Laboratory Staff Training: Formats, CPD and Annual Planning

What training does ISO 15189:2022 expect for laboratory staff?

ISO 15189:2022 expects the laboratory to define the competence needed for each role, train staff to that level, assess their competence before and during independent work, and keep records that prove it. Training alone is not enough: the standard looks for evidence that each person can actually perform the tasks they are authorised to do.

The personnel requirements (clause 6.2 of the 2022 edition) cover:

• Competence requirements for each function, including education, qualifications, training, experience and demonstrated skills.
• Training for the quality management system, the processes a person works in, the laboratory information system, health and safety, ethics and confidentiality.
• Competence assessment using defined criteria, with periodic reassessment and retraining when performance falls short.
• Authorisation of personnel for specific activities, such as selecting methods, reviewing and releasing results, and operating particular equipment.
• Continuing education and professional development, with the effectiveness of the programme reviewed.
• Personnel records showing each of the above.

Assessors from KENAS, SADCAS and other accreditation bodies will sample these records, and SLIPTA auditors look at the same evidence when awarding star ratings. If you are still mapping the wider journey, read our guide to the ISO 15189 accreditation process.

Which laboratory training formats are available, and how do they compare?

There are five common formats for laboratory staff training: in-person cohorts, live online cohorts, in-house delivery at your laboratory, self-paced e-learning and mentorship. Each suits a different need and budget.

How do you choose the right format for your team?

Start with what needs to change: if staff need to know something, use self-paced learning; if they need to do something, use live training; if the whole laboratory needs to work differently, bring the training in-house.

1. Knowledge gaps (for example, what changed in ISO 15189:2022, or the basics of Westgard rules): self-paced material or a short live online session is usually enough.
2. Skills gaps (for example, conducting an internal audit, writing a nonconformity, running an FMEA): choose a live cohort with practical exercises, in person or online.
3. Culture change (for example, staff do not report occurrences, or the QMS lives only in the quality office): train the whole team together in-house, then support it with mentorship.
4. Sustaining change: after any course, use mentorship or internal follow-up so new practice survives the first busy month.

How do you build an annual training plan linked to competence assessment?

An annual training plan starts from your competence requirements and assessment results, not from a list of available courses. Training should close a documented gap, and the next competence assessment should show whether it worked.

1. List roles and required competencies for each, including technical, quality and safety tasks.
2. Review last year’s evidence: competence assessments, internal audit findings, occurrence reports, EQA results and complaints.
3. Identify gaps by person and by team, and decide which are knowledge, skills or culture gaps.
4. Select formats and providers using the decision guide above, and schedule them against the training calendar and your workload.
5. Define how effectiveness will be checked, for example direct observation, a witnessed audit, or a reduction in repeat nonconformities.
6. Record everything in personnel files: attendance, certificates, assessment results and authorisations.
7. Review the plan at management review and adjust it for the next year.

How many CPD points do medical laboratory professionals in Kenya need?

KMLTTB requires practitioners to attain at least 50 CPD points in the previous year, with evidence such as certificates and attendance lists, to renew their annual practice licence. Requirements can change, so check the current rules on the KMLTTB licence renewal page.

Before you book any course, from any provider, ask whether it is approved for CPD points by the board and how many points it carries. Do not assume that a certificate of completion automatically earns CPD points. Practitioners in other countries should check with their own regulator.

For managers, aligning the training plan with CPD needs is efficient: the same course can close a competence gap for the laboratory and contribute to an individual’s professional development record, where approved.

What does a laboratory training budget look like?

A simple budget multiplies the fee per person by the number of staff for each course, then compares that total with in-house delivery and adds mentorship for follow-through. Using Elmenta pricing (USD 350 per 8 hours of training, so USD 1,050 for a 3-day course), an illustrative plan might be:

If your laboratory is building its quality system from the beginning, the five-day Establishing and Maintaining a Laboratory QMS course (USD 1,750) is the better first step for your quality officer, with Lead Implementer to follow.

Travel, accommodation and bench cover are extra for in-person cohorts. If six or more staff need the same course, ask for an in-house quote: every Elmenta course can be delivered for a laboratory team, and the comparison is often worthwhile. Quarterly courses also include the first month of Elmenta Lab Pro mentorship free.

What should you look for in a laboratory training provider?

Look for facilitators with real laboratory and accreditation experience, content mapped to the current standard, practical exercises, and honesty about what the certificate means.

• Current content: courses based on ISO 15189:2022, not the withdrawn 2012 edition.
• Practising facilitators: lead auditors, quality managers and specialty scientists who have worked in accredited laboratories.
• Practical work: case studies, audit simulations and exercises using laboratory documents.
• Clear outcomes: stated learning objectives you can map to your competence requirements.
• Transparent certification: a provider should state whether it issues a certificate of completion, a professional certification or CPD points, and on whose authority.
• Flexible delivery: in person, online and in-house options, so you can match format to need.
• Follow-up support: mentorship or post-course help so learning is applied.

For the broader system that training supports, see our guide to building a laboratory quality management system, and the WHO Laboratory Quality Management System handbook, which treats personnel as one of the 12 quality system essentials.

How can Elmenta help you train your laboratory team?

Elmenta runs every course each quarter in person in Nairobi (consecutive days, 08:00 to 16:00 EAT) and live online (Monday, Wednesday and Friday, 18:00 to 20:00 EAT on Zoom), in cohorts of 5 to 30. Facilitators include ISO 15189 lead auditors, quality managers with CAP accreditation experience and specialty laboratory scientists. Each participant receives a certificate of completion.

Browse all laboratory courses, request in-house training for your laboratory team, or keep progress going with Elmenta Lab Pro mentorship.