ISO 15189 2022 have undergone major changes
Major changes of ISO 15189 2022 .
ISO 15189 2022 published on December 2022 and undergone major changesThere were two key reasons for the review. Firstly, because the parent standard – ISO/IEC 17025:2017 – had been updated to comply with the structure of the normative ISO 9001:2015, and secondly, as ISO/IEC 17025:2017 is a normative reference of ISO 15189, there was a requirement for the documents to be aligned. Also ISO 15189:2012 had reached its periodic review date.
The standard theme is the existing requirement of the standard are largely unchanged. Meaning that most (not all) the existing requirement is remain valid. The 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Quality Manager is withdrawn new Quality management is introduced.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 is rewritten, sentences and word omitted to maintain flexibility , added some more wording and reorganized.
- Standard created for more learning and implementation opportunity by referring companion standard
- Instead of comparing with ISO15189:2012, read the standard as new and understand the gap and implement the same
ISO 15189:2012
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.
Definition of Medical laboratory – Laboratory for the biological, microbiological, immunological, chemical, immunohaematological, hematological, biophysical, cytological, pathological or other examination of materials derived from the human body for the purpose of providing information for the diagnosis, prevention and treatment of disease in, or assessment of the health of, human beings, and which may provide a consultant advisory service covering all aspects of laboratory investigations including interpretations of results and advice on further appropriate investigations.
The following are the basic requirements for ISO 15189 certification/accreditation:
- A well documented procedure analysis by the laboratories.
- Training manual provided by the laboratories.
- ISO 15189 requires an effective detailed analysis of medical laboratory procedures in a bid to make sure that all weaknesses have been identified.
- Detailed evaluation reports of the existing quality management system as well as other monitoring and evaluation reports.
- A detail audit of management reviews.
The ISO 15189 certification has a set of unique benefits and the main objective of certification is quality assurance.
The benefits are listed here below:
- An ISO 15189 certification promotes development of an international reputable image for your organization through Quality Assurance and Management Systems.
- Promotes a strong degree of consistency in compliance to medical laboratory laws and legislation both from an international and national perspective.
- Fundamentally critical in promoting laboratory efficiency and responsibility for better results and service delivery.
- The certification program also has been very critical in promoting modern laboratory practices that include professionalism and expertise in conduction of medical activities in the labs.
- Ultimately, promote the growth of customer satisfaction in organizations involved in medical laboratory testing.
- Accreditation ensures technical competence of the laboratory.
- Insurance, corporate customer, clinician and patient get confidence on the test results issued by the Accreditation Body.
Medical Laboratory accreditation (ISO 15189)
Accreditation Body provides accreditation to the internationally recognised standard ISO 15189:2012 Medical Laboratories – requirements for quality and competence.
Accreditation covers the following disciplines:
- Clinical Biochemistry – Toxicology – Endocrinology
- Haematology – Blood Transfusion
- Microbiology – Virology – Parasitology – Serology – Mycology
- Histopathology – Cytology – Mortuaries/ Anatomic pathology
- Immunology
- Genetics/Molecular biology
- Andrology
- Clinical pathology
Who can provide Accreditation:
List of Accreditation Body can be checked from ILAC Website www.ilac.org