The Impact of Software on ISO 9001

ISO 9001 software codeHistorically, one of the most common criticisms of ISO 9001 and barriers to its adoption has been its stringent documentation requirements. These are, admittedly, formidable. Yet the widespread use of software, specifically developed to manage documentation and other aspects of a Quality Management System (QMS), has largely put these concerns to rest.

The early days of ISO 9000 implementation generated stacks of three-ring binders filled with hard copies of QMS manuals. Master copies were likely stored electronically in directories and files that emulated a physical filing system. Any time a portion of the documentation was updated, fresh hard copies of the affected documents had to be distributed to replace the now-outdated sheets. As a result, changes were labor-intensive and presented multiple opportunities for human error.

The greatest impact of QMS software on ISO 9001 implementation has thus been document control. QMS software is, in essence, a database or electronic repository for an organization’s documents and records. With this database in place, the software can then perform various tasks which would otherwise require a human. These may include:

  • Intelligent Document Categorization and Retrieval: QMS software packages can keep track of various document attributes so that when a user needs a particular portion of documentation, the QMS software can instantaneously provide it.
  • Version Control: Nearly any QMS software will offer version control. All master files are stored in the software’s database. When anyone updates or changes a document, these changes themselves are identified and stored, usually along with a backup of the old version of the document. Changes propagate immediately to all users so that everyone is kept up-to-date. The software also prevents multiple users from making conflicting changes to any document.
  • Report Generation: Most versions of QMS software can automatically extract data from various documents to generate reports. Most QMS software comes with predefined report templates and usually allows users to define custom reports as well.
  • Assisted Document and Process Creation: Generic templates for documents and procedures packaged with QMS software allows the creator of a new document or procedure to focus on content rather than formatting, nomenclature, or compliance-related “busy-work.”
  • Automated Data Entry: Some QMS software packages are able to auto-populate forms with data extracted from internally-stored documents or from existing related forms. In some applications, software may also collect and record measurements from quality assurance instrumentation, production equipment, etc.

In recent years, more and more QMS software packages have also been offering cloud-based storage and synchronization, effectively removing any restraints imposed by large distances between users.

Beyond document control, QMS software often provides these additional valuable capabilities:

  • Smart notifications: Each person involved in a QMS can be assigned roles in the QMS software. The software can then generate timely notifications for events like calibrations, document reviews, audits, etc., and send these to the appropriate personnel.
  • Continual Improvement: QMS software may automatically generate and e-mail non-conformance reports and related data analysis summaries. It can then track corrective action afterward and send notifications, as needed, to ensure that issues are addressed.
  • Audit Assistance: Many types of QMS software have built-in modules to automate audit-related tasks and schedules.
  • Training: Some QMS software packages have integrated training tools to help personnel get up to speed as quickly as possible.

In short, the impact of software on ISO 9001 cannot be overstated; it has effectively removed the biggest hurdles to ISO 9001 adoption.