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ISO 15189 CERTIFICATION

ISO 15189 Certification

IAS is one of the best ISO Certification Body in Iraq. The ISO 15189 certification is highly recommended for all types of organizations in Iraq, irrespective of size & category. The International Standard Organization (ISO) 15189 Certification has raised new excitement among laboratory professionals. On one hand, ISO 15189 satisfies the desire to undertake a pathway addressing the high degree of quality of laboratory performance measured according to the important role of Laboratory Medicine throughout patient care. 

ISO 15189 certification in Iraq by IAS ensures that the current strategy of your organization meets the minimum requirements of the international standards and ensures that it is capable of effectively enhance the constant productivity of your business. Meeting the requirements of ISO 15189:2012 standard will provide a system that will be of real-time benefit to your organization to help and manage your business effectively and put best-practice methodologies.

Optimizing Quality Management with ISO 15189 certification:

Clinical laboratories were using other International Standards for certification before the introduction of ISO 15189. The last revision of the ISO 15189, issued in 2015, impresses an assessment of service effectiveness. 

The uniqueness of the ISO 15189 is tailor-made to implement in medical laboratories. This Standard requires the implementation of criteria and procedures to assure appropriateness of how laboratory guarantees its effective contribution to result in interpretation, among different physicians. 

Beyond medical skills, the competence of all the different professionals working in the laboratory has to be established. The calibration and verification of pipettes, the procedures for instrument maintenance or validation of Internal Quality Control are examples of practical activities where technicians’ competence verified according to ISO 15189.

The process to get ISO certificate is as follows:

  • Provide us your business information, our executive will visit your premises
  • Our executive will assess your business activity & will provide you quote.
  • You need to sign a certification agreement (application Form) & pay certification fees
  •               The process of ISO certification has 2 stages
                   Stage 1: Readiness Audit
                   Stage 2: Effectiveness Audit
  • If your organization clears, the audit without any Nc’s an ISO 15189:2012 certificate will be awarded to your organization (or) the Effective Closure of the identified nonconformity (s), the Certificate will be awarded.
  • A yearly surveillance audit will be conducted Followed by the next 2 years of certificate validity.
  • Advantages of ISO 15189 Certification:
  • Minimizes process errors, Communication improvement

  • Improved quality products and services

  • Standards maintained by annual/Periodic assessments and continual improvement.

Benefits of ISO 15189 Certification:

  •  ISO 15189 Certification is the gateway to the effective implementation and use of the quality management system.These standards range from the basic ISO 15189 to ISO 15189–Medical Laboratories ISO 13485 Medical Devices and ISO 17025–Competence of Testing and Calibration Laboratories.
  • ISO 15189 -Quality management system requirement is specific to medical laboratories requirements. Clinical laboratories have many benefits by achieving compliance with ISO 15189 Certification. 
  • ISO 15189 Certification reduces risks, encourages the sharing of best practices and stimulates innovation with systematic implementation. For payers and healthcare providers, a Certification is a tool that assures that clinical lab services are a safe, reliable and good value for patients. It also provides a mechanism for measuring quality improvements and supporting consistency.
  • For patients, accreditation gives confidence that the services they receive are competent and safe, which can be a significant selling point for a medical laboratory.

Benefits of ISO 15189 to your customers:

One of the main benefits of ISO 15189 accreditation is that it is globally recognized laboratory certification to ISO 15189 will have their certificates and test reports accepted in over 80 different economies across the world, representing 95% of global GDP.