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Quality Management

 

Quality Management

With the quality management as the main body, KingMed Diagnostics successfully integrates CAP-LAP (College of American Pathologists), ISO1589, CMA (China Metrology Accreditation), CMAF ( Food Inspection Agency Accreditation Certificate), ISO/IEC17025, ISO9001, and Performance Excellence Model and many systems, and the practicing enterprise sustained success and excellent management model.

 

Technical Quality

Adhere to the fair, accurate and fast results as the starting point and the attaching point, implement strict monitoring on the six key elements that may affect the test results - Man, Machine, Material, Method, Environment, and Measurement, and ensure that over 80% of specimens are issued within 24 hours; by means of the remote real-time monitoring mode, introduce the  internal  quality control situation of all subordinate laboratories into the international comparison database, and ensure the quality of internal quality control; attend the proficiency testing programs or external quality assessment of more than twenty authoritative quality assessment agencies at home and abroad, and ensure the comparability of test results; attend NGSP (American National Glycohemoglobin Standardization Program) traceability programs, and ensure the test results to be With international standards  . And ultimately ensure the test quality can continue to meet the requirements.

 

Figure 1 5M1E (Man, Machine, Material, Method, Environment, and Measurement) Technical Quality Assurance Model of KingMed Diagnostics

 

Management Quality

Adhere to the quality policy - "fair, accurate, fast, innovative, to create a seamless-connection service chain, and pursue zero defect quality target", all the management elements are included in the quality scope, attach great importance to the quality team building and quality staff development, as of the end of 2013, the Group has totally 443 full-time and part-time quality staff, so as to ensure the effective implementation of quality management.
 

Figure 2   Management Quality Implementation of KingMed Diagnostics

 

Certification and Accreditation

Under the guidance of “inquiring quality culture”, KingMed Diagnostics constantly sprints in the international advanced quality management standards, and has been certificated and accreditated by a number of external agencies. On the basis of the integration of multiple domestic and foreign quality standards, she continues to create the first in China: the first clinical testing agency to pass the accreditation of ISO/IEC 17025:1999, the first independent clinical testing agency to pass ISO9001: 2000 quality system certification, the first medical laboratory to obtain “Quality Award”, and the first third-party medical laboratory to obtain the accreditation of ISO15189: 2007.
 

Figure 3 KingMed Diagnostics’ Management Innovation Mileage with Quality as Main Line

 

 

Great Quality Events of KingMed
 

2002

On December 6, KingMed (Guangzhou) obtained ISO/IEC17025 Laboratory Accreditation Certificate issued by the predecessor of China National Accreditation Service for Conformity Assessment - China National Accreditation Board for Laboratories (CNAL), and became the first third-party medical testing agency that passed the Accreditation of ISO / IEC 17025 from the National Laboratory in China. 

 

2004

On August 26, KingMed (Guangzhou) obtained ISO9001 Quality System Certification issued by Bureau Veritas Quality International (BVQI), and is the first third-party clinical testing service agency that passed ISO9001 International Quality System Certification in China. 

 

2006

On September 26, KingMed (Guangzhou) obtained two awards including “Guangdong Province Quality Award” and “Guangdong Province Advanced Enterprise Implementing Superior Performance Model” issued by Guangdong Province Quality Association, and became the first clinical medical service agency winning this award in China. 

 

2008

On May 13, KingMed (Guangzhou) obtained the Laboratory Accreditation Program (CAP-LAP) Certificate issued by College of American Pathologists (CAP), and the recognition field is the most complete in China. 

On June 6, Limited-Thomas Medical Laboratory (the predecessor of Hong Kong KingMed) obtained the Laboratory Accreditation Certificate issued by Hong Kong Laboratory Accreditation Scheme (HKLAS). 

On December 10,  Hygiene Testing Department of KingMed (Guangzhou) obtained the laboratory qualification accreditation and metrology accreditation (China Metrology Accreditation, CMA) certificate issued by the Administration of Quality and Technology Supervision of Guangdong Province.

 

2009

On August 10, KingMed (Guangzhou) obtained ISO15189 laboratory accreditation certificate issued by China National Accreditation Service for Conformity Assessment (CNAS), and is China’s first medical laboratory winning recognition of both College of American Pathologists (CAP-LAP) and ISO15189. 

 

2010

On March 19, KingMed(Nanjing) obtained ISO15189 Laboratory Accreditation Certificate issued by China National Accreditation Service for Conformity Assessment (CNAS).

On September 1, KingMed (Guangzhou) obtained First-level traceability certificate of American National Glycohemoglobin Standardization Program (NGSP).

On September 10, KingMed(Jinan) obtained ISO15189 Laboratory Accreditation Certificate issued by China National Accreditation Service for Conformity Assessment (CNAS).

 

2011

On March 14, KingMed(Hefei) obtained ISO15189 Laboratory Accreditation Certificate issued by China National Accreditation Service for Conformity Assessment (CNAS).

On April 11, KingMed(Zhengzhou) obtained ISO15189 Laboratory Accreditation Certificate issued by China National Accreditation Service for Conformity Assessment (CNAS).

On April 14, KingMed(Fuzhou) obtained ISO15189 Laboratory Accreditation Certificate issued by China National Accreditation Service for Conformity Assessment (CNAS).

 

2012

On February 29, Sanitary Testing Department of KingMed (Guangzhou) obtained Food Inspection Agency Accreditation Certificate (CMAF) certificate issued by the Administration of Quality and Technology Supervision of Guangdong Province.

 

2013

On January 22, KingMed(Xi'an) obtained ISO15189 Laboratory Accreditation Certificate issued by China National Accreditation Service for Conformity Assessment (CNAS).

On February 27, KingMed(Shanghai) obtained the Laboratory Accreditation Program (CAP-LAP) Certificate issued by College of American Pathologists (CAP). So far, KingMed Diagnostics has become the first medical laboratory group in China that has two subsidiary companies to win CAP-LAP accredited laboratory.

On April 11, KingMed(Kunming) obtained ISO15189 Laboratory Accreditation Certificate issued by China National Accreditation Service for Conformity Assessment (CNAS).

On May 13, KingMed(Jilin) obtained ISO15189 Laboratory Accreditation Certificate issued by China National Accreditation Service for Conformity Assessment (CNAS).

At the end of the year, KingMed(Tianjin), KingMed(Chongqing), and KingMed(Changsha) successively accepted the ISO15189 on-site audit by CNAS.

 

2014

On January 14, KingMed(Ghuangzhou) obtained 2013 (first) “Haizhu District Director Quality Award” issued by Haizhu District People's Government of Guangzhou City. 

Up to now, as many as 13 subsidiary companies of KingMed Diagnostics have accepted ISO15189  inspection, occupying a half of the third-party medical testing laboratory accreditation, and has become the third-party medical laboratory group of China with the most accredited laboratories. Two laboratories subordinate to KingMed Group have obtained First-level traceability certificate of American National Glycohemoglobin Standardization Program (NGSP). Meanwhile, KingMed Diagnostics is also the first medical laboratory group in China that has two subsidiary companies to win CAP-LAP accredited laboratory.