, and |
| standard is ISO 7197:2006, which deals with | | | | your certification automatically improves the |
| neosurgical implants. Following is a brief discussion | | | | perception of your company and its products. |
| about the horizontal standards most often applied to | | | | Standards are not permanent and often updated or |
| medical device companies. ISO 13485:2003-Quality | | | | replaced by new one over the due period. |
| system: ISO 13485 was adopted in Europe in 1996 | | | | Following are some examples of standards: |
| and is a modified version of ISO 9001 but with | | | | EN60601- ELECTRICAL SAFETY |
| additional requirements especially tailored for the | | | | Any medical device company that makes a device |
| medical device industry. Most people believe that ISO | | | | with an electrical component knows about EN60601 |
| 13485:2003 and many standards in general, is a | | | | series. This standard deals with electrical safety and |
| requirement, but this is not true. It is voluntary in the | | | | electromagnetic compatibility(EMC). (CE marking) |
| context of the European directives for medical | | | | EN 980- Use of symbols on labeling |
| devices. It is true that you are required to meet the | | | | ISO 14971- RISK MANAGEMENT |
| quality system requirements outlined in the | | | | ISO 1497:2000 sets a formal process for dealing with |
| directives(Annex 2 and Annex 5 specifically), but how | | | | risk and focuses on how your company can produce |
| you are going to meet those quality system | | | | safer products. |
| requirements is left to you, ISO 13485 is a voluntary | | | | |