ISO 13485 Medical Devices Consulting services

#ISO13485Consulting #MedicalDevicesServices #Pharmaceutical #Pharmadomain

Major areas of impact of the ISO 13485 Medical Devices at organizations. :

  1. Expansion in 13485 QMS coverage and scope
  2. Required interactions with external parties
  3. New requirements for leadership engagement
  4. Expanded legal compliance requirements
  5. Need for risk-based planning and controls
  6. New documentation requirements
  7. Expanded operational control requirements
  8. Changes in competence and awareness requirements
  9. Impacts on the internal audit program
  10. Increased certification costs

VQMSTM benefits of ISO 13485 are as follows :

  • Determine the needs and expectations of customers for ISO 13485 – Medical Devices at organization
  • Determine the capability of Org. process for customers based on ISO 13485, as per basic processes implementation
  • Establish 9001 quality policies, quality objectives and climatic changes & Risk Management
  • Necessary to motivate people to satisfy these needs – related to organizational standard
  • ISO 13485 help Design, implement and manage qms performance of inter-related processes to implement the global quality policy and attain the org. objectives
  • updated ISO 13485 Measure and analyze the effectiveness of each process in fulfilling its objectives, and
  • Pursue the continual improvement of the global environmental system from an objective evaluation of its performance

ISO 13485  Consulting at VQMSTM consists of :

  1. Overview – Scope Understanding 
  2. Contract or SLA towards Implementation
  3. Identified Managers or ISO 13485 Project Implementation
  4. Training towards ISO 13485 Implementation
  5. ISO 13485 Piolting (stage based)
  6. Reviews and Verification
  7. Go-ahead towards ISO 13485 implementation

For Consulting and Implementation Assignments :

  • VQMSTM conducts pre-analysis – Gaps analysis towards ISO 13485 Quality Management System in your organization
  • provides actual plan related to consulting – implementation – Audit Management
  • Executes the plan, been finalized by the client or management.
  • Appx. man days invested will be 10-15, for min 2-4 processes

VQMSTM  Post Consulting and Implementation :

  • VQMSTM assist in regular review of project management
  • Assisting in improving and monitoring growth towards Business excellence
  • Provide exclusive consulting towards other areas of improvement.

For any query please mail at [email protected]

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