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What is the validation and verification process as per ISO 17029 and ISO 14065?

Verifavia perform all its verification and validation activities according to ISO 17029:2019 and ISO 14065:2021:

1. Pre-Engagement
  • Initial Inquiry and Feasibility: Initially, discussing the client’s needs and the feasibility of the verification or validation, including an evaluation of any potential conflicts of interest to ensure impartiality and confidentiality.
  • Conflict of Interest Check: Ensuring no conflicts of interest that might affect impartiality.
2. Engagement
  • Formal Agreement: Establishing a contract that defines the scope, objectives, timeline, and responsibilities.
  • Document Submission: Collecting necessary documentation from the client related to the subject matter to be verified or validated.
3. Planning
  • Planning the Verification/Validation: Developing a detailed plan that outlines methodologies, tools, and resources needed for the assignment.
  • Team Assignment: Selecting a competent team based on the necessary skills and knowledge for the task.
4. Execution
  • Data Collection and Analysis: Collecting and reviewing evidence, conducting analyses, and performing site visits as required.
  • Assessment: Evaluating compliance with the relevant standards and identifying any discrepancies or issues.
5. Review
  • Internal Review: Conduct an internal review of the findings and assessments to ensure accuracy and completeness before finalizing the report.
  • Client Feedback: Engage with the client to discuss the preliminary findings, providing an opportunity for any factual corrections or additional input.
6. Reporting
  • Draft Report: Preparing a draft report that details findings and any non-conformities for internal review and client feedback.
  • Final Report: Issuing the final verification or validation report, providing a comprehensive review of outcomes.
7. Records
  • Maintaining Records: Keeping detailed records of all documentation and communication throughout the verification or validation process for 10 years. This is essential for transparency, accountability, and future audits or reviews or complaints or appeals.
8. Post-Verification/Validation Activities
  • Facts Discovered After the Opinion Statement: Managing any significant information that comes to light after the verification or validation opinion has been issued. If such information could impact the verification or validation results, it may necessitate a reassessment or correction in the report.
  • Follow-up: Engaging in any necessary follow-up actions to ensure that the client addresses identified non-conformities.
  • Continual Improvement: Using feedback and insights gained from the process to enhance the body’s procedures and effectiveness.
9. Recertification/Renewal (if applicable)
  • Periodic Review: Conducting periodic reviews and re-assessments as required, especially for ongoing commitments, to ensure ongoing compliance and to address any operational changes.
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