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ISO 15189
What is ISO 27001:2005 Information Security Management System (ISMS)?

ISO 15189 Medical laboratories — Particular requirements for quality and competence specifies the quality management system requirements particular to medical laboratories. The standard was developed by the International Organisation for Standardisations's Technical Committee 212 (ISO/TC 212). ISO/TC 212 assigned ISO 15189 to a working group to prepare the standard based on the details of ISO/IEC 17025:1999 General requirements for the competence of testing and calibration laboratories. This working group included provision of advice to users of the laboratory service, the collection of patient samples, the interpretation of test results, acceptable turnaround times, how testing is to be provided in a medical emergency and the lab's role in the education and training of health care staff.

While the standard is based on ISO/IEC 17025 and ISO 9001, it is a unique document that takes into consideration the specific requirements of the medical environment and the importance of the medical laboratory to patient care.

Benefits of ISO 15189 accreditation :-
Improved national and global reputation and image of the laboratory.
Continually improving data quality and laboratory effectiveness.
Having a basis for most other quality systems related to laboratories, such as Good Laboratory Practices.
Mutual Recognition Agreement (MRA) amongst various countries test report is acceptable without repetition of analysis.
Customer satisfaction is achieved through introduction of Quality Management System which is a part of ISO 15189
All test equipment will be calibrated and traceable to National Standards so that accuracy of results will be ascertained & maintained.
Laboratory will be participating in Inter laboratory Comparison program so that quality level of the lab with respect to other accredited lab can be determined.
Quality control checks will be carried out periodically by which system is always maintained.
National and international recognition (eg CTs)
Meets purchaser or regulatory specifications
Decision makers can rely on test results
Improves staff motivation and esteem
Ensure better support in the event of legal challenge
Saves money by getting it right the first time

How can Sterling International Consulting help to get ISO 15189 for Medical Laboratories?
Sterling International Consulting consists of full-time trainers and consultants having huge experience and exposure in ISO 15189 consulting, implementation and training. Our Team offers a variety of Consulting Services and Solutions. We have clients in more than 30 countries for various certifications like ISO 9001, ISO 14001, OHSAS 18001, HACCP ISO 22000 and ISO 27001. We have proven our mettle in providing the authentic ISO 15189 Certification Services to our clients spreading worldwide. ISO 15189 implementations with the consultants and experts of Sterling International Consulting not only assures 100% successful ISO 15189 certification but also improves process performance and business operations.

Sterling International Consulting partners organizations across the world to implement and achieve ISO 15189 certification. Our consulting approach is highly professional, time bound and effective resulting in ease of implementation and adds value to the business processes of the client organization. We provide ISO 15189 training, consulting, implementation and certification services in India, USA, UK, Saudi Arabia, UAE, Europe and African countries

We have an enviable record of customer satisfaction.

Sterling International Consulting offers comprehensive series that will help you to achieve ISO 15189 certification. We provide assistance to
Comprehensively review organization's existing programs and systems in the food chain (Gap Analysis
Establish policy and objectives.
Identify documentation requirements
Train personnel
Implement new programs such as internal audit and management review.
Help you seek certification for ISO 15189

In addition to consultancy (Online and Onsite), we provide following training :-
ISO 15189 Overview Training
ISO 15189 for the SME
Developing ISO 15189 documentation
ISO 15189 Internal auditor Training

Our Office:-
Sterling International Consulting FZE
Level 6, Office 605 - The Fairmont,
Sheikh Zayed Road, PO BOX 27363,
Dubai, United Arab Emirates
Mobile No.: + 971 505842597
Telephone: + 971 4 455 8677
Fax No. :+ 971 4 455 8556