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
9.4.5 Identifying and recording findings Audit findings to be identified, classified and recorded. 9.4.5.1 Nonconformities not to be recorded as opportunities for improvement. (See N3(ed2): Cl 9.4.1) 9.4.5.2 Findings of nonconformity to be recorded against a specific requirement, contain a statement of NC, and identify objective evidence. AOs are to ensure nonconformities are understood and are to refrain from suggesting the cause of nonconformity or a solution. 9.4.5.3 Unresolved diverging opinions to be recorded. 9.4.5.4 9.4.6 Preparing audit conclusions Review findings, classify nonconformities, agree upon audit conclusions, agree upon follow-up actions, and confirm the appropriateness of, or identify modifications for, the audit programme. 9.4.7 Conducting the closing meeting Closing meeting with management, and those responsible for functions or process, to present audit conclusions, ensure nonconformities are understood, and the timeframe for response is agreed. Attendance recorded. 9.4.7.1 Agenda to include items defined in this clause. 9.4.7.2 Opportunity for questions given. Unresolved diverging opinions to be recorded and referred to the AO. 9.4.7.3 9.4.8 Audit report Written report for each audit. AO not to record opportunities for improvement (See N3(ed2): Cl 9.4.1) 9.4.8.1 Report to provide an accurate, concise and clear record that allows an informed certification decision and includes the items defined in this clause. (See also N3(ed2): Cl 8.2) 9.4.8.2 Report to include the statements and conclusions defined in this clause (See also N3(ed2): Cl 8.2) 9.4.8.3 9.4.9 Cause analysis of nonconformities
Establish, document, implement and maintain a management system that is capable of supporting and demonstrating the consistent achievement of the requirements of Clause 10.2 of 17021-1:2015 10.2.1 Top Management shall; establish and document policies and objectives, provide evidence of commitment to development and implementation of the QMS, ensure understanding, implementation and maintenance at all levels of the AO and assign responsibility and authority for the establishment, implementation and maintenance of processes and procedures and for reporting to top management on performance and any need for improvement. 10.2.1 10.2.2 Management system manual Applicable requirements addressed in a manual or associated documents. Documentation to be accessible to personnel 10.2.2 10.2.3 Control of Documents Define procedures for the control of documents (internal and external) defined in this clause (a-g) 10.2.3 10.2.4 Control of Records Define procedures for the control of records defined in this clause, the retention of records to meet contractual and legal obligations and to ensure access is consistent with confidentiality arrangements. (N3(ed2): Cl 10.1.2 – >15 years) 10.2.4 10.2.5 Management Review Management establish procedures to review its management system at planned intervals (at least annually) to ensure its continuing suitability, adequacy and effectiveness. 10.2.5.1 Elements of review inputs as defined in this clause 10.2.5.2 Elements of review outputs as defined in this clause 10.2.5.3 10.2.6 Internal audits AO establish procedures for internal audits 10.2.6.1 An audit programme shall be planned, taking into consideration the importance of the processes and areas to be audited, as well as the results of previous audits 10.2.6.2