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ISO 15189 Accreditation Services

ISO 15189 Accreditation Services
ISO 15189 Accreditation Services
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Product Code : 02
Brand Name : Samarth Consultants
Price And Quantity
  • Minimum Order Quantity
  • 1 Unit
  • Price
  • 2 lakh INR/Unit
Product Description
What is ISO 15189:2012?

ISO 15189 dictates the requirements for quality, competence and abilities in medical laboratories.

It governs the quality management systems in these medical laboratories. Laboratory customers, regulating authorities and accreditation bodies also use this certification to determine, confirm or recognize the competence of medical laboratories.

ISO 15189:2012 Certification Overview

A country could have specific regulations and requirements that apply to some or all of the professional personnel and their activities in the medical laboratories.

We provide the following benefits with the ISO 15189:2012 certifications:

  • Improvement in the national and global reputation and image of the laboratory.
  • Continually improving data quality and laboratory effectiveness.
  • A predefined basis for all the major quality systems, related to the laboratories, such as Good Laboratory Practices.
  • Mutual Recognition Agreement (MRA) in several different countries where test report is acceptable without repetition of analysis.
  • Customer satisfaction is achieved through the introduction of a Quality Management System which is a part of ISO 15189.

During ISO 15189 Certification Consulting we provide:

  1. Awareness training to the laboratory personnel.
  2. A gap analysis of the existing systems of the laboratory.
  3. Process mapping and process definition.
  4. Documentation including manuals, procedures, work instructions, test instructions, checklists, formats etc.
  5. Step by step assistance in proficiency testing, inter-laboratory comparison and measurement of uncertainty.
  6. Assistance in documentation implementation.
  7. Internal auditor training and conduct of internal audit.
  8. Pre-assessment audit and pre-certification audit.
  9. Assistance during the entire phase of accreditation audit.
  10. Post-certification assistance in system maintenance.

We Provide the Following Services Corresponding to the ISO 15189 Accreditation:

  1. Consulting
  2. Training
  3. Implementation
  4. Certification

Options of Accreditation Available:

  1. NABCB
  2. UKAS
  3. DAKKS
  4. DAC
  5. JAZ ANZ
  6. IAS
  7. EGAC


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