ISO 9001 and ISO 13485 address the concept of Control of Production and Service. In ISO 9001, it states “The organization shall plan and carry out production and service provision under controlled conditions.” ISO 13485 expands on this by saying “The control must be performed and achieved according to the planning requirements specified…”. Essentially, a company needs to understand the product, as well as the processes related to it, and then plan to use appropriate equipment to produce this product. The process must be controlled throughout production.
When considering the controlled conditions, mentioned above, these areas must be evaluated and included:
- Make sure the necessary information is available, describing the process(es) in detail
- There should be work instructions provided, as needed.
- Equipment used must be suitable, and should include a maintenance program
- There needs to be monitoring and measuring equipment available for use (for testing and inspection purposes, as well as for calibration and validation programs)
- Processes should be in place for the release of product, delivery of product, along with post- delivery activities
A common starting point in addressing these requirements is the creation of a Control Plan. The Control Plan can serve as a work instruction, along with providing a training tool. From there, it’s fairly easy to assemble the necessary procedures and to identify the check points for monitoring and measuring.
Processes, once developed and validated, must be periodically re-validated to ensure the results are still acceptable.
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