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This document provides requirements and recommendations for supervisors and operators of point-of-care testing (POCT) services where POCT is performed without medical laboratory training, supervision or support. It includes the key components that should be considered to provide safe and reliable POCT results.
Self-testing is excluded from this document.
]]>This International Standard specifies the general requirements for the peer assessment process to be carried out by agreement groups of accreditation bodies or conformity assessment bodies. It addresses the structure and operation of the agreement group only insofar as they relate to the peer assessment process.
This International Standard is not concerned with the wider issues of the arrangements for the formation, organization and management of the agreement group, and does not cover how the group will use peer assessment in deciding membership of the group. Such matters, which could for example include a procedure for applicants to appeal against decisions of the agreement group, are outside the scope of this International Standard.
NOTE 1 Further information on the wider issues is contained in ISO/IEC Guide 68.
]]>This document provides guidance to validation/verification programme owners, validation/verification bodies and interested parties on the development, content and operation of validation/verification programmes.
When implemented by validation/verification bodies, this document is intended to be used in conjunction with ISO/IEC 17029 and sector-specific applications of ISO/IEC 17029.
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| Standard number | MS ISO/IEC TS 17012:2024 |
| Title and Sub-titles | Conformity assessment — Guidelines for the use of remote auditing methods in auditing management systems |
| Status | Current |
| Replaces | |
| Replaced by | |
| Edition | First |
| Technical Committee | MSB/TC 9 - Conformity Assessment |
| ICS | 03.120.20 |
| Publication date | 2025/03/06 |
| Corrected version | |
| Government Notice No. | General Notice No. 298 of 2025 |
| Number of Pages | 24 |
| Amendments/ Corrigendums | |
| Availability | Yes |
| Note |
| Standard number | MS ISO/IEC TS 17021-15:2023 |
| Title and Sub-titles | Conformity assessment requirements for bodies providing audit and certification of management systems Part 15: Competence requirements for auditing and certification of management systems for quality in healthcare organizations |
| Status | Current |
| Replaces | |
| Replaced by | |
| Edition | First |
| Technical Committee | MSB/TC 9 - Conformity Assessment |
| ICS | 03.120.20 |
| Publication date | 2020/03/06 |
| Corrected version | |
| Government Notice No. | General Notice No. 298 of 2025 |
| Number of Pages | 5 |
| Amendments/ Corrigendums | |
| Availability | Yes |
| Note |
| Standard number | MS ISO 20658:2023 |
| Title and Sub-titles | Requirements for the collection and transport of samples for medical laboratory examinations |
| Status | Current |
| Replaces | |
| Replaced by | |
| Edition | First |
| Technical Committee | MSB/TC 9 - Conformity Assessment |
| ICS | 11.100.01 |
| Publication date | 2024/04/13 |
| Corrected version | |
| Government Notice No. | GN No 407 of 2024 |
| Number of Pages | 42 |
| Amendments/ Corrigendums | |
| Availability | Yes |
| Note |
| Standard number | MS ISO/IEC TS 17021-13:2021 |
| Title and Sub-titles | Conformity assessment - Requirements for bodies providing audit and certification of management systems - Part 1: Competence requirements for auditing and certification of compliance management systems |
| Status | Current |
| Replaces | |
| Replaced by | |
| Edition | |
| Technical Committee | MSB/TC 9 - Conformity Assessment |
| ICS | |
| Publication date | |
| Corrected version | |
| Government Notice No. | |
| Number of Pages | |
| Amendments/ Corrigendums | |
| Availability | Yes |
| Note |
| Standard number | MS ISO IEC 17043:2023 |
| Title and Sub-titles | Conformity assessment - General requirements for proficiency testing |
| Status | Current |
| Replaces | MS ISO IEC 17043:2010 |
| Replaced by | |
| Edition | Second |
| Technical Committee | MSB/TC 9 - Conformity Assessment |
| ICS | 03.120.20 |
| Publication date | 2024/04/13 |
| Corrected version | |
| Government Notice No. | GN No 407 of 2024 |
| Number of Pages | 36 |
| Amendments/ Corrigendums | |
| Availability | Yes |
| Note |
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).
| Standard number | MS ISO 15189:2022 |
| Title and Sub-titles | Medical laboratories -Requirements for quality and competence |
| Status | Current |
| Replaces | MS ISO 15189:2012 |
| Replaced by | |
| Edition | Fourth |
| Technical Committee | MSB/TC 9 - Conformity Assessment |
| ICS | 03.120.10; 11.100.01 |
| Publication date | 2023/04/21 |
| Corrected version | |
| Government Notice No. | General Notice No. 529 of 2023 |
| Number of Pages | 62 |
| Amendments/ Corrigendums | |
| Availability | Yes |
| Note |
| Standard number | MS ISO/IEC 17060:2022 |
| Title and Sub-titles | Conformity assessment - Code of good practice |
| Status | Current |
| Replaces | MS ISO/IEC Guide 60:2004 |
| Replaced by | |
| Edition | First |
| Technical Committee | MSB/TC 9 - Conformity Assessment |
| ICS | 03.120.20 |
| Publication date | 2022/10/01 |
| Corrected version | |
| Government Notice No. | General notice No. 1490 of 2022 |
| Number of Pages | 7 |
| Amendments/ Corrigendums | |
| Availability | Yes |
| Note |