Global Manager Group Introduces ISO 15189:2022 Document Matrix List of ISO 15189:2022 Documents for Certification – Manual, Procedures, SOP, Forms, Audit Checklist, etc. Website: www.globalmanagergroup.com E-mail ID: sales@globalmanagergroup.com
649 USD Document / Format No. Documented Information Title Reference ISO 15189 Clause # 4.0 General requirements 4.0 4.1 Impartiality 4.1 E/SYS/06 Impartiality policy 4.1 F/PUR/08 Sub–contractors / External service provider’s agreement 4.1 QP/01 Procedure for Maintaining impartiality of laboratory activities 4.1 F/SYS/16 Risk assessment and opportunity sheet 4.1 4.2 Confidentiality 4.2 QP/01 Procedure for maintaining confidentiality of patient’s information 4.2 F/PUR/08 Sub–contractors / External service provider’s agreement 4.2 F/TRG/06 Impartiality and Confidentiality agreement 4.2 4.3 Requirements regarding patients E/SYS/07 Patient’s rights 4.3 5.0 Structural and governance requirements 5.0 5.1 Legal entity 5.1 5.2 Laboratory director 5.2 5.3 Laboratory activities 5.3 5.4 Structure and authority 5.4 5.5 Objectives and policies 5.5 5.6 Risk management 5.6 QP/31 Procedure for Risk assessment 5.6 F/SYS/16 Risk assessment and opportunity sheet 5.6 6.0 Resource requirements 6.0 6.1 General 6.1 6.2 Personnel 6.2 QP/03 Procedure for personnel and training 6.2 F/TRG/01 Training calendar 6.2 F/TRG/02 Training report 6.2 F/TRG/03 Induction training report 6.2 F/TRG/04 Job description and specification 6.2 F/TRG/05 Skill matrix 6.2 F/TRG/06 Impartiality and Confidentiality agreement 6.2 F/TRG/07 Appointment letter 6.2 DEMO BUY
ISO 15189:2022 Document Compliance Matrix
F/TRG/08 Employee competence report 6.2 F/TRG/09 Management system training effectiveness report 6.2 F/TRG/10 Competence assessment report 6.2 6.3 Facilities and environmental conditions 6.3 6.4 Equipment 6.4 QP/04 Procedure for equipment 6.4 QP/05 Procedure for equipment acceptance procedure 6.4 QP/06 Procedure for responding to any manufacturer's recall 6.4 F/PUR/05 Inspection report 6.4 F/OPN/01 Equipment history card 6.4 F/OPN/02 Preventive maintenance schedule 6.4 F/OPN/03/XX Equipment wise preventive maintenance checkpoints 6.4 F/STR/03 Gate pass 6.4 F/STR/01 Goods inward register 6.4 F/STR/02 Stock register 6.4 6.5 Equipment calibration and metrological traceability 6.5 QP/07 Procedure for equipment calibration 6.5 F/SYS/10 Calibration status of equipment 6.5 6.6 Reagents and consumables 6.6 QP/08 Procedure for reception, storage, acceptance testing and inventory management of reagents and consumables 6.6 F/STR/01 Goods inward register 6.6 F/STR/02 Stock register 6.6 6.7 Service agreements 6.7 QP/09 Procedure to establish and periodically review agreements for providing laboratory activities 6.7 F/CSD/01 Request for examination 6.7 6.8 Externally provided products and services 6.8 QP/10 Procedure for externally provided products and services 6.8 QP/11 Procedure for selecting and evaluating referral laboratories and consultants 6.8 F/PUR/01 Purchase Order 6.8 F/PUR/02 Indent (Purchase requisition) 6.8 F/PUR/03 Approved Supplier List 6.8 F/PUR/04 Supplier Registration form 6.8 F/PUR/05 Inspection report 6.8 F/PUR/06 Supplier Evaluation report 6.8 7.0 Process requirements 7.0 7.1 General 7.1 7.2 Pre-examination processes 7.2 QP/12 Procedure for all pre-examination activities and make them accessible to relevant personnel 7.2
QP/13 Procedure for managing oral requests for examinations 7.2 QP/14 Procedures for the collection and handling of primary samples 7.2 QP/15 Procedure for transportations of samples 7.2 QP/16 Procedure for sample receipt 7.2 QP/17 Procedure and appropriate facilities for securing patient samples, ensuring sample integrity and preventing loss or damage during, handling, preparation and storage 7.2 F/CSD/01 Request for examination 7.2 F/CCC/01 Sample collection register 7.2 F/CCC/02 Sample rejection register 7.2 F/CSD/05 Inward register 7.2 7.3 Examination processes 7.3 QP/18 Procedure for verification of examination method 7.3 QP/19 Procedure for validation of examination method 7.3 QP/20 Procedure for evaluation of measurement uncertainty (MU) 7.3 QP/21 Procedure for monitoring the validity of results 7.3 F/QCD/07 Method validation report 7.3 F/QCD/01 Four Year Plan for Quality Control 7.3 F/QCD/02 IQC Analysis report 7.3 F/QCD/03 ILC Analysis report 7.3 7.4 Post-examination processes 7.4 QP/22 Procedure for reporting the results 7.4 QP/23 Procedure for automated selection, review, release and reporting of results 7.4 QP/24 Procedures for issue of amended or revised results 7.4 QP/25 Procedures for identification, access, storage, preservation and safe disposal of clinical samples 7.4 ========= Examination report 7.4 ========= Sample disposal records 7.4 7.5 Nonconforming work 7.5 QP/26 Procedures for identification and control of non–conformities 7.5 F/OPN/04 Control of nonconformity work report 7.5 7.6 Control of data and information management 7.6 7.7 Complaints 7.7 QP/27 Procedures for management of complaints or other feedback received from clinicians, patients, laboratory staff or other parties 7.7 F/CSD/03 Complain register 7.7 F/CSD/04 Complain report 7.7
7.8 Continuity and emergency preparedness planning 7.8 QP/28 Procedure for continuity and emergency preparedness planning 7.8 MEP/01 Major Emergency Preparedness Plan 7.8 ========== Mock drill records 7.8 8.0 Management system requirements 8.0 8.1 General requirements 8.1 8.2 Management system documentation 8.2 8.3 Control of management system documents 8.3 QP/29 Procedure for control of documents 8.3 F/SYS/01 Master list and distribution list of documents 8.3 F/SYS/02 Change note 8.3 F/SYS/14 Periodic document review report 8.3 8.4 Control of records 8.4 QP/10 Procedure for control of quality and technical records 8.4 F/SYS/04 Master list of records 8.4 8.5 Actions to address risks and opportunities for improvement 8.5 QP/31 Procedure for risk assessment 8.5 F/SYS/16 Risk assessment and opportunity sheet 8.5 8.6 Improvement 8.6 F/CSD/02 User feedback form 8.6 8.7 Nonconformities and corrective actions 8.7 QP/32 Procedure for corrective action 8.7 F/SYS/03 Corrective action report 8.7 8.8 Evaluations 8.8 QP/33 Procedure for internal audit 8.8 F/SYS/06 Audit plan 8.8 F/SYS/07 Internal audit nonconformity report 8.8 F/SYS/08 Clause wise document wise audit review report 8.8 F/SYS/11 Audit observation report 8.8 8.9 Management reviews 8.9 QP/34 Procedure for management review 8.9 F/SYS/12 Circular (MRM Agenda) 8.9 F/SYS/13 Minutes of meeting 8.9