Competence Evaluation Criteria Program Administrator, Lead Auditor/Final Reviewer, Auditor, and Technical Expert competence levels will differ and depend on their roles in the assessment program. The initial and ongoing competence level required for each role is described in Appendix B. Auditing Organizations shall use this information to formulate and maintain training plans for Program Administrators, Lead Auditors/Final Reviewers, Auditors, and Technical Experts to ensure that they achieve the necessary competence levels. The learning process could include; formal assessment skills training and education, on the job assessment experience, professional development activities, supervisor/manager coaching and mentoring, etc. Methods of Evaluation: Initial and Re-Evaluation Auditing Organizations shall evaluate the competence of Lead Auditors/Final Reviewers, Technical Experts, and Auditors using a combination of monitoring methods that may include; Review of records of audits or inspections, education, training, etc. Feedback from the audited manufacturers, peers, and supervisors Interviews Observation of performance Testing Re-Evaluation An Auditing Organization shall evaluate Lead Auditors/Final Reviewers, Technical Experts, and Auditors for continued recognition of competence at least every 3 years. An Auditing Organization shall confirm skills and personal attributes of Lead Auditors and Auditors through a witness audit every 3 years. Reaffirmation of Code of Conduct Personnel involved in the audit are to reaffirm their commitment to the Code of Conduct (see IMDRF MDSAP WG N3 clause 7.1.6) on an annual basis. This should be in the form of a signed statement kept on file. Records of Pre-requisites, Competence Evaluation and Monitoring Auditing Organizations maintain current and accurate records associated with the evaluation and maintenance of competencies. Auditor competence files and audit logs shall demonstrate how auditors meet the requirements contained in this document and are to include: Auditor name, position, and contact information. Pre-requisite and subsequent education Results of evaluation of the Auditor’s competence in the role of Lead Auditor/Final Reviewer, Technical Expert, or Auditor according to the requirements in this document. Audit/Inspection/Assessment experience
Competence Evaluation Criteria Program Administrator, Lead Auditor/Final Reviewer, Auditor, and Technical Expert competence levels will differ and depend on their roles in the assessment program. The initial and ongoing competence level required for each role is described in Appendix B. Auditing Organizations shall use this information to formulate and maintain training plans for Program Administrators, Lead Auditors/Final Reviewers, Auditors, and Technical Experts to ensure that they achieve the necessary competence levels. The learning process could include; formal assessment skills training and education, on the job assessment experience, professional development activities, supervisor/manager coaching and mentoring, etc. Methods of Evaluation: Initial and Re-Evaluation Auditing Organizations shall evaluate the competence of Lead Auditors/Final Reviewers, Technical Experts, and Auditors using a combination of monitoring methods that may include; Review of records of audits or inspections, education, training, etc. Feedback from the audited manufacturers, peers, and supervisors Interviews Observation of performance Testing Re-Evaluation An Auditing Organization shall evaluate Lead Auditors/Final Reviewers, Technical Experts, and Auditors for continued recognition of competence at least every 3 years. An Auditing Organization shall confirm skills and personal attributes of Lead Auditors and Auditors through a witness audit every 3 years. Reaffirmation of Code of Conduct Personnel involved in the audit are to reaffirm their commitment to the Code of Conduct (see IMDRF MDSAP WG N3 clause 7.1.6) on an annual basis. This should be in the form of a signed statement kept on file. Records of Pre-requisites, Competence Evaluation and Monitoring Auditing Organizations maintain current and accurate records associated with the evaluation and maintenance of competencies. Auditor competence files and audit logs shall demonstrate how auditors meet the requirements contained in this document and are to include: Auditor name, position, and contact information. Pre-requisite and subsequent education Results of evaluation of the Auditor’s competence in the role of Lead Auditor/Final Reviewer, Technical Expert, or Auditor according to the requirements in this document. Audit/Inspection/Assessment experience
imdrf-tech-131209-competence-and-training-requirements-140901.docx