CDEM laboratory ISO 9001:2015 certified

The CDEM laboratory which is only one year old, yet competing with giants in the field obtained ISO9001:2015 certification in May, 2017.

The laboratory performs a wide repertoire of tests in different fields – from routine to highly specialised. The tests include routine chemistry (glucose, HbA1c, renal function tests, liver function tests, lipid profiles, tests for heart attacks and heart failure), special tests (thyroid functions, testosterone, cortisols, vitamin D, insulin and many hormones), haematology (full blood count, prothrombin time, blood picture), microbiology (urine and wound swab cultures).

Today 70% of clinical decisions (whether to treat or not) are taken depending on laboratory test results. Therefore quality of reports from a medical laboratory is very important. Most of the patients in our country have well recognised the need of the quality of report and choose only the best labs to get the blood tests done.

It’s a wonderful for such young laboratory to get ISO9001:2015 certification so soon. There are several reasons to this.

• The laboratory is equipped with world renowned, state-of-the art fully automated analysers with latest technology. 
• Internal quality control is done according to international guidelines.
• Quality of individual tests is monitored by Randox laboratories of UK and Biorad laboratories of USA.
• Laboratory is closely supervised by a group of prominent consultant pathologists led by Dr. Gaya Katulanda, consultant chemical pathologist.
• Laboratory is built recently following current international regulations maintaining optimal environmental conditions for equipment and functioning.
• Specially selected experienced and qualified bunch of medical laboratory technologists perform tests while they are continuously trained and assessed. 
• The patient information and data handling is fully computerised and barcoding is used to identify samples minimising human errors.
• The risk to community is stopped by good waste disposal methods.
• There is a safe and patient-friendly blood collection room with disabled access.
• All instructions for patient preparation and specimen collection are given by well trained staff
• Continuous feedback by leading endocrinologists, nephrologists and  cardiologists 

All above and the dedication of staff has led to obtaining the certification with no delay. 

What is ISO9001:2015?

ISO 9001 is a standard that sets out the requirements for a quality management system in any organisation. It helps a medical laboratory to be more efficient and improve satisfaction of users and customers. This standard focuses on a strong customer care, motivation   of top management, the good laboratory processes and continual improvement. Using ISO 9001:2015 standard medical laboratories such as CDEM ensures that customers get consistent, good quality test results and services, which in turn brings many benefits to patients as well as to the laboratory .

Benefits of ISO9001:2015 to a medical laboratory

All laboratory processes are documented and understood by everyone in the laboratory. This increases accuracy of testing and well as timeliness. As a requirement of the standard the laboratory meets the necessary regulatory requirements e.g.: registration at PHRC (Private health Regulatory Council). Most of the insurance companies, foreign employment agencies, and business organisations in the country require ISO 9001 to draw up business contracts with a medical lab. Obtaining certification by ISO9001 helps CDEM to expose the laboratory to new markets. As the lab designs the processes according to ISO9001 standard the associated risks are identified and addressed. 

ISO and CDEM

The management of the CDEM is not only satisfied with obtaining ISO 9001 but also crave for continual improvement and continuous streamlining of processes to maintain a customer friendly stature. The journey to become a leading medical laboratory just started and nourished by ISO 9001 certification. They hope ISO9001 certification is a jewel in the crown of CDEM laboratory.