ISO 15189 - Medical Laboratory Accreditation

8/19/2019 ISO 15189 - Medical Laboratory Accreditation

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PPT Presentation onISO 15189 Medical

Laboratory Accreditation

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What is ISO 15189?

ISO 15189 standard provided a generic framework for a laboratory quality

management system, essential elements relative to clinical laboratories

were missing. Consequently , the laboratory community approached to

create a standard specifically for the unique requirements of clinical

laboratory practice.

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Purpose of ISO 15189

• Laboratories accredited to ISO 15189 are formally

recognized to be competent, thus providing a ready means for

customers to identify and select medical testing and clinical

analysis services.

• Compliance to ISO 15189 aids the laboratories to determine

whether they are performing their work correctly and to

appropriate standards, and provides them with a benchmark

for maintaining that competence.

• Compliance to ISO 15189 is an effective marketing tool for

medical and clinical laboratories and a passport to submit

tenders to contractors that require independently verified

laboratories.









ISO - 15189: A Two-Part Standard

ISO 15189 International Standard, based upon ISO 17025 and

ISO 9001, provides requirements for competence and quality

that are particular to medical laboratories. While this

International Standard is intended to use throughout

recognized disciplines of medical laboratory services. ISO15189 requirements consist of two parts,

• Management Requirements

• Technical Requirements


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• Management Requirement: This includes the requirements

of all parts of ISO 9001, moreover it includes the requirement

of conformity assessment body, for example, impartiality and

independence from any other party.

• Technical Requirements: This includes the requirements of

laboratory competence (e.g. personnel, facility, instrument,

and examination methods), moreover it requires that

laboratories shall participate proficiency testing(s) and

laboratories’ examination results shall have traceability of

measurements and implement uncertainty of measurement.









Implementation of ISO 15189

• Gaining support for the program from higher management

• Baseline assessment of the laboratories against ISO 15189

standard

• Gap analysis, recommendations for improvement

•

Development of action plan and agreed upon timeline• Formation of a Laboratory Management Committee to

oversee implementation and practice of quality standards

• Training of laboratory staff, laboratory management on ISO

15189 and its implementation

• Support with generic quality documents (management and

technical) and its adaptation into document control system

• Periodic monitoring of the implementation, mentoring and

off site and onsite technical support

• Pre accreditation assessment

•Support in submission of the application for accreditation









Importance of ISO 15189

AccreditationAccreditation to ISO 15189 places five additional critical

criteria on medical laboratories which include:

• Providing advice on the type of sample, and testing that may

be required• Interacting with clinical staff by placing a responsibility on

the laboratory to liaise with clinician who refer patient samples

for testing about the quality of their services.

• Providing on the opinions on results of testing in relation to

diagnosis and patient care

• Collecting samples or if not, providing information on

collection procedures, sample containers and sample volumes;

and

• Ethical practice – first duty is to the patient, not to the

‘customer’.









Features of ISO 15189

• Streamlined process for committee reviews

• Visualized flowcharts of document approvals

• Control of document creation and templates

• Automatic notifications of new/revised documents

•

Advanced search capability• Record of user review

• Administrator dashboard with upcoming document reviews

• Automatic versioning and archival of documents

• Regulatory alerts









Conclusion

Implementation ISO 15189 standards improved the overall

quality of laboratories, not only for tests under the scope of

accreditation, but all tests performed in the laboratory.

Furthermore, accreditation has spurred an interest in other

laboratories to improve their quality. With adequate resourcesand support from management, ISO 15189 compliance is an

achievable and sustainable goal for medical laboratories in

developing countries, where national standards might not be

developed.









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Documents

ISO 15189 - Medical Laboratory Accreditation