Assessor Training: Medical Laboratories (ISO/IEC 15189:2007)
This 3-day residential course aims to provide an understanding of ISO/IEC 15189:2007 and training in the assessment of its application for the accreditation of medical laboratories.
What are the benefits?
The course will enable delegates to gain knowledge of the particular requirements for quality and competence for medical laboratories, as defined in ISO/IEC 15189:2007 and used as the criteria for accreditation, and to gain a practical understanding of the assessment methodology used by a National Accreditation Body through lectures, exercises and role play.
Who Should Attend?
The course is for those without previous laboratory assessment experience who expect to become involved in the assessment of medical laboratories using ISO/IEC 15189:2007 as a basis for accreditation. The training is designed to meet the needs of the assessment staff of a National Accreditation Body, but the course is also likely to be of benefit to senior laboratory staff.
Course content
Day 1
- Introduction and briefing
- Background to accreditation, UKAS and the international scene
- Holistic Approach to assessment and accreditation
- Open Feedback and discussions on pre-course work
- Overview of the process of accreditation
- Case Studies - identification of possible non conforming situations with report back
- Interpretations and Clinical Advice
- Flexible Scopes
- Accreditation standards
Day 2
- Quality Management system documentation and documentation review
- Initial documentation review exercise, including an assessment of documentation against the requirements of the standard with report back
- Method of reporting findings from pre-assessment activities
- Exercise – detailed documentation review of a test procedure– group work with report back
- Purpose of the introductory meeting
- Observing the organisation at work – management of an assessment visit
- Recording findings
- Preventive and corrective action
- Witnessing a test for the purposes of an assessment including an exercise on recording associated findings.
Day 3
- Report back on recording findings exercise
- Calibration and traceability
- Calibration exercise – review of information included on a certificate, followed by report back
- Internal audit and management system review - assessing an organisation’s internal audit system and the management review - benefits to the assessment
- Private meeting of assessors and final meeting – format, structure and purpose
- Exercise - preparation for final meeting
- Exercise - final meeting role-play
- Discussion and feedback
- Post assessment activities
- Open forum and close course
A pre-course exercise must be completed prior to attending.
When |
Where |
Fee |
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15-17 November 2011
11-13 June 2012
6-8 November 2012 |
2012 courses will be held at
Sunningdale Park, Ascot, Berkshire |
Residential Course fee £1350 + VAT.
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Residential Course Fee: £1350 .00 + vat.Fee includes comprehensive course materials and refreshments. Also included is accommodation for two nights, breakfast and dinner on the two days and lunch on each day of the course.or
Book online or download the booking form