ISO9

The next level of documentation required of ISO compliant companies is the quality procedures document. Quality procedures need to address each element of the ISO 9000 standard, and specify what processes are to be done, who in the organization will perform these processes, and what procedures will be followed for performing them.

ISO not only requires that an organization documents its processes and procedures, but also that it controls the documentation in such a way that the following requirements are met:

Current versions of the documentation must be readily available to all employees who perform the work being documented.

Obsolete or superseded documentation must be removed from the system, or clearly identified so as to prevent their inadvertent use.

All documentation, and any changes to it, must be reviewed and approved by functionally competent personnel.

ISO documents are most effectively controlled and distributed using online electronic document delivery. If electronic document delivery is not available, hard copy documents must be maintained. All manuals must be promptly updated as changes are released. Should registrars find outdated documentation in place during annual audits, findings of nonconformance will be registered against the organization. The number and severity of the nonconformances found will have a negative impact on the maintenance of ISO 9000 certification. A study by the British Standards Institute in 1992 found that 42% of the failures to achieve ISO registration were directly attributable to problems with documentation and document control.