ISO 13485 in Turkey
What is ISO 13485?
ISO 13485 is one of the most comprehensive standard in the world that refers to the requirements for a quality service process system for organizations that provide medical device manufacturing, sales or service.
ISO 13485 Quality Management System is the nature of the organization and technical support infrastructure for the product. Institutions should identify all requirements and processes to improve product quality. The implementation of the standard varies according to other factors such as the size of an organization and the number of employees. In fact, that is the main objective of the ISO 13485 standard; Different solutions based on the standard substance is put forward.
The ISO 13485 standard is a specific standard for Medical Devices and is based on the ISO 9001 Quality Management System as it is based on almost all standards. Iso 14969 standard aims to report this standard is also associated with these standards.
What does ISO 13485 cover in Turkey?
ISO 13485 Standard for medical devices from inputs to design and development processes of an organization; to comply with legal requirements related to the published medical devices and them to meet their customers' expectations and is a standard aimed at continuous improvement.
In areas covered by standard;
- Medical device manufacturers
- Companies that selling medical devices
- Companies providing medical equipment technical service
- Companies engaged in medical device software
Why is Iso 13485 Important in Turkey?
Why is Iso 13485 important? We can respond in the following way. It provides many advantages for organizations that want to sell their products in different countries in the global world market. For instance, the European Union market in the European Union directives for medical devices according to what if apply; will be allowed free trades for medical companies of medical devices also they may export their products in global marketplace. The standard has increased its importance in Turkey because of the European Union entry process in our country.
In the global marketplace, the ISO 13485 Standard and its documentation are sought not only in the European Union or Turkey but also in the trade of medical devices to the other countries for instance Canada.
How to Acquire ISO 13485 in Turkey?
How to get ISO 13485? Quality System as ISO 13485 certification and testing process regarding the establishment of counseling services we provide to you. ISO 13485 is a standard that covers all of the medical devices sector. Based on ISO 9001 and Medical Devices is an area within the requirements specific to the industry standards.
How to get ISO 13485? You need to follow a set of procedures. We can list these procedures as follows;
- Identify 13485 quality system requirements and customer requirements
- Documents identified and planning
- Determining hygiene requirements by ISO 13485 that related using of medical devices.
- Planning of ISO 13485 internal audit
- Establish and implement the inspection
- Preparation of a report on the results of the certification audit
- To make application for ISO 13485 certified
SİSTEM KALİTE is a firm that offer ISO 1348 consulting services. You could get via the other offices such ISO 13485 Izmir and ISO 13485 İstanbul professional consulting services office in Turkey or you may contact online to us.