4.11.4 Monitoring of corrective actions 4.11.5 Additional audits 4.12 PREVENTIVE ACTION Identification of improvements and 4.12.1 potential sources of non-conformances Action plans 4.12.2 Procedures for preventive actions 4.13 CONTROL OF RECORDS 4.13.1 General Procedures for quality and technical 4.13.1.1 records 4.13.1.2 Record retention Security and confidentiality of records 4.13.1.3 Procedures to protect and back-up 4.13.1.4 electronic records 4.13.2 Technical records 4.13.2.1 Record content 4.13.2.2 Observations, data and calculations 4.13.2.3 Error correction 4.14 INTERNAL AUDITS Periodic, in accordance with a predetermined schedule and procedure 4.14.1 Scope of audit Quality manager responsibilities Trained, independent staff 4.14.2 Corrective action, client notification 4.14.3 Internal audit records 4.14.4 Follow-up audit activities 4.15 MANAGEMENT REVIEW Predetermined schedule and procedure; covers: suitability of policies and procedures; reports from managerial and supervisory personnel; outcome of recent internal audits; 4.15.1 corrective and preventive actions; assessments by external bodies; results of comparisons or proficiency tests; changes in the volume and type of the work; client feedback;
4.11.4 Monitoring of corrective actions 4.11.5 Additional audits 4.12 PREVENTIVE ACTION 4.12.1 Identification of improvements and potential sources of non-conformances Action plans 4.12.2 Procedures for preventive actions 4.13 CONTROL OF RECORDS 4.13.1 General 4.13.1.1 Procedures for quality and technical records 4.13.1.2 Record retention 4.13.1.3 Security and confidentiality of records 4.13.1.4 Procedures to protect and back-up electronic records 4.13.2 Technical records 4.13.2.1 Record content 4.13.2.2 Observations, data and calculations 4.13.2.3 Error correction 4.14 INTERNAL AUDITS 4.14.1 Periodic, in accordance with a predetermined schedule and procedure Scope of audit Quality manager responsibilities Trained, independent staff 4.14.2 Corrective action, client notification 4.14.3 Internal audit records 4.14.4 Follow-up audit activities 4.15 MANAGEMENT REVIEW 4.15.1 Predetermined schedule and procedure; covers: suitability of policies and procedures; reports from managerial and supervisory personnel; outcome of recent internal audits; corrective and preventive actions; assessments by external bodies; results of comparisons or proficiency tests; changes in the volume and type of the work; client feedback;
CRA-F-05-%2017025-ASSESSMENT%20CHECKLIST%20&%20REPORT(TESTING)-.docx