Curriculum
ISO 15189:2022 for the laboratory director and quality manager [L-01]
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Start here
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Course pre-test
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Part I — Scope and structure of ISO 15189:2022
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Part II — Key management requirements
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Part III — Key technical requirements
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Part IV — Implementation pathway and accreditation
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Course post-test
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Resources
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Capstone & certificate
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Text lesson
Chapter 1 · Scope and structure of ISO 15189:2022
ISO 15189:2022 is the international standard for medical laboratory quality and competence. It covers both management requirements (Clause 8) and technical requirements (Clause 7), plus general requirements (Clause 4), structural and governance requirements (Clause 5), and resource requirements (Clause 6). The 2022 revision aligns more closely with ISO 9001:2015 and introduces explicit requirements for point-of-care testing, impartiality, and risk-based thinking.
Practical example
A new quality manager has just joined the laboratory. Good practice: The laboratory director provides the QM with a copy of ISO 15189:2022, walks through the clause structure, and maps each clause to the laboratory’s existing procedures to identify gaps. Poor practice: The QM is told to ‘read the standard and figure it out’ with no orientation — leading to months of confusion about which clauses apply.
What this means for your practice: ISO 15189 must be owned at the senior level. The laboratory director and QM must both understand the standard, not just the QM. Accreditation assessors will interview the director.