ISO Audit Checklist and Standards

An ISO audit checklist is an indispensable part of an ISO audit, helping ensure that a company can successfully complete an audit and meet ISO quality standards, including ISO 9001. Manufacturing companies in all industries can benefit from an ISO audit checklist, particularly if the audit checklist ties into a company's overall quality management system (QMS).

Meeting ISO 9001:2008 - Standards with Automated Tools

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Importance of an ISO Audit Checklist

Internal and third-party audits are required by ISO 9000 and other quality standards. An ISO audit certifies that a company's internal processes comply with the ISO standard. It is meant to verify that the system is working as it is supposed to, identify areas for improvement, and correct or prevent identified issues. While audits and inspections are challenging, companies can improve their chances of success by creating an ISO compliance checklist. Creating an audit checklist and plan requires reviewing the relevant ISO standard and knowing what an auditor wants when evaluating records and personnel.

Example of ISO Audit Checklist

Quality Policy:

A quality policy is a core element of an ISO audit, as it defines the company’s quality goals and objectives and provides an outline for creating and measuring the performance of quality objectives. Employees should be able to explain the quality policy and how it relates to their work and the overall audit plan.

Quality Objectives:

Quality objectives are measurable steps toward achieving the quality policy. Because auditors often want to see data and records proving that a company has established and documented an ISO audit plan, employees should know where the organization’s quality objectives can be found.


Documentation of standard operating procedures (SOPs) helps prove that work processes and practices are controlled properly. Employees should know where documented procedures are located and be able to find them quickly, as it means they are better prepared to answer an ISO auditor’s relevant questions.

Quality Events:

A company’s ability to respond to quality events is indicative of its commitment to continual improvement, a vital element of ISO compliance. Auditors want documented, readily accessible proof that employees know when to use a nonconformance report and when to initiate a corrective and preventive action (CAPA) process.

Value of an Automated Audit Checklist

Pairing automation with an effective audit checklist can make ISO audits faster, easier, and more effective. Quality and compliance software can streamline life science and manufacturing companies’ quality and compliance processes in a fraction of the time required by manual or partially electronic processes. Robust audit software solutions enable companies to master their ISO compliance checklists, streamline ISO audits, and allow them to take control of their audit processes, quality, compliance, and growth.

How to Prep for ISO Audits

Prior to an ISO audit, it is critical that a company has a well-prepared plan and team. Having an ISO checklist in place will help companies take all the necessary steps to prepare for a successful ISO audit:

  • Conduct Internal Audits: Perform rigorous internal audits regularly. This makes it easier to discover issues before they become big problems identified during external audits.
  • Implement Corrective Actions: When recurring problems are identified, take and document appropriate corrective action. This minimizes the risk that an auditor will delay ISO certification.
  • Review QMS: On an annual basis, review the entire QMS, including quality policies, process changes, ISO audit plans, nonconformance issues, CAPAs, customer feedback, etc.
  • Monitor Objectives: Monitor quality objectives continuously, and modify them when appropriate, to ensure ISO auditors can see progress has been tracked and objectives have been met.

MasterControl Checklist

With proper preparation and robust software, an ISO audit doesn’t have to be grueling. Designed to integrate every aspect of the quality system with audit data, tasks, and documents, MasterControl’s software solutions provide robust document management, reporting, and analytics capabilities. By enabling robust audit checklists and facilitating enhanced visibility into audit and inspection activities, MasterControl automation simplifies audit planning and execution.

QMS Provider for the FDA

MasterControl solutions are used by the most trusted leaders in life sciences and manufacturing industries. Since 2009, the U.S. Food and Drug Administration (FDA) has been using a variety of MasterControl’s Quality Excellence™ solutions to improve the quality processes of the Office of Regulatory Affairs (ORA) and the Division of Pharmaceutical Analysis in the Center for Drug Evaluation and Research (CDER).