Course Overview

ISO 15189 2012 have undergone major changes.ISO 151892012 had gone through a thorough review done by the international technical committee member and new ISO 15189 2022 published in the month of December 2022. The new standard is available in ISO webstore. There had been two primary reasons for which this review has been done by the community over the years. Firstly, it took place because the actual standard which is ISO/IEC 17025:2017 – had gone through a significant change. It had been done to obey the structure of the standardizing ISO 9001:2015. Secondly, ISO/IEC 17025:2017 is a standard reference of ISO 15189.However, there was a need to make the documents aligned to each other. In addition to this, ISO 15189:2012 had already reached its assigned review date. Therefore, a review had been inevitable. Despite the detailed review of the documents, the reviewers decided to remain close to the standard theme of the documents. The content is mostly unchanged to protect its facts. The meaning of the content is mostly valid even though it has been through a thorough review process. The standard document is written in the similar line with ISO 9001 2015 and ISO/IEC 17025 2017The standard contain minimum requirement of quality and competence and services are encouraged to view this as such that continues improvement should always be sought. The standard is written in line with ISO 9001 2015 and ISO/IEC 17025 2017 New ISO 15189: 2022 is risk based, patient focused and encourages continuous improvement in medical laboratories. Quality Manager is withdrawn new Quality management is introduced. Quality Manual is now optional not recommended by the standard.
  • ISO 15189 2012 content had been rewritten. Some sentences and words had been omitted to maintain flexibility of the document. In addition, some words are added for the fluidity of content.
  • This standard had been developed for better learning and higher implementation opportunities.
  • It is wise to read the standard as a new document instead of comparing it with ISO15189:2012.
Institute of Applied Quality Management, IAQM organize Training on Revised ISO 15189 2022 standard with major changes. This training is online, physical in house customized training is also organized Learn from the well-known faculties including Dr. Sambhu Chakraborty is an international repute faculty Dr. Chakraborty was Selected by Indian Council of Medical Research (ICMR) in their Advisory and Drafting committee for preparation of Nations’ 1st Guideline Good Clinical Laboratory Practice (GCLP). He uses a plethora of case studies to teach the students. Course materials also covered huge medical case studies.

Why people should attend:

  •  They will be able tolearn about major changes between ISO151898:2022 and ISO 15189:2012
  •  It helps them to know the transition process
  •  They will come to know thenew requirement of ISO 15189 2022 clause wise
  •  It explains the Documentation and implementation requirement
  •  They will come to know the test report validation process
  •  It explains the quality control requirement process
  •  It includes Laboratory risk management process
  •  They will be able to know the audit requirement

Who should attend:

  • The Medical Laboratory professionals
  • The quality professionals
  • The Bio chemists and the pathologists
  • The Laboratory Quality Managers

Course objectives:

  • To train students to be prepared for the new challenges of ISO 15189 2022 requirements
  • To teach students to implement reviewed new standard in the laboratory
  • To update students about quality and accreditation process.
  • To offer training as an Internal Auditor

Course coverage:

  • ISO15189 2022 requirements for medical laboratory accreditation
  • Major changes highlight between ISO 15189 2022 and ISO 15189: 2012
  • Major documentation and implementation requirements
  • Internal audit principle and practices
  • Internal audit documentation
  • Internal Nonconformance writing
  • Internal audit summary report preparation

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