Medical Laboratories: Quality and Competence
Shows that a medical laboratory is competent and produces reliable results.
A complete documentation kit written to ISO 15189:2022 for medical laboratories: manual, policies, procedures, SOPs, forms, registers, process maps, quality indicator and risk frameworks, audit and management review packs, an implementation roadmap, sector guides and commercial templates, with every clause mapped to the document that meets it, and control of competence, equipment and traceability, reagent lots, pre-examination, method verification, quality control and EQA, reporting and critical results built into the system.
- Edition 2022
- 147 Word + 32 Excel files
- One organization
- Downloads open 7 days after payment
You need this if
- You run a medical or clinical laboratory.
- You are preparing for laboratory accreditation.
- You need method verification, quality control and EQA on record.
Look here instead if you inspect equipment, vehicles or sites rather than test patient samples. ISO/IEC 17020:2026 Inspection Body Management Systems →
What you get, in numbers
Counted from the files in the pack. Every file title is listed further down.
What this toolkit is not
Worth knowing before you buy.
Not the certificate
Accreditation is decided by an independent accreditation body after it audits a system you have run for some months, with records. No toolkit can guarantee it.
Not the ISO text
The standard is copyrighted and sold by ISO and national standards bodies. Buy your own copy. The toolkit describes requirements in its own words.
Not a consultant
We do not assess your organization. You review, adapt and approve every document before you use it.
What’s inside
15 numbered folders. Open any folder to see the title of every file in it. Titles only: the files themselves are delivered after payment.
00Start Here
Six guides: read-me, how to implement with an initial review checklist, documentation structure, quick start, an ISO 15189:2022 clause mapping guide, and an accreditation preparation guide.
6 files
- WordSH-001 Read Me Guide
- WordSH-002 How to Implement Guide
- WordSH-003 Documentation Structure Guide
- WordSH-004 Quick Start Guide
- WordSH-005 ISO 15189-2022 Clause Mapping Guide
- WordSH-006 Accreditation Preparation Guide
01Master Index
One Excel register of every controlled document: number, title, type, owner, section, retention and clause, with review dates and overdue flags.
1 file
- ExcelREG-01 Master Document Register
02Manual
The Laboratory Management System Manual, section-numbered to match clauses 4 to 8: impartiality and confidentiality, structure and the Laboratory Director, objectives and risk, personnel, facilities, equipment and traceability, reagents and providers, the pre-examination, examination and post-examination processes, and the management system.
1 file
- WordLMS-001 Laboratory Management System Manual
03Procedures (P-001 to P-024)
Document and record control, structure and Director, activities and objectives, impartiality, risk, personnel and competence, facilities, equipment, calibration and traceability, reagents, providers, pre-examination, sample transport and receipt, method verification and validation, uncertainty and intervals, quality control and EQA, reporting and critical results, nonconforming work, information systems, complaints, continuity, indicators and audit, management review and corrective action. Each has a flowchart, responsibility table, controls, risk and indicator matrices.
24 files
- WordP-001 Document Control Procedure
- WordP-002 Record Control Procedure
- WordP-003 Legal Entity, Structure, Director and Authority Procedure
- WordP-004 Laboratory Activities, Objectives and Policies Procedure
- WordP-005 Impartiality, Confidentiality and Patient Requirements Procedure
- WordP-006 Risk Management and Improvement Procedure
- WordP-007 Personnel and Competence Procedure
- WordP-008 Facilities and Environmental Conditions Procedure
- WordP-009 Equipment Management Procedure
- WordP-010 Calibration and Metrological Traceability Procedure
- WordP-011 Reagents and Consumables Procedure
- WordP-012 Service Agreements and External Providers Procedure
- WordP-013 Pre-examination Information, Requests and Sample Collection Procedure
- WordP-014 Sample Transport, Receipt and Handling Procedure
- WordP-015 Method Verification and Validation Procedure
- WordP-016 Measurement Uncertainty, Reference Intervals and Decision Limits Procedure
- WordP-017 Examination Procedures and Validity of Results Procedure
- WordP-018 Result Review, Reporting and Post-examination Procedure
- WordP-019 Nonconforming Work Procedure
- WordP-020 Data and Information Management Procedure
- WordP-021 Complaints Procedure
- WordP-022 Continuity and Emergency Preparedness Procedure
- WordP-023 Quality Indicators and Internal Audit Procedure
- WordP-024 Management Review and Corrective Action Procedure
04Policies (POL-001 to POL-012)
Quality and competence, impartiality and confidentiality, document and record control, risk management, personnel, facilities and equipment, reagents and providers, pre-examination, examination and validity of results, reporting and data, complaints and continuity, and evaluation and improvement.
12 files
- WordPOL-001 Quality and Competence Policy
- WordPOL-002 Impartiality, Independence and Confidentiality Policy
- WordPOL-003 Document and Record Control Policy
- WordPOL-004 Risk Management Policy
- WordPOL-005 Personnel and Competence Policy
- WordPOL-006 Facilities, Equipment and Metrological Traceability Policy
- WordPOL-007 Reagents, Consumables and External Providers Policy
- WordPOL-008 Pre-examination Policy
- WordPOL-009 Examination and Validity of Results Policy
- WordPOL-010 Reporting, Post-examination, Data and Information Policy
- WordPOL-011 Complaints, Nonconforming Work and Continuity Policy
- WordPOL-012 Evaluation, Review and Improvement Policy
05SOP Library (SOP-001 to SOP-022)
Step-by-step task instructions with flowcharts and acceptance criteria: competence assessment, environmental monitoring, equipment repair, calibration, lot acceptance, referral laboratories, sample collection, reception and rejection, method verification, uncertainty, internal quality control, EQA, result release, critical results, nonconforming work, downtime, complaints, audit and corrective action.
22 files
- WordSOP-001 Document Issue and Withdrawal
- WordSOP-002 Records Filing and Retention
- WordSOP-003 Competence Assessment and Authorization
- WordSOP-004 Environmental Monitoring
- WordSOP-005 Equipment Maintenance and Repair
- WordSOP-006 Calibration and Traceability Verification
- WordSOP-007 Reagent and Lot Acceptance
- WordSOP-008 Referral Laboratory Management
- WordSOP-009 Primary Sample Collection
- WordSOP-010 Sample Reception and Registration
- WordSOP-011 Sample Rejection and Storage
- WordSOP-012 Method Verification
- WordSOP-013 Measurement Uncertainty Evaluation
- WordSOP-014 Internal Quality Control
- WordSOP-015 External Quality Assessment and Comparison
- WordSOP-016 Result Validation and Release
- WordSOP-017 Critical Result Notification
- WordSOP-018 Nonconforming Work Handling
- WordSOP-019 LIS Backup and Downtime
- WordSOP-020 Complaint Handling
- WordSOP-021 Internal Audit Conduct
- WordSOP-022 Corrective Action Tracking
06Forms (FR-001 to FR-051)
Fifty-one forms. Each comes with field descriptions, a blank form that prints on its own, and a completed example record.
51 files
- WordFR-001 Document Change Request
- WordFR-002 Document Review Record
- WordFR-003 Record Disposal Authorization
- WordFR-004 Laboratory Structure and Authority Record
- WordFR-005 Laboratory Director Responsibilities Record
- WordFR-006 Scope of Laboratory Activities
- WordFR-007 Quality Objectives Plan
- WordFR-008 Impartiality Risk Assessment
- WordFR-009 Confidentiality and Impartiality Declaration
- WordFR-010 Risk and Opportunity Assessment
- WordFR-011 Improvement Suggestion and Project Record
- WordFR-012 Competence Assessment
- WordFR-013 Training Record
- WordFR-014 Authorization to Perform Activities
- WordFR-015 Environmental Monitoring Record
- WordFR-016 Equipment Record
- WordFR-017 Equipment Maintenance and Repair Record
- WordFR-018 Calibration and Traceability Record
- WordFR-019 Reagent and Consumable Acceptance Record
- WordFR-020 Lot Verification Record
- WordFR-021 External Provider Evaluation
- WordFR-022 Referral Laboratory Review
- WordFR-023 Request Form Review
- WordFR-024 Primary Sample Collection Record
- WordFR-025 Sample Transport and Receipt Record
- WordFR-026 Sample Acceptance and Rejection Record
- WordFR-027 Method Verification Report
- WordFR-028 Method Validation Report
- WordFR-029 Measurement Uncertainty Evaluation
- WordFR-030 Reference Interval and Decision Limit Review
- WordFR-031 Internal Quality Control Review
- WordFR-032 External Quality Assessment Review
- WordFR-033 Interlaboratory Comparison Record
- WordFR-034 Result Review and Release Record
- WordFR-035 Critical Result Notification Record
- WordFR-036 Report Amendment Record
- WordFR-037 Nonconforming Work Report
- WordFR-038 LIS Validation and Change Record
- WordFR-039 Complaint Record
- WordFR-040 Continuity Plan Test Record
- WordFR-041 Quality Indicator Definition Sheet
- WordFR-042 Quality Performance Report
- WordFR-043 Annual Audit Programme
- WordFR-044 Audit Plan
- WordFR-045 Internal Audit Checklist
- WordFR-046 Audit Report
- WordFR-047 Auditor Competence Record
- WordFR-048 Management Review Agenda
- WordFR-049 Management Review Minutes
- WordFR-050 Management Review Action Plan
- WordFR-051 Corrective Action Record
07Registers (REG-01 to REG-18)
Eighteen Excel registers with examples, drop-down lists, automatic calculations, due dates and flags: personnel authorization (expired), equipment (overdue maintenance or calibration), calibration and traceability, reagent lots (used unverified or expired), method verification (used before approval), quality control and EQA (action missing), rejections and nonconforming work (recall missing), critical results (minutes to notify), complaints, environment, indicators, corrective actions and audits.
18 files
- ExcelREG-01 Document Register
- ExcelREG-02 Record Register
- ExcelREG-03 Requirements Register
- ExcelREG-04 Risk and Opportunity Register
- ExcelREG-05 Personnel Competence and Authorization Register
- ExcelREG-06 Equipment Register
- ExcelREG-07 Calibration and Traceability Register
- ExcelREG-08 Reagent and Consumable Lot Register
- ExcelREG-09 External Provider and Referral Laboratory Register
- ExcelREG-10 Method Verification and Validation Register
- ExcelREG-11 Quality Control and EQA Register
- ExcelREG-12 Sample Rejection and Nonconforming Work Register
- ExcelREG-13 Critical Result Register
- ExcelREG-14 Complaint Register
- ExcelREG-15 Environmental Monitoring Register
- ExcelREG-16 Quality Indicators Register
- ExcelREG-17 Corrective Action Register
- ExcelREG-18 Audit Register
08Process Maps
Eight swimlane maps with inputs, outputs, owners and indicator links: structure and risk, personnel, facilities and equipment, reagents and providers, pre-examination, methods and validity of results, reporting and support, and audit and improvement.
8 files
- WordPM-01 Structure, Impartiality, Scope and Risk Process Map
- WordPM-02 Personnel, Competence and Authorization Process Map
- WordPM-03 Facilities, Equipment and Traceability Process Map
- WordPM-04 Reagents, Consumables and External Providers Process Map
- WordPM-05 Pre-examination Information, Collection, Transport and Receipt Process Map
- WordPM-06 Method Verification, Uncertainty and Validity of Results Process Map
- WordPM-07 Reporting, Nonconforming Work, Data, Complaints and Continuity Process Map
- WordPM-08 Documents, Indicators, Audit, Review and Corrective Action Process Map
09Indicators & Risk
97 quality indicators with formulas and targets in a filterable matrix, corporate and department frameworks, a balanced scorecard, a 5 x 5 risk matrix with 38 example risks, and an improvement opportunity matrix with 25 examples.
6 files
- WordKPI-01 Corporate Indicator Framework
- WordKPI-02 Department Indicator Framework
- ExcelKPI-03 Balanced Scorecard
- ExcelKPI-04 Process Indicator Matrix
- ExcelRSK-01 Risk Management Matrix
- ExcelRSK-02 Opportunity Matrix
10Audit
Annual audit programme covering every clause, section and site, audit plan with witnessing of examinations, notification, auditor competence matrix, a 42-question checklist by clause, a complete audit report and a findings tracker.
7 files
- WordAUD-01 Annual Audit Programme
- WordAUD-02 Audit Plan
- WordAUD-03 Audit Notification
- ExcelAUD-04 Auditor Competence Matrix
- ExcelAUD-05 Audit Checklist by Clause
- WordAUD-06 Audit Report
- ExcelAUD-07 Follow-up Tracker
11Management Review
Agenda, inputs checklist covering every input of clause 8.9 including external assessment and EQA, completed sample minutes with the required outputs, action plan and a dashboard.
5 files
- WordMRV-01 Management Review Agenda
- WordMRV-02 Management Review Inputs Checklist
- WordMRV-03 Management Review Minutes Template
- ExcelMRV-04 Management Review Action Plan
- ExcelMRV-05 Management Review Dashboard
12Implementation
A twelve-month roadmap with activities, milestones, deliverables and responsibilities, and a task tracker.
2 files
- WordIMP-01 Implementation Roadmap
- ExcelIMP-02 Implementation Tracker
13Customization
Guides with risks, controls and indicators for hospital laboratories, pathology, microbiology and molecular, point-of-care programmes, public health, blood banks, genetic testing, veterinary, occupational health and mobile laboratories, and laboratory networks.
10 files
- WordCUS-01 Hospital and Independent Clinical Laboratories Customization Guide
- WordCUS-02 Pathology and Histology Laboratories Customization Guide
- WordCUS-03 Microbiology and Molecular Diagnostic Laboratories Customization Guide
- WordCUS-04 Point-of-Care Testing Programmes Customization Guide
- WordCUS-05 Public Health and Reference Laboratories Customization Guide
- WordCUS-06 Blood Banks and Transfusion Laboratories Customization Guide
- WordCUS-07 Genetic, Reproductive and Specialist Testing Laboratories Customization Guide
- WordCUS-08 Veterinary and Research Diagnostic Laboratories Customization Guide
- WordCUS-09 Occupational Health, Screening and Mobile Laboratories Customization Guide
- WordCUS-10 Laboratory Networks, Chains and Consolidated Services Customization Guide
14Commercial
Gap assessment checklist, accreditation readiness checklist, implementation and training proposal templates, consultancy agreement template and assessment preparation checklist.
6 files
- ExcelCOM-01 Gap Assessment Checklist
- ExcelCOM-02 Certification Readiness Checklist
- WordCOM-03 Implementation Proposal Template
- WordCOM-04 Training Proposal Template
- WordCOM-05 Consultancy Agreement
- ExcelCOM-06 Audit Preparation Checklist
Sample pages
Pages from the delivered files, before your company details are applied.
After you download
The order most organizations follow.
Before you buy
Is the text of ISO 15189 included?
No. The standard is copyrighted by ISO and sold by ISO and national standards bodies. Buy your own copy of ISO 15189:2022. The toolkit describes requirements in its own words and maps every clause to the document that meets it, so you can check each against the standard.
Which edition does the kit follow?
ISO 15189:2022 (fourth edition, published December 2022), the current edition. It replaced ISO 15189:2012 and ISO 22870 (point-of-care testing), whose requirements are now included. The transition period ended on 6 December 2025, so accreditation to the 2012 edition is no longer valid; confirm the position with your accreditation body.
Does the kit get us accredited?
No document set can. ISO 15189 is mainly used by accreditation bodies to assess the technical competence of laboratories for their scope, including observation of work and review of quality control and external quality assessment results. The kit gives you a complete, clause-mapped documentation baseline and tools for operating the system, but accreditation is decided only by the accreditation body after assessment, and it depends on demonstrated competence and results.
Does it give clinical or legal advice, or include our examination procedures?
No. The kit gives no clinical or legal advice and does not replace manufacturer instructions or local regulation. It does not contain your examination procedures: the SOP library gives models, and you write each procedure from your manufacturer instructions and your own verification data.
Are the examples and figures real data?
No. Names, limits, intervals, uncertainty values, critical result limits, turnaround times and cases in example records are fictional and marked as examples. Set your own from your methods, manufacturer instructions, regulation and validation data.
Can we edit the documents after purchase?
Yes. Files are delivered as standard, unlocked .docx and .xlsx files. Nothing is watermarked or restricted. Items such as prepared-by names and company profile facts are left for you to complete.
How long can we download the files?
For 7 days from payment. In that time you can enter your company details, correct them and regenerate, and download as often as you need. After 7 days the purchase stays in your account history, but the download closes. Save the ZIP somewhere safe.
What if we need the files again later?
Buying the same toolkit again is a new order with its own 7-day download window. Each purchase is listed separately in your account.
Licence
One purchase licenses one organization to use, edit and adapt the documents for its own management system. You may not resell, share or publish the toolkit or its templates. Each file carries a footer line with the buyer’s email and order number. Full wording is in the Terms & licence.