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ISO 19011 provides guidelines for quality and/or systems audits. It explains how to prepare an ISO audit checklist, sampling plans, and forms for recording information such as findings associated with an ISO audit.
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The ISO 19011 guidelines offers four resources to help companies:
These resources provided by ISO 19011 enable companies to:
ISO 19011 helps companies prepare an ISO audit checklist that meets their specific needs. A simple checklist is shown below:
1) What is the auditor or notified body member planning on inspecting?
2) Was the inspection provoked or is it a routine procedure?
3) Will the auditor need access to specific documentation during the ISO 19011 audit?
4) Is there a planned methodology for the quick retrieval of documentation and proof of all essential audit trails
5) Will the auditor need access to specific personnel members as he or she conducts the audit?
ISO 19011 also provides guidelines for more elaborate checklists, which may be required for the scope of some audits.
The MasterControl quality management suite consists of configurable, easy-to-use, and connected applications to help companies meet the requirements of ISO 19011. The suite helps companies automate, streamline, and manage the following applications: document control, change control, training control, audits, corrective/preventive action (CAPA), customer complaints, and other documents and forms-based business processes. And, best of all, MasterControl helps in compliance with ISO 19011 standards under a single Web-based platform.
In addition to ISO 19011, The MasterControl Quality Suite helps companies meet the requirements for just about any ISO standard, e.g., ISO 9000 (ISO 9000 2000 or ISO 9001 2000), ISO 13485, or ISO 14000, to name but a few.