Standard
UPDATE AVAILABLE
AS ISO 15189-2013
[Superseded]Medical laboratories — Requirements for quality and competence
Adopts ISO 15189:2012 to specify requirements for quality and competence particular to medical laboratories.
Published: 14/05/2013
Pages: 50
Table of contents
Cited references
Content history
Table of contents
Header
About this publication
Preface
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Management requirements
4.1 Organization and management responsibility
4.1.1 Organization
4.1.1.1 General
4.1.1.2 Legal entity
4.1.1.3 Ethical conduct
4.1.1.4 Laboratory director
4.1.2 Management responsibility
4.1.2.1 Management commitment
4.1.2.2 Needs of users
4.1.2.3 Quality policy
4.1.2.4 Quality objectives and planning
4.1.2.5 Responsibility, authority and interrelationships
4.1.2.6 Communication
4.1.2.7 Quality manager
4.2 Quality management system
4.2.1 General requirements
4.2.2 Documentation requirements
4.2.2.1 General
4.2.2.2 Quality manual
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 Reviews of staff performance
5.1.8 Continuing education and professional development
5.1.9 Personnel records
5.2 Accommodation and environmental conditions
5.2.1 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
5.4.2 Information for patients and users
5.4.3 Request form information
5.4.4 Primary sample collection and handling
5.4.4.1 General
5.4.4.2 Instructions for pre-collection activities
5.4.4.3 Instructions for collection activities
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 of examination procedures
5.5.1.1 General
5.5.1.2 Verification of examination procedures
5.5.1.3 Validation of examination procedures
5.5.1.4 Measurement uncertainty of measured quantity values
5.5.2 Biological reference intervals or 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
5.6.2.1 General
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 General
5.9.2 Automated selection and reporting of results
5.9.3 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
Annex B
Bibliography
Cited references in this standard
[Current]
International vocabulary of metrology — Basic and general concepts and associated terms (VIM)
[Superseded]
General requirements for the competence of testing and calibration laboratories
Content history
[Current]
[Superseded]
[Superseded]
DR AS ISO 15189
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