🔥🔥 Don’t Miss Out on Our End of Autumn Sale. If you have any questions, feel free to click the bottom right corner to contact our customer service..

Concat us[email protected]
Shopping Cart

No products in the cart.

🔍
BS EN ISO 15189:2022+A11:2023

BS EN ISO 15189:2022+A11:2023

$215.11

Medical laboratories. Requirements for quality and competence

Published By Publication Date Number of Pages
BSI 2023 78
PDF Format Searchable Printable Preview Now
Guaranteed Safe Checkout
Categories: ,

If you have any questions, feel free to reach out to our online customer service team by clicking on the bottom right corner. We’re here to assist you 24/7.
Email:[email protected]

PDF Catalog

PDF Pages PDF Title
2 undefined
12 Foreword
13 Introduction
15 1 Scope
2 Normative references
3 Terms and definitions
22 4 General requirements
4.1 Impartiality
4.2 Confidentiality
4.2.1 Management of information
23 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
24 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
25 5.4 Structure and authority
5.4.1 General
5.4.2 Quality management
5.5 Objectives and policies
26 5.6 Risk management
6 Resource requirements
6.1 General
6.2 Personnel
6.2.1 General
6.2.2 Competence requirements
27 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
28 6.3.2 Facility controls
6.3.3 Storage facilities
6.3.4 Personnel facilities
6.3.5 Sample collection facilities
29 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
30 6.4.6 Equipment adverse incident reporting
6.4.7 Equipment records
31 6.5 Equipment calibration and metrological traceability
6.5.1 General
6.5.2 Equipment calibration
6.5.3 Metrological traceability of measurement results
32 6.6 Reagents and consumables
6.6.1 General
6.6.2 Reagents and consumables — Receipt and storage
6.6.3 Reagents and consumables — Acceptance testing
6.6.4 Reagents and consumables — Inventory management
33 6.6.5 Reagents and consumables — Instructions for use
6.6.6 Reagents and consumables — Adverse incident reporting
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
34 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
35 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
36 7.2.4 Primary sample collection and handling
37 7.2.5 Sample transportation
38 7.2.6 Sample receipt
7.2.7 Pre-examination handling, preparation, and storage
39 7.3 Examination processes
7.3.1 General
7.3.2 Verification of examination methods
7.3.3 Validation of examination methods
40 7.3.4 Evaluation of measurement uncertainty (MU)
7.3.5 Biological reference intervals and clinical decision limits
41 7.3.6 Documentation of examination procedures
7.3.7 Ensuring the validity of examination results
44 7.4 Post-examination processes
7.4.1 Reporting of results
46 7.4.2 Post-examination handling of samples
47 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
48 7.6.3 Information systems management
7.6.4 Downtime plans
7.6.5 Off site management
7.7 Complaints
7.7.1 Process
49 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
50 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
51 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
52 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
53 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
54 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
55 8.9 Management reviews
8.9.1 General
8.9.2 Review input
8.9.3 Review output
57 Annex A (normative) Additional requirements for Point-of-Care Testing (POCT)
58 Annex B (informative) Comparison between ISO 9001:2015 and ISO 15189:2022 (this document)
68 Annex C (informative) Comparison between ISO 15189:2012 and ISO 15189:2022 (this document)
75 Bibliography

Related products

BS EN ISO 15189:2022+A11:2023
$215.11