This 3 day course aims to provide an understanding of ISO 15189: 2012 and training in the assessment of its application for the accreditation of medical laboratories. A copy of BS EN ISO 15189:2012 can be purchased and downloaded from the BSI Shop.
This highly practical and interactive 1-day course is designed to provide learners within the healthcare sector with the skills and knowledge to develop their organisational processes in line with the requirements of ISO 22870:2016, ensuring that they have sound mechanisms in place to consistently deliver technically valid services and examination results to their patients.
This course has been developed to support ISO 15189 accredited customers wishing to extend their scope to include ISO 22870 Point-of-care Testing (PoCT).
Copies of BS EN ISO 15189:2012 and 22870:2016 can be purchased from the BSI Shop.
By the end of this course, delegates will have:
- the knowledge and skills to structure your quality management system, define the organisational structure and document appropriate responsibilities.
- an increased awareness of the supplementary requirements of 22870:2016 in addition to those of 15189:2012.
- key knowledge of the concepts for identifying critical aspects of your own service, ensuring effective review to assist in conformance with ISO 22870.
- the skills and knowledge to undertake a structured preparation for UKAS application and assessment for ISO 22870 PoCT.
- Framework for service delivery
- Background on healthcare standard supplementary requirements
- Effective organisational structure to meet 22870:2016 including legal entity
- Pre-examination process design
- Operators and collection, sample booking and retention
- Criticality of equipment, reagents and consumables
- Remote procurement and management of stock, acceptance testing and records
- Remote selection, assurance of static and mobile equipment, ongoing evaluation and monitoring, responsive recall
- Fitness for purpose of Examination
- Implementation, qualification and verification
- Uncertainty of measurement on reference ranges and generated results
- Comparability of equipment across service
- Defining key responsibilities including coordinators, qualifications, competence and confidentiality in these settings
- Validity of results
- Internal Quality control; design, assurance, fail-safes
- External quality assurance; rationale and plan to meet normative documents
- Post-Examination & reporting
- Abnormal results. traceability and IT systems
Who should attend
This course is designed for any individuals responsible for, or involved in, the management of services, quality support and/or technical delivery of activities relating to PoCT healthcare providers such as Medical laboratories, ward-based testing, primary care testing and periphery locations (e.g. Pharmacies) in the following roles:
- Service/Organisation Managers
- PoCT Technical or Operational Managers, Leads and Coordinators
- Quality managers, Coordinators and Officers
Meet the trainers
This course is delivered by:
Having joined UKAS in 20 a 07, Darren ishighly experienced Assessment Manager and Lead Assessor of medical laboratories. Darren has an expert knowledge of the requirements of ISO 15189 and ISO 17043 and how they are interpreted by UKAS. Darren holds a BSc in Microbiology and an MSc in Quality Management and Improvement.
Dates and locations
|26 January 2021 - 29 January 2021||Virtual Training Course|