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 n/a Program Administrator determine audit team competence required, select the audit team members, and determine audit duration Evaluation of quality management system Lead Auditor / n/a Auditor Evaluation of product/process related Technical Expert n/a technologies Evaluation of Technical Documentation Technical Expert n/a Evaluation of Regulations Lead Auditor / n/a Auditor / Technical Expert 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 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) An organization that audits a medical device manufacturer for Auditing Organization: conformity with quality management system requirements and other medical device
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
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