At least one individual within the senior management having 7.1.4 overall responsibility for all MDSAP medical device audits Capability to carry out tasks under its responsibility with integrity 7.1.5 and technical competence Adherence of auditors and staff to the Code of Conduct defined 7.1.6 in this clause 17021-1:2015 7.2 Personnel involved in the certification activities Sufficient and competent personnel for managing and 7.2.1 supporting audit programs and other certification work Sufficient number, or access to, lead auditors, auditors, and 7.2.2 technical experts for the and volume of work Clearly informing each person of their duties, responsibilities and 7.2.3 authorities Processes for selecting, training, authorizing auditors, and for 7.2.4 selecting and familiarizing experts, including an initial evaluation of the ability to apply required knowledge and skills - as observed on-site audit by a competent evaluator. (See N3(ed2): Cl 6.1.4, ) Processes for achieving and demonstrating effective auditing, 7.2.5 including the use of auditors with generic auditing knowledge and skills as well as knowledge and skills for auditing in specific technical Ensuring auditors and technical experts knowledgeable of 7.2.6 processes and requirements, and have access to up-to-date documented procedures, information and instructions Identify training needs and offer or provide access to specific 7.2.7 training to ensure personnel are competent for the functions they perform. (See N3(ed2): Cl 6.1.4, ) Competence of person(s) making certification decisions 7.2.8 Satisfactory performance of personnel involved in audit and 7.2.9 certification activities. Documented process for monitoring competence and performance. Review of competence and performance records to identify training needs Procedure to monitor auditors on-site, review audit reports, and 7.2.10 client or market feedback Periodically observe performance of each auditor on-site 7.2.11
At least one individual within the senior management having overall responsibility for all MDSAP medical device audits 7.1.4 Capability to carry out tasks under its responsibility with integrity and technical competence 7.1.5 Adherence of auditors and staff to the Code of Conduct defined in this clause 7.1.6 17021-1:2015 7.2 Personnel involved in the certification activities Sufficient and competent personnel for managing and supporting audit programs and other certification work 7.2.1 Sufficient number, or access to, lead auditors, auditors, and technical experts for the and volume of work 7.2.2 Clearly informing each person of their duties, responsibilities and authorities 7.2.3 Processes for selecting, training, authorizing auditors, and for selecting and familiarizing experts, including an initial evaluation of the ability to apply required knowledge and skills - as observed on-site audit by a competent evaluator. (See N3(ed2): Cl 6.1.4, ) 7.2.4 Processes for achieving and demonstrating effective auditing, including the use of auditors with generic auditing knowledge and skills as well as knowledge and skills for auditing in specific technical 7.2.5 Ensuring auditors and technical experts knowledgeable of processes and requirements, and have access to up-to-date documented procedures, information and instructions 7.2.6 Identify training needs and offer or provide access to specific training to ensure personnel are competent for the functions they perform. (See N3(ed2): Cl 6.1.4, ) 7.2.7 Competence of person(s) making certification decisions 7.2.8 Satisfactory performance of personnel involved in audit and certification activities. Documented process for monitoring competence and performance. Review of competence and performance records to identify training needs 7.2.9 Procedure to monitor auditors on-site, review audit reports, and client or market feedback 7.2.10 Periodically observe performance of each auditor on-site 7.2.11
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