| There are two things that can help the medical | | | | be authorized for CE identification, and permission to |
| industry by leaps and bounds: | | | | sell within the European Union will be granted. |
| Quality regulation for medical equipment, medicine, | | | | The ISO, or International Organization for |
| and dental products, and... | | | | Standardization, is an international-standards-setting |
| A completely free market | | | | organization composed of a number of |
| This should only make sense. With a free market, | | | | representatives from a number of national standards |
| you have multiple companies competing with each | | | | organizations from all participating countries. The ISO |
| other. Each one striving hard to outdo the other, | | | | is stationed in Geneva, Switzerland. |
| trying to develop new solutions and alternatives, and | | | | The ISO defines itself as a non-governmental |
| new, more effective, more efficient equipment. And, | | | | organization, although it often sets standards that |
| of course, with some degree of quality control, bad | | | | become law, either through the use of treaties or |
| drugs are kept off the market, shoddy equipment | | | | national standards. This makes the ISO much more |
| isn't sold, and patients can rest easy. | | | | powerful than your average non-governmental |
| The ISO 13485 is an ISO standard, first published in | | | | organization. The ISO is generally considered a |
| 2003, representing certain requirements for a | | | | consortium with strong governmental links. |
| comprehensive management system, and for the | | | | As of this writing, the ISO has 157 national members |
| designing and manufacturing of medical instruments | | | | from a total of 195 countries in the world. There are |
| and equipment. The ISO 13485 supersedes earlier | | | | three membership categories for ISO participants: |
| documents, including the 1997 EN 46001 and 46002. | | | | Member Bodies |
| The 13485 is a stand alone document, but is | | | | National bodies considered to be the most |
| harmonized with the ISO 9001. One difference | | | | representative standards body in each participating |
| between these two documents; the 9001 requires | | | | country. These are the ISO members with voting |
| for an organization to demonstrate continued | | | | rights. |
| improvement on all products, while the 13485 only | | | | Correspondent Members |
| requires that a quality system be implemented and | | | | Countries that lack their own standards organizations. |
| maintained. | | | | These members stay up to date on the going-ons |
| The document is very important, as it is generally | | | | within the ISO, but do not actually participate in the |
| seen as the first step for any medical device | | | | initiating or voting on standards. |
| manufacturer in the process of achieving compliance | | | | Subscriber Members |
| with regulatory requirements. Medical Devices, dental | | | | Countries with small or struggling economies, these |
| tools and In-Vitro Diagnostic Medical Devices must | | | | members pay reduced membership fees and follow |
| conform to EEC-decrees 93/42/EEC and 98/69/EEC, | | | | the development of ISO standards. |
| and their adherence must be assessed to prove | | | | What the ISO has done for the medical industry has |
| conformity before any sales are permitted. The most | | | | been very helpful. Before the ISO, it was much |
| common method to prove conformity would be | | | | easier to buy, well, crummy, unreliable equipment. |
| Quality Management System certification, according | | | | Today, an ISO-certified company can be trusted to |
| to ISO 9001 and/or 13485 by a Conformity | | | | create quality dental products. |
| Assessment Body, or CAB. A positive assessment will | | | | |