WORLD TRADE  
ORGANIZATION  G/TBT/N/DOM/65 
2 September 2009 
 (09-4100) 
Committee on Technical Barriers to Trade Original:   Spanish 
  
NOTIFICATION 
 
The following notification is being circ ulated in accordance with Article 10.6. 
 
1. Member to Agreement notifying:   DOMINICAN REPUBLIC
 
If applicable, name of local government involved (Articles 3.2 and 7.2):  
2. Agency responsible:  
Dirección General de Normas y Sistemas de Calidad , DIGENOR  
(Directorate-General of Standards and Quality Systems) Edificio de Oficinas Gubernamentale s "Juan Pablo Duarte", piso 11 
Avenida México, esquina Leopoldo Navarro 
Santo Domingo, Dominican Republic Tel.: +1-809-686-2205 Fax: +1-809-688-3843 E-mail: direcciongeneral@gob.do
 
Website: http://www.digenor.gob.do  
Name and address (including telephone  and fax numbers, e-mail and website 
addresses, if available) of  agency or authority designated to handle comments 
regarding the notification shall be  indicated if different from above:  
3. Notified under Article 2.9.2 [ X], 2.10.1 [ ], 5.6.2 [ ], 5.7.1 [ ], other:  
4. Products covered (HS or CCCN where applicable, otherwise national tariff heading.  
ICS numbers may be provided in addition, where applicable):   International 
Classification for Standards (ICS) code 11.100.99 
5. Title, number of pages and langua ge(s) of the notified document:  NORDOM 11:  
32-004 Medicina de Laboratorio.  Calidad Para Laboratorios de Salud  (Dominican 
Standard (NORDOM) 11:32-004 - Laboratory medicine.  Health laboratory quality) 
(46 pages, in Spanish). 
6. Description of content:   Definitions;  management requirements;  technical requirements;  
selection, handling and transport of samples;  issuing of results. 
7. Objective and rationale, including the nature of urgent problems where applicable:  
To provide the country's health laboratories with a National Standard on Health Laboratory 
Quality so that they can operate in accordan ce with standardized criteria that will enable 
them to help improve the quality of life of their users. 
 
To help to enhance the effectiveness and effici ency of the analytical process in laboratories 
in the Dominican Republic. G/TBT/N/DOM/65 
Page 2  
 
   To provide general standards for each stage of the laboratory analytical process, within the 
framework of the health sector reform process.  To contribute to the setting up of a quality management system for laboratories in the regional health services network.  
8. Relevant documents:  
6.1 Badia Jiménez, A., Calidad:  Enfoque ISO 9000 (Quality:  A focus on ISO 9000).  
Ediciones Deusto, Bilbao, 1998.  
6.2 Boquet, E., et al., Mejoría Continua de la Calidad.  Guía para los Laboratorios 
Clínicos de América Latina  (Ongoing quality improvement.  Guide for clinical laboratories 
in Latin America).  Editorial Panamericana, Mexico, 1995.  6.3 Burnett, David, Acreditación del Laboratorio Clínico (Clinical laboratory 
accreditation).  Editorial Reverté S.A., Barcelona, 1998. 
 6.4 Latin American Confederation of Clinical Biochemistry (COLABIOCLI), Guía 
para la elaboración de Manuales de Acreditación (Guide to preparing accreditation 
manuals), 2001.  
6.5 Ministry of Public Health, Cuba.  Buenas Prácticas de Laboratorio Clínico, 
Regulación 3-95 (Good clinical laboratory practices, Regulation No. 3-95) . 
 6.6 Documento informativo para la aplicación de la Norma 15189/2003 en los 
laboratorios de América Latina y el Caribe  (Information document concerning the 
implementation of Standard 15189/2003 in La tin American and Caribbean laboratories), 
Caribbean Epidemiology Centre (CAREC). 
 6.7 Norma Española UNE-EN 591.  Requisitos para manuales de utilización de los 
Instrumentos de Diagnóstico in Vitro de uso Profesional  (Spanish Standard UNE-EN 591, 
Requirements for user manuals on in vitro di agnostic instruments for professional use), 
1995.  
6.8 Federation of Bioanalyst Associ ations of Venezuela (FECOBIOVE), Manual de 
acreditación de laboratorios  (Laboratory accreditation manual), Caracas, 1999. 
 6.9  Fernández Espina, C., El aseguramiento de calidad en el laboratorio clínico 
(Quality assurance in the clinical laboratory) .  Acta Bioquímica Clínica Latinoamericana 
1999, Vol.  XXXIII, pp. 49-68. 
 
6.10 Fernández Espina, C., Gestión de calidad en el laboratorio Clínica  (Quality 
management in the clinical laboratory).  Editorial Médica Panamericana, first edition, 
Madrid, 2005.  
6.11 Guía de Buena Ejecución de los Análisis Clínicas (Guide to good clinical analysis 
practices), Paris, 1995.  6.12 Argentine Biochemistry Foundation (FBA), Manual de Acreditación de 
laboratorios  (Laboratory accreditation manual), Buenos Aires, 1999. 
  G/TBT/N/DOM/65 
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6.13 Guía para el manual de calidad de AEFA  (Guide to the Spanish Association of 
Analyst Pharmacists quality manual), Madrid, 1998.  6.14 ISO 9000-2000, Quality management systems - Fundamentals and vocabulary 
 
6.15 ISO 9001-2000, Quality management systems - Requirements.  6.16 ISO 15189-2003, Medical laboratories - Particular requirements for quality and 
competence, 2003. 
 
6.17 ISO/IEC 17025-2005, General requirements for the competence of testing and calibration laboratories.  6.18 ISO 19011, Guidelines for quality and/or environmental management systems 
auditing. 
 6.19 Morán Villatoro, L., Obtención de muestras sanguíneas de calidad analítica  
(Obtaining blood samples of analytical quality).  Editorial Médica Panamericana, first edition, 2001. 
 
6.20 Niño H., and L.  Barrera, Garantía de Calidad en el Laboratorio Clínico  (Quality 
assurance in the clinical laboratory), Colombia, 1993.  6.21 Normas Nacionales de Bioseguridad para Laboratorio .  Directrices y Requisitos 
Generales para la Bioseguridad en los Laboratorios /SESPASIDIGENOR 2004  (National 
biosecurity standards for laboratories.  Gene ral guidelines and requirements for biosecurity 
in laboratories/SESPASIDIGENOR 2004), National Directorate for Laboratories, Ministry of Public Health and Social Welfare, Dominican Republic.  6.22 Executive Commission for Health Sector Reform (CERSS), Agenda Estratégica 
Nacional  (National strategic agenda), Dominican Republic. 
 6.23  Executive Commission for Health Sector Reform (CERSS), El Modelo 
Dominicano de Prestación de Servicios de Salud  (The Dominican model for the provision 
of health services), Dominican Republic. 
 
6.24 Ley General de Salud, 42-01 (General Law on Health No. 42-01), Dominican 
Republic.  6.25 Ley Sistema Dominicano Seguridad Social, 87-01  (Law No. 87-01 on the 
Dominican Social Security System), Dominican Republic. 
 
6.26 Ley sobre el SIDA, 55-93  (Law on AIDS No. 55-93), Dominican Republic. 
 6.27  Reglamento para la habilitación y funci onamiento de los Laboratorios Clínicos y 
de Salud Pública  (Regulations on the approval and functi oning of clinical and public health 
laboratories), Ministry of Public Health a nd Social Welfare, Dominican Republic, 2004. 
 6.28 Reglamento para la habilitación y funcionam iento de Bancos de Sangre y Servicios 
de Transfusión  (Regulations on the approval and func tioning of blood banks and transfusion 
services), Ministry of Publ ic Health and Social Welfar e, Dominican Republic, 2004. G/TBT/N/DOM/65 
Page 4  
 
   
6.29 Reglamento para el Registro de Reactivos para Diagnóstico Clínico  (Regulations 
on the registration of clinical diagnostic reagents), Ministry of Public Health and Social Welfare, Dominican Republic, 2004.  
6.30 Reglamentos Generales de la Ley de Salud  (General regulations under the Law on 
Health), Ministry of Public Health and Social Welfare, Dominican Republic, 2004. 
 6.31 Reglamentos Generales de la Ley de Salud II  (General regulations under the 
Law on Health II), Ministry of Public Hea lth and Social Welfare, Dominican Republic, 
2005. 
 6.32 Sánchez, A., El modelo Dominicano de prestac ión de servicios de salud, una 
apuesta de futuro  (The Dominican model for the provision of health services, an investment 
for the future), Dominican Republic, 2005. 
 
6.33 Servat, A. G., Manual para Documentar Sistemas de Calidad  (Manual on quality 
system documentation), Prentice Hall Hispanoamericana S. A., Mexico, 1999.  6.34 Terragno, Raquel, Transporte de Especimenes para Diagnostico (Transporting 
diagnostic specimens).  Acta Bioquímica C línica Latinoamericana, 2005, Volume 39, 
No. 2, pp. 217-223.  6.35 European Union, Grupo de Sistemas de Calidad y Acreditación , Criterios 
Esenciales para Sistemas de Calidad de Laboratorios de Bioquímica Clínica en la Unión 
Europea (UE) (Group on working systems and accreditation, Essential criteria for quality 
systems in clinical biochemistry laborator ies in the European Union), EC4, 1996. 
9. Proposed date of adoption: 
Proposed date of entry into force:   28 November 2008 
28 May 2009 
10. Final date for comments:   - 
11. Texts available from:  National enquiry point [ ] or address, telephone and fax 
numbers and e-mail and website addresses, if available, of other body: 
Dirección General de Normas y Sistemas de Calidad (DIGENOR) 
Edificio de Oficinas Gubernamentale s "Juan Pablo Duarte", piso 11 
Avenida México, esquina Leopoldo Navarro 
Santo Domingo, Dominican Republic Tel.: +1-809-686-2205 Fax: +1-809-688-3843 E-mail: cendoc@digenor.gob.do
 
Website: http://www.digenor.gob.do