Internal Auditing courses for ISO Management Systems for medical devices and laboratories
We offer a range of “Internal Auditing courses for ISO Management Systems for medical devices and laboratories courses:
Internal Auditing for ISO 13485 : 2016 Medical Devices: Level 3 Award in Principles of Effective Auditing and Inspection (RQF accredited course)
ISO 13485:2016 is the Standard for the manufacture of medical devices and Clause 8.2.2 contains the requirement for a system for internal auditing. The organisation shall conduct internal audits at planned intervals to determine whether the quality management system a) conforms to the planned arrangements (see 7.1), to the requirements of this International Standard and to the quality management system requirements established by the organisation, and b) is effectively implemented and maintained.
Internal Auditor Course for ISO 17025 Internal Quality Auditing for Laboratories: Level 3 Award in Principles of Effective Auditing and Inspection (RQF accredited course)
Many laboratories have adopted the ISO 17025 Quality Management System standard, and a fundamental element is the measurement of system and process performance using a process-based approach by trained internal auditors.
Internal Auditing Course for ISO 15189 Medical Laboratory Quality Management Systems: Level 3 Award in Principles of Effective Auditing and Inspection (RQF accredited course)
ISO 15189 is the standard for diagnostic laboratories to demonstrate their competence to deliver reliable services. Clause 4.14.5 describes the requirement for Internal Audits.
Internal auditing is fundamental to any quality improvement initiative. Many hospital laboratories have adopted the ISO 15189 Quality Management System standard.