ISO 13485 Certification in Lebanon is one of the important quality management systems for medical devices which make sure that all the medical devices meet the regulatory compliance laws and customer need &expectations. The requirements of ISO 13485 standard provides a place to keep the experts and other customers safe in hospitals, clinics and other medical setups. ISO 9001 is a basic standard where all the other standards follows this model approach and ISO 13485 follows this model approach which is specifically developed for the manufacturing of devices related to medical industry. The main aim or goal of an ISO 13485 standard is to provide harmonized medical device regulatory requirements.
The objective of ISO 13485 certification in Lebanon is to reduce legal and safety risk while creating more economical working conditions. It is one of the internationally recognized standards specifying the requirements for quality system and safety system for medical device manufacturing industries. It helps the medical industries to get more recognition that it is more trustworthy and reputable providers.
It helps the organization to demonstrate consistent development, production, design, storage installation, distribution, servicing, decommissioning and disposal of devices and other activities related to design and development. The requirements of the quality management system for medical device involves in entire life cycle of manufacturing process of medical devices in the industries and it can be applied to the organization irrespective of size and type.
ISO 13485 can be used by the suppliers or by the external parties such as a distributor, manufacturers and so on for providing the services or products to medical device industries. Implementing the requirements of ISO 13485 certification in Lebanon by external party or supplier might be an independent choice or it can be mandatory for certain legal requirements given by the country or by contractual request from their clients.