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Wardour Lab ISO 15189:2022 pack
An ISO 15189:2022-structured quality manual, procedures and Excel records for medical laboratories and POCT services.
Who it's for
- Independent and private pathology laboratories
- Labs applying for UKAS accreditation for the first time
- Clinics overseeing point-of-care testing (Annex A)
What you get
- 34 Word documents: policies, procedures and templates
- 16 Excel registers and logs with drop-downs and worked examples
- Start Here folder: user guide, contents index, regulatory mapping matrix, and licence terms and disclaimer
- 12 months of updates, emailed automatically
Full contents
Taken from the pack's contents index. Codes are shown as supplied, and you can change the prefix to your own.
Quality management system (8)
WD-LAB-QMS-001Laboratory Quality ManualWD-LAB-QMS-002Control of Management System DocumentsWD-LAB-QMS-003Control of RecordsWD-LAB-QMS-004Nonconformities, Corrective Action and Improvement ProcedureWD-LAB-QMS-005Nonconforming Work ProcedureWD-LAB-QMS-006Laboratory Complaints ProcedureWD-LAB-QMS-007Internal Audit and Evaluation ProcedureWD-LAB-QMS-008Management Review Procedure
Governance, impartiality and risk (6)
WD-LAB-GOV-001Impartiality and Confidentiality PolicyWD-LAB-GOV-002Patient-Centred Requirements PolicyWD-LAB-GOV-003Laboratory Director and Key Roles ResponsibilitiesWD-LAB-GOV-004Laboratory Risk Management ProcedureWD-LAB-GOV-005Laboratory Data and Information Management ProcedureWD-LAB-GOV-006Laboratory Continuity and Emergency Preparedness Plan
Resources: people, facilities, equipment, suppliers (7)
WD-LAB-RES-001Personnel Competence, Training and Authorisation ProcedureWD-LAB-RES-002Facilities and Environmental Conditions ProcedureWD-LAB-RES-003Equipment Management ProcedureWD-LAB-RES-004Calibration and Metrological Traceability ProcedureWD-LAB-RES-005Reagents and Consumables ProcedureWD-LAB-RES-006Service Agreements and Referral Laboratories ProcedureWD-LAB-RES-007Externally Provided Products and Services Procedure
Pre-examination (2)
WD-LAB-PRE-001Pre-examination Processes: Requests, Sample Collection and Patient InformationWD-LAB-PRE-002Sample Transport, Receipt, Acceptance and Rejection Procedure
Examination and quality control (8)
WD-LAB-EXA-001Selection, Verification and Validation of Examination MethodsWD-LAB-EXA-002Measurement Uncertainty ProcedureWD-LAB-EXA-003Biological Reference Intervals and Clinical Decision Limits ProcedureWD-LAB-EXA-004Internal Quality Control ProcedureWD-LAB-EXA-005External Quality Assessment and Interlaboratory Comparison ProcedureWD-LAB-EXA-006Comparability of Examination Results ProcedureWD-LAB-EXA-007Examination Process Controls and Release of ResultsWD-LAB-EXA-008Examination Procedure (SOP) Template
Post-examination and reporting (2)
WD-LAB-POS-001Reporting of Results and Critical Result Notification ProcedureWD-LAB-POS-002Post-examination Sample Storage, Retention and Disposal Procedure
Point-of-care testing (1)
WD-LAB-POC-001Point-of-Care Testing Management Procedure
Forms, registers and logs (Excel) (16)
WD-LAB-FRM-001Examination Repertoire and User Handbook DataWD-LAB-FRM-002Document Master ListWD-LAB-FRM-003Nonconformity and CAPA LogWD-LAB-FRM-005Laboratory Risk RegisterWD-LAB-FRM-006Competence and Authorisation MatrixWD-LAB-FRM-007Equipment Register and Maintenance RecordWD-LAB-FRM-008Reagent and Consumable Lot LogWD-LAB-FRM-009Environmental Monitoring LogWD-LAB-FRM-010Approved Supplier RegisterWD-LAB-FRM-011Method Verification / Validation RecordWD-LAB-FRM-012Quality Indicators and Management Review InputsWD-LAB-FRM-013Measurement Uncertainty CalculatorWD-LAB-FRM-015EQA Performance LogWD-LAB-FRM-004Internal Audit Programme and Clause CoverageWD-LAB-FRM-016ISO 15189:2022 Gap Analysis WorkbookWD-LAB-FRM-014Internal QC Log and Levey-Jennings Chart
CQC and regulatory mapping highlights
Number of documents mapped to each CQC key question:
17Safe
13Effective
1Caring
4Responsive
15Well-led
The mapping matrix links documents to 20 of CQC's 34 quality statements and 9 of Regulations 4 to 20A of the Health and Social Care Act 2008 (Regulated Activities) Regulations 2014.
Most-covered quality statements
- Safe systems, pathways and transitions (Safe, 12 documents)
- Delivering evidence-based care and treatment (Effective, 12 documents)
- Governance, management and sustainability (Well-led, 11 documents)
- Monitoring and improving outcomes (Effective, 8 documents)
- Learning, improvement and innovation (Well-led, 6 documents)
- Learning culture (Safe, 3 documents)
Most-covered regulations
- Reg 12 Safe care and treatment (24 documents)
- Reg 17 Good governance (19 documents)
- Reg 15 Premises and equipment (6 documents)
- Reg 18 Staffing (3 documents)
- Reg 9 Person-centred care (2 documents)
- Reg 11 Need for consent (2 documents)
ISO 15189:2022
Documents reference 33 of the 35 clause headings in the mapping matrix, including clause 4 (impartiality, confidentiality, patients), 5.6 risk management, 7.3 examination processes and Annex A point-of-care testing. Clause numbers and titles only: the standard's text is not included and you need your own copy from ISO or BSI.
The mapping is indicative. It shows where a document supports a requirement, not that you comply with it. Templates must be adapted, checked and approved for your service, and buying them does not guarantee CQC registration, a rating or UKAS accreditation. See the disclaimer.