{"id":"https://openalex.org/W7130516593","doi":"https://doi.org/10.25259/jlp_316_2025","title":"Translating global standards to local practice: Comparing International Organization for Standardization 15189:2012 and 2022 with implementation insights from the National Accreditation Board for Testing and Calibration Laboratories 112 in India","display_name":"Translating global standards to local practice: Comparing International Organization for Standardization 15189:2012 and 2022 with implementation insights from the National Accreditation Board for Testing and Calibration Laboratories 112 in India","publication_year":2026,"publication_date":"2026-02-19","ids":{"openalex":"https://openalex.org/W7130516593","doi":"https://doi.org/10.25259/jlp_316_2025"},"language":"en","primary_location":{"id":"doi:10.25259/jlp_316_2025","doi":"https://doi.org/10.25259/jlp_316_2025","is_oa":true,"landing_page_url":"https://doi.org/10.25259/jlp_316_2025","pdf_url":"https://jlabphy.org/content/164/2026/0/1/pdf/JLP-316-2025.pdf","source":{"id":"https://openalex.org/S4210187584","display_name":"Journal of Laboratory Physicians","issn_l":"0974-2727","issn":["0974-2727","0974-7826"],"is_oa":true,"is_in_doaj":false,"is_core":true,"listed_in":["cwts-core"],"host_organization":"https://openalex.org/P4310320000","host_organization_name":"Thieme Medical Publishers (Germany)","host_organization_lineage":["https://openalex.org/P4310320000"],"host_organization_lineage_names":["Thieme Medical Publishers (Germany)"],"type":"journal"},"license":"cc-by-nc-sa","license_id":"https://openalex.org/licenses/cc-by-nc-sa","version":"publishedVersion","is_accepted":true,"is_published":true,"raw_source_name":"Journal of Laboratory Physicians","raw_type":"journal-article"},"volume":null,"type":"article","indexed_in":["crossref"],"open_access":{"is_oa":true,"oa_status":"gold","oa_url":"https://jlabphy.org/content/164/2026/0/1/pdf/JLP-316-2025.pdf","any_repository_has_fulltext":false},"authorships":[{"author_position":"first","author":{"id":"https://openalex.org/A5126374469","display_name":"Renu Gupta","orcid":null,"observed_orcids":[]},"institutions":[{"id":"https://openalex.org/I4210118052","display_name":"Institute of Human Behaviour and Allied Sciences","ror":"https://ror.org/02brfgh04","country_code":"IN","type":"facility","lineage":["https://openalex.org/I4210118052"]}],"countries":["IN"],"is_corresponding":false,"raw_author_name":"Renu Gupta","raw_affiliation_strings":["Department of Microbiology, Institute of Human Behaviour and Allied Sciences, Delhi, India,"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Department of Microbiology, Institute of Human Behaviour and Allied Sciences, Delhi, India,","institution_ids":["https://openalex.org/I4210118052"]}]},{"author_position":"last","author":{"id":"https://openalex.org/A5059729874","display_name":"Rachna Agarwal","orcid":"https://orcid.org/0000-0003-2604-9809","observed_orcids":["https://orcid.org/0000-0003-2604-9809"]},"institutions":[{"id":"https://openalex.org/I4210118052","display_name":"Institute of Human Behaviour and Allied Sciences","ror":"https://ror.org/02brfgh04","country_code":"IN","type":"facility","lineage":["https://openalex.org/I4210118052"]}],"countries":["IN"],"is_corresponding":true,"raw_author_name":"Rachna Agarwal","raw_affiliation_strings":["Department of Neurochemistry, Institute of Human Behaviour and Allied Sciences, Delhi, India,"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Department of Neurochemistry, Institute of Human Behaviour and Allied Sciences, Delhi, India,","institution_ids":["https://openalex.org/I4210118052"]}]}],"institutions":[],"countries_distinct_count":1,"institutions_distinct_count":1,"corresponding_author_ids":["https://openalex.org/A5059729874"],"corresponding_institution_ids":["https://openalex.org/I4210118052"],"apc_list":{"value":200,"currency":"USD","value_usd":200},"apc_paid":{"value":200,"currency":"USD","value_usd":200},"fwci":0.0,"has_fulltext":true,"cited_by_count":0,"citation_normalized_percentile":{"value":0.10850505,"is_in_top_1_percent":false,"is_in_top_10_percent":false},"cited_by_percentile_year":null,"biblio":{"volume":"18","issue":null,"first_page":"175","last_page":"183"},"is_retracted":false,"is_paratext":false,"is_xpac":false,"primary_topic":{"id":"https://openalex.org/T11314","display_name":"Clinical Laboratory Practices and Quality Control","score":0.9854000210762024,"subfield":{"id":"https://openalex.org/subfields/2737","display_name":"Physiology"},"field":{"id":"https://openalex.org/fields/27","display_name":"Medicine"},"domain":{"id":"https://openalex.org/domains/4","display_name":"Health Sciences"}},"topics":[{"id":"https://openalex.org/T11314","display_name":"Clinical Laboratory Practices and Quality Control","score":0.9854000210762024,"subfield":{"id":"https://openalex.org/subfields/2737","display_name":"Physiology"},"field":{"id":"https://openalex.org/fields/27","display_name":"Medicine"},"domain":{"id":"https://openalex.org/domains/4","display_name":"Health Sciences"}},{"id":"https://openalex.org/T12871","display_name":"Healthcare Quality and Management","score":0.006899999920278788,"subfield":{"id":"https://openalex.org/subfields/3605","display_name":"Health Information Management"},"field":{"id":"https://openalex.org/fields/36","display_name":"Health Professions"},"domain":{"id":"https://openalex.org/domains/4","display_name":"Health Sciences"}},{"id":"https://openalex.org/T13164","display_name":"Quality and Management Systems","score":0.005900000222027302,"subfield":{"id":"https://openalex.org/subfields/1408","display_name":"Strategy and Management"},"field":{"id":"https://openalex.org/fields/14","display_name":"Business, Management and Accounting"},"domain":{"id":"https://openalex.org/domains/2","display_name":"Social Sciences"}}],"keywords":[{"id":"https://openalex.org/keywords/iso-15189","display_name":"ISO 15189","score":0.9639999866485596},{"id":"https://openalex.org/keywords/medical-laboratory-accreditation","display_name":"clinical laboratory accreditation","score":0.921999990940094},{"id":"https://openalex.org/keywords/standards-implementation","display_name":"standard implementation","score":0.6200000047683716},{"id":"https://openalex.org/keywords/risk-based-thinking","display_name":"risk-based thinking","score":0.6819999814033508},{"id":"https://openalex.org/keywords/point-of-care-testing","display_name":"point-of-care testing","score":0.8510000109672546},{"id":"https://openalex.org/keywords/laboratory-quality-management","display_name":"laboratory quality management","score":0.734000027179718},{"id":"https://openalex.org/keywords/internal-quality-control","display_name":"internal quality control","score":0.7419999837875366},{"id":"https://openalex.org/keywords/equipment-calibration","display_name":"equipment calibration","score":0.8820000290870667},{"id":"https://openalex.org/keywords/laboratory-governance","display_name":"laboratory governance","score":0.6190000176429749}],"concepts":[{"id":"https://openalex.org/C61521584","wikidata":"https://www.wikidata.org/wiki/Q705899","display_name":"Accreditation","level":2,"score":0.7197999954223633},{"id":"https://openalex.org/C188087704","wikidata":"https://www.wikidata.org/wiki/Q369577","display_name":"Standardization","level":2,"score":0.7103000283241272},{"id":"https://openalex.org/C106436119","wikidata":"https://www.wikidata.org/wiki/Q836575","display_name":"Quality assurance","level":3,"score":0.6226000189781189},{"id":"https://openalex.org/C110354214","wikidata":"https://www.wikidata.org/wiki/Q6314146","display_name":"Engineering management","level":1,"score":0.559499979019165},{"id":"https://openalex.org/C100521375","wikidata":"https://www.wikidata.org/wiki/Q2015382","display_name":"Competence (human resources)","level":2,"score":0.5550000071525574},{"id":"https://openalex.org/C153876917","wikidata":"https://www.wikidata.org/wiki/Q899704","display_name":"Traceability","level":2,"score":0.5020999908447266},{"id":"https://openalex.org/C46717995","wikidata":"https://www.wikidata.org/wiki/Q7268785","display_name":"Quality of analytical results","level":5,"score":0.4672999978065491},{"id":"https://openalex.org/C41008148","wikidata":"https://www.wikidata.org/wiki/Q21198","display_name":"Computer science","level":0,"score":0.46709999442100525},{"id":"https://openalex.org/C201289532","wikidata":"https://www.wikidata.org/wiki/Q608513","display_name":"Quality management system","level":4,"score":0.44600000977516174},{"id":"https://openalex.org/C2779343474","wikidata":"https://www.wikidata.org/wiki/Q3109175","display_name":"Context (archaeology)","level":2,"score":0.4375999867916107},{"id":"https://openalex.org/C199521495","wikidata":"https://www.wikidata.org/wiki/Q181487","display_name":"Audit","level":2,"score":0.42590001225471497},{"id":"https://openalex.org/C195094911","wikidata":"https://www.wikidata.org/wiki/Q14167904","display_name":"Process management","level":1,"score":0.4174000024795532},{"id":"https://openalex.org/C2777146004","wikidata":"https://www.wikidata.org/wiki/Q14949826","display_name":"CLARITY","level":2,"score":0.37619999051094055},{"id":"https://openalex.org/C2779530757","wikidata":"https://www.wikidata.org/wiki/Q1207505","display_name":"Quality (philosophy)","level":2,"score":0.37209999561309814},{"id":"https://openalex.org/C127413603","wikidata":"https://www.wikidata.org/wiki/Q11023","display_name":"Engineering","level":0,"score":0.3617999851703644},{"id":"https://openalex.org/C2776588390","wikidata":"https://www.wikidata.org/wiki/Q1334738","display_name":"International standard","level":2,"score":0.3587999939918518},{"id":"https://openalex.org/C2777267654","wikidata":"https://www.wikidata.org/wiki/Q3519023","display_name":"Test (biology)","level":2,"score":0.3343000113964081},{"id":"https://openalex.org/C5911748","wikidata":"https://www.wikidata.org/wiki/Q4072285","display_name":"Conformity assessment","level":2,"score":0.3188000023365021},{"id":"https://openalex.org/C56739046","wikidata":"https://www.wikidata.org/wiki/Q192060","display_name":"Knowledge management","level":1,"score":0.3140000104904175},{"id":"https://openalex.org/C71405471","wikidata":"https://www.wikidata.org/wiki/Q757012","display_name":"Quality management","level":3,"score":0.31060001254081726},{"id":"https://openalex.org/C86251818","wikidata":"https://www.wikidata.org/wiki/Q816754","display_name":"Benchmarking","level":2,"score":0.2919999957084656},{"id":"https://openalex.org/C201995342","wikidata":"https://www.wikidata.org/wiki/Q682496","display_name":"Systems engineering","level":1,"score":0.2858999967575073},{"id":"https://openalex.org/C46304622","wikidata":"https://www.wikidata.org/wiki/Q374814","display_name":"Certification","level":2,"score":0.28119999170303345},{"id":"https://openalex.org/C2781050149","wikidata":"https://www.wikidata.org/wiki/Q552070","display_name":"Good laboratory practice","level":4,"score":0.2752000093460083},{"id":"https://openalex.org/C2778012447","wikidata":"https://www.wikidata.org/wiki/Q1034415","display_name":"Scope (computer science)","level":2,"score":0.27480000257492065},{"id":"https://openalex.org/C51704429","wikidata":"https://www.wikidata.org/wiki/Q827792","display_name":"Quality control","level":3,"score":0.2736000120639801},{"id":"https://openalex.org/C43214815","wikidata":"https://www.wikidata.org/wiki/Q7310987","display_name":"Reliability (semiconductor)","level":3,"score":0.265500009059906},{"id":"https://openalex.org/C112930515","wikidata":"https://www.wikidata.org/wiki/Q4389547","display_name":"Risk analysis (engineering)","level":1,"score":0.2644999921321869},{"id":"https://openalex.org/C160713754","wikidata":"https://www.wikidata.org/wiki/Q1389965","display_name":"Maintainability","level":2,"score":0.26100000739097595},{"id":"https://openalex.org/C170856484","wikidata":"https://www.wikidata.org/wiki/Q6452684","display_name":"Internal audit","level":3,"score":0.25839999318122864},{"id":"https://openalex.org/C26517878","wikidata":"https://www.wikidata.org/wiki/Q228039","display_name":"Key (lock)","level":2,"score":0.25429999828338623}],"mesh":[],"locations_count":1,"locations":[{"id":"doi:10.25259/jlp_316_2025","doi":"https://doi.org/10.25259/jlp_316_2025","is_oa":true,"landing_page_url":"https://doi.org/10.25259/jlp_316_2025","pdf_url":"https://jlabphy.org/content/164/2026/0/1/pdf/JLP-316-2025.pdf","source":{"id":"https://openalex.org/S4210187584","display_name":"Journal of Laboratory Physicians","issn_l":"0974-2727","issn":["0974-2727","0974-7826"],"is_oa":true,"is_in_doaj":false,"is_core":true,"listed_in":["cwts-core"],"host_organization":"https://openalex.org/P4310320000","host_organization_name":"Thieme Medical Publishers (Germany)","host_organization_lineage":["https://openalex.org/P4310320000"],"host_organization_lineage_names":["Thieme Medical Publishers (Germany)"],"type":"journal"},"license":"cc-by-nc-sa","license_id":"https://openalex.org/licenses/cc-by-nc-sa","version":"publishedVersion","is_accepted":true,"is_published":true,"raw_source_name":"Journal of Laboratory Physicians","raw_type":"journal-article"}],"best_oa_location":{"id":"doi:10.25259/jlp_316_2025","doi":"https://doi.org/10.25259/jlp_316_2025","is_oa":true,"landing_page_url":"https://doi.org/10.25259/jlp_316_2025","pdf_url":"https://jlabphy.org/content/164/2026/0/1/pdf/JLP-316-2025.pdf","source":{"id":"https://openalex.org/S4210187584","display_name":"Journal of Laboratory Physicians","issn_l":"0974-2727","issn":["0974-2727","0974-7826"],"is_oa":true,"is_in_doaj":false,"is_core":true,"listed_in":["cwts-core"],"host_organization":"https://openalex.org/P4310320000","host_organization_name":"Thieme Medical Publishers (Germany)","host_organization_lineage":["https://openalex.org/P4310320000"],"host_organization_lineage_names":["Thieme Medical Publishers (Germany)"],"type":"journal"},"license":"cc-by-nc-sa","license_id":"https://openalex.org/licenses/cc-by-nc-sa","version":"publishedVersion","is_accepted":true,"is_published":true,"raw_source_name":"Journal of Laboratory Physicians","raw_type":"journal-article"},"sustainable_development_goals":[],"sustainable_development_goals_aurora":[{"id":"https://metadata.un.org/sdg/17","score":0.5098055005073547,"display_name":"Partnerships for the goals"}],"study_designs":[],"awards":[],"funders":[],"has_content":{"grobid_xml":true,"pdf":true},"content_urls":{"pdf":"https://content.openalex.org/works/W7130516593.pdf","grobid_xml":"https://content.openalex.org/works/W7130516593.grobid-xml"},"referenced_works_count":5,"referenced_works":["https://openalex.org/W2076366157","https://openalex.org/W4382570314","https://openalex.org/W4390484266","https://openalex.org/W4391175469","https://openalex.org/W4413214483"],"related_works":[],"abstract_inverted_index":{"The":[0,25,43],"International":[1],"Organization":[2],"for":[3,11,77,99,138],"Standardization":[4],"(ISO)":[5],"15189":[6,179],"is":[7,46],"the":[8,19,31,69,85,92,95,153,168,172,185,199],"global":[9,112],"benchmark":[10],"quality":[12,132,141],"and":[13,35,40,54,58,64,84,101,127,134,144,174,180,204,220,228],"competence":[14],"in":[15,222,233],"medical":[16],"laboratories,":[17],"ensuring":[18],"reliability":[20],"of":[21,87,110,167,177],"patient":[22,124],"test":[23],"results.":[24],"newly":[26],"released":[27],"ISO":[28,154,178],"15189:2022":[29],"replaces":[30],"earlier":[32],"2012":[33,173],"edition":[34,45],"introduces":[36,115],"several":[37],"key":[38],"structural":[39,53],"conceptual":[41],"changes.":[42],"2022":[44,175],"reorganized":[47],"into":[48],"five":[49],"clauses:":[50],"General":[51],"requirements,":[52],"governance,":[55],"resource,":[56],"process,":[57],"management":[59],"system,":[60],"bringing":[61],"greater":[62],"clarity":[63],"embedding":[65],"risk-based":[66],"thinking":[67],"throughout":[68],"laboratory\u2019s":[70],"operations.":[71],"Major":[72],"updates":[73,183],"include":[74],"strengthened":[75],"requirements":[76],"risk":[78],"management,":[79],"impartiality,":[80],"laboratory":[81,217],"director":[82],"accountability,":[83],"integration":[86],"point-of-care":[88],"testing":[89],"(POCT).":[90],"In":[91],"Indian":[93,186],"context,":[94],"National":[96],"Accreditation":[97],"Board":[98],"Testing":[100],"Calibration":[102],"Laboratories":[103],"(NABL":[104],"112)":[105],"provides":[106,163],"a":[107,164],"localized":[108],"interpretation":[109],"these":[111,182,210],"standards.":[113],"It":[114],"practical":[116,206],"measures":[117],"such":[118,156],"as":[119,157],"classifying":[120],"laboratories":[121],"based":[122,197],"on":[123,198],"load":[125],"(Micro":[126],"Mini":[128],"laboratories),":[129],"mandating":[130],"full-time":[131],"managers,":[133],"providing":[135],"detailed":[136],"protocols":[137],"equipment":[139],"calibration,":[140],"control":[142],"(QC),":[143],"information":[145],"system":[146],"validation.":[147],"Several":[148],"NABL":[149,189],"specifications":[150],"extend":[151],"beyond":[152],"baseline,":[155],"daily":[158],"internal":[159],"QC.":[160],"This":[161,212],"review":[162],"comparative":[165],"assessment":[166],"major":[169],"changes":[170],"between":[171],"versions":[176],"interprets":[181],"within":[184],"context":[187],"through":[188],"112.":[190],"Furthermore,":[191],"it":[192],"discusses":[193],"common":[194],"implementation":[195],"challenges":[196],"author\u2019s":[200],"real-world":[201],"audit":[202],"observations":[203],"offers":[205],"suggestions":[207],"to":[208,215],"address":[209],"gaps.":[211],"analysis":[213],"aims":[214],"guide":[216],"professionals,":[218],"clinicians,":[219],"administrators":[221],"navigating":[223],"accreditation,":[224],"thereby":[225],"supporting":[226],"safer":[227],"more":[229],"dependable":[230],"healthcare":[231],"delivery":[232],"India.":[234]},"counts_by_year":[],"updated_date":"2026-08-26T07:47:46.906454","created_date":"2026-02-19T00:00:00"}