Iso 13485 consultant11/19/2022 Customer satisfaction – through delivery of products that consistently meeting customer requirements as well as quality, safety and legal requirements.Conduct mockdrill for traceability of product as well as production recall, etc.Conduct management review meeting in presence of Top Management to guide the organization for effective implementation on all the issues related to Quality management systems – Requirements for regulatory purposes,.Conduct internal audit to check readiness for the certification.Help in effective implementation of ISO 13485 system by periodic visit till ISO 13485:2016 certification,.ISO 13485 training to all levels of employees within the organization,.Formats to establish the objective evidence of implementation and to ensure control over all the activities.Standard Operating Procedures ( SOPs) to control identified activities having risk potential to the human during the use of such medical devices.Identification of applicable regulatory requirements and ensure compliance with the regulatory requirements.
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