Draft Details
- The ISO 15189:2022 handbook: a practical guide...
- DRAFT HANDBOOK
- Legal Notice for Draft Handbook
- Preface
- + How to use this handbook
- Part 1 presents text from ISO 15189:2022 and r...
- Part 2 presents concise and user-friendly temp...
- Part 3 provides a glossary of related document...
- Disclaimer
- + Introduction
- History of ISO 15189
- Specific terms used in ISO Standards
- Medical laboratories: Functions and issues
- + The laboratory total testing cycle
- The pre-examination phase
- The examination phase
- The post-examination phase
- Quality partners
- Application of ISO 15189 — With and without ac...
- Revision process 2018 - 2022
- Changes in the 4th Edition of ISO 15189
- Part 1: Guidance and tips
- + 3 Terms and definitions
- New or revised definitions in the 4th edition ...
- Definitions excluded from the 4th edition of I...
- Terms still used in the 4th edition of ISO 151...
- Terms and definitions from ISO 15189: 2022
- Abbreviations
- + 4 General requirements
- 4.1 Impartiality
- + 4.2 Confidentiality
- 4.2.1 Management of information
- 4.2.2 Release of information
- 4.2.3 Personnel responsibility
- 4.3 Requirements regarding patients
- + 5 Structural and governance requirements
- 5.1 Legal entity
- + 5.2 Laboratory director
- 5.2.1 Laboratory director competence
- 5.2.2 Laboratory director responsibilities
- 5.2.3 Delegation of duties
- + 5.3 Laboratory activities
- 5.3.1 General
- 5.3.2 Conformance with requirements
- 5.3.3 Advisory activities
- + 5.4 Structure and authority
- 5.4.1 General
- 5.4.2 Quality management
- 5.5 Objectives and policies
- 5.6 Risk management
- + 6 Resource requirements
- 6.1 General
- + 6.2 Personnel
- 6.2.1 General
- 6.2.2 Competence requirements
- 6.2.3 Authorization
- 6.2.4 Continuing education and professional dev...
- 6.2.5 Personnel records
- + 6.3 Facilities and environmental conditions
- 6.3.1 General
- 6.3.2 Facility controls
- 6.3.3 Storage facilities
- 6.3.4 Personnel facilities
- 6.3.5 Sample collection facilities
- + 6.4 Equipment
- 6.4.1 General
- 6.4.2 Equipment requirements
- 6.4.3 Equipment acceptance procedure
- 6.4.4 Equipment instructions for use
- 6.4.5 Equipment maintenance and repair
- 6.4.6 Equipment adverse incident reporting
- 6.4.7 Equipment records
- + 6.5 Equipment calibration and metrological tra...
- 6.5.1 General
- 6.5.2 Equipment calibration
- 6.5.3 Metrological traceability of measurement ...
- + 6.6 Reagents and consumables
- 6.6.1 General
- 6.6.2 Reagents and consumables — Receipt and st...
- 6.6.3 Reagents and consumables — Acceptance tes...
- 6.6.4 Reagents and consumables — Inventory mana...
- 6.6.5 Reagents and consumables — Instructions f...
- 6.6.6 Reagents and consumables — Adverse incide...
- 6.6.7 Reagents and consumables — Records
- + 6.7 Service agreements
- 6.7.1 Agreements with laboratory users
- 6.7.2 Agreements with POCT operators
- + 6.8 Externally provided products and services
- 6.8.1 General
- 6.8.2 Referral laboratories and consultants
- 6.8.3 Review and approval of externally provide...
- + 7 Process requirements
- 7.1 General
- + 7.2 Pre-examination processes
- 7.2.1 General
- 7.2.2 Laboratory information for patients and u...
- + 7.2.3 Requests for providing laboratory examina...
- 7.2.3.1 General
- 7.2.3.2 Oral requests
- + 7.2.4 Primary sample collection and handling
- 7.2.4.1 General
- 7.2.4.2 Information for pre-collection activiti...
- 7.2.4.3 Patient consent
- 7.2.4.4 Instructions for collection activities
- 7.2.5 Sample transportation
- + 7.2.6 Sample receipt
- 7.2.6.1 Sample receipt procedure
- 7.2.6.2 Sample acceptance exceptions
- + 7.2.7 Pre-examination handling, preparation, an...
- 7.2.7.1 Sample protection
- 7.2.7.2 Criteria for additional examination req...
- 7.2.7.3 Sample stability
- + 7.3 Examination processes
- 7.3.1 General
- 7.3.2 General Verification of examination metho...
- 7.3.3 Validation of examination methods
- 7.3.4 Evaluation of measurement uncertainty (MU...
- 7.3.5 Biological reference intervals and clinic...
- 7.3.6 Documentation of examination procedures
- + 7.3.7 Ensuring the validity of examination resu...
- 7.3.7.1 General
- 7.3.7.2 Internal quality control (IQC)
- 7.3.7.3 External quality assessment (EQA)
- 7.3.7.4 Comparability of examination results
- + 7.4 Post-examination processes
- + 7.4.1 Reporting of results
- 7.4.1.1 General
- 7.4.1.2 Result review and release
- 7.4.1.3 Critical result reports
- 7.4.1.4 Special considerations for results
- 7.4.1.5 Automated selection, review, release an...
- 7.4.1.6 Requirements for reports
- 7.4.1.7 Additional information for reports
- 7.4.1.8 Amendments to reported results
- 7.4.2 Post-examination handling of samples
- 7.5 Nonconforming work
- + 7.6 Control of data and information management
- 7.6.1 General
- 7.6.2 Authorities and responsibilities for info...
- 7.6.3 Information systems management
- 7.6.4 Downtime plans
- 7.6.5 Off site management
- + 7.7 Complaints
- 7.7.1 Process
- 7.7.2 Receipt of complaint
- 7.7.3 Resolution of complaint
- 7.8 Continuity and emergency preparedness plann...
- + 8 Management system requirements
- + 8.1 General requirements
- 8.1.1 General
- 8.1.2 Fulfilment of management system requireme...
- 8.1.3 Management system awareness
- + 8.2 Management system documentation
- 8.2.1 General
- 8.2.2 Competence and quality
- 8.2.3 Evidence of commitment
- 8.2.4 Documentation
- 8.2.5 Personnel access
- + 8.3 Control of management system documents
- 8.3.1 General
- 8.3.2 Control of documents
- + 8.4 Control of records
- 8.4.1 Creation of records
- 8.4.2 Amendment of records
- 8.4.3 Retention of records
- + 8.5 Actions to address risks and opportunities ...
- 8.5.1 Identification of risks and opportunities...
- 8.5.2 Acting on risks and opportunities for imp...
- + 8.6 Improvement
- 8.6.1 Continual improvement
- 8.6.2 Laboratory patients, user, and personnel ...
- + 8.7 Nonconformities and corrective actions
- 8.7.1 Actions when nonconformity occurs
- 8.7.2 Corrective action effectiveness
- 8.7.3 Records of nonconformities and corrective...
- + 8.8 Evaluations
- 8.8.1 General
- 8.8.2 Quality indicators
- + 8.8.3 Internal audits
- 8.8.3.1 The laboratory shall conduct internal a...
- 8.8.3.2 The laboratory shall plan, establish, i...
- + 8.9 Management reviews
- 8.9.1 General
- 8.9.2 Review input
- 8.9.3 Review output
- + Annex A - Normative
- A.1 General
- A.2 Governance
- A.3 Quality assurance program
- A.4 Training program
- + Part 2: Templates
- + 1 Example of a quality manual
- Introduction
- 1 Scope
- 2 Reference Publications
- 3 Definitions
- 4 General
- 5 Quality Management System
- 6 Patient Safety and Quality of Care
- 7 Structural and Governance Requirements
- 8 Personnel
- 9 Facilities and Environmental Conditions
- 10 Equipment
- 11 Reagents and Consumables
- 12 Service Agreements
- 13 Infection Prevention and Control
- + 14 Pre-Examination Processes
- A. Primary Sample Collection
- B. Identification of Samples and Sample Integr...
- C. Sample Receipt, Assessment, Accessioning, S...
- D. Transport of Samples
- + 15 Examination Processes
- A. Preparation of the Sample for Testing
- B. Analytical Procedures
- C. Instrument Calibration and Maintenance
- D. Quality Control
- E. Proficiency Testing
- + 16 Post-Examination Processes
- A. Result Review and Validation
- B. Critical Value Reporting
- C. Reporting Results
- D. Use of Test Results
- E. Data Interpretation
- F. Quality Assurance and Continuous Improvemen...
- 2 Job Description
- 3 Orientation Process Checklist
- 4 Competency Assessment Form
- 5 Equipment Verification Log
- 6 a. FREEZER TEMPERATURE RECORDING FORM
- 6 b. REFRIGERATOR TEMPERATURE RECORDING FORM
- 7 Equipment Identification and Maintenance Form...
- 8 Supplier Evaluation Form
- + 9 Example of a primary sample collection manual...
- Introduction
- + 1 Test requests
- 1.1 Medical indications and test selection
- 1.2 Instructions on how to complete paper or el...
- 1.3 Testing priorities
- 1.4 Verbal requests
- 1.5 Additional examination requests
- 1.6 Sample accessioning
- + 2 Patient information
- 2.1 Information and instructions for patients
- 2.2 Safety precautions
- 2.3 Labelling and packaging of self-collected s...
- 2.4 Patients with communication challenges
- + 3 Patient preparation
- 3.1 Patient identification
- 3.2 Patient assessment and selection of collect...
- 3.3 Consent forms
- + 4 Sample collection
- 4.1 Types of sample collections
- 4.2 Timed collections
- 4.2 Collection priorities
- 4.3 Sample labelling
- 4.5 Sample acceptance and rejection criteria
- 5 Sample stabilization, transport, and storage
- 6 Disposal of materials
- 7 Storage of examined samples
- + 8 List of laboratory tests offered
- 8.1 Total bilirubin
- 10 Oral Request Form
- 11 Temporary Identification Form
- 12 Blood Collection Volume Form
- 13 Automated Delivery System Maintenance Log
- 14 Sample Rejection Form
- 15 Standard Operating Procedure (SOP) template
- 16 Policy Template
- 17 Non-Conformities and Incidents Form
- 18 Non-Conformities and Incidents Log
- 19 Root cause analysis and corrective actions r...
- 20 Environmental Conditions Log
- Part 3: Glossary of resources
Designation:CSA 15189HB:25
Source:CSA
Contact:[email protected]
Contact name:Anne-Marie Martel
Review start date:Nov 1, 2024
Review end date:Dec 31, 2024
Categories:Health Care and Medical Devices
Contact email:thuy.ton(at)csagroup.org
You may comment on any section of this document by clicking the “Submit Comment” link at the bottom of the relevant section.