The functions covered by a Regulatory Authority, within the of this document, and the independence of the roles assigned are described in Table 1. Functions Assessment Decision Making Conduct a review of the assessment n/a Program Administrator application to determine assessment team competence requirements, select assessment team members, and determine assessment duration Assessment of a the Auditing Lead Assessor / n/a Organization’s management system Assessor Assessment of the Auditing Lead Assessor / n/a Organization’s competence (IMDRF Assessor MDSAP WG N4) Assessment of the conformity of the Lead Assessor / n/a Auditing Organization with regulatory Assessor requirements (IMDRF MDSAP WG N3) Approval of Assessment Results n/a Recognition Manager Table 1: Regulatory Authority Functions and Roles Reference(s) IMDRF MDSAP N3 - Requirements for Medical Device Auditing Organizations for Regulatory Authority Recognition IMDRF MDSAP N4 - Competence and Training Requirements for Auditing Organizations IMDRF MDSAP N5 - Regulatory Authority Assessment Method for the Recognition and Monitoring of Medical Device Auditing Organizations 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. Definitions
The functions covered by a Regulatory Authority, within the of this document, and the independence of the roles assigned are described in Table 1. Functions Assessment Decision Making Conduct a review of the assessment application to determine assessment team competence requirements, select assessment team members, and determine assessment duration n/a Program Administrator Assessment of a the Auditing Organization’s management system Lead Assessor / Assessor n/a Assessment of the Auditing Organization’s competence (IMDRF MDSAP WG N4) Lead Assessor / Assessor n/a Assessment of the conformity of the Auditing Organization with regulatory requirements (IMDRF MDSAP WG N3) Lead Assessor / Assessor n/a Approval of Assessment Results n/a Recognition Manager Table 1: Regulatory Authority Functions and Roles Reference(s) IMDRF MDSAP N3 - Requirements for Medical Device Auditing Organizations for Regulatory Authority Recognition IMDRF MDSAP N4 - Competence and Training Requirements for Auditing Organizations IMDRF MDSAP N5 - Regulatory Authority Assessment Method for the Recognition and Monitoring of Medical Device Auditing Organizations 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. Definitions
imdrf-tech-131209-assessor-competence-and-training-140901.docx