CIBIC - Centro de Diagnóstico Médico de Alta Complejidad S.A. Pte. Roca 740 - S2000CXP – Rosário – ArgentinaTe: 54-341-4722424 Fax: 54-341-4262913 E-mail: info@cibic.com.ar Web: www.cibic.com.ar
| Certificates and accreditations in Quality assurance System |
| # |
Certificate |
Range of application |
Organism |
Number of certification |
Valid until |
| 1 |
ISO 9001:2000 Certificate |
Processes and services involved in front desk assistance simple extraction and simple reception, pre-analytic, and post analytic processes, as well as post-sale service for these specialties; flow citometry, hematology, clinical chemistry, serology, radio-immune assay, microbiology, molecular biology and clinical study division. |
IRAM |
9000-1373 |
15/11/2008 |
| 2 |
ISO 9001:2000 Certificate |
IQNet |
AR-QS-1373 |
15/11/2008 |
| 3 |
MA2 Standard Accreditation of Program of Laboratory Accreditation |
Accreditation Laboratory Manual version 2 - March 1999 |
FBA |
23899 |
31/10/2007 |
| 4 |
ITAES Standard Accreditation of Clinical Tests Laboratory |
Ambulatory Diagnostics and Treatment Centers Manual – Clinical and Microbiology Laboratory – January 2003 – version 1. |
ITAES |
------- |
30/03/2010 |
| Certificates of assistance in External Quality Control Programs |
| # |
Program |
Range of application |
Organism |
| 1 |
Prog. Nac. de CC en Bacteriology |
Strain id and antibiotic susceptibility testing. |
Malbrán |
| 3 |
ProgBA - Immunology |
Thyroxin / Triiodothyronine / Free Thyroxin / Thyrotropin / Anti Microsomal / Anti-Thyroperoxidase / Luteinizing hormone / Follicle Stimulating hormone / Prolactin / Gonodotropin Corionic Beta sub-unit ( GH ) / Immunoglobulin E/ Insulin / Estradiol / Progesterone / Androstenedione / Cortisol / Testosterone / Dihydrotestosterone Sulfate / Free Testosterone / 17-hidroxi-Progesterone / Carcinoma embryonic Antigen / Fetoprotein alpha / Ferritin / Growth Hormone / Prostate Specific Antigen / CA 15-3 / CA 19-9 / Free CA –125/ PSA |
CEMIC |
| 4 |
ProgBA - Neonatal Assays |
Thyrotrofin / Fenilalanin / Galactose |
CEMIC |
| 5 |
ProgBA - Hematology |
RBC / WBC / HB / HTO / MCV / MCH / MCHC/ Platelets |
CEMIC |
| 6 |
ProgBA - Serology |
Hepatitis B (HbsAg and Anti Core) / HIV (Anti-HIV I y II) / Hepatitis C (anti HCV) / HTLV / Chagas / Syphilis / Brucellosis / Toxoplasmosis / Rubella / Hepatitis A (anti HAV totales) / Herpes I y II (HSV) / Cytomegalovirus (CMV) |
CEMIC |
| 7 |
ProgBA - Clinical Chemistry |
Urea / Glucose / Total Cholesterol / HDL and LDL Cholesterol / Uric Acid / Creatine / Total Proteins / Albumin / Triglyceride / Iron (serum) / Total Bilirrubin / ALT / AST / LDH / CPK / Amylase / FAL / Gamma GT / Sodium / Potassium / Calcium / Magnesium / Chlorine / Phosphorus |
CEMIC |
| 8 |
PEEC |
Clinical Chemistry , Bacteriology, Parasitology, Hematology, Immuno-serology, Instrumental, Urine, Mycology, Proteinogram, VIH (Total 56 test) |
FBA |
| 9 |
CAP |
HCV RNA Cobas Amplicor |
College of American Pathologists |
| 10 |
CAP |
HIV Carga Viral Cobas Amplicor |
College of American Pathologists |
| # |
Certificate |
Organism |
Participate |
| 1 |
Training Requirements IATA / ICAO |
World Courier |
Gabriela García Camacho |
| 2 |
Training Requirements IATA / ICAO |
World Courier |
Laura Barberio |
BIOMEDICA DE REFERENCIA S.A. DE C.V. LABORATORIO DE ANALISIS CLINICOS Montes Urales 786 Col. Lomas de Chapultepec. Ciudad de México, C.P. 11000Tel. (55) 55 40 91 80; Fax (55) 55 40 91 99 E-mail: voz_del_cliente@bioderef.com; Web: www.biomedicadereferencia.com
| Certificates and Accreditations in Quality Assurance |
| # |
Certificate |
Scope |
Institution |
ID Register |
Validity date |
| 1 |
ISO 9001:2000 Certificate by the Mexican Institute of Normalization and Certification, IMNC. |
Clinical Analysis services, since the collection of the primary sample until the delivery of the report of results, in the areas of Bacteriology, Clinical Chemistry, Endocrinology, Hematology, Immunology, Urine analysis and Special Test (referred to Mayo Medical Laboratories) |
IMNC México |
RSGC-163 |
2010-10-01 |
| 2 |
ISO 9001:2000 Certificate by International Quality Net, IQNet. |
IQNet |
MX-RSGC-163 |
2010-10-01 |
| 3 |
Accreditation in agreement of ISO STD 15189:2003 requirements by the Mexican Accreditation Entity, EMA. |
Laboratory Accreditation in the following disciplines: Clinical Chemistry, Hematology and Coagulation |
EMA |
23899 |
2011-09-05 |
| Participation in External Quality Assurance Programs, EQAS |
| # |
Program |
Scope |
Institution |
| 1 |
Quality Assurance Program PACAL, Mexico |
In the following areas: Clinical Chemistry, Hematology, Bacteriology, Parasites presence, Immunology and urine analysis. Achievements: Since 1998 to 2007, because of its performance, the laboratory has maintained as one of the first 25 labs of about 800 labs participating in the program. |
PACAL |
| 2 |
Medical Laboratory Evaluation, MLE, U.S.A. Immunology |
Thyroxin / Triiodothyronine / Free / Anti-Thyroperoxidase / Immunoglobulin E/ Insulin / Cortisol / TSH |
MLE |
| 3 |
Medical Laboratory Evaluation, MLE, U.S.A. Clinical Chemistry |
Urea / Glucose / Total Cholesterol / HDL and LDL Cholesterol / Uric Acid / Creatine / Total Proteins / Albumin / Triglyceride / Iron (serum) / Total Bilirrubin / ALT / AST / LDH / CPK / Amylase / FAL / Gamma GT / Sodium / Potassium / Calcium / Magnesium / Chlorine / Phosphorus |
MLE |
| 4 |
ProgBA - Hematology |
RBC / WBC / HB / HTO / MCV / MCH / MCHC/ Platelets |
CEMIC |
| 5 |
ProgBA - Clinical Chemistry |
Urea / Glucose / Total Cholesterol / HDL and LDL Cholesterol / Uric Acid / Creatine / Total Proteins / Albumin / Triglyceride / Iron (serum) / Total Bilirrubin / ALT / AST / LDH / CPK / Amylase / FAL / Gamma GT / Sodium / Potassium / Calcium / Magnesium / Chlorine / Phosphorus |
CEMIC |
| 6 |
Mexican Association of Clinical Chemistry, Quality Assessment Program, PEEC AMBC |
Clinical Chemistry, Hematology, Bacteriology, Parasites identification. |
AMBC |
| Recognitions in Best Practices in Personnel Management |
| # |
Recognition |
Validity Period |
Institution |
| 1 |
New Labour Culture, NUEVA CULTURA LABORAL. People is the most important resource for the Organization. |
2005 |
Economy Ministry, National Quality Prize |
| 2 |
The laboratory was between the 100 best enterprises in Job Practices in Mexico |
2007 |
Great Place to Work Institute |
| Participation in standardization process |
| # |
Process developed in Mexico |
Validity Period |
Institution |
| 1 |
Spanish version of the ISO 15189:2003 Standard : “Medical Laboratories-Particular requirements for quality and competence” or NMX-EC-15189-IMNC-2006 |
2004-2006 |
Mexican Institute of Normalization and Certification, IMNC |
| 2 |
Review group ISO DIS 9001:2008. Ten Mexican organizations validating the Standard for its sector. (Health Care Services |
2006 |
Technical Committee |
| 3 |
Member of the Clinical Laboratories Subcommittee for the Accreditation |
2006 |
Mexican Accreditation Entity |
Laboratório Martinez PradoBv. Artigas 1129 – CP 11200. Montevideo - UruguayTel. ++598 2 403 4828* FAX: ++598 2 409 5689 E-mail: info@martinezprado.com.uy
| Certificados de Calidad |
| # |
Certificado |
Ambito de aplicación |
Organismo |
Número de certificado |
Válido hasta |
| 1 |
Certificado ISO 9001:2000 |
Servicio de análisis clínicos incluyendo las etapas preanalítica, analítica y pos analítica para los siguientes procesos: Bacteriología, Bioquímica Especializada, Bioquímica General, Citometría de Flujo, Hematología, Inmunología, Parasitología y Micología, Laboratorio en Sanatorio Americano y áreas de Extracciones en Torre de los Profesionales y Seguro Americano |
LATU Sistema – Quality Austria |
150/01 |
19/12/2009 |
| 2 |
Certificado ISO 9001:2000 |
OQS |
2088/0 |
19/12/2009 |
| 3 |
Certificado ISO 9001:2000 |
IQNET |
Registro nº 2088/0 |
19/12/2009 |
| Programas de evaluación externa de la calidad |
| # |
Programa |
Ambito de aplicación |
Organism |
-
|
CECC - Bioquímica clínica |
Urea/ Glucosa/ Colesterol total/ Acido úrico/ Creatinina/ Proteínas totales/ Sodio/ Potasio/ Cloruro/ Albúmina/ Calcio/ Fósforo/ Triglicéridos/ Bilirrubina total/ Alanito amino transferasa/ Fosfatasa alcalina/ Gamma glutamil transpeptidasa/ Amilasa/ Aspartato amino transferasa/ Dehidrogenasa láctica/ Creatinkinasa total/ Magnesio/ Colesterol HDL/ |
Asociación Bioquímica Uruguaya |
-
|
CECC – Inmunología |
TSH/ T4 libre/ ß HCG |
Asociación Bioquímica Uruguaya |
-
|
Programa de evaluación externa de desempeño en Serología |
Sífilis (FTA ABs/)/ Sífilis (RPR – Carbón)/ Chagas (HAI)/ HIV 1 y 2/ HVB HBs Ag/ HVB anti HBc/ HVC |
Servicio Nal. De Laboratorios – M.S.P. |
-
|
Biosystem – Bioquímica Clínica |
Urea/ Glucosa/ Colesterol total/ Acido úrico/ Creatinina/ Proteínas totales/ Sodio/ Potasio/ Cloruro/ Albúmina/ Calcio/ Fósforo/ Triglicéridos/ Bilirrubina total/ Alanito amino transfrerasa/ Fosfatasa alcalina/ Gamma glutamil transpeptidasa/ Amilasa/ Aspartato amino transferasa/ Dehidrogenasa láctica/ Creatinkinasa total/ Magnesio/ Colesterol HDL/ |
Biosystem - España |
-
|
ProgBA - Hormonas Proteicas |
Luteinizante / Folículo estimulante / Prolactina / Gonadotrofina Coriónica (HCG) / Inmunoglobulina E / Insulina |
CEMIC |
-
|
ProgBa - Hormonas Esteroides |
Estradiol / Progesterona / Androstenediona / Cortisol / Testosterona / Sulfato de Dehidroepiandrosterona / Testosterona Libre / 17-hidroxi-Progesterona / SHBG |
CEMIC |
-
|
ProgBa - Marcadores Tumorales |
Antígeno Carcinoembrionario / Alfafetoproteína / Ferritina / Hormona de Crecimiento / Antígeno Prostático Específico total/ Antígeno Prostático Específico libre / CA 15-3 / CA 19-9 / CA -125 |
CEMIC |
| # |
Certificado |
Organismo |
Participantes |
| 1 |
Curso de certificación de sustancias infecciosas y especimenes diagnósticos IATA |
World Courier |
Juan Vizziano |
MEDLAB S.A.C.
Av. Santa Cruz 367 Miraflores - Lima - Perú
Te: (511) 441-2266 Fax: (511) 441-6432 E-mail: atencionalcliente@medlab.com.pe Web: www.medlab.com.pe
|
Certificates and accreditations in Quality assurance System
|
|
#
|
Certificate
|
Range of application
|
Organism
|
Number of certification
|
Valid until
|
|
1
|
I SO 9001:2000 Certificate
|
Customer Services and Clinical Pathology Tests (Hematology, Chemistry, Immunology and Microbiology), in Medlab Central Laboratory.
Atención al Cliente y Análisis Clínicos (Hematológicos, Bioquímicos, Inmunológicos y Microbiológicos), en el Laboratorio Central de Medlab.
|
ABS Quality Evaluations
|
70137
|
09/02/2009
|
|
Certificates of assistance in External Quality Control Programs
|
|
#
|
Program
|
Range of application
|
Organism
|
|
1
|
RIQAS
|
Immunoassay Programme
|
Randox International Quality Assessment Scheme
|
|
2
|
RIQAS
|
Biochemistry Programme
|
Randox International Quality Assessment Scheme
|
|
3
|
RIQAS
|
Hematology Programme
|
Randox International Quality Assessment Scheme
|
|
4
|
UNITY
|
Coagulation tests
|
BIORAD
|
|
#
|
Certificate
|
Organism
|
Participate
|
|
1
|
Training Requirements IATA / RI
|
Rosyma Internacional S.A
|
Cristobal Gregorio Semillán López
|
|
2
|
Training Requirements IATA / RI
|
Rosyma Internacional S.A
|
Oscar Miguel Carrasco Fernández
|
|
3
|
Training Requirements IATA / RI
|
Rosyma Internacional S.A
|
Dennis Alberto Quiber Llamoca
|
|
4
|
Training Requirements IATA / RI
|
Rosyma Internacional S.A
|
Ana María Díaz Montes
|
|
5
|
Training Requirements IATA / RI
|
Rosyma Internacional S.A
|
Juan Carlos Aguilar Tordoya
|
|