This is the last clause of the standard. It states the remaining requirements for a quality management system meant to be applied for medical devices suppliers and manufacturers. The Clause - 8 is divided into five sub-clauses:
General (Clause - 8.1)
Monitoring and measurement (Clause - 8.2)
(Clause - 8.3) Control of nonconforming product
(Clause - 8.4) Analysis of data
(Clause - 8.5) Improvement
General (Clause - 8.1)
This clause is about planning requirements about measurement analysis and improvement.

Plan processes related to monitoring, measurement, and analysis.
Plan how monitoring methods will be utilized to confirm conformity and effectiveness.
Plan how measurement will be utilized to ascertain conformity and effectiveness.
Plan how analytics will be utilized to make sure conformity and effectiveness.

(Continued...)