Document Control in Processs-Oriented Environments

Process-oriented document management is primarily about structuring and controlling company processes and production workflows. Suitable documentation and the transparent visualization of processes, responsibilities, targets, and risks directly assist companies on their way to successful business conduct. However, as is so often the case in quality management, it is equally as much about fulfilling the requirements of standards and regulations.

Controlling Documented Information

According to chapter 7.5.1 of ISO 9001:2015, an organization’s quality management system shall contain not only the documented information required by ISO 9001, but also the information that the organization has determined to be necessary for the effectiveness of the QM system. The standard also contains numerous requirements regarding updating, control, and archiving of documents. When, for example, creating and updating documents, the organization must ensure that appropriate marking and formatting as well as appropriate review and approval with regard to suitability and appropriateness are ensured. This means ensuring that documented information is always available where it is needed and adequately protected.

The organisation shall then consider the following activities during the subsequent control processes:

  • Distribution, access, retrieval, and use of documents
  • Filing/storage and preservation, including preservation of legibility
  • Monitoring changes (version control)
  • Storage and future whereabouts

Requirements for Processes in ISO 9001:2015

Similar requirements also apply to the topic of process management. Chapter 4.4 "Quality management system and its processes" of the ISO 9001:2015 standard, for example, sets out corresponding requirements for processes in the company. It states, among other things, that

  • Inputs
  • Results (output)
  • Correlations
  • Resources
  • Responsibilities
  • Risks
  • Opportunities
  • Measurability

must be determined for processes relevant to the company. Due to the high significance of documented information in the ISO 9001 the topics of document management, process management, and the handling of process-related information in the context of the QM-system all become elementary components of a modern CAQ system.

Process-Oriented Document Control

The combination of the QBD.Net document management system and the Process.Net Process Management Software puts a variety of powerful document control and process visualization functions at your disposal. Applying Process.Net and QBD.Net in tandem allows you to set the tracks for efficient and effective product and process documentation right from the product development process onwards. All of this means that you can always provide sound and verifiable information with respect to your entire product and process history and can create a dynamic and continuous improvement process which benefits everyone from the individual employee to the overall company.

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