Review the manufacturer’s n/a Program Administrator application to determine Table 1: audit team competence Auditing required, select the audit team members, and determine audit duration Evaluation of quality Lead Auditor / n/a management system Auditor Evaluation of Technical Expert n/a product/process related technologies Evaluation of Technical Technical Expert n/a Documentation Evaluation of Regulations Lead Auditor / n/a Auditor / Technical Expert Approval of Results n/a Final Reviewer Organization Functions and Roles Reference(s) Normative Reference: International Organization for Standardization (ISO)/ International Electrotechnical Commission (IEC) ISO/IEC 17021:2011 - Conformity Assessment – Requirements for bodies providing audit and certification of management system. GHTF/SG3/N19:2012 - Quality management system Medical devices - – Nonconformity Grading System for Regulatory Purposes and Information Exchange General References: GHTF/SG1/N78:2012 - Principles of Conformity Assessment for Medical Device. GHTF/SG1/N46:2008 - Principles of Conformity Assessment of In Vitro Diagnostic (IVD) Medical Devices. GHTF/SG1/N71:2012 - Definition of the Terms 'Medical Device' and 'In Vitro Diagnostic (IVD) Medical Device.' ISO/IEC Conformity assessment Vocabulary and general principles – – Definitions A systematic, independent, and documented process for obtaining records, Audit: statements of fact or other relevant information and assessing them objectively to determine the extent to which specified requirements are fulfilled. (ISO 17000:2004)
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) Normative Reference: International Organization for Standardization (ISO)/ International Electrotechnical Commission (IEC) ISO/IEC 17021:2011 - Conformity Assessment – Requirements for bodies providing audit and certification of management system. GHTF/SG3/N19:2012 - Quality management system – Medical devices - Nonconformity Grading System for Regulatory Purposes and Information Exchange General References: GHTF/SG1/N78:2012 - Principles of Conformity Assessment for Medical Device. GHTF/SG1/N46:2008 - Principles of Conformity Assessment of In Vitro Diagnostic (IVD) Medical Devices. GHTF/SG1/N71:2012 - Definition of the Terms 'Medical Device' and 'In Vitro Diagnostic (IVD) Medical Device.' ISO/IEC – Conformity assessment – Vocabulary and general principles 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)
imdrf-tech-131209-auditing-requirements-140901.docx