An FPC system conforming with the requirements of ISO 9001, and made product-specific to the requirements of this International Standard, shall be considered to satisfy the above requirements.
The results of inspections, tests or assessments requiring action shall be recorded, as shall, any action was taken. The action to be taken when control values or criteria are not met shall be recorded and retained for the period specified in the manufacturer’s PFC procedures.
The responsibility, authority and relationship between personnel that manages, performs or verifies work affecting product conformity shall be defined. This applies in particular to personnel that needs to initiate actions preventing product non-conformities from occurring, actions in case of non-conformities and to identify and register product conformity problems.
All measuring and testing equipment shall be calibrated or verified and regularly inspected according to documented procedures, frequencies, and criteria.
All equipment used in the manufacturing process shall be regularly inspected and maintained to ensure that use, wear or failure does not cause inconsistency in the manufacturing process.
Inspections and maintenance shall be carried out and recorded in accordance with the manufacturer’s written procedures and the records retained for the period defined in the manufacturer’s FPC procedures.
The factory production control system shall document the various stages in the design of the products, identify the checking procedure and those individuals responsible for all stages of design.
During the design process itself, a record shall be kept of all checks, their results, and any corrective actions were taken. This record shall be sufficiently detailed and accurate to demonstrate that all stages of the design phase and all checks have been carried out satisfactorily.
The specification of all incoming raw materials shall be documented, as shall the inspection scheme for ensuring their conformity.
The manufacturer shall plan and carry out production under controlled condition.
The manufacturer shall establish procedures to ensure that the production tolerances allow for the product performances to be in conformity with the declared values derived from initial type testing.
The characteristics and the means of verification are given in the following table.