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BS EN ISO 15189:2022

BS EN ISO 15189:2022

$215.11

Medical laboratories. Requirements for quality and competence

Published By Publication Date Number of Pages
BSI 2022 76
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This document specifies requirements for quality and competence in medical laboratories. This document is applicable to medical laboratories in developing their management systems and assessing their competence. It is also applicable for confirming or recognizing the competence of medical laboratories by laboratory users, regulatory authorities and accreditation bodies. This document is also applicable to point-of-care testing (POCT). NOTE            International, national, or regional regulations or requirements can also apply to specific topics covered in this document.

PDF Catalog

PDF Pages PDF Title
2 undefined
4 European foreword
Endorsement notice
8 Foreword
9 Introduction
11 1 Scope
2 Normative references
3 Terms and definitions
18 4 General requirements
4.1 Impartiality
4.2 Confidentiality
4.2.1 Management of information
19 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
20 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
21 5.4 Structure and authority
5.4.1 General
5.4.2 Quality management
5.5 Objectives and policies
22 5.6 Risk management
6 Resource requirements
6.1 General
6.2 Personnel
6.2.1 General
6.2.2 Competence requirements
23 6.2.3 Authorization
6.2.4 Continuing education and professional development
6.2.5 Personnel records
6.3 Facilities and environmental conditions
6.3.1 General
24 6.3.2 Facility controls
6.3.3 Storage facilities
6.3.4 Personnel facilities
6.3.5 Sample collection facilities
25 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
26 6.4.6 Equipment adverse incident reporting
6.4.7 Equipment records
27 6.5 Equipment calibration and metrological traceability
6.5.1 General
6.5.2 Equipment calibration
6.5.3 Metrological traceability of measurement results
28 6.6 Reagents and consumables
6.6.1 General
6.6.2 Reagents and consumables ā€” Receipt and storage
6.6.3 Reagents and consumables ā€” Acceptance testing
6.6.4 Reagents and consumables ā€” Inventory management
29 6.6.5 Reagents and consumables ā€” Instructions for use
6.6.6 Reagents and consumables ā€” Adverse incident reporting
6.6.7 Reagents and consumables ā€” Records
6.7 Service agreements
6.7.1 Agreements with laboratory users
6.7.2 Agreements with POCT operators
30 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 provided products and services
31 7 Process requirements
7.1 General
7.2 Pre-examination processes
7.2.1 General
7.2.2 Laboratory information for patients and users
7.2.3 Requests for providing laboratory examinations
32 7.2.4 Primary sample collection and handling
33 7.2.5 Sample transportation
34 7.2.6 Sample receipt
7.2.7 Pre-examination handling, preparation, and storage
35 7.3 Examination processes
7.3.1 General
7.3.2 Verification of examination methods
7.3.3 Validation of examination methods
36 7.3.4 Evaluation of measurement uncertainty (MU)
7.3.5 Biological reference intervals and clinical decision limits
37 7.3.6 Documentation of examination procedures
7.3.7 Ensuring the validity of examination results
40 7.4 Post-examination processes
7.4.1 Reporting of results
42 7.4.2 Post-examination handling of samples
43 7.5 Nonconforming work
7.6 Control of data and information management
7.6.1 General
7.6.2 Authorities and responsibilities for information management
44 7.6.3 Information systems management
7.6.4 Downtime plans
7.6.5 Off site management
7.7 Complaints
7.7.1 Process
45 7.7.2 Receipt of complaint
7.7.3 Resolution of complaint
7.8 Continuity and emergency preparedness planning
8 Management system requirements
8.1 General requirements
8.1.1 General
46 8.1.2 Fulfilment of management system requirements
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
47 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
48 8.4.3 Retention of records
8.5 Actions to address risks and opportunities for improvement
8.5.1 Identification of risks and opportunities for improvement
8.5.2 Acting on risks and opportunities for improvement
49 8.6 Improvement
8.6.1 Continual improvement
8.6.2 Laboratory patients, user, and personnel feedback
8.7 Nonconformities and corrective actions
8.7.1 Actions when nonconformity occurs
50 8.7.2 Corrective action effectiveness
8.7.3 Records of nonconformities and corrective actions
8.8 Evaluations
8.8.1 General
8.8.2 Quality indicators
8.8.3 Internal audits
51 8.9 Management reviews
8.9.1 General
8.9.2 Review input
8.9.3 Review output
53 Annex A (normative) Additional requirements for Point-of-Care Testing (POCT)
54 Annex B (informative) Comparison between ISO 9001:2015 and ISO 15189:2022 (this document)
64 Annex C (informative) Comparison between ISO 15189:2012 and ISO 15189:2022 (this document)
71 Bibliography

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BS EN ISO 15189:2022
$215.11