Certificato ISO 13485-2003

a Contemporary health system relies on technology in the field of medicine and human resources. SZUTEST, Notified Body group NB, provides certification services for ISO 13485: 2003 — management System medical quality with its experienced staff.

a Contemporary health system relies on technology, health and human resources. Medical devices, one aspect of health technologies, equip health care providers with tools to effectively perform their functions. Although medical devices provide an opportunity for better service, the lack of a national system of selection, procurement, use and management may lead to a disproportionate escalation of costs of delivery of medical services. Member States need to create systems of technical regulation and standardization of the selection, procurement, use and management of these instruments.

Most of the world's population feels the need to have access to safe and reliable medical devices in local health systems. The regional situation is difficult to assess given the current knowledge gaps and lack of data. However, several studies indicated a number of issues related to the management of medical devices at the time when the regional market for medical products is growing. Without proper management of demand, through actual needs assessment, adequate procurement, proper installation, preventive maintenance, rational use and quality assurance providers would be difficult to keep increasing the costs.

SZUTEST, Notified Body group NB, provides certification services for ISO 13485: 2003 – "quality management System medical devices".

ISO 13485: 2003 specifies requirements for a quality management system where an organization needs to demonstrate its competence in the production of medical devices and related services that meet customer requirements and regulatory requirements applicable to medical devices and related services.

the Main objective of ISO 13485: 2003 is to facilitate harmonized regulatory requirements for medical devices to quality management systems.Therefore, ISO 13485 includes some particular requirements for medical devices and excludes some of the requirements of ISO 9001 that are not appropriate as regulatory requirements. Because of these exclusions, organizations, a quality management system which conform to this international standard cannot claim conformity to ISO 9001 unless their quality management system do not meet all the requirements of ISO 9001.

Notified the Authorities in most major markets (including the European Union, USA, Canada, Japan, and Taiwan) require, or prefer, that manufacturers selling medical products in these countries had independent audited and certified quality management system. System compliant with ISO 13485 speeds up access products to countries that require this.

In some markets, distributors of medical devices must also comply with regulatory requirements. That is why these distributors prefer to implement a quality management system that meets the requirements of the standard 13485.

the EU Directive on medical devices 93/42 / EEC and 98/79 / EEC In Vitro Diagnostic Medical Device Regulations(Rules for InVitro Diagnostic use of Medical devices) requires manufacturers of medical devices maintained an adequate system of product quality. Application of the quality system must ensure that products comply with provisions of the Directives on medical devices. All the elements, requirements and provisions adopted by the manufacturer for the quality system shall be documented systematically in the form of written procedures (for example, the quality programmes, quality plans, quality manuals and quality records). A significant demonstration of compliance with the requirements of the EU Directive is an independent assessment of the quality system. This often means the certification of a quality management system in accordance with ISO 13485: 2003.

Additional aspects that should be covered by the quality management System include:

Technical documentation

reference to the basic requirements of Annex I of Directive on medical devices

Information about harmonized standards and regulations of medical equipment.

risk Analysis

Instructions on marking and use of

Different languages

Aftermarket control

Reporting in the system of vigilance

certain documents

SZUTEST is accredited by Turkish Accreditation Agency (member of the European Community Accreditation) according to EN ISO 17021. The scope of our accreditation covers EN ISO 13485:2003 and assessment of quality management Systems based on this standard.