Chapter 2 · Key management requirements

Clause 8 covers: document control, record control, handling nonconformities, corrective action, continual improvement, management review, and internal audit. The quality manager owns these processes. Management review must be conducted at planned intervals and must address performance data, external feedback, risk findings, and improvement actions. Minutes must be documented.

Practical example

The QM is preparing for the annual management review. Good practice: The QM compiles data on QC failures, EQA results, turnaround times, complaints, nonconformities, and corrective actions from the past year. The director chairs the meeting and the outcomes are documented with assigned owners and deadlines. Poor practice: The management review is a 20-minute discussion with no agenda and no minutes — assessors will reject this.

What this means for your practice: Management review is not an administrative box-tick. It is the mechanism by which the laboratory’s leadership takes accountability for quality performance and drives improvement.