Ensuring information is created, captured, documented, distributed, monitored, controlled and processed in a way which will enable all relevant interested parties / stakeholders to execute their processes quickly and correctly is very important for a successful QMS. A great deal of information is documented and it may include manuals, SOP’s, flow charts, quality plans, drawings, templates, forms, checklists, records, databases, emails, electronic data, software records, website, software code etc.
Those documented information needs to be controlled for QMS wherever the standard mentions “Maintain and / or Retain Documented Information”
Capabilities of this software ensures that you can upload controlled document, you can track when it was modified / changed, and version numbers will be auto generated for each change which is controlled. Documents should be controlled for change and any documents of external origin needs to be controlled as well as per ISO 9001:2015 standard. Location, retention period, disposal/archival mechanism and authority for the documented information which needs to be retained is also to be controlled.
Documented Information module of Effivity ensures you meet various requirements specific to documented information across the standard in an effective, efficient and simple manner. Below steps demonstrate capabilities of this module and how you can comply with requirements with respect to various related clauses of the standard:-
An intelligent module level home page welcomes user to the module with all compliance options available in the module on left side menu. This home page shows quality objectives for the department, available / recently changed documents, real time graphical analysis on the basis of data / information captured in the system, alerts for pending tasks, quick links for common / regular tasks etc. Module level help is also given at appropriate places.
1. Define the department, document type and document name for specific document to be controlled and upload related files.
2. Define retention and disposal/ archival mechanism and authority for forms and checklist.
3. Raise change request for any document.
4. Define external document by providing details like document name, department, revision number, revision date.
5. Ensure documented information is available to various users as per access control rights. Cloud based software ensures the information is available and is protected whenever required through secured encryption of data.
Comprehensive capabilities of this module ensures all the requirements pertaining to documented information of an organization are addressed in a quick and simplified manner while achieving 100% compliance to requirements of ISO 9001:2015 standard. Contact us at info at effivity.com for further information or visit www.effivity.com to subscribe to our award winning and one of its kind of ISO 9001 compliance software.