Iso Certification Services In Chandigarh

The ISO 13485 standard can be the differentiating factor in the vendor selection process in healthcare engineering as independent quality auditors will analyse back into the supply chain to establish and prove that the products supplied to the original equipment manufacturer (OEM) are of the highest quality. ISO 13485 Standard is a documentation database that intends to get you up to date with the ISO 13485 quality management system. The program includes ten modules with forms, templates and the document structure required by the ISO 13485 standard. ISO 13485 is suitable for all the organizations involved in the medical device lifecycle and looking for an improvement in the way the organization is operated and managed. In recent years, ISO 13485:2003 has become the worldwide reference standard for the companies dealing with medical devices. However, it is important to note that the European Union requires compliance to additional Quality Management System (QMS) procedures and regulatory requirements before they will approve your device for sale.

ISO 13485:2016 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements. Such organizations can be involved in one or more stages of the life-cycle, including design and development, production, storage and distribution, installation, or servicing of a medical device and design and development or provision of associated activities (e.g., technical support). ISO 13485:2016 can also be used by suppliers or external parties that provide product, including quality management system-related services to such organizations. ISO 13485 training is specially tailored to provide learners with in-depth knowledge of implementing and managing a Medical Devices Quality Management System. This training focuses on providing learners with the knowledge of designing and building medical devices that meet globally recognized quality standards of ISO 13485. In addition, our ISO 13485 training courses allow learners to implement the ISO 13485 quality standards and stay ahead of medical device regulatory needs. ISO 13485 training also provides knowledge of tools for a complete audit to test the efficiency of the system. This training includes exams to validate the knowledge and skills of the learners for successfully designing, producing, installing, and maintaining the medical devices. 

The processes required by ISO 13485:2016 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. 

Requirements of ISO 13485:2016 are applicable to organizations regardless of their size and regardless of their type except where explicitly stated. Wherever requirements are specified as applying to medical devices, the requirements apply equally to associated services as supplied by the organization.