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ISO 15189 Certification

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The quality management system requirements related to laboratories are laid forth in ISO 15189 Certification Requirements for Quality and Competence. In 2012, the improved version—which cancelled and replaced the 2007 release of the earlier version—was made available. The standard was developed by ISO/TC 212, an ISO technical body. They assigned the working group ISO 15189 the duty of creating the norm based on ISO/IEC 17025:1999. (General specifications for testing and calibration laboratories’ proficiency.) At all levels of the healthcare system, the standard specifies stringent quality management criteria for laboratories. The goals of the standard for lab operations include assuring the accuracy and traceability of patient data, maintaining the integrity and safety of lab supplies, keeping an eye on the facility’s environmental conditions, and assisting the public.

health-related choices.

The fact that this International Standard ISO 15189 addresses both administrative and technical requirements for determining people’s competence makes it the gold standard for certifying medical laboratories. Thus, ISO 15189 Services guarantees that the laboratory has been evaluated in accordance with globally acknowledged standards intended to enhance the existence of a quality system, and technical competence, and that the staff is actually capable of producing technically sound results and pertinent data for each test’s intended use.


With these simple steps, acquiring ISO 15189 is now a piece of the cake.

  • Find out more about ISO 15189.
  • To learn about your shortcomings, conduct a gap analysis.
  • Plan your idea to get around any obstacles.
  • Inform your team and workers about the standard.
  • QMS Manual
  • Processes and Procedures for QMS
  • Advice for Test Methods Data for each test parameter’s estimated z-score, inter-lab comparisons, and validation
  • Guidance for measuring uncertainty values for each test parameter during computation
  • Instructions for performing a risk/opportunity evaluation.
  • Guidance and performance during internal audits, as well as internal audit training.
  • A Certifying Body External Audit.

 Getting an accreditation certificate.

Instant Business Growth

Both small and large organizations can utilize this


More effective internal management

Reduced waste

A rise in production, efficiency, and profit

Reduces errors

Increased service and product quality

Improved delivery and production schedule
Annual evaluations uphold standards.
Benefits of ISO 15189 Certification
  • The laboratory’s national and international reputation has benefited from ISO 15189.
  • Services for ISO 15189 Certification guarantee ongoing improvements in data quality and lab efficiency.
  • It is ensured that test reports are acceptable with repeated analysis by having a foundation for the majority of other quality systems connected to laboratories, such as the Good Laboratory Practices (GLP) Mutual Recognition Agreement (MRA) among various countries.
  • Customer satisfaction is attained by the implementation of ISO 15189 The correctness of the results shall be guaranteed and maintained by the calibration and traceability of all test equipment to National Standards.
  • To compare its quality to that of other accredited laboratories, the laboratory will take part in an interlaboratory comparison program.
  • ISO 15189 Certification that frequent quality control checks will be done to make sure the system is always in excellent condition.


Cost of ISO 15189 Certification

Obviously, the reaction is that it depends. It is important to consider the expense of fostering an ISO 45001 Specialist, the expense of the administration framework, the expense of norms, the expense of guidance, the expense of selecting experts, and the expense, of everything being equal. A more modest business might make a particular instalment, while a bigger business might spend fundamentally more.

Our Advice

An internationally recognized consultancy that offers common Certifications is B2BCert. Ascent has qualified people with more than 10 years of expertise who can assist with your company’s standard application. At B2BCert, we offer instruction and a thorough understanding of the application of the ISO 15189 standard and its significance. We at B2BCert are qualified and competent in the following areas:

  1. understanding of documentation needs
  2. understanding of regulatory obligations
  3. understanding of test method documentation
  4. understanding of test method validation

Assuming that you are considering how to get ISO 15189 Certification. If it’s not too much trouble, contact B2BCERT, a main worldwide organization giving interviews, confirmation, reviews, and other related help all over the globe. You can undoubtedly arrive at B2BCERT by just visiting where you can talk with a specialist or you can likewise compose an inquiry to so one of our masters will reach you at the earliest to give the most ideal arrangement on the lookout.

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