About ISO 15189


ISO 15189:2012 Standard Outline

The ISO 15189 standard is based upon ISO/IEC 17025 and ISO 9001. ISO 15189 provides the requirements for competence and quality specific to medical laboratories. Please refer to the ISO website for more information regarding all of these standards:

International Organization for Standardization 


 

Foreword

Introduction

1. Scope

2. Normative references

3. Terms and definitions

4. Management requirements
4.1 Organization and management responsibility
4.1.1 Organization
4.1.2 Management responsibility
4.2 Quality management system
4.2.1 General requirements
4.2.2 Documentation requirements
4.3 Document control
4.4 Service agreements
4.4.1 Establishment of service agreements
4.4.2 Review of service agreements
4.5 Examination by referral laboratories
4.5.1 Selecting and evaluating referral laboratories and consultants
4.5.2 Provision of examination results
4.6 External services and supplies
4.7 Advisory services
4.8 Resolution of complaints
4.9 Identification and control of nonconformities
4.10 Corrective action
4.11 Preventive action
4.12 Continual improvement
4.13 Control of records
4.14 Evaluation and audits
4.14.1 General
4.14.2 Periodic review of requests, and suitability of procedures, and sample requirements
4.14.3 Assessment of user feedback
4.14.4 Staff suggestions
4.14.5 Internal audit
4.14.6 Risk management
4.14.7 Quality indicators
4.14.8 Reviews by external organizations
4.15 Management review
4.15.1 General
4.15.2 Review input
4.15.3 Review activities
4.15.4 Review output

5. Technical requirements
5.1 Personnel
5.1.1 General
5.1.2 Personnel qualifications
5.1.3 Job descriptions
5.1.4 Personnel introduction to the organizational environment
5.1.5 Training
5.1.6 Competence assessment
5.1.7 Review of staff performance
5.1.8 Continuing education and professional development
5.1.9 Personnel records
5.2 Accommodation and environmental conditions
5.21 General
5.2.2 Laboratory and office facilities
5.2.3 Storage facilities
5.2.4 Staff facilities
5.2.5 Patient sample collection facilities
5.2.6 Facility maintenance and environmental conditions
5.3. Laboratory equipment, reagents, and consumables
5.3.1 Equipment
5.3.1.1 General
5.3.1.2 Equipment acceptance testing
5.3.1.3 Equipment instructions for use
5.3.1.4 Equipment calibration and metrological traceability
5.3.1.5 Equipment maintenance and repair
5.3.1.6 Equipment adverse incident reporting
5.3.1.7 Equipment records
5.3.2 Reagents and consumables
5.3.2.1 General
5.3.2.2 Reagents and consumables - reception and storage
5.3.2.3 Reagents and consumables - acceptance testing
5.3.2.4 Reagents and consumables - inventory management
5.3.2.5 Reagents and consumables - instructions for use
5.3.2.6 Reagents and consumables - adverse incident reporting
5.3.2.7 Reagents and consumables - records
5.4 Pre-examination processes
5.4.1 General requirements
5.4.2 Information for patients and users
5.4.3 Request form information
5.4.4 Primary sample collection and handling
5.4.5 Sample transportation
5.4.6 Sample reception
5.4.7 Pre-examination handling, preparation and storage
5.5 Examination processes
5.5.1 Selection, verification and validation procedures
5.5.2 Biological reference intervals and clinical decision values
5.5.3 Documentation of examination procedures
5.6 Ensuring quality of examination results
5.6.1 General
5.6.2 Quality control
5.6.2.2 Quality control materials
5.6.2.3 Quality control data
5.6.3 Interlaboratory comparisons
5.6.3.1 Participation
5.6.3.2 Alternative approaches
5.6.3.3 Analysis of interlaboratory comparison samples
5.6.3.4 Evaluation of laboratory performance
5.6.4 Comparability of examination results
5.7 Post-examination processes
5.7.1 Review of results
5.7.2 Storage, retention and disposal of clinical samples
5.8 Reporting of results
5.8.1 General
5.8.2 Report attributes
5.8.3 Report content
5.9 Release of results
5.9.1 Automated selection and reporting of results
5.9.2 Revised reports
5.10 Laboratory information management
5.10.1 General
5.10.2 Authorities and responsibilities
5.10.3 Information system management

Annex A Correlation with ISO 9001:2008 and ISO/IEC 17025:2005
Annex B Correlation with ISO 15189:2007
Bibliography