JOURNAL OF AN AUDITOR

  MEDICAL DEVICE REGULATION EUROPE What is the difference between Regulation and Directive? What permission is required to get your medical device to be sold in Europe?   There are quite differences between regulation and directive. Firstly, a competent authority has 28 member states in the EU and each one of this member states have it’s own competent authority ,therefore, to publish and to direct are in their responsibility. The rules come from the European Commission as a pioneer. Notified body audit manufacturers to ensure compliance with European Union rules. Secondly, there are 3 directives that are rule. The organizations need to follow this 3 directives in order to manufacture a medical device, to get permission and also to set up the medical device in Europe; a) Active Implantable Medical Device Directive, b) The Medical Device Directive, c) The Directive of in Vitro Diagnostic Medical Devices. Then, in medical devices, categorization is also s...

 TO GET ISO 9001 CERTIFIED:   All of these are reasons to have ISO 9001 certified. My company has ISO 9001 certified because this was the first customer requirement. If the organization cannot prove its QMS, you cannot have a chance to work with them. Also, Implementing ISO 9001 will improve your company's reputation. To market, the company's compliance to ISO 9001 internationally is a must! Having a System always brings quality. When the company products, they should comply with contractual obligations and expectations. Having a system or having ISO 9001 certified will provide a competitive advantage.  On the other hand, ISO 9001 is just a guide on how to build QMS. Here the most essential thing is each department to work integrated. Working integratedly and consciously provides continuity, efficiency, and continuous improvement and helps us measure the effectiveness of the System.  There are many advantages to have ISO 9001 certified. Some of them are: ...

ANNEX SL-Management Systems Standard ISO is the network which include national standardization of more than 160 countries. Since 1947, ISO has been published of more than 19000. ISO the management principle includes leadership, process approach, improvement, relationship management, customer focus, staff commitment, and evidence-based decision-making. Until today, ISO the management system standard has been published with a lot of systematical improvements and different structures. All these standards had different structures and systems. This situation caused complications, confusion and difficulties during the application phase. In order to eliminate problems of this type, ISO “Annex SL” developed. First, Annex SL is designed for a name of ISO Guide 83. Then now, Annex SL has confirmed with the last revision. After that, all the new published standards like under the structures of Annex SL and also the available revisions of standards will publish according to this structu...