{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,3,19]],"date-time":"2026-03-19T12:27:35Z","timestamp":1773923255845,"version":"3.50.1"},"reference-count":28,"publisher":"Wiley","issue":"12","license":[{"start":{"date-parts":[[2025,9,7]],"date-time":"2025-09-07T00:00:00Z","timestamp":1757203200000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Vox Sanguinis"],"published-print":{"date-parts":[[2025,12]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Background and Objectives<\/jats:title>\n                    <jats:p>The International Society of Blood Transfusion (ISBT) Quality Management Working Party (QM\u2010WP) initiated a project to harmonize the definitions commonly used in quality management within blood establishments (BEs) around the world. A working group was established with the aim of providing simple, unambiguous definitions that can be applied in a standardized way.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Materials and Methods<\/jats:title>\n                    <jats:p>Common references available internationally were consulted in drafting a list of definitions relating to quality management. The criteria for selecting the most appropriate definition included clarity, simplicity, comprehensiveness and optimal applicability.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>The resulting list of definitions was published on the ISBT website in July 2023, with reference sources quoted for each definition. Individual references can be accessed via links appearing at the end of the document.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusion<\/jats:title>\n                    <jats:p>BEs are encouraged to utilize the document when developing internal quality system documents. The list is not prescriptive but is meant to serve as a recommendation. It is understood, however, that establishments in some countries are obliged to follow national legislation and terminology. It is the intention of the ISBT QM\u2010WP to periodically review the list of definitions, performing updates when required.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1111\/vox.70108","type":"journal-article","created":{"date-parts":[[2025,9,8]],"date-time":"2025-09-08T00:07:56Z","timestamp":1757290076000},"page":"1273-1282","source":"Crossref","is-referenced-by-count":1,"title":["Definitions used in quality management of blood establishments: A report of the\n                    <scp>ISBT<\/scp>\n                    Quality Management Working Party"],"prefix":"10.1111","volume":"120","author":[{"ORCID":"https:\/\/orcid.org\/0009-0009-4958-1874","authenticated-orcid":false,"given":"Lesley","family":"Bust","sequence":"first","affiliation":[{"name":"Africa Society for Blood Transfusion (AfSBT)  Cape Town South Africa"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Christian","family":"Seidl","sequence":"additional","affiliation":[{"name":"German Red Cross Blood Donor Services (RCBDS) \u2013 EuBIS Academy  Frankfurt am Main Germany"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-9951-6119","authenticated-orcid":false,"given":"Tomislav","family":"Vuk","sequence":"additional","affiliation":[{"name":"Croatian Institute of Transfusion Medicine  Zagreb Croatia"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Yan","family":"Qiu","sequence":"additional","affiliation":[{"name":"Beijing Red Cross Blood Center  Beijing China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Nigar","family":"Ertu\u011frul \u00d6r\u00fc\u00e7","sequence":"additional","affiliation":[{"name":"Consultant on Blood Banking and Transfusion Medicine  Ankara Turkey"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"name":"ISBT Quality Management Working Party","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2025,9,7]]},"reference":[{"key":"e_1_2_8_2_1","unstructured":"ISBT Quality Management Working Party.Definitions Utilised in Quality Management of Blood Establishments. Available from:https:\/\/www.isbtweb.org\/isbt-working-parties\/quality-management\/resources.html. Last accessed 10 Feb 2025."},{"key":"e_1_2_8_3_1","unstructured":"World Health Organization (WHO).Guidance on Implementation of a Quality System in Blood Establishments. 2023. Available from:https:\/\/iris.who.int\/handle\/10665\/376096. Last accessed 11 Feb 2025."},{"key":"e_1_2_8_4_1","volume-title":"Standards for blood banks and transfusion services","author":"Association for the Advancement of Blood & Biotherapies (AABB)","year":"2022"},{"key":"e_1_2_8_5_1","volume-title":"Guide to the preparation, use and quality assurance of blood components","author":"European Directorate for the Quality of Medicines & HealthCare (EDQM)","year":"2023"},{"key":"e_1_2_8_6_1","unstructured":"Secretariat of Pharmaceutical Inspection Convention (PIC\/S).Guide to Good Manufacturing Practice for Medicinal Products: PE 009\u201016 (Part II). 2022. Available from:https:\/\/www.tga.gov.au\/sites\/default\/files\/2024\u201003\/pe\u2010009\u201016\u2010gmp\u2010guide\u2010part\u2010ii\u2010basic\u2010requirements\u2010apis.pdf. Last accessed 10 Feb 2025."},{"key":"e_1_2_8_7_1","unstructured":"Australian Government Department of Health and Aged Care Therapeutic Goods Administration.Biovigilance Responsibilities of Sponsors of Biologicals. 2017. Available from:https:\/\/www.tga.gov.au\/resources\/guidance\/biovigilance\u2010responsibilities\u2010sponsors\u2010biologicals. Last accessed 11 Feb 2025."},{"key":"e_1_2_8_8_1","unstructured":"European Commission.Commission Directive 2002\/98\/EC of European Parliament and of the Council of 27 January 2003 Setting Standards of Quality and Safety for the Collection Testing Processing Storage and Distribution of Human Blood and Blood Components and Amending Directive 2001\/83\/EC. Available from:https:\/\/eur-lex.europa.eu\/eli\/dir\/2002\/98\/oj\/eng. Last accessed 10 Feb 2025."},{"key":"e_1_2_8_9_1","unstructured":"World Health Organization (WHO).Guidelines on Good Manufacturing Practices for Blood Establishments. Available from:https:\/\/www.who.int\/publications\/m\/item\/trs961-annex4. Last accessed 10 Feb 2025."},{"key":"e_1_2_8_10_1","unstructured":"World Health Organization (WHO).Guidance on Increasing Supplies of Plasma Derived Medicinal Products in Low\u2010 and Middle\u2010Income Countries through Fractionation of Domestic Plasma. 2021. Available from:https:\/\/iris.who.int\/bitstream\/handle\/10665\/340171\/9789240021815-eng.pdf?sequence=1. Last accessed 10 Feb 2025."},{"key":"e_1_2_8_11_1","unstructured":"European Commission.EudraLex Volume 4 Good Manufacturing (GMP) Guidelines. Available from:https:\/\/health.ec.europa.eu\/medicinal-products\/eudralex\/eudralex-volume-4_en. Last accessed 10 Feb 2025."},{"key":"e_1_2_8_12_1","unstructured":"American Society for Quality (ASQ).ASQ Quality Glossary. Available from:https:\/\/asq.org\/quality-resources\/quality-glossary. Last accessed 3 Feb 2025."},{"key":"e_1_2_8_13_1","unstructured":"Food and Drug Administration (FDA).BER Instructions for Completing the Electronic Blood Establishment Registration and Product Listing Form. Available from:https:\/\/www.fda.gov\/media\/116432\/download. Last accessed 10 Feb 2025."},{"key":"e_1_2_8_14_1","unstructured":"European Commission.Commission Directive 2005\/62\/EC of 30 September 2005 Implementing Directive 2002\/98\/EC of the European Parliament and of the Council as Regards Community Standards and Specifications Relating to a Quality System for Blood Establishments. Available from:https:\/\/eur-lex.europa.eu\/legal-content\/EN\/ALL\/?uri=celex%3A32005L0062. Last accessed 10 Feb 2025."},{"key":"e_1_2_8_15_1","unstructured":"International Organization for Standardization (ISO).ISO 9000:2015 Quality Management Systems \u2013 Fundamentals and Vocabulary. Available from:https:\/\/www.iso.org\/standard\/45481.html. Last accessed 3 Feb 2025."},{"key":"e_1_2_8_16_1","unstructured":"European Commission.Commission Directive 2006\/86\/EC of 24 October 2006 Implementing Directive 2004\/23\/EC of the European Parliament and of the Council as Regards Traceability Requirements Notifications of Serious Adverse Reactions and Events. Available from:https:\/\/eur-lex.europa.eu\/legal-content\/EN\/TXT\/?uri=celex%3A32006L0086. Last accessed 10 Feb 2025."},{"key":"e_1_2_8_17_1","unstructured":"European Union.EuBIS Manual and Guide for Quality Management and Inspection of Blood Establishments Reflecting European Best Practice within the Area Addressing the Quality and Safety of Blood. Version 1.0.1 (2016). Available from:https:\/\/www.eubis-europe.eu\/blood_manual_ordering.php. 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Last accessed 10 Feb 2025."},{"key":"e_1_2_8_25_1","unstructured":"International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH).ICH Harmonized Tripartite Guideline: Pharmaceutical Development Q8 (R2). Available from:https:\/\/database.ich.org\/sites\/default\/files\/Q8_R2_Guideline.pdf. Last accessed 10 Feb 2025."},{"key":"e_1_2_8_26_1","unstructured":"European Commission.Commission Directive 2004\/23\/EC of the European Parliament and of the Council of 31 March 2004 on Setting Standards of Quality and Safety for the Donation Procurement Testing Processing Preservation Storage and Distribution of Human Tissues and Cells. Available from:https:\/\/eur\u2010lex.europa.eu\/LexUriServ\/LexUriServ.do?uri=OJ:L:2004:102:0048:0058:en:PDF. Last accessed 10 Feb 2025."},{"key":"e_1_2_8_27_1","unstructured":"U.S. Food and Drug Administration (FDA).Q9 (R1) Quality Risk Management: Guidance for Industry. Available from:https:\/\/www.fda.gov\/regulatory\u2010information\/search\u2010fda\u2010guidance\u2010documents\/q9r1\u2010quality\u2010risk\u2010management. Last accessed 10 Feb 2025."},{"key":"e_1_2_8_28_1","unstructured":"U.S. National Institute of Standards and Technology (NIST).NIST SP 800\u201030 Rev. 1 Guide for Conducting Risk Assessments. Available from:https:\/\/csrc.nist.gov\/pubs\/sp\/800\/30\/r1\/final. Last accessed 10 Feb 2025."},{"key":"e_1_2_8_29_1","unstructured":"European Union.Standard Operating Procedure (SOP) Manual: European Standard Operating Procedure (SOP) Methodology Reflecting European Best Practice within the Area Addressing the Quality and Safety of Blood. Available from:https:\/\/www.eubis-europe.eu\/blood_manual_details.php. 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