Updating your documents and records
“You get what you inspect, not what you expect!”
Becoming ISO certified is just the beginning of the regulatory compliance ride. Maintaining certification is the most challenging part of the certification process. Remaining certified requires not only following the processes and procedures that were set, but it also requires that you improve your processes and that you record the evidence of such by keeping up with your documentation, updating procedures when the processes change, revising work instructions when more efficient methods are discovered, filling out review forms, filling out training records when training was done, and much more…
Ensuring the availability of up to date documentation and the timely availability of records will allow you to deliver evidence that you are keeping your document management system valid.
Good Document Management System is designed to support compliance and includes version control, detailed file histories, tracking, source tagging, comments, authority control.
Version control is the process by which different drafts and versions of a document or record are managed. It is a tool which tracks a series of draft documents, culminating in a final version. It provides an audit trail for the revision and update of these finalized versions. A good document management software should be able to register and store all the revisions and versions that a user has been worked on. Since approvals are important from auditor’s point of view, it should contain an option for sending files for approval with clearly stated who approved the document, when and which version. On this manner, using obsolete documents is clearly avoided. Of course, approvals demand electronic signature feature be implemented.
One of the main segments is to know who, when and why requested the document. Every document or record is an outcome of a quality requirement or company affair, but it’s important to know from where and whom does it comes from, that’s why got DMS should provide detailed file history.
The document management process also offers more productivity improvements for the team. Rather than mining through filing cabinets to find information, simply search for the information from your computer. Documents don’t become lost. Being able to easily find information and knowledge from indexed content allows you to improve decision making and reduce the amount of time lost looking for information.
Note: When testing an eQMS, verify the search capabilities of the DMS!
A good DMS should work for you, not you for it. It should be user-friendly and team focused to support whatever kind of Project the team is working on. It should be there to support other aspects of how teams work and the tools they use to get that done.
With the system like this, you might be less anxious about a pending audit?