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ISO 13485:2016 Specifically for Medical Devices is an internationally recognized standard and provides best framework in setting up a quality management system to those organizations who are involved in the design, production, installation and servicing of medical devices and related services. A medical device is a product, such as an instrument, machine, implant or in vitro reagent, that is intended for use in the diagnosis, prevention and treatment of diseases or other medical conditions. Safety & Quality cannot be compromised in the medical industry that’s why manufacturers are adopting this standard to assure their quality management system to avoid the risks during the use of devices and instruments. The standard is designed to assist organizations in focusing their management system and therefore practices on strengthening its risk management approach and meeting regulatory requirements. Hospitals and hospital’s medical devices supplying companies demand from manufactures of medical devices for the certification of ISO 13485:2016.
ISO 13485:2016 is the current version of ISO 13485 standard, previously it was known as ISO 13485:2003 and it is a part of ISO family, ISO (The International Organization for the Standardization) is a non-profit organization and doesn’t conduct audits itself. Most of the countries have formed their own accreditation bodies to authorize the certification bodies, Accreditation and certification bodies charge their fee against their services. Accredited certificate issued by any accredited certification body is entirely accepted worldwide.
After finalization of agreement with client, Quality Systems’ experts visit to client’s premises and conduct the complete gap analysis of existing system against the ISO 13485 standard and discuss the gap report to the management, identified gaps could be in documents, implementation, employee’s awareness, statuary and regulatory compliances. We commence work according to the agreed timelines as per final gap report and proceed for the audit once all the documentation, implementation, and other requirements are done. Our technical team provides complete assistance, support and cooperation throughout the process to make certification audit successful in first attempt.
An ISO 13485 certificate is not awarded once-and-for-all, it must be renewed before expiration of the certificate. After applying for the audit to the certification body they conduct the initial audits in two stages; First is stage one audit and next is stage two audit. After the successful conduction of audit, certification body issues the certificate with validity of one year till next yearly surveillance audit and in three years of certification cycle, certification body conducts two surveillance audits with one year of intervals. Basically, audit will be conducted every year in the period of three years. After completion of three years of audit cycle re-audit will be conducted to continue the process of certification.
Charges of ISO 13458 certification can not be flat or same for every organization, please contact us in this regard.
Quality Systems is working with the team of qualified and experienced consultants and trainers having vast industrial experience, most of our consultants are also lead auditors who are aware to the expectations of auditors from your management system during the audit. Quality systems is assisting across the world to implement and achieve the ISO 13485 certification. Our consultation methodology is highly professional, time bound and effective and we always add value to the business process of the client’s organization.
Our ISO 13485 complete package comprised on following segments such as training, implementation, consultation, gap analysis, documentation, internal audits, pre assessment, certification audit through world’s most recognized accredited certification body and post certification enhancement / maintenance services to enable your organization to get the best outcome of ISO 13485 QMS. Our services are globally accepted, authoritative and benchmarked in the field of ISO 13485 Quality Management System for Medical Devices.