Planning product realization

The organization shall plan and develop the processes required for product realization. Such planning must be consistent with both customer requirements and QMS requirements, thus including:

• quality objectives and requirements for the product.

  in the case of repair of instrumentation the service request shall include information on technical requirements, such as...

  expected performance of the instrument after repair. description of instrument operation/actuators. special requirements for operation (if any). results expected for which date.

  
  
• the need to establish processes, documents and resource provision.

  you may take into account the following issues:

  is there previous experience on similar task? plan of actions to perform the repair. search/procurement of technical documentation. availability of spare parts/alternative replacements. instrumentation for performance evaluation available?

  
  
• required verification, validation, monitoring, inspection and test activities specific to the product and the criteria for product acceptance.
  
  
• records needed to provide evidences that processes and the resulting product meet the requirements.

  examples of records:

  service request. modifications to original request/plan of actions. results of internal quality control check. copy of delivered report of results/ customer acceptance.