ISO 13485 Quality Systems

There are two things that can help the medical industry by leaps and bounds:

Quality regulation for medical equipment, medicine, and dental products, and…

A completely free market

This should only make sense. With a free market, you have multiple companies competing with each other. Each one striving hard to outdo the other, trying to develop new solutions and alternatives, and new, more effective, more efficient equipment. And, of course, with some degree of quality control, bad drugs are kept off the market, shoddy equipment isn’t sold, and patients can rest easy.

The ISO 13485 is an ISO standard, first published in 2003, representing certain requirements for a comprehensive management system, and for the designing and manufacturing of medical instruments and equipment. The ISO 13485 supersedes earlier documents, including the 1997 EN 46001 and 46002.

The 13485 is a stand alone document, but is harmonized with the ISO 9001. One difference between these two documents; the 9001 requires for an organization to demonstrate continued improvement on all products, while the 13485 only requires that a quality system be implemented and maintained.

The document is very important, as it is generally seen as the first step for any medical device manufacturer in the process of achieving compliance with regulatory requirements. Medical Devices, dental tools and In-Vitro Diagnostic Medical Devices must conform to EEC-decrees 93/42/EEC and 98/69/EEC, and their adherence must be assessed to prove conformity before any sales are permitted. The most common method to prove conformity would be Quality Management System certification, according to ISO 9001 and/or 13485 by a Conformity Assessment Body, or CAB. A positive assessment will be authorized for CE identification, and permission to sell within the European Union will be granted.

The ISO, or International Organization for Standardization, is an international-standards-setting organization composed of a number of representatives from a number of national standards organizations from all participating countries. The ISO is stationed in Geneva, Switzerland.

The ISO defines itself as a non-governmental organization, although it often sets standards that become law, either through the use of treaties or national standards. This makes the ISO much more powerful than your average non-governmental organization. The ISO is generally considered a consortium with strong governmental links.

As of this writing, the ISO has 157 national members from a total of 195 countries in the world. There are three membership categories for ISO participants:

Member Bodies

National bodies considered to be the most representative standards body in each participating country. These are the ISO members with voting rights.

Correspondent Members

Countries that lack their own standards organizations. These members stay up to date on the going-ons within the ISO, but do not actually participate in the initiating or voting on standards.

Subscriber Members

Countries with small or struggling economies, these members pay reduced membership fees and follow the development of ISO standards.

What the ISO has done for the medical industry has been very helpful. Before the ISO, it was much easier to buy, well, crummy, unreliable equipment. Today, an ISO-certified company can be trusted to create quality dental products.

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Conference Phones Connect Your Business

Today’s global market requires world-class solutions to organizational problems. One of the most common problems is the need to communicate when people are separated by time and distance. In the Information Age, the ability to communicate in an effective and timely manner is the key to success. Call conferences are powerful tools to achieve organizational goals. That is why choosing the correct equipment for your needs is very important.

What Are They Good For?

There is a wide variety of conference phones available on the market at this moment. These run the entire gamut of price and features. Through the use of a conference phone, you can set up meetings and discussions as if all the parties were present in the room with you. This is a cost-efficient method of negotiating and dealing between parties in separate locations. That is why their use is rapidly becoming a fixture in most corporate offices. They are very useful tools in operational communications activities.

Conference phones will increase overall productivity and more than justify their purchase cost. They help to bridge gaps within the organization by making it possible to interact without the need for physical proximity. Effort is unified and multiplied to better achieve goals that have been laid out.

The Different Types

When you purchase a phone system, consider your company’s size and objectives. Plain vanilla audio conference phones use speakers and are essentially speakerphones with more advanced features. They also incorporate push-to-talk microphones in their design. Videophones can send and receive compressed or full motion video to all parties. They need high bandwidth transmission lines to do so. Some conference phones can even utilize Internet access to integrate graphics and e-mail. You will not need a computer in the conference room any more.

The Contenders

Room or office size is the main consideration in the purchase of conference phones. The parameters of a typical company meeting will also influence your decision. An example is the need for hands-free conferencing with multiple lines. Headset access is also another option that is commonly present in conference phones.

Polycom is a leader in manufacturing conferencing equipment. They make the Polycom Voicestation for smaller offices. For medium-sized conference rooms, there is the Polycom Sound Station 2. The Polycom Sound Station 2 Wireless offers 24 hours of talk time and cell phone dialing features.

Another top seller is Clearone’s line of conference phones. They offer noise and echo cancellation. On the other hand, Spracht Conference Phones allow for 360 degrees of coverage.

The main thing to remember when choosing between conference phones is that the product should fit the needs of the company. Extra fancy features that will not be used just add up to useless costs. If you do not need these features, then consider something other than the manufacturer’s flagship model. Your accounting department will thank you for it. Remember that conference phones are just the means to an end. At the end of the day, it is how you utilize all this technology that matters.