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All About ISO certification in Iraq

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All About ISO certification in Iraq

ISO certification in Iraq the biggest advantage for the organisation for having a better stability. ISO 13485 is generally called as the quality management system for medical industries. ISO 13485 standard plays a very major role in having the quality management system in a proper way of implemented in the organisation where they are involving with the manufacturing and designing of medical devices. This International Standard specifies requirements for a quality management system that can be used by an organization involved in one or more stages of the life-cycle of a medical device, including design and development, production, storage and distribution, installation, servicing and final decommissioning and disposal of medical devices, and design and development, or provision of associated activities (e.g. technical support). The requirements in this International Standard can also be used by suppliers or other external parties providing product (e.g. raw materials, components, subassemblies, medical devices, sterilization services, calibration services, distribution services, maintenance services) to such organizations. The supplier or external party can voluntarily choose to conform to the requirements of this International Standard or can be required by contract to conform. Factocert helps in the best implementation of ISO 13485 standard in your organization.

This International Standard can also be used by internal and external parties, including certification bodies, to assess the organization’s ability to meet customer and regulatory requirements applicable to the quality management system and the organization’s own requirements. It is emphasized that the quality management system requirements specified in this International Standard are complementary to the technical requirements for product that are necessary to meet customer and applicable regulatory requirements for safety and performance.

Requirements of this International Standard are applicable to organizations regardless of their size and regardless of their type except where explicitly stated. Wherever requirements are specified ISO 9001 Certification in Iraq  as applying to medical devices, the requirements apply equally to associated services as supplied by the organization. The processes required by this International Standard that are applicable to the organization, but are not performed by the organization, are the responsibility of the organization and are accounted for in the organization’s quality management system by monitoring, maintaining, and controlling the processes.

Considering the history of international organisation for standardization (ISO) after the World War II, united Nations standards coordinator (UNSCC) approaches international Federation of the national standardizing association (ISA) join together and established ISO in February, 1947. The international standards that are published by ISO assistant Organisation in many ways. Regardless of the size of the organisation and the Industry that the organisation is involved in, assistant from international standards implementation in the organisation will always help the organisation to run in a better administration. Which process in the organisation with respect to every department will have a documentation for the easy and smooth run. The headquarters of ISO (international organisation for standardization) is located in Geneva, Switzerland. The Framework that ISO established in the organisation I help B company to grow in a very successful manner in the current market field. Across 164 countries ISO standards are accepted and considered it as a necessary factor for an organisation. International standard will help the organisation to have a global recognition and international data exchange.

Why we recommend Factocert!

Factocert is one of the finest Global leaders in Consulting, training, Audit and certification sector in the current market. Put efforts far enough to understand and fulfil our customer requirements completely with the cent percent satisfaction. Pragmatic approach and in cultivating industry best practice is being our unique consultation methodology. Customer satisfaction, is proven to be our strong believe. We have the mantra "your success is Our success". Unique documentation technique helps the organisation to overcome te implementation of ISO standard by our expertise advisors. Oral efficiency of an organisation also involved the improvements in each individual organisation. Our enrich training of internal audit improves the quality of internal auditors or process head of the organisation. To make sure the implemented tool is running smoothly, the review meeting that is conducted among the management will have the effectiveness of the process reports which will be analysed and Factocert that ensures that all the process is reviewed at a highest possible level.

 

 

 

 

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