ISO 9001 implementation requires a reliable document control system. Managing the quality system documentation is a huge undertaking.
In the early years of ISO 9000 implementation, document control was mainly done with hard copies of documents in three-ring binders while document masters were stored in electronic files. When documentation was updated, hard copies of new documents were distributed to update quality system manuals throughout the company. It was a labor-intensive manual process with a lot of opportunity for error and continued use of obsolete documents.
ISO 9001 Software has Become More Sophisticated
There are a number of things to consider when choosing the proper type of ISO 9001 software with the capabilities necessary to handle the quality management system.
The first consideration is choosing software that complies with the ISO 9001 standards and includes templates and sample documents to guide the company in creating the proper levels of documentation necessary for certification. The complexity of a computer software package depends on whether an organization has an existing quality management system.
The software should fit with the level of document control a company currently has:
- No written policies, procedures or work instructions
- Some written documentation but not conforming to any quality system requirements
- Written documentation with a manual document control and change system
- A quality system similar to ISO 9001 standards
- An automated quality system with decentralized document control system
ISO 9001 software should match the company’s current stage to minimize the cost and time involved in automating the quality management system. Too little capability will leave gaps in the system, and a system far beyond the needs of the company will create a complicated system that is difficult to understand, and most likely will not be fully implemented and maintained.
The quality management software automates document control and delivery, provides information about performance, conformance, manages document revisions and accessibility. The software allows revisions to be made electronically and instantly accessible to computer work stations throughout the organization. It is also used to document and track corrective and preventive actions. Computer software can also be used to train employees on the quality management system. Software systems should also have an adequate security system to assign access codes to those responsible for maintaining the integrity of the system documentation and records.
Other ISO 9001 Software Considerations
Another consideration in choosing basic ISO 9001 software is the company’s ability and need to make document changes. Some companies with limited products or services may make occasional changes or updates. Others will need more flexible systems that can make frequent, multiple changes quickly and notify users throughout the organization in both domestic and foreign locations. New companies that are developing products or services will need flexible, user-friendly software packages to handle frequent, even daily changes.
Another consideration in choosing ISO 9001 software is the technical ability and experience of those responsible for managing the quality management system. Large companies with a Quality Manager with a quality management team can handle a more complicated system than a small company with an employee who manages the quality system in addition to his other responsibilities.
The existing computer system, server capacity and other technical capabilities in place are other considerations when choosing ISO 9001 software. Will the software work with the existing computer system, or will system alterations driving up cost and add implementation time? Can the software be customized to fit the organization or industry quality requirements?
Different industries have different requirements.
The automotive industry requires software compatible with QS-9000 standards. The Aircraft/Aerospace industry software must be compatible with AS9100 standards. Service industries, health care, food and beverage, and military installations require specific quality system software.
Taking into consideration these factors, choosing quality system management software that is in compliance with quality system standards and meets the needs of the organization’s structure and culture are the most important selection criteria. With basic software in place, a company is ready to go through the steps to ISO 9001 implementation.