Lomaen Medical Inspection Body

Quality Inspection Terms

Inspection Terms

• Lomaen Medical IB’s in-house standard procedures and methods are used by qualified and competent inspectors to complete inspections for scopes 1, 3, 4, 5, 6 of the SAHPGL-RDN-XR-01 v1- Guideline for QC in Medical Diagnostic X-Ray Imaging Systems.
• All inspectors are expected to conduct inspections impartially and to regard all information as highly confidential as agreed to & signed on our statement of impartiality & pressures per ISO 17020 guidelines.
• The relevant documentation shall be submitted to the regulator (SAPHRA) monthly for annual results, or within 7 days for acceptance results, subject to the honouring of agreed payments.
• Relevant results and certificates shall be submitted to the client daily or as soon as humanly possible subject to the honouring of agreed payments.
• Clients holding an account with Lomaen Medical shall receive a QA file with all contents required for the acceptance test or the first tests done by Lomaen Medical IB (Results and administrative documents). Updating the file from then on shall be the responsibility of the client.
• Lomaen Medical IB is authorized by the client to submit to the radiation board the confidential data required by the SAHPGL-RDN-XR-01 v1 – Guideline for QC in Medical Diagnostic X-Ray Imaging Systems, and to provide confidential information to contracted auditors as required during the process of internal audits.
• When Lomaen Medical IB is required by law or authorized by contractual arrangements to release confidential information, the client or individual concerned will, unless prohibited by law, be notified in writing of the information provided.
• The inspection services and the quality management system of Lomaen Medical IB are subject to ongoing and regular internal review by the IB and external review by SANAS.
• The client acknowledges that any information, reports, or certificates received from Lomaen Medical IB must be treated as confidential unless permission to disclose is obtained in writing from the IB management or controlled disclosure is required by law.
• The parties indemnify and hold each other harmless against any claims of whatsoever nature and however arising safe wilful and negligent acts or omissions of their respective employees and agents acting within the course and scope of their duties as such.

Impartiality Statement

The client declares that there are no close relationships between any of the client’s employees and Lomaen Medical or SAHPRA or SANAS.

Please contact Lomaen Medical if you wish to declare such a relationship.

The client declares that the above information is true and that the client will remain impartial in all activities of the inspection process.