051659 - Ministerstvo obrany

ČOS 051659
1. vydání
Příloha C
Validation
Ensure user training.
Activate the system.
Demonstrate the installed system is capable
of delivering its required services.
Record the installation data, including the
operational configuration, anomalies
detected, actions taken and lessons learned.
Description
Activities
The Validation Process provides objective Prepare a validation plan.
evidence that the services provided by a Ensure that any operators, enabling system
system when in use comply with for validation and associated facilities are
stakeholders’ requirements.
ready in order to conduct validation.
Conduct validation to demonstrate
conformance of services to stakeholder
requirements.
Make available validation data on the
system according to legal, regulatory or
product sector requirements.
As appropriate to agreement terms or
organizational objectives, conduct validation
to isolate that part of the system giving rise
to a non-conformance.
Analyze, record and report validation data
according to criteria defined in the
validation strategy.
Operation
Description
Activities
The purpose of the Operation Process is to Obtain other services related to operation of
use the system in order to deliver its the system.
services.
Assign trained, qualified personnel to be
operators.
Activate the system in its intended
operational situation to deliver instances of
service or continuous service according to
its intended purpose.
Consume materials, as required, to sustain
the services.
Monitor operation to ensure that the system
is operated in accordance with the
operations plans, in a safe manner and
compliant with legislated guidelines
concerning occupational safety and
environmental protection.
Monitor the system operation to confirm that
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