A quality system is only as strong as the people running it
Accreditation depends on staff who understand why the quality system exists, not just which forms to fill in. This programme takes your team through laboratory QMS principles and the requirements of ISO 15189:2022, then into the day-to-day work that keeps a quality system alive: controlling documents, managing nonconformities, auditing and acting on risk.
It is designed for quality officers, laboratory managers and scientists who need to build a quality management framework from scratch, or bring an existing one up to the 2022 edition of the standard.
Training is delivered in-house at our Nairobi training facility, live online, or on-site at your laboratory, where exercises can draw on your own documents and workflows.
What the training covers
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ISO 15189:2022 implementation training
The structure and requirements of the standard, what changed in the 2022 edition, and how each clause translates into laboratory practice.
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Internal auditor certification
Planning and conducting internal audits, writing clear findings, and following them through to closure.
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Document control and records management
Setting up a controlled document system: numbering, review and approval, distribution, and retention of records.
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Non-conformance and CAPA management
Recording nonconformities, finding the root cause, and corrective and preventive action that holds.
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Risk-based thinking workshops
Identifying and assessing risks to quality and patient safety, and building controls into routine work.
What you receive
Internal auditor certification
Participants who complete the internal auditor module are certified to take part in your laboratory's internal audit programme.
Training records
Attendance and completion records for each participant, ready to file as evidence of staff training and competency.
Course materials
Reference notes and working templates for document control, nonconformity records and internal audits.
Practical exercises
Case-based exercises drawn from laboratory scenarios, or from your own documents when training runs on-site.
Common questions
Who should attend?
Quality officers and quality managers, laboratory managers, and scientists who are taking on quality or internal audit responsibilities. No prior ISO 15189 experience is needed.
Can the training be run at our laboratory?
Yes. Alongside in-house training in Nairobi and live online sessions, our trainers can deliver the programme on-site at your facility, using your own documents and processes in the exercises.
Is this the same as the online QMS certification?
No. This is instructor-led training. The self-paced Laboratory QMS fundamentals certification is a separate programme, listed with our online certification programmes on the Training page.
Can the content be tailored?
Yes. For hospital groups, government laboratories and academic institutions we design custom programmes around your scope, your equipment and your team.