Manufacturing companies in all industries can benefit from an ISO audit checklist, particularly if the ISO audit checklist ties into a company's overall quality management system. This helps assure that the company meets FDA regulatory requirements and ISO quality standards (such as ISO 9001 2000).
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To efficiently conduct an ISO audit, the ISO audit checklist need not be elaborate. It can be very simple (as shown below), but the checklist is an indispensable part of the ISO audit.
1) What is the auditor or notified body member planning on inspecting? (e.g., clinical trials, CAPA processes, training procedures, etc.)
2) Was the inspection provoked or is it a routine procedure?
3) Will the auditor need access to specific documentation during the audit?
4) Is there a planned methodology or a method 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?
MasterControl, a provider of GxP process, document control and quality audit software solutions enables life science and manufacturing companies to streamline quality and compliance processes in a fraction of the time required with manual or hybrid processes which can be possible with the help of MasterControl's software for ISO audit checklists. We also offer MasterControl Audit for companies that want to ensure that they can pass an ISO audit or an FDA audit.
To learn more about an ISO standard or ISO audit, the ISO audit checklist, or ISO 19011, which provides guidelines for quality and / or systems audits, please feel free to contact a MasterControl representative.