Although other aspects of controls required by ISO 9001 may be critical, none receives as much attention as subclause 7.5.1--”Control of production and service provision.” Almost every organization must develop processes for delivering services or producing products. Subclause 7.5.1 focuses on the key concept that processes must be carried out under controlled conditions. Considerations for achieving controlled conditions are clearly stated, along with the requirements to determine the extent to which production and service operations are planned, established, documented, verified, and validated.

These considerations begin with understanding the specifications for the product that the processes will produce. The organization must determine the production and service processes that should be controlled and the outputs that must be achieved at each stage of processing.

Also, the organization must consider the equipment necessary to meet the product requirements, including their sequence and operating conditions. In some cases new equipment must be designed or procured.

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