ISO 19011

ISO 19011 Guidelines for Quality and/or Systems Audit

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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How ISO 19011 Helps Companies?

The ISO 19011 guidelines offers four resources to help companies:

  • A clear explanation of the principles of management systems auditing.
  • Guidance on the management of audit programs.
  • Guidance on the conduct of internal or external audits.
  • Advice on the competence and evaluation of auditors.

These resources provided by ISO 19011 enable companies to:

  • Avoid confusion about the objectives of audit programs.
  • Ensure that audit reports follow the best format and contain all of the relevant information.
  • Evaluate the competence of the audit team to comply with ISO 19011 standards.
  • Avoid duplication of effort when conducting combined environmental and quality audits.

Preparing an ISO 19011 Audit Checklist

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.

MasterControl ISO 19011 Quality Management Suite

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.

For More Information on ISO 19011

To learn more about ISO 19011, and the ISO standards MasterControl can help companies comply with, please feel free to contact a MasterControl representative.