ISO 15189:2012
Superseded
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
View Superseded by
Medical laboratories — Requirements for quality and competence
Available format(s)
Hardcopy , PDF , PDF 3 Users , PDF 5 Users , PDF 9 Users
Superseded date
12-06-2022
Superseded by
Language(s)
French, English, Russian
Published date
11-05-2012
Important note : All end users must be registered with an Account prior to user licenses being assigned.
ISO 15189:2012 specifies requirements for quality and competence in medical laboratories.
ISO 15189:2012 can be used by medical laboratories in developing their quality management systems and assessing their own competence. It can also be used for confirming or recognizing the competence of medical laboratories by laboratory customers, regulating authorities and accreditation bodies.
| DevelopmentNote |
Supersedes ISO/DIS 15189. (11/2012)
|
| DocumentType |
Standard
|
| Pages |
56
|
| PublisherName |
International Organization for Standardization
|
| Status |
Superseded
|
| SupersededBy | |
| Supersedes |
| Standards | Relationship |
| ONORM EN ISO 15189 : 2014 | Identical |
| DS EN ISO 15189 : 2013 | Identical |
| UNE-EN ISO 15189:2013 | Identical |
| NF EN ISO 15189 : 2012 | Identical |
| NBN EN ISO 15189 : 2013 | Identical |
| NEN EN ISO 15189 : 2015 | Identical |
| NS EN ISO 15189 : 2012 | Identical |
| I.S. EN ISO 15189:2012 | Identical |
| PN EN ISO 15189 : 2013 | Identical |
| SN EN ISO 15189 : 2013 | Identical |
| UNI EN ISO 15189 : 2013 | Identical |
| AS ISO 15189-2013 | Identical |
| SS-EN ISO 15189:2012 | Identical |
| EN ISO 15189:2012 | Identical |
| SAC GB/T 22576.1:2018 | Identical |
| BIS IS/ISO 15189 : 2012 | Identical |
| BS EN ISO 15189:2012 | Identical |
| DIN EN ISO 15189:2014-11 | Identical |
| NBR ISO 15189 : 2015 | Identical |
| GOST R ISO 15189 : 2009 | Identical |
| CSA Z15189 : 2003 | Identical |
| I.S. EN ISO 15195:2003 | LABORATORY MEDICINE - REQUIREMENTS FOR REFERENCE MEASUREMENT LABORATORIES |
| ISO Guide 35:2017 | Reference materials — Guidance for characterization and assessment of homogeneity and stability |
| I.S. EN ISO 18812:2003 | HEALTH INFORMATICS - CLINICAL ANALYSER INTERFACES TO LABORATORY INFORMATION SYSTEMS - USE PROFILES |
| BS ISO 16638-1 : 2015 COR 2017 | RADIOLOGICAL PROTECTION - MONITORING AND INTERNAL DOSIMETRY FOR SPECIFIC MATERIALS - PART 1: INHALATION OF URANIUM COMPOUNDS |
| PD CEN/TS 16827-2:2015 | Molecular in vitro diagnostic examinations. Specifications for pre-examination processes for FFPE tissue Isolated proteins |
| I.S. EN ISO 11737-1:2018&LC:2018 | STERILIZATION OF HEALTH CARE PRODUCTS - MICROBIOLOGICAL METHODS - PART 1: DETERMINATION OF A POPULATION OF MICROORGANISMS ON PRODUCTS (ISO 11737-1:2018) |
| 15/30327269 DC : 0 | BS EN ISO 17034 - GENERAL REQUIREMENTS FOR THE COMPETENCE OF REFERENCE MATERIAL PRODUCERS |
| PD ISO/TS 17518:2015 | Medical laboratories. Reagents for staining biological material. Guidance for users |
| DD CEN/TS 15224:2005 | Health services. Quality management systems. Guide for the use of EN ISO 9001:2000 |
| ECA ILAC P10 : 2013 | ILAC POLICY ON TRACEABILITY OF MEASUREMENT RESULTS |
| PD CEN/TS 16827-3:2015 | Molecular in vitro diagnostic examinations. Specifications for pre-examination processes for FFPE tissue Isolated DNA |
| 17/30349163 DC : 0 | BS ISO 20387 - BIOTECHNOLOGY - BIOBANKING - GENERAL REQUIREMENTS FOR BIOBANKING |
| OIML G 21 : 2017 | GUIDANCE FOR DEFINING THE REQUIREMENTS FOR A CERTIFICATION SYSTEM FOR PREPACKAGES |
| PD CEN/TS 16835-1:2015 | Molecular in vitro diagnostic examinations. Specifications for pre-examination processes for venous whole blood Isolated cellular RNA |
| S.R. CEN/TS 16827-3:2015 | MOLECULAR IN VITRO DIAGNOSTIC EXAMINATIONS - SPECIFICATIONS FOR PRE-EXAMINATION PROCESSES FOR FFPE TISSUE - PART 3: ISOLATED DNA |
| CSA ISO 14971 : 2007 | MEDICAL DEVICES - APPLICATION OF RISK MANAGEMENT TO MEDICAL DEVICES |
| CSA Z15190 : 2005 : R2010 | MEDICAL LABORATORIES - REQUIREMENTS FOR SAFETY |
| CEI UNI 70099 : 2010 | INTERNATIONAL VOCABULARY OF METROLOGY - BASIC AND GENERAL CONCEPTS AND ASSOCIATED TERMS (VIM) |
| UNE-EN ISO/IEC 17043:2010 | Conformity assessment - General requirements for proficiency testing (ISO/IEC 17043:2010) |
| RSSB GE/GN8570 : ISSUE 2 | GUIDANCE ON THE MANAGEMENT OF DRUGS AND ALCOHOL |
| AAMI ISO 14971 : 2007 : INC : ERR 1 : 2007 | MEDICAL DEVICES - APPLICATION OF RISK MANAGEMENT TO MEDICAL DEVICES |
| ASTM E 2538 : 2006 : R2011 | Standard Practice for Defining and Implementing Pharmacotherapy Information Services within the Electronic Health Record (EHR) Environment and Networked Architectures (Withdrawn 2020) |
| ISO/IEC 17011:2017 | Conformity assessment — Requirements for accreditation bodies accrediting conformity assessment bodies |
| ISO/IEC 17043:2010 | Conformity assessment — General requirements for proficiency testing |
| CEN/TS 16826-2:2015 | Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for snap frozen tissue - Part 2: Isolated proteins |
| CEN/TS 15224:2005 | Health services - Quality management systems - Guide for the use of EN ISO 9001:2000 |
| CEN/TS 16835-1:2015 | Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for venous whole blood - Part 1: Isolated cellular RNA |
| CEN/TS 16827-3:2015 | Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for FFPE tissue - Part 3: Isolated DNA |
| CEN/TS 16835-2:2015 | Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for venous whole blood - Part 2: Isolated genomic DNA |
| EN ISO 18812:2003 | Health informatics - Clinical analyser interfaces to laboratry information systems - Use profiles (ISO 18812:2003) |
| CLSI M52:2010(R2020) | Verification of Commercial Microbial Identification and Antimicrobial Susceptibility Testing Systems |
| ISO/TR 22869:2005 | Medical laboratories Guidance on laboratory implementation of ISO 15189: 2003 |
| 17/30331313 DC : 0 | BS EN ISO 20186-2 - MOLECULAR IN VITRO DIAGNOSTIC EXAMINATIONS - SPECIFICATIONS FOR PRE-EXAMINATION PROCESSES FOR VENOUS WHOLE BLOOD - PART 2: ISOLATED GENOMIC DNA CORRECT |
| ECA ILAC G3 : 2012 | GUIDELINES FOR TRAINING COURSES FOR ASSESSORS USED BY ACCREDITATION BODIES |
| 16/30326649 DC : 0 | BS EN ISO 20184-1 - MOLECULAR IN-VITRO DIAGNOSTIC EXAMINATIONS - SPECIFICATIONS FOR PRE-EXAMINATION PROCESSES FOR FROZEN TISSUE - PART 1: ISOLATED RNA |
| CSA PLUS 15189 : 2010 | THE ISO 15189:2007 ESSENTIALS - A PRACTICAL HANDBOOK FOR IMPLEMENTING THE ISO 15189:2007 STANDARD FOR MEDICAL LABORATORIES |
| PD CEN/TS 16827-1:2015 | Molecular in vitro diagnostic examinations. Specifications for pre-examination processes for FFPE tissue Isolated RNA |
| BS EN ISO 16638-1:2017 | Radiological protection. Monitoring and internal dosimetry for specific materials Inhalation of uranium compounds |
| PD ISO/TS 17822-1:2014 | <i>In</i> <i>vitro</i> diagnostic test systems. Qualitative nucleic acid-based <i>in</i> <i>vitro</i> examination procedures for detection and identification of microbial pathogens General requirements, terms and definitions |
| OIML V 2-200 : 2012 | INTERNATIONAL VOCABULARY OF METROLOGY - BASIC AND GENERAL CONCEPTS AND ASSOCIATED TERMS (VIM) |
| 16/30331322 DC : 0 | BS EN ISO 20166-2 - MOLECULAR IN VITRO DIAGNOSTIC EXAMINATIONS - SPECIFICATIONS FOR PRE-EXAMINATIONS PROCESSES FOR FORMALIN-FIXED AND PARAFFIN-EMBEDDED (FFPE) TISSUE - PART 2: ISOLATED PROTEINS |
| PD CEN/TS 16826-2:2015 | Molecular in vitro diagnostic examinations. Specifications for pre-examination processes for snap frozen tissue Isolated proteins |
| CEN/TS 16945:2016 | Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for metabolomics in urine, venous blood serum and plasma |
| PD ISO GUIDE 35:2017 | Reference materials. Guidance for characterization and assessment of homogeneity and stability |
| CSA Z22870 : 2007 : R2013 | POINT-OF-CARE TESTING (POCT) - REQUIREMENTS FOR QUALITY AND COMPETENCE |
| CSA Z22870:2007 | POINT-OF-CARE TESTING (POCT) - REQUIREMENTS FOR QUALITY AND COMPETENCE |
| BS EN ISO/IEC 17025:2017 | General requirements for the competence of testing and calibration laboratories |
| I.S. EN ISO 16638-1:2017 | RADIOLOGICAL PROTECTION - MONITORING AND INTERNAL DOSIMETRY FOR SPECIFIC MATERIALS - PART 1: INHALATION OF URANIUM COMPOUNDS (ISO 16638-1:2015) |
| I.S. EN ISO 17034:2016 | GENERAL REQUIREMENTS FOR THE COMPETENCE OF REFERENCE MATERIAL PRODUCERS (ISO 17034:2016) |
| PREN ISO 15189 : DRAFT 2011 | MEDICAL LABORATORIES - PARTICULAR REQUIREMENTS FOR QUALITY AND COMPETENCE |
| ECA ILAC G26 : 2012 | GUIDANCE FOR THE IMPLEMENTATION OF A MEDICAL LABORATORY ACCREDITATION SYSTEM |
| UNE-EN ISO 18113-1:2012 | In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 1: Terms, definitions and general requirements (ISO 18113-1:2009) |
| ASTM E 2538 : 2006 | Standard Practice for Defining and Implementing Pharmacotherapy Information Services within the Electronic Health Record (EHR) Environment and Networked Architectures |
| ISO 14971:2007 | Medical devices Application of risk management to medical devices |
| CEI UNI EN ISO 14971 : 2013 | MEDICAL DEVICES - APPLICATION OF RISK MANAGEMENT TO MEDICAL DEVICES |
| I.S. EN ISO 22870:2016 | POINT-OF-CARE TESTING (POCT) - REQUIREMENTS FOR QUALITY AND COMPETENCE (ISO 22870:2016) |
| I.S. EN ISO 14971:2012 | MEDICAL DEVICES - APPLICATION OF RISK MANAGEMENT TO MEDICAL DEVICES (ISO 14971:2007, CORRECTED VERSION 2007-10-01) |
| DIN EN ISO 14971:2013-04 | MEDICAL DEVICES - APPLICATION OF RISK MANAGEMENT TO MEDICAL DEVICES (ISO 14971:2007) |
| BS EN ISO 22870:2016 | Point-of-care testing (POCT). Requirements for quality and competence |
| PD ISO Guide 34:2009 | General requirements for the competence of reference material producers |
| PD CEN/TS 16945:2016 | Molecular in vitro diagnostic examinations. Specifications for pre-examination processes for metabolomics in urine, venous blood serum and plasma |
| UNE-EN ISO 17034:2017 | General requirements for the competence of reference material producers (ISO 17034:2016) |
| PD CEN/TS 16826-1:2015 | Molecular in vitro diagnostic examinations. Specifications for pre-examination processes for snap frozen tissue Isolated RNA |
| PD CEN/TS 16835-3:2015 | Molecular in vitro diagnostic examinations. Specifications for pre-examination processes for venous whole blood Isolated circulating cell free DNA from plasma |
| 04/30090846 DC : DRAFT JUL 2004 | BS ISO 22870 - POINT-OF-CARE TESTING (POCT) - REQUIREMENTS FOR QUALITY AND COMPETENCE |
| UNE-ISO/IEC GUIA 99:2012 IN | International vocabulary of metrology. Basics and general concepts and associated terms (VIM) |
| BS ISO 18385:2016 | Minimizing the risk of human DNA contamination in products used to collect, store and analyze biological material for forensic purposes. Requirements |
| ISO/IEC Guide 99:2007 | International vocabulary of metrology Basic and general concepts and associated terms (VIM) |
| UNE-EN ISO 16638-1:2018 | Radiological protection - Monitoring and internal dosimetry for specific materials - Part 1: Inhalation of uranium compounds (ISO 16638-1:2015) |
| 14/30296672 DC : 0 | BS ISO GUIDE 33 - REFERENCE MATERIALS - GOOD PRACTICE IN USING REFERENCE MATERIALS |
| 16/30326643 DC : 0 | BS EN ISO 20166-1 - MOLECULAR IN VITRO DIAGNOSTIC EXAMINATIONS - SPECIFICATIONS FOR PRE-EXAMINATION PROCESSES FOR FORMALIN-FIXED AND PARAFFIN-EMBEDDED (FFPE) TISSUE - PART 1: ISOLATED RNA |
| CSA Z316.7 : 2012 : INC : UPD 1 : 2014 | PRIMARY SAMPLE COLLECTION FACILITIES AND MEDICAL LABORATORIES - PATIENT SAFETY AND QUALITY OF CARE - REQUIREMENTS FOR COLLECTING, TRANSPORTING, AND STORING SAMPLES |
| S.R. CEN/TS 16835-3:2015 | MOLECULAR IN VITRO DIAGNOSTIC EXAMINATIONS - SPECIFICATIONS FOR PRE-EXAMINATION PROCESSES FOR VENOUS WHOLE BLOOD - PART 3: ISOLATED CIRCULATING CELL FREE DNA FROM PLASMA |
| ISO 18385:2016 | Minimizing the risk of human DNA contamination in products used to collect, store and analyze biological material for forensic purposes — Requirements |
| S.R. CEN/TS 16827-2:2015 | MOLECULAR IN VITRO DIAGNOSTIC EXAMINATIONS - SPECIFICATIONS FOR PRE-EXAMINATION PROCESSES FOR FFPE TISSUE - PART 2: ISOLATED PROTEINS |
| ISO/TS 20658:2017 | Medical laboratories — Requirements for collection, transport, receipt, and handling of samples |
| UNI CEI EN ISO/IEC 17043 : 2010 | CONFORMITY ASSESSMENT - GENERAL REQUIREMENTS FOR PROFICIENCY TESTING |
| ISO Guide 34:2009 | General requirements for the competence of reference material producers |
| ISO 15190:2003 | Medical laboratories Requirements for safety |
| BS EN ISO 15195:2003 | Laboratory medicine. Requirements for reference measurement laboratories |
| BS EN ISO 14971:2012 | Medical devices. Application of risk management to medical devices |
| ISO 15195:2003 | Laboratory medicine Requirements for reference measurement laboratories |
| I.S. EN ISO/IEC 17011:2017 | CONFORMITY ASSESSMENT - REQUIREMENTS FOR ACCREDITATION BODIES ACCREDITING CONFORMITY ASSESSMENT BODIES (ISO/IEC 17011:2017) |
| EN 14136:2004 | Use of external quality assessment schemes in the assessment of the performance of in vitro diagnostic examination procedures |
| UNI CEN ISO/TS 22367 : 2010 | MEDICAL LABORATORIES - REDUCTION OF ERROR THROUGH RISK MANAGEMENT AND CONTINUAL IMPROVEMENT |
| EN ISO 22870:2016 | Point-of-care testing (POCT) - Requirements for quality and competence (ISO 22870:2016) |
| ECA ILAC P9 : 2014 | ILAC POLICY FOR PARTICIPATION IN PROFICIENCY TESTING ACTIVITIES |
| S.R. CEN/TS 16826-1:2015 | MOLECULAR IN VITRO DIAGNOSTIC EXAMINATIONS - SPECIFICATIONS FOR PRE-EXAMINATION PROCESSES FOR SNAP FROZEN TISSUE - PART 1: ISOLATED RNA |
| CLSI MM14 A : 1ED 2005 | PROFICIENCY TESTING (EXTERNAL QUALITY ASSESSMENT) FOR MOLECULAR METHODS |
| PD CEN/TS 16835-2:2015 | Molecular in vitro diagnostic examinations. Specifications for pre-examination processes for venous whole blood Isolated genomic DNA |
| DIN 58964:2015-09 | Quality assurance of POCT results - Assessment criteria for comparison measurement and implementation |
| 11/30173018 DC : 0 | BS EN ISO 15189 - MEDICAL LABORATORIES - PARTICULAR REQUIREMENTS FOR QUALITY AND COMPETENCE |
| ECA ILAC P15 : 2016 | APPLICATION OF ISO/IEC 17020:2012 FOR THE ACCREDITATION OF INSPECTION BODIES |
| PD ISO/TS 20658:2017 | Medical laboratories. Requirements for collection, transport, receipt, and handling of samples |
| 09/30205176 DC : 0 | ISO/TS 25680 - MEDICAL LABORATORIES - CALCULATION AND EXPRESSION OF MEASUREMENT UNCERTAINTY |
| I.S. EN ISO 18113-1:2011 | IN VITRO DIAGNOSTIC MEDICAL DEVICES - INFORMATION SUPPLIED BY THE MANUFACTURER (LABELLING) - PART 1: TERMS, DEFINITIONS AND GENERAL REQUIREMENTS (ISO 18113-1:2009) |
| 14/30289934 DC : 0 | BS ISO 18385 - MINIMIZING THE RISK OF DNA CONTAMINATION IN PRODUCTS USED TO COLLECT AND ANALYSE BIOLOGICAL MATERIAL FOR FORENSIC PURPOSES |
| 16/30331325 DC : 0 | BS EN ISO 20166-3 - MOLECULAR IN VITRO DIAGNOSTIC EXAMINATIONS - SPECIFICATIONS FOR PRE- EXAMINATION PROCESSES FOR FORMALIN-FIXED AND PARAFFIN-EMBEDDED (FFPE) TISSUE - PART 3: ISOLATED DNA |
| 06/30146511 DC : 0 | BS ISO 18113-1 - CLINICAL LABORATORY TESTING AND IN VITRO DIAGNOSTIC MEDICAL SYSTEMS - INFORMATION SUPPLIED BY THE MANUFACTURER (LABELLING) - PART 1: TERMS, DEFINITIONS AND GENERAL REQUIREMENTS |
| DD ISO/TS 22367 : 2008 | MEDICAL LABORATORIES - REDUCTION OF ERROR THROUGH RISK MANAGEMENT AND CONTINUAL IMPROVEMENT |
| UNI CEI EN ISO 14971 : 2012 | MEDICAL DEVICES - APPLICATION OF RISK MANAGEMENT TO MEDICAL DEVICES |
| BS ISO 15190:2003 | Medical laboratories. Requirements for safety |
| CSA Z15190 : 2005 : R2015 | MEDICAL LABORATORIES - REQUIREMENTS FOR SAFETY |
| 16/30312185 DC : 0 | BS EN ISO/IEC 17011 - CONFORMITY ASSESSMENT - REQUIREMENTS FOR ACCREDITATION BODIES ACCREDITING CONFORMITY ASSESSMENT BODIES |
| UNI CEI 70099 : 2008 | INTERNATIONAL VOCABULARY OF METROLOGY - BASIC AND GENERAL CONCEPTS AND ASSOCIATED TERMS (VIM) |
| CSA Z15190 : 2005 | MEDICAL LABORATORIES - REQUIREMENTS FOR SAFETY |
| AAMI ISO 14971 : 2007 : R2010 | MEDICAL DEVICES - APPLICATION OF RISK MANAGEMENT TO MEDICAL DEVICES |
| S.R. CEN/TS 16945:2016 | MOLECULAR IN VITRO DIAGNOSTIC EXAMINATIONS - SPECIFICATIONS FOR PRE-EXAMINATION PROCESSES FOR METABOLOMICS IN URINE, VENOUS BLOOD SERUM AND PLASMA |
| CEI UNI EN ISO 17034 : 1ED 2018 | GENERAL REQUIREMENTS FOR THE COMPETENCE OF REFERENCE MATERIAL PRODUCERS |
| BS ISO 17034 : 2016 | GENERAL REQUIREMENTS FOR THE COMPETENCE OF REFERENCE MATERIAL PRODUCERS |
| ISO/TS 17822-1:2014 | In vitro diagnostic test systems Qualitative nucleic acid-based in vitro examination procedures for detection and identification of microbial pathogens Part 1: General requirements, terms and definitions |
| BS EN ISO/IEC 17011:2017 | Conformity assessment. Requirements for accreditation bodies accrediting conformity assessment bodies |
| EN ISO 14971:2012 | Medical devices - Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01) |
| ISO/TS 17518:2015 | Medical laboratories — Reagents for staining biological material — Guidance for users |
| ISO/IEC 17025:2017 | General requirements for the competence of testing and calibration laboratories |
| ISO 16638-1:2015 | Radiological protection — Monitoring and internal dosimetry for specific materials — Part 1: Inhalation of uranium compounds |
| I.S. EN ISO/IEC 17043:2010 | CONFORMITY ASSESSMENT - GENERAL REQUIREMENTS FOR PROFICIENCY TESTING |
| UNE-EN ISO/IEC 17011:2017 | Conformity assessment - Requirements for accreditation bodies accrediting conformity assessment bodies (ISO/IEC 17011:2017) |
| ISO 18812:2003 | Health informatics — Clinical analyser interfaces to laboratory information systems — Use profiles |
| ISO 18113-1:2009 | In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 1: Terms, definitions and general requirements |
| UNE-EN ISO/IEC 17025:2017 | General requirements for the competence of testing and calibration laboratories (ISO/IEC 17025:2017) |
| ISO 17034:2016 | General requirements for the competence of reference material producers |
| ISO 22870:2016 | Point-of-care testing (POCT) — Requirements for quality and competence |
| DIN EN ISO/IEC 17043:2010-05 | Conformity assessment - General requirements for proficiency testing (ISO/IEC 17043:2010) |
| EN ISO 16638-1:2017 | Radiological protection - Monitoring and internal dosimetry for specific materials - Part 1: Inhalation of uranium compounds (ISO 16638-1:2015) |
| CEN/TS 16827-2:2015 | Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for FFPE tissue - Part 2: Isolated proteins |
| EN ISO 17034:2016 | General requirements for the competence of reference material producers (ISO 17034:2016) |
| EN ISO/IEC 17043:2010 | Conformity assessment - General requirements for proficiency testing (ISO/IEC 17043:2010) |
| EN ISO 18113-1:2011 | In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 1: Terms, definitions and general requirements (ISO 18113-1:2009) |
| DD CEN ISO/TS 22367:2010 | Medical laboratories. Reduction of error through risk management and continual improvement |
| Z316.8-18 | Requirements for the design, development, and validation of laboratory-developed tests used for the screening, diagnosis, and management of clinical conditions |
| BS EN ISO/IEC 17043:2010 | Conformity assessment. General requirements for proficiency testing |
| BS EN ISO 17034:2016 | General requirements for the competence of reference material producers |
| DIN EN ISO 18113-1:2013-01 | In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 1: Terms, definitions and general requirements (ISO 18113-1:2009) |
| UNE-CWA 16393:2014 | Laboratory biorisk management - Guidelines for the implementation of CWA 15793:2008 |
| BS EN ISO 18113-1:2011 | In vitro diagnostic medical devices. Information supplied by the manufacturer (labelling) Terms, definitions and general requirements |
| 17/30326658 DC : 0 | BS EN ISO 20186-1 - MOLECULAR IN VITRO DIAGNOSTIC EXAMINATIONS - SPECIFICATIONS FOR PRE-EXAMINATION PROCESSES FOR VENOUS WHOLE BLOOD - PART 1: ISOLATED CELLULAR RNA |
| S.R. CEN ISO TS 22367:2010 | MEDICAL LABORATORIES - REDUCTION OF ERROR THROUGH RISK MANAGEMENT AND CONTINUAL IMPROVEMENT |
| ECA ILAC G27 : 2017 | GUIDANCE ON MEASUREMENTS PERFORMED AS PART OF AN INSPECTION PROCESS |
| CEI UNI EN ISO/IEC 17043 : 2011 | CONFORMITY ASSESSMENT - GENERAL REQUIREMENTS FOR PROFICIENCY TESTING |
| 16/30331319 DC : 0 | BS EN ISO 20184-2 - MOLECULAR IN-VITRO DIAGNOSTIC EXAMINATIONS - SPECIFICATIONS FOR PRE-EXAMINATION PROCESSES FOR FROZEN TISSUE - PART 2: ISOLATED PROTEINS |
| PD ISO GUIDE 33:2015 | Reference materials. Good practice in using reference materials |
| I.S. CEN TS 15224:2006 | HEALTH SERVICES - QUALITY MANAGEMENT SYSTEMS - GUIDE FOR THE USE OF EN ISO 9001:2000 |
| CSA ISO 14971 : 2007 : R2017 | MEDICAL DEVICES - APPLICATION OF RISK MANAGEMENT TO MEDICAL DEVICES |
| CSA ISO 14971 : 2007 : R2012 | MEDICAL DEVICES - APPLICATION OF RISK MANAGEMENT TO MEDICAL DEVICES |
| CSA Z316.7 : 2012 | PRIMARY SAMPLE COLLECTION FACILITIES AND MEDICAL LABORATORIES - PATIENT SAFETY AND QUALITY OF CARE - REQUIREMENTS FOR COLLECTING, TRANSPORTING, AND STORING SAMPLES |
| ISO Guide 33:2015 | Reference materials — Good practice in using reference materials |
| S.R. CEN/TS 16827-1:2015 | MOLECULAR IN VITRO DIAGNOSTIC EXAMINATIONS - SPECIFICATIONS FOR PRE-EXAMINATION PROCESSES FOR FFPE TISSUE - PART 1: ISOLATED RNA |
| S.R. ISO TR 22869:2006 | MEDICAL LABORATORIES - GUIDANCE ON LABORATORY IMPLEMENTATION OF ISO 15189: 2003 |
| S.R. CEN/TS 16826-2:2015 | MOLECULAR IN VITRO DIAGNOSTIC EXAMINATIONS - SPECIFICATIONS FOR PRE-EXAMINATION PROCESSES FOR SNAP FROZEN TISSUE - PART 2: ISOLATED PROTEINS |
| S.R. CEN/TS 16835-1:2015 | MOLECULAR IN VITRO DIAGNOSTIC EXAMINATIONS - SPECIFICATIONS FOR PRE-EXAMINATION PROCESSES FOR VENOUS WHOLE BLOOD - PART 1: ISOLATED CELLULAR RNA |
| S.R. CWA 16393:2012 | LABORATORY BIORISK MANAGEMENT - GUIDELINES FOR THE IMPLEMENTATION OF CWA 15793:2008 |
| S.R. CEN/TS 16835-2:2015 | MOLECULAR IN VITRO DIAGNOSTIC EXAMINATIONS - SPECIFICATIONS FOR PRE-EXAMINATION PROCESSES FOR VENOUS WHOLE BLOOD - PART 2: ISOLATED GENOMIC DNA |
| UNI EN ISO 18113-1 : 2012 | IN VITRO DIAGNOSTIC MEDICAL DEVICES - INFORMATION SUPPLIED BY THE MANUFACTURER (LABELLING) - PART 1: TERMS, DEFINITIONS AND GENERAL REQUIREMENTS |
| IWA 1:2005 | Quality management systems Guidelines for process improvements in health service organizations |
| EN ISO 15195:2003 | Laboratory medicine - Requirements for reference measurement laboratories (ISO 15195:2003) |
| ISO/TS 22367:2008 | Medical laboratories Reduction of error through risk management and continual improvement |
| BS EN ISO 18812:2003 | Health informatics. Clinical analyser interfaces to laboratory information systems. Use profiles |
| CEN ISO/TS 22367:2010 | Medical laboratories - Reduction of error through risk management and continual improvement (ISO/TS 22367:2008, including Cor 1:2009) |
| DIN EN 14136:2004-08 | Use of external quality assessment schemes in the assessment of the performance of in vitro diagnostic examination procedures |
| CEN/TS 16835-3:2015 | Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for venous whole blood - Part 3: Isolated circulating cell free DNA from plasma |
| CEN/TS 16826-1:2015 | Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for snap frozen tissue - Part 1: Isolated RNA |
| DIN EN ISO 15195:2004-01 | LABORATORY MEDICINE - REQUIREMENTS FOR REFERENCE MEASUREMENT LABORATORIES |
| CEN/TS 16827-1:2015 | Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for FFPE tissue - Part 1: Isolated RNA |
| UNE-EN ISO 22870:2017 | Point-of-care testing (POCT) - Requirements for quality and competence (ISO 22870:2016) |
| CLSI EP12:2023 | Evaluation of Qualitative, Binary Output Examination Performance |
| CLSI QMS02:2024 | Developing and Managing Laboratory Documents |
| CLSI PRE05:2024 | Processes for the Collection of Urine Specimens |
| CEI UNI EN ISO/IEC 17043:2024-05 | Conformity assessment General requirements for the competence of proficiency testing providers |
| CEI UNI EN ISO 20387:2021 | Biotechnology - Biobanking - General requirements for biobanking (ISO 20387:2018) |
| CLSI C49:2018(R2023) | Analysis of Body Fluids in Clinical Chemistry |
| ISO/IEC 17025:2005 | General requirements for the competence of testing and calibration laboratories |
| ISO/IEC 17000:2004 | Conformity assessment Vocabulary and general principles |
| ISO 5725-1:1994 | Accuracy (trueness and precision) of measurement methods and results — Part 1: General principles and definitions |
| CLSI GP27 A2 : 2ED 2007 | USING PROFICIENCY TESTING TO IMPROVE THE CLINICAL LABORATORY |
| ISO 19011:2011 | Guidelines for auditing management systems |
| ISO 1087-1:2000 | Terminology work Vocabulary Part 1: Theory and application |
| CLSI GP29 A : 1ED 2002 | VALIDATION OF LABORATORY TESTS WHEN PROFICIENCY TESTING IS NOT AVAILABLE |
| ISO 15194:2009 | In vitro diagnostic medical devices Measurement of quantities in samples of biological origin Requirements for certified reference materials and the content of supporting documentation |
| ISO/IEC 27001:2013 | Information technology — Security techniques — Information security management systems — Requirements |
| ISO 22870:2016 | Point-of-care testing (POCT) — Requirements for quality and competence |
| CLSI QMS13 A : 1ED 2011 | QUALITY MANAGEMENT SYSTEM: EQUIPMENT |
| EN 1614:2006 | Health informatics - Representation of dedicated kinds of property in laboratory medicine |
| CLSI I/LA33 P : 1ED 2009 | VALIDATION OF AUTOMATED DEVICES FOR IMMUNOHEMATOLOGIC TESTING PRIOR TO IMPLEMENTATION |
| AS ISO 20387:2020 | Biotechnology - Biobanking - General requirements for biobanking |
| CLSI QMS04 A2 : 2ED 2007 | LABORATORY DESIGN |
| CLSI GP33 A : 1ED 2010 | ACCURACY IN PATIENT AND SAMPLE IDENTIFICATION |
| CLSI H57 A : 1ED 2008 | PROTOCOL FOR THE EVALUATION, VALIDATION, AND IMPLEMENTATION OF COAGULOMETERS |
| CLSI EP31 A : 1ED 2008 | VERIFICATION OF COMPARABILITY OF PATIENT RESULTS WITHIN ONE HEALTH CARE SYSTEM |
| AS ISO 22367:2021 | Medical laboratories - Application of risk management to medical laboratories |
| CLSI GP17 A2 : 2ED 2004 | CLINICAL LABORATORY SAFETY |
| CLSI GP29 A2 : 2ED 2008 | ASSESSMENT OF LABORATORY TESTS WHEN PROFICIENCY TESTING IS NOT AVAILABLE |
| ISO/IEC 17011:2004 | Conformity assessment General requirements for accreditation bodies accrediting conformity assessment bodies |
| CLSI M29 A3 : 3ED 2005 | ACQUIRED INFECTIONS; APPROVED GUIDELINE |
| CLSI GP44 A4 : 4ED 2010 | PROCEDURES FOR THE HANDLING AND PROCESSING OF BLOOD SPECIMENS FOR COMMON LABORATORY TESTS |
| CLSI GP31 A : 1ED 2009 | LABORATORY INSTRUMENT IMPLEMENTATION, VERIFICATION, AND MAINTENANCE |
| ISO/IEC Guide 99:2007 | International vocabulary of metrology Basic and general concepts and associated terms (VIM) |
| CLSI AUTO10 A : 1ED 2006 | AUTOVERIFICATION OF CLINICAL LABORATORY TEST RESULTS |
| CLSI GP40 A4 : 4ED 2006 | PREPARATION AND TESTING OF REAGENT WATER IN THE CLINICAL LABORATORY |
| CLSI EP15 A2 : 2ED 2006 | USER VERIFICATION OF PERFORMANCE FOR PRECISION AND TRUENESS |
| ISO 15190:2003 | Medical laboratories Requirements for safety |
| CLSI GP41 A6 : 6ED 2007 | PROCEDURES FOR THE COLLECTION OF DIAGNOSTIC BLOOD SPECIMENS BY VENIPUNCTURE |
| ISO/IEC 17043:2010 | Conformity assessment — General requirements for proficiency testing |
| ISO Guide 30:2015 | Reference materials — Selected terms and definitions |
| CLSI EP32 R : 1ED 2006 | METROLOGICAL TRACEABILITY AND ITS IMPLEMENTATION |
| CLSI QMS11 A : 1ED 2007 | MANAGEMENT OF NONCONFORMING LABORATORY EVENTS |
| ISO/TS 22367:2008 | Medical laboratories Reduction of error through risk management and continual improvement |
| ISO 9001:2015 | Quality management systems — Requirements |
| CLSI EP17 A : 1ED 2004 | PROTOCOLS FOR DETERMINATION OF LIMITS OF DETECTION AND LIMITS OF QUANTITATION |
| ISO 9000:2015 | Quality management systems — Fundamentals and vocabulary |
| ISO/IEC Guide 2:2004 | Standardization and related activities — General vocabulary |
| CLSI GP42 A6 : 6ED 2008 | PROCEDURES AND DEVICES FOR THE COLLECTION OF DIAGNOSTIC CAPILLARY BLOOD SPECIMENS |
| CLSI GP9 A : 1ED 98 | SELECTING AND EVALUATING A REFERRAL LABORATORY |
| CLSI C24 A3 : 3ED 2006 | STATISTICAL QUALITY CONTROL FOR QUANTITATIVE MEASUREMENT PROCEDURES: PRINCIPLES AND DEFINITIONS |
| CLSI GP16-A3 : 2009 | Urinalysis; Approved Guideline—Third Edition |
| CLSI GP35 P : 1ED 2009 | DEVELOPMENT AND USE OF QUALITY INDICATORS FOR PROCESS IMPROVEMENT AND MONITORING OF LABORATORY QUALITY |
| AS ISO 20658:2019 | Medical laboratories - Requirements for collection, transport, receipt, and handling of samples |
| CLSI AUTO8 A : 1ED 2006 | MANAGING AND VALIDATING LABORATORY INFORMATION SYSTEMS |
| EN 12435:2006 | Health informatics - Expression of results of measurements in health sciences |
| CLSI GP2 A5 : 5ED 2006 | LABORATORY DOCUMENTS - DEVELOPMENT AND CONTROL |
| CLSI H26 A2 : 2ED 2010 | VALIDATION, VERIFICATION, AND QUALITY ASSURANCE OF AUTOMATED HEMATOLOGY ANALYZERS |
| ISO 27799:2016 | Health informatics Information security management in health using ISO/IEC 27002 |
| ISO 3534-1:2006 | Statistics — Vocabulary and symbols — Part 1: General statistical terms and terms used in probability |
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