ISO 13485 is a particularly developed standard for Quality Management System of medical devices and equipment. This standard specifies requirements to effectively implement and maintain the quality of medical devices. Also, the ISO 13485 provides guidance for manufacturers/suppliers to deal with medical devices directives, regulations and responsibilities.
The ISO 13485 has similar connection with ISO 9001. But the major difference is that ISO 9001 requires the continual improvement of the organization whereas ISO 13485 requires the effective implementation of the medical devices/equipment. Further, the ISO 13485 standard also provides requirements to consistently meet the customers and applicable statutory requirements.
IAS provides ISO 13485 Certification in Kuwait and also in various countries such as India, Philippines, Bangladesh, Oman, Singapore, Malaysia, Indonesia, Thailand, Saudi Arabia, UAE, Qatar and so on. We are an UQAS accredited ISO 13485 Certification Body, followed by millions of the organizations all over the world. We help organizations to meet the requirements of ISO 13485 standard and to enhance the overall performance of the Quality management System.
ISO 13485 Certification demonstrates the quality of the business and its products. It expands your business locally and as well as helps you attract overseas clients. This certification establishes the commitment of delivering high-quality medical devices. Also, the ISO 13485 Certification inspires the manufactures to produce defect-less products and ensures the safety of the employees.
ISO is an International Organization for Standardization that develops standards to assess the products, services and systems’ quality, safety and efficiency. It is an independent, non-governmental organization. It provides international standards with effective requirements to drive betterment in the organizations’ management system, manufacturing process, and services. ISO is famous for developing standards but it does not issue ISO certification or conformity assessments. It is done by external certification body like IAS (Integrated Assessment Services).
IAS is a globally recognized platform for management system certifications. We offer process certifications in Kuwait on various ISO standards. We also provide product certifications such as Green, Kosher, CE Marking, Halal, HACCP, GOST-R, etc.
IAS has professionally trained auditors who have vast industry experience to guide the organizations throughout the certification and auditing processes. Our auditing process has two stages such as readiness audit and effectiveness audit.
Our auditors will carry out the audit based on the application form submitted by your organization. After completing the auditing procedures, the auditor will provide you the audit report with non-conformities (If any). We also guide you with corrections and corrective actions.
The organization has to take actions on those non-conformities within the specified time given by our auditors. Finally, IAS will issue the certificate that the organization is satisfied the requirements and has effective management system. Further, we also provide surveillance audits to ensure the continual improvement of the organization.
IAS is also a vast training platform for ISO 13485 lead auditor course, ISO 13485 internal auditor course and awareness and foundation training courses. Kindly contact us, to know more about the auditing procedure and certification process.