Definition of the term („What is an Installation Qualification?“) The installation qualification (IQ) documents the implementation of the requirements previously specified (e.g. in the design qualification) as part of the setup and…
The ISO 13485 is an ISO norm containing the requirements for a comprehensive management system of the creation of medicinal products. The most recent edition of the norm has been…
ISO 9001:2015 defines general principles and terms relating to quality management. It also defines the minimum quality management requirements that an organisation must meet in order to manufacture products that…
Definition of the term („What does ISO certification mean?“) The ISO certification is a process designed to prove the compliance with certain requirements. For example, ISO 9001 specifies the requirements…