What is the ISO 19011 Standard?

The ISO 19011 standard provides guidelines to companies and organizations that conduct both external and external quality audits. The standard 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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ISO 19011 Guidelines

ISO 19011 helps companies in four distinct ways. It provides a clear explanation of the principles of management systems auditing; it assigns guidance on the management of audit programs; it provides procedures on the conduct of internal and external audits; and it offers advice on the competence and evaluation of auditors.

ISO 19011 Audit Checklist

ISO 19011 assists companies in the preparation of an ISO audit checklist that meets their specific needs and criteria:

  • What is the auditor or notified body planning to inspect?
  • Was the inspection provoked or is it a routine procedure?
  • Will the auditor need access to specific documentation during the ISO 19011 audit?
  • Is there a planned methodology for the quick retrieval of documentation and proof of all essential audit trails?
  • Will the auditor need access to specific personnel as he or she conducts the audit?

ISO 19011 Certification

ISO 19011 certification enables companies to avoid confusion about the objectives of its audit programs. It also helps ensure that audit reports follow the best format and contain all relevant information while also showing companies how to evaluate the competence of the audit team in complying with the ISO 19011 standard. Finally, ISO certification eliminates the duplication of efforts when companies conduct combined environmental and quality audits.

Benefits of the ISO 19011 Standard

The ISO 19011 standard presents companies with the following advantages:

  • Makes sure your audit program objectives are in line with the management system policies and objectives
  • Helps you complete required external and internal audits.
  • Allows you to review the results and process to evaluate trends and address risks.
  • Assists you to significantly decrease problem areas in quality and general business processes.

ISO 19011 Software and MasterControl

MasterControl is a leading provider of ISO 19011 software solutions that allow companies to meet ISO 19011 and U.S. Food and Drug Administration (FDA) standards more quickly and on a regular basis without large quality administration expenditures. MasterControl’s ISO 19011 solutions are easy to configure and use and include modules for document control, training, change control, deviations, CAPA and nonconformance management.

MasterControl and the FDA

MasterControl and its partner, i4DM, have served as the quality management system (QMS) providers for the U.S. Food and Drug Administration’s (FDA) Office of Regulatory Affairs since 2009. They also serve as QMS providers for the Division of Pharmaceutical Analysis, part of the FDA’s Center for Drug Evaluation and Research (CDER).