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ISO 15189:2012 Medical laboratories — Particular requirements for quality and competence

Author: John Mills
by John Mills
Posted: Feb 09, 2021
iso 15189

ISO 15189 was originally published in 2003, but revised in 2007 to better reflect ISO 17025 to a greater extent it went through a further round of changes in 2012 to include a new department on laboratory information management, and has since remained the same.

ISO 15189 applies to medical field businesses that rely on taking criteria, conducting regular experiments, and evaluating scientific results related to their or other organizations' operations. It is also worth considering whether your company is involved in the design, manufacture, or sale of products to medical companies, as the standard demonstrates credibility in a highly regulatory industry.

ISO 15189 Medical Laboratories - Special requirements for quality and competency include special quality management system requirements for medical laboratories. The standard was developed by standardization by an international organization. ISO 15189:2012 can be used by medical laboratories in developing their quality management systems and assessing their own competence. It can also be used for confirming or recognizing the competence of medical laboratories by laboratory customers, regulating authorities and accreditation bodies.

The ISO 15189 Documentation requirements are following, which can accelerate the documentation, process for ISO 15189 accreditation.

  • Sample ISO 15189 Manual
  • Mandatory Procedures
  • Standard Operating Procedures
  • Exhibits
  • ISO 15189 Audit Checklist

The Biggest advantage of an organization gets out of ISO 15189 QMS is improvement in business process control through process standardization. No matter what benefits you are looking for with ISO 15189 certification, we will ensure that your organization benefits from ISO 15189 implementation and certification. Now a days, many ready-to-use ISO 15189 documents for medical laboratories as well we covid-19 testing laboratories are available online. It saves a lot of time and cost in document preparation. It gives value for money to customers and the number of payback is very low.

Benefits of ISO 15189 accreditation:-

  • Enhance national and global reputation and image of the laboratory.
  • Continually Enhance data quality and laboratory effectiveness.
  • Having a basis for most other quality systems Connected to laboratories, such as good Laboratory Practices.
  • Customer satisfaction is reached through introduction of Quality Management System which is a part of ISO 15189.
  • All test equipment will be calibrated and be 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 labs can be determined.
Quality control checks will be carried out periodically by which system is always maintained.

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Author: John Mills

John Mills

Member since: Aug 30, 2013
Published articles: 42

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