ISO 15189:2012 Medical Laboratories

ISO 15189:2012 Medical Laboratories

ISO 15189:2012 specifies requirements for quality and competence in medical laboratories.
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.
General requirements for the competence of testing and calibration laboratories

What is ISO 15189:2012?

ISO 15189 is important for medical laboratories because it is a globally recognised accreditation that will allow the organisation to ensure the reliability, competence, integrity, and overall quality of your laboratories practices. It is crucial to the perception of your entire organisation as trustworthy, credible, and competent to your customers or business partners.

Benefits of ISO 15189 accreditation?

There are many key benefits of meeting ISO 15189 accreditation standards. Important benefits include:

  • By meeting ISO 15189 standards, you will be compliant with the relevant legal requirements to your sector.
  • It is internationally recognised, meaning institutions around the world will be reassured of the quality of your practices – the International Laboratory Accreditation Cooperation (ILAC) endorsement of ISO accreditation
  • Demonstrating you meet this common, strict prerequisite for many tender application processes and healthcare insurance programs.
  • To meet the increasing demand for producing data that is globally consistent.
  • You can gain an advantage over competitors who do not hold ISO 15189 certification.
  • Increasing your chances of achieving preferred supplier/partner status with new or existing customers.
  • Saving money by implementing more efficient practices and avoiding costly mistakes.
  • Greater process effectiveness and efficiency by removing duplication of tasks.
  • Proactive risk management of the risks inherent in medical testing laboratories.
  • Effective document control and control of records.
  • You can demonstrate a commitment to protecting data
  • Proactive continual process improvement, driving process KPIs

QMS Solutions services

We provide full systems support at all stages of development. Services include:

  • Completion of an initial assessment and gap analysis
  • The preparation of all required systems documentation Note: systems requirements may be addressed via digital / automated
  • Training and mentoring throughout systems development
  • Completion of internal audit as a pre-requisite to certification
  • Support with the completion of the annual management review as a pre-requisite to certification
  • ISO 13131:2021 provides guidelines for quality objectives and procedures for each domain. Organizations can apply the quality and risk management processes as part of management planning to develop quality objectives and procedures appropriate to the telehealth services they provide.

Steps to Certification

QMS Solutions will complete the application for certification and liaise with the certification body to ensure a successful outcome.