ISO audits are conducted to verify that your organization’s internal processes align with the relevant ISO standards you’re obligated to satisfy. An ISO audit — and the ISO certification it is aimed toward — helps inspire existing and potential customers’ confidence in your products. Automating your ISO audit processes and activities with ISO audit software can substantively accelerate compliance efforts.
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ISO audits provide on-site verification of compliance-related processes, products and systems. To achieve this verification, three types of ISO audits are conducted: first-party audits, second-party audits and third-party audits. A first-party audit is conducted internally by company staff to measure the effectiveness of ISO-related processes. A second-party, or supplier audit, is commonly spearheaded by a lead auditor within the organization who works to validate that the work that vendors who supply products and/or services to the organization are meeting the requirements of the ISO auditing standard. This type of audit may also include external audits by customers. A third-party audit is conducted by an accredited registrar for certification purposes. Registrars perform two-stage certification audits to verify conformance against the relevant ISO standard before issuing an official certification.
Each ISO standard provides a blueprint that indicates what companies need to do to achieve and maintain compliance. Because an ISO audit provides a snapshot of a company's progress toward meeting regulatory goals, it is the most beneficial tool a company can employ to monitor and document its compliance status.
Examples of standards that most life science or similarly regulated manufacturing companies conduct ISO audits against include ISO 9001:2015 (and other standards in the ISO 9000 family that pertain to quality management) and ISO 13485 (quality systems for medical device manufacturers). ISO audits are invaluable components of assessing adherence to these and other standards such as:
The unparalleled ISO audit software solutions provided by MasterControl enable companies to streamline ISO audits and allow them to take control of their audit processes, quality, compliance and growth. MasterControl ISO audit software systems are designed to make ISO audits faster, easier and more effective. MasterControl integrates every aspect of the quality system with audit data and tasks while simultaneously simplifying audit scheduling and execution. Users can even use MasterControl’s ISO audit software to launch quality event forms (for CAPAs, nonconformances, etc.) directly from an ISO audit finding, which streamlines audit processes and ensures that issues are thoroughly addressed. With its robust document management, reporting and analytics capabilities, the system provides enhanced visibility into audit activities to both auditors and management.
Regulatory agencies like ISO and FDA encourage manufacturers’ use of effectual audit software applications, provided that the systems are suitably validated in a way that maximizes their capacity to avoid quality problems and product defects. As proof of MasterControl’s ability to facilitate compliance with ISO auditing standards and other regulatory requirements, the FDA’s Office of Regulatory Affairs (ORA), the lead office for FDA field activities, has relied on MasterControl software since 2009 as the primary tool its quality managers use to uniformly apply and monitor work processes and products.
To learn more about accelerating ISO audits with MasterControl, please contact a MasterControl representative.