Professional Documents
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Technology
1. Propagate quality responsibilities
5. Standardise procedures
Standardisation is vital in
ensuring the reproducibility and
repeatability of performance
specifications. It provides a
common ground and baseline
template on how a certain
process should be executed to
achieve an acceptable outcome.
The CQO must ensure that processes (especially process changes) have
been analysed and verified before they are standardised. Standardisation
serves as an important tool to harmonise multi-site QMS framework,
specify requirements clearly, and to assess process differences at subcontractor locations as well as their related risks.
Continuous improvement is
part of the medical device
QMS obligation. The CQO
must be able to map out
product continuous
improvement plans and
priorities based on data
obtained from various
sources such as risk
management and complaints investigation. He or she is responsible for