ISO 13485 Auditor Medical Devices

13485 Medical Devices : Auditor Certifications

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ISO 13485 QMS Standards – is a Quality management standard used globally for medical devices. It is used to establish and update your organization’s Quality Management System (QMS). 

ISO is a process standard for medical devices, it generally help organizations achieve standards of process quality that are recognized and respected throughout the world.

Some of the requirements in ISO 13485 Standards include a set of procedures that cover all key processes in the business; monitoring processes to ensure they are effective; keeping adequate records; checking output for defects, with appropriate and corrective action where necessary; regularly reviewing individual processes and the quality system itself for effectiveness; and facilitating continual improvement for medical devices.

Features & benefits of LEAD AUDITOR /Auditor Certification – ISO 13485 are as follows :

• Identify the Gaps analysis / needs and expectations of customers for Medical Devices
• Validates the capability of process for customers, as per iso 13485
• Check whether established 13485 are as per quality, policies, objectives, performance
• Check Design, implement and manage organizational performance of inter-related processes to implement the global environment policy and attain the org. objectives
• Measure and analyze the effectiveness of each process in fulfilling its objectives, and
• Analyze towards continual improvement of the organizational system from an objective evaluation of its performance

For AUDIT Implementation Assignments :

• VQMS^TM conducts pre-analysis – Gaps analysis towards ISO 13485
• Identifies right Gaps related to Audit Management
• Executes the plan, been finalized by the client or management.
• Appx. man days invested will be 1-3, for min 2-4 processes

Interested Participants or Audiences ?

VQMS^TM specifically designed program, meets the requirements of the following: 

• Leader of projects in Pharma/HR/Admin/ Management team of Organizations
• Managers or Future managers including management students
• Fresh or exp engineering Bpharma graduates / MBA’s / Professionals / Job seekers.
• Quality Assurance Engineers, Team leaders, IT or Non-IT Professionals, Practitioners, Software Quality Assurance team members and Jr /Senior Management
• Any other professional members who are doing research, innovations or consulting in process improvement practices

For any query please mail at [email protected]