The functions covered by an Auditing Organization, within the scope of this document, and the independence of the roles assigned are described in Table 1. Functions Decision Making Review the manufacturer’s application to determine audit team competence required, select the audit team members, and determine audit duration n/a Program Administrator Evaluation of quality management system Lead Auditor / Auditor n/a Evaluation of product/process related technologies Technical Expert n/a Evaluation of Technical Documentation Technical Expert n/a Evaluation of Regulations Lead Auditor / Auditor / Technical Expert n/a Approval of Results n/a Final Reviewer Table 1: Auditing Organization Functions and Roles Reference(s) GHTF/SG1/N78:2012 - Principles of Conformity Assessment for Medical Device ISO 9000:2005 - Quality management systems — Fundamentals and vocabulary ISO/IEC 17000:2004 – Conformity assessment – Vocabulary and general principles ISO/IEC 17021:2011 - Conformity Assessment – Requirements for bodies providing audit and certification of management system. ISO/IEC TS 17021-3:2013 - Conformity Assessment – Requirements for bodies providing audit and certification of management system – Part 3: Competence requirements for auditing and certification of quality management systems. Definitions Audit: A systematic, independent, and documented process for obtaining records, statements of fact or other relevant information and assessing them objectively to determine the extent to which specified requirements are fulfilled. (ISO 17000:2004) Auditing Organization: An organization that audits a medical device manufacturer for conformity with quality management system requirements and other medical device
Interviewing: Plans, conducts, and documents results of discussions with individuals in such a manner as to achieve assessment objectives; ability to determine accuracy of information from interviewees and potential indicators of further follow-up action. Skilled in obtaining relevant, reliable, and useful information from individuals at all levels in the audited organization. Teamwork: Provides constructive feedback to assessment team members. Ability to identify needs and methods for performance improvement; assists with handling performance issues. Provides environment to maximize Auditor proficiency. Conflict Resolution: Recognizes the potential and actual sources of personnel conflict from assessment program stakeholders. Achieves results through diplomatic handling of disagreements and potential conflict; works effectively and cooperates with other individuals and departments to resolve conflicts. Supervision: Plans, organizes, directs, monitors, and evaluates the work of others assigned to assessment projects. Writing Literacy: Creates and concise reports and presentations that are based on objective evidence. Uses correct spelling, grammar, and punctuation to produce logical and accurate written documentation and correspondence. Communicates ideas, information, and messages, which may contain technical material, in a logical, organized, and coherent manner. Time Management: Monitors progress against objectives and completes duties in timely and effective manner. Records Management: maintains accurate and objective records of facts and observations made. Cultural Sensitivity: Observant and respectful to different cultures. Autonomy: Ability to work independently and adjust to unforeseen circumstances with minimal assistance. Technical Competencies Regulatory requirements: Knowledge of the medical device regulatory requirements of the recognizing Regulatory Authority(s) to enable an assessment of the applicability and compliance with such laws, regulations, and standards. Including knowledge of the principles and applications of medical device quality management system requirements, risk management system requirements, etc. Medical devices: Knowledge of medical devices and the related manufacturing activities, including: their intended use types of medical devices including their complexities, technologies, and risk classifications
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
Active Implantable Medical Devices Devices for stimulation or inhibition Devices delivering Drugs or other substances Devices substituting or replacing organ functions Radioactive seeds for interstitial radiotherapy Other active medical devices In Vitro Diagnostic Medical Devices Reagents and reagent products, calibrators and control materials for In Vitro Diagnostic Medical Devices clinical chemistry immunochemistry hematology microbiology infectious immunochemistry histology/cytology genetic testing In Vitro Diagnostic Instruments and software In Vitro Diagnostic medical devices for near-patient use devices for home use near-patient use other than home use Other In Vitro Diagnostic medical devices Specify Medical Devices incorporating specific substances or technologies Medical device containing medicinal or biologically active substances Medical devices containing or manufactured using tissue of animal origin Medical devices containing human blood derivatives Medical devices using micro-machinery and MEMS Medical devices containing nanomaterial Medical devices using biologically active coatings or materials being wholly or mainly absorbed by the body