domenica, gennaio 25, 2004
nuovo TR ISO per sistemi qualita` ISO/DTR2 14969 application of ISO 13485
ISO/TC 210 N 227 - Draft technical report
ISO/DTR2 14969 - Medical devices - Quality management systems - Guidance on the application of ISO 13485:2003 (Revision of ISO 14969:1999)
This Technical Report provides guidance to assist in the development,
implementation, and maintenance of quality management systems that aim to meet the requirements of ISO 13485 for organizations that design and develop, produce, install, and service medical devices, or that design, develop and provide related services.
ISO 13485 specifies the quality management system requirements for medical
devices for regulatory purposes. ISO 13485 accommodates the previous ISO 13488 by permissible exclusion as specified in clause 1.2 of ISO 13485.
discussion at the meeting in Sydney on 9-11 February 2004
comments by 2004-01-27
approval for publication of the draft as a Technical Report, by 2004-01-27
Informazioni in www.LABMEDICO.it
e http://snipurl.com/41dz
ISO/TC 210 N 227 - Draft technical report
ISO/DTR2 14969 - Medical devices - Quality management systems - Guidance on the application of ISO 13485:2003 (Revision of ISO 14969:1999)
This Technical Report provides guidance to assist in the development,
implementation, and maintenance of quality management systems that aim to meet the requirements of ISO 13485 for organizations that design and develop, produce, install, and service medical devices, or that design, develop and provide related services.
ISO 13485 specifies the quality management system requirements for medical
devices for regulatory purposes. ISO 13485 accommodates the previous ISO 13488 by permissible exclusion as specified in clause 1.2 of ISO 13485.
Informazioni in www.LABMEDICO.it
e http://snipurl.com/41dz
SOP in preparazione presso
Health Protection Agency, Colindale
Evaluations & Standards Laboratory
Specialist & Reference Microbiology Division
* QSOP 46 Aminoglycoside and glycopeptide assays in clinical microbiology
laboratories
* BSOP 38 Investigation of bone marrow
* BSOP 51 Investigation of swabs for meningococci
* BSOP 57 Investigation of bronchoalveolar lavage, sputum and associated
specimens
These documents have been drawn up by the National Standard Methods Working
Group for standardising clinical bacteriology methods and virology /
serology methods. The National Working Groups developing SOPs, algorithms
and guidance notes are multi professional and include staff from the HPA and
NHS across the UK and representatives from the ACM, AMM, CVN (for
virology/serology) and the IBMS.
Health Protection Agency, Colindale
Evaluations & Standards Laboratory
Specialist & Reference Microbiology Division
* QSOP 46 Aminoglycoside and glycopeptide assays in clinical microbiology
laboratories
* BSOP 38 Investigation of bone marrow
* BSOP 51 Investigation of swabs for meningococci
* BSOP 57 Investigation of bronchoalveolar lavage, sputum and associated
specimens
These documents have been drawn up by the National Standard Methods Working
Group for standardising clinical bacteriology methods and virology /
serology methods. The National Working Groups developing SOPs, algorithms
and guidance notes are multi professional and include staff from the HPA and
NHS across the UK and representatives from the ACM, AMM, CVN (for
virology/serology) and the IBMS.
NCCLS GP21-A2 Training Verification for Laboratory Personnel;Approved Guideline
This document provides background and recommends an
infrastructure for developing a training verification program
that meets quality/regulatory objectives. (See related
publication GP02-A3.)
Document Excerpt
Chairholder: David E. Nevalainen, Ph.D. Abbott Laboratories
Member Price: $35
Non-Member Price: $85
http://www.nccls.org/free/GP21-A.pdf
This document provides background and recommends an
infrastructure for developing a training verification program
that meets quality/regulatory objectives. (See related
publication GP02-A3.)
Document Excerpt
Chairholder: David E. Nevalainen, Ph.D. Abbott Laboratories
Member Price: $35
Non-Member Price: $85
http://www.nccls.org/free/GP21-A.pdf
NCCLS GP17-A2 Clinical Laboratory Safety
NCCLS GP17-A Clinical Laboratory Safety; Approved Guideline
*American National Standard. This document contains general
guidelines for implementing a high-quality laboratory safety
program. The framework is adaptable to any laboratory.
Document Excerpt
Chairholder: Robert P. Buchwald, M.D. DeGraff Memorial Hospital
Member Price: $45
Non-Member Price: $105
http://www.nccls.org/free/GP17-A.pdf
NCCLS GP17-A Clinical Laboratory Safety; Approved Guideline
*American National Standard. This document contains general
guidelines for implementing a high-quality laboratory safety
program. The framework is adaptable to any laboratory.
Document Excerpt
Chairholder: Robert P. Buchwald, M.D. DeGraff Memorial Hospital
Member Price: $45
Non-Member Price: $105
http://www.nccls.org/free/GP17-A.pdf
BCSH Guidelines on fibrinogen assays - Br J Haematol, Vol 121, Issue 3, pp. 396-404Guidelines on fibrinogen assays
Ian J. Mackie1, Steven Kitchen2, Samuel J. Machin1, Gordon D. O. Lowe3, on
behalf of the Haemostasis and Thrombosis Task Force of the British Committee for
Standards in Haematology
http://www.blackwell-synergy.com/links/doi/10.1046/j.1365-2141.2003.04256.x/abs/;jsessionid=ctf6aD_6Qlq-
Ian J. Mackie1, Steven Kitchen2, Samuel J. Machin1, Gordon D. O. Lowe3, on
behalf of the Haemostasis and Thrombosis Task Force of the British Committee for
Standards in Haematology
http://www.blackwell-synergy.com/links/doi/10.1046/j.1365-2141.2003.04256.x/abs/;jsessionid=ctf6aD_6Qlq-
NCCLS New Standards and Guidelines
New Documents:
AUTO7-P, Laboratory Automation: Data Content for Specimen Identification;
Proposed Standard
H1-A5, Tubes and Additives for Venous Blood Specimen Collection; Approved
Standard-Fifth Edition
H3-A5, Procedures for the Collection of Diagnostic Blood Specimens by
Venipuncture; Approved Standard-Fifth Edition
I/LA24-P, Fluorescence Calibration and Quantitative Measurement of Fluorescence
Intensity; Proposed Guideline
M11-A6, Methods for Antimicrobial Susceptibility Testing of Anaerobic Bacteria;
Approved Standard-Sixth Edition
M40-A, Quality Control of Microbiological Transport Systems; Approved Standard
M100-S14, Performance Standards for Antimicrobial Susceptibility Testing;
Fourteenth Informational Supplement
New Electronic Product:
EP21-A-C, Total Error Estimator
NCCLS Information [ncclsinfo@nccls.org]
New Documents:
AUTO7-P, Laboratory Automation: Data Content for Specimen Identification;
Proposed Standard
H1-A5, Tubes and Additives for Venous Blood Specimen Collection; Approved
Standard-Fifth Edition
H3-A5, Procedures for the Collection of Diagnostic Blood Specimens by
Venipuncture; Approved Standard-Fifth Edition
I/LA24-P, Fluorescence Calibration and Quantitative Measurement of Fluorescence
Intensity; Proposed Guideline
M11-A6, Methods for Antimicrobial Susceptibility Testing of Anaerobic Bacteria;
Approved Standard-Sixth Edition
M40-A, Quality Control of Microbiological Transport Systems; Approved Standard
M100-S14, Performance Standards for Antimicrobial Susceptibility Testing;
Fourteenth Informational Supplement
New Electronic Product:
EP21-A-C, Total Error Estimator
NCCLS Information [ncclsinfo@nccls.org]
NCCLS ISO StandardsISO 15189, Medical laboratories - Particular requirements for quality and
competence
ISO 15190 Medical laboratories - Requirements for safety
ISO 15195 Laboratory medicine - Requirements for reference measurement
laboratories
ISO 15197, In vitro diagnostic test systems - Requirements for blood-glucose
monitoring systems for self-testing in managing diabetes mellitus
ISO 17511, In vitro diagnostic medical devices - Measurement of quantities in
biological samples - Metrological traceability of values assigned to calibrators
and control materials
ISO 18153, In vitro diagnostic medical devices - Measurement of quantities in
biological samples - Metrological traceability of values for catalytic
concentration of enzymes assigned to calibrators and control materials
New Draft ISO Standards
ISO/DIS 15198 Clinical laboratory medicine - In vitro diagnostic medical devices
- Validation of manufacturer's recommendations for user quality control
ISO/CD 22869 Technical Report: Medical Laboratories - Guidance on laboratory
implementation of ISO 15189
ISO/CD 22870, Amendment to 15189: Annex D - Point-of-Care Testing (POCT)
NCCLS Information [ncclsinfo@nccls.org]
competence
ISO 15190 Medical laboratories - Requirements for safety
ISO 15195 Laboratory medicine - Requirements for reference measurement
laboratories
ISO 15197, In vitro diagnostic test systems - Requirements for blood-glucose
monitoring systems for self-testing in managing diabetes mellitus
ISO 17511, In vitro diagnostic medical devices - Measurement of quantities in
biological samples - Metrological traceability of values assigned to calibrators
and control materials
ISO 18153, In vitro diagnostic medical devices - Measurement of quantities in
biological samples - Metrological traceability of values for catalytic
concentration of enzymes assigned to calibrators and control materials
New Draft ISO Standards
ISO/DIS 15198 Clinical laboratory medicine - In vitro diagnostic medical devices
- Validation of manufacturer's recommendations for user quality control
ISO/CD 22869 Technical Report: Medical Laboratories - Guidance on laboratory
implementation of ISO 15189
ISO/CD 22870, Amendment to 15189: Annex D - Point-of-Care Testing (POCT)
NCCLS Information [ncclsinfo@nccls.org]
link The ISO Cafe`
http://www.iso.ch/iso/en/commcentre/isocafe/index.html
Need to know about ISO and international standardization? You may be a student
assigned a project, an educator who needs to develop a teaching module, or a
journalist with an article deadline to meet.
Welcome to The ISO Café! Go and get yourself a cup of coffee, tea or a
refreshing glass of water, relax in front of the screen and discover the big,
wide world of ISO standards.
http://www.iso.ch/iso/en/commcentre/isocafe/index.html
Need to know about ISO and international standardization? You may be a student
assigned a project, an educator who needs to develop a teaching module, or a
journalist with an article deadline to meet.
Welcome to The ISO Café! Go and get yourself a cup of coffee, tea or a
refreshing glass of water, relax in front of the screen and discover the big,
wide world of ISO standards.
EN ISO 15225:2000/prA1 Nomenclature - Specification for a
nomenclature system for medical devicesCodifica UNI AOY00182
Mittente CEN/TC 257 - Symbols and information provided with
medical devices and nomenclature for regulatory data exchange
Data documento 11/10/2003
Oggetto EN ISO 15225:2000/prA1 Nomenclature - Specification for
a nomenclature system for medical devices for the purpose of
regulatory data exchange - Amendment 1 (ISO 15225:2000/FDAM
1:2003)
Tipologia documento INCHIESTA CEN/ISO
nomenclature system for medical devicesCodifica UNI AOY00182
Mittente CEN/TC 257 - Symbols and information provided with
medical devices and nomenclature for regulatory data exchange
Data documento 11/10/2003
Oggetto EN ISO 15225:2000/prA1 Nomenclature - Specification for
a nomenclature system for medical devices for the purpose of
regulatory data exchange - Amendment 1 (ISO 15225:2000/FDAM
1:2003)
Tipologia documento INCHIESTA CEN/ISO
NCCLS I/LA23-P Qualita Immunometria
NCCLS I/LA23-P
Assessing the Quality of Immunoassay Systems: Radioimmunoassays,
and Enzyme, Fluorescence, and Luminescence Immunoassays;
Proposed GuidelineThis guideline addresses components for harmonizing and
assessing the quality of immunoassay systems for several
commonly used dose-response indicator categories, e.g.,
radioisotopes, enzymes, fluorescence, luminescence, reagents,
and experimental components criteria essential to characterizing
an immunoassay.
Document Excerpt
W. Harry Hannon, Ph.D., Centers for Disease Control and
prevention
http://www.nccls.org./doc.asp?ac=7
http://www.nccls.org./free/ILA23-P.pdf
NCCLS I/LA23-P
Assessing the Quality of Immunoassay Systems: Radioimmunoassays,
and Enzyme, Fluorescence, and Luminescence Immunoassays;
Proposed GuidelineThis guideline addresses components for harmonizing and
assessing the quality of immunoassay systems for several
commonly used dose-response indicator categories, e.g.,
radioisotopes, enzymes, fluorescence, luminescence, reagents,
and experimental components criteria essential to characterizing
an immunoassay.
Document Excerpt
W. Harry Hannon, Ph.D., Centers for Disease Control and
prevention
http://www.nccls.org./doc.asp?ac=7
http://www.nccls.org./free/ILA23-P.pdf
NCCLS I/LA26-P Immunologia Cellulare
NCCLS I/LA26-P
Performance of Single Cell Immune Response Assays; Proposed
GuidelineThis document contains methods of intracellular cytokine
evaluation, major histocompatibility complex (MHC) tetramer
quantitation, and enzyme-linked immunospot (ELISPOT) technology.
This document provides basic aspects of specimen collection,
transport, and preparation, in addition to quality assurance and
test validation approaches.
Document Excerpt
Alan L. Landay, Ph.D., Rush-Presby-St. Luke's Medical Center
http://www.nccls.org./doc.asp?ac=7
http://www.nccls.org./free/ILA26-p.pdf
NCCLS I/LA26-P
Performance of Single Cell Immune Response Assays; Proposed
GuidelineThis document contains methods of intracellular cytokine
evaluation, major histocompatibility complex (MHC) tetramer
quantitation, and enzyme-linked immunospot (ELISPOT) technology.
This document provides basic aspects of specimen collection,
transport, and preparation, in addition to quality assurance and
test validation approaches.
Document Excerpt
Alan L. Landay, Ph.D., Rush-Presby-St. Luke's Medical Center
http://www.nccls.org./doc.asp?ac=7
http://www.nccls.org./free/ILA26-p.pdf
NCCLS H49-P Monitoraggio anticoagulati in point-of-care
NCCLS H49-P
Point-of-Care Monitoring of Anticoagulation Therapy; Proposed
GuidelineThis document provides guidance to users and manufacturers of
point-of-care coagulation devices for monitoring heparin and
warfarin anticoagulant therapy, and to ensure reliable results
comparable to those obtained by routine clinical laboratory
testing.
Document Excerpt
J. Heinrich Joist, M.D., Ph.D., St. Louis University Hospital
http://www.nccls.org./doc.asp?ac=6
http://www.nccls.org./free/H49-P.pdf
NCCLS H49-P
Point-of-Care Monitoring of Anticoagulation Therapy; Proposed
GuidelineThis document provides guidance to users and manufacturers of
point-of-care coagulation devices for monitoring heparin and
warfarin anticoagulant therapy, and to ensure reliable results
comparable to those obtained by routine clinical laboratory
testing.
Document Excerpt
J. Heinrich Joist, M.D., Ph.D., St. Louis University Hospital
http://www.nccls.org./doc.asp?ac=6
http://www.nccls.org./free/H49-P.pdf
EN ISO 15225:2000/prA1 Nomenclature - Specification for a
nomenclature system for medical devices
Codifica UNI AOY00182
Mittente CEN/TC 257 - Symbols and information provided with
medical devices and nomenclature for regulatory data exchange
Data documento 11/10/2003
Oggetto EN ISO 15225:2000/prA1 Nomenclature - Specification for
a nomenclature system for medical devices for the purpose of
regulatory data exchange - Amendment 1 (ISO 15225:2000/FDAM
1:2003)
Tipologia documento INCHIESTA CEN/ISO
www.UNI.com
nomenclature system for medical devices
Codifica UNI AOY00182
Mittente CEN/TC 257 - Symbols and information provided with
medical devices and nomenclature for regulatory data exchange
Data documento 11/10/2003
Oggetto EN ISO 15225:2000/prA1 Nomenclature - Specification for
a nomenclature system for medical devices for the purpose of
regulatory data exchange - Amendment 1 (ISO 15225:2000/FDAM
1:2003)
Tipologia documento INCHIESTA CEN/ISO
www.UNI.com
