Quality Assurance

The purpose of the Quality Assurance function is to verify that our high quality demands are maintained. The following activities are important factors in this process.

Risk management

A risk assessment has been performed to determine how the processes affect the quality of the products. This process includes indentification of risks, risk assessment, evaluation of risks, control of risks and the output of the risk management. Risk management is a continuous process and the assessment is updated regularly, especially if changes are made to the processes.

Corrective and Preventive Actions (CAPA)

ISO 13485 requires that we maintain the effect of the processes, to keep a consistent quality of our products. To maintain a consistent quality it is sometimes necessary to improve our system. Improvements can be both corrections of discrepancies and preventive steps to avoid the appearance of discrepancies. A CAPA is initiated to document the investigation regarding a suggestion for improvement or a discrepancy where the cause could not be immediately established.

Observations and handling of discrepancies

Observation reports are used in order to document suggestions for improvement and different unforeseen events, as for example working environment insufficiencies or deviations during manufacture. If the observation report regards a discrepancy, i.e. a deviation from internal routines, specification or deficiencies in the quality system, it is immediately reported to QA after reviewed by the department manager. If the case needs further investigation a CAPA is initiated.

Change control

All kind of changes or alterations within the quality system are controlled by certain routines. A "Change request" has to be approved by the process-owner, the production- and marketing manager together with the QA manager before it is introduced into the system. Before a change is approved an evaluation of the impact on the risk assessment is performed.

Validation

Validation is a manner in which we institute documented evidence that most likely confirm that a particular process consequently will generate products that meet certain specifications. In cases where the quality cannot be covered by verification, the production process is validated.

Internal and External Audits

Audits are performed in order to confirm that activities within the different processes correspond to internal and external demands, as well as to investigate the efficiency and suitability of the Quality Management System. During an internal audit, it is verified that the company policy is implemented throughout the entire organization.