The assessment method specific to a particular medical device regulatory scheme may take into account additional requirements from the jurisdictions addressed in the scheme. References Requirements for Medical Device Auditing Organizations for Regulatory Authority – Recognition Competence and Training Requirements for Auditing Organizations – Regulatory Authority Assessment Method for the Recognition and Monitoring of – Medical Device Auditing Organizations Regulatory Authority Assessor Competence and Training Requirements – MDSAP Assessment and Decision Process for the Recognition of an Auditing – Organization 24 Medical Device Single Program (MDSAP): Medical Device Regulatory Audit – Reports IMDRF/MDSAP WG/N29 Clarification of the Term Entity” for MDSAP – “Legal Recognition Purposes 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. Principles of Conformity Assessment for Medical Device – Quality management system Medical devices Nonconformity Grading System for – – – Regulatory Purposes and Information Exchange Definitions 3.1 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) 3.2 An organization that audits a medical device manufacturer for Auditing Organization: conformity with quality management system requirements and other medical device regulatory requirements. Auditing Organizations may be an independent organization or a Regulatory Authority which perform regulatory audits. 3.3 A government body or entity that exercises a legal right to Regulatory Authority: control the use or sale of medical devices within its jurisdiction, and that may take
The assessment method specific to a particular medical device regulatory scheme may take into account additional requirements from the jurisdictions addressed in the scheme. References – Requirements for Medical Device Auditing Organizations for Regulatory Authority Recognition – Competence and Training Requirements for Auditing Organizations – Regulatory Authority Assessment Method for the Recognition and Monitoring of Medical Device Auditing Organizations – Regulatory Authority Assessor Competence and Training Requirements – MDSAP Assessment and Decision Process for the Recognition of an Auditing Organization 24 – Medical Device Single Program (MDSAP): Medical Device Regulatory Audit Reports IMDRF/MDSAP WG/N29 – Clarification of the Term “Legal Entity” for MDSAP Recognition Purposes 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. – Principles of Conformity Assessment for Medical Device – Quality management system – Medical devices – Nonconformity Grading System for Regulatory Purposes and Information Exchange Definitions 3.1 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) 3.2 Auditing Organization: An organization that audits a medical device manufacturer for conformity with quality management system requirements and other medical device regulatory requirements. Auditing Organizations may be an independent organization or a Regulatory Authority which perform regulatory audits. 3.3 Regulatory Authority: A government body or entity that exercises a legal right to control the use or sale of medical devices within its jurisdiction, and that may take
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