Run this checklist to perform an internal audit on a quality management system (QMS) against the ISO 9001:2015 requirements.
Introduction: Enter basic details Preparing for the audit: Establish context of the audit Establish objectives of the audit Establish scope of the audit Establish criteria of the audit Ensure audit monitoring systems are in place Request documented information from auditee Assign audit roles and responsibilities: Assign audit team Assign audit team lead Reviewing documented information: Review auditee's documented information (Conditional) Resolve documented information issue(s) Prepare an audit plan Assign work to audit team Initiating the audit: Make arrangements with the auditee Conduct open meeting Ensure relevant audit information is accessible Collecting evidence (context of the organization): Assess the organization and its context Assess needs and expectations of interested parties Assess scope of QMS Collecting evidence (leadership): Assess leadership of the QMS Assess customer focus Assess quality policy Assess organizational roles and responsibilities Collecting evidence (QMS planning): Assess documentation of risks and opportunities Assess quality objectives Assess procedures for changes to QMS Collecting evidence (support): Assess organization and allocation of QMS resources Assess HR integration with QMS Assess QMS infrastructure Assess QMS work environment Assess systems for monitoring and measurement of resources Assess organizational knowledge of the QMS Assess QMS competence Assess QMS awareness Assess communication of QMS within the organization Assess documented information Collecting evidence (operation): Assess process control Assess determination of requirements for products and services Assess design and development of products and services Assess design and development inputs Assess design and development controls Assess design and development outputs Assess design and development changes Assess control of externally provided products and services Assess type and extent of control Assess information for external providers Assess control of production and service provision Assess identification and traceability of production control Assess control of external provider/customer property Assess preservation procedures Assess post-delivery activities Assess control of changes Assess release of products and services Assess control of nonconforming outputs Collecting evidence (performance evaluation): Assess QMS performance evaluation Assess customer satisfaction Assess performance analysis and evaluation procedures Assess internal audit procedures Assess management review procedures Collecting evidence (improvement): Assess procedures for nonconformity and corrective action Assess procedures for continuous improvement Audit findings: Review audit evidence and findings Closing the audit: Prepare audit report Issue audit report (Conditional) Prepare for audit follow-up Prepare for closing meeting Conduct closing meeting Complete the audit Related checklists:
There are four main objectives of an ISO 9001 audit:
This checklist is not intended to be a script that the auditor follows verbatim. Rather, it should be used as a tool to ensure that the basic requirements have been addressed and that adequate evidence has been recorded.
"The most effective audits are those during which auditors simply talk with the auditees to learn everything they can about the process being audited." - Ann W. Phillips, from ISO 9001:2015 Internal Audits Made Easy
This checklist is designed as a supplement, and is not intended to replace ISO 9001.
For best results, users are encouraged to edit the checklist and modify the contents to best suit their use cases, as it cannot provide specific guidance on the particular risks and controls applicable to every situation.
Typically, management system auditors will prepare custom checklists that reflect the specific scope, scale, and objectives of the quality management system being audited.
Before beginning preparations for the audit, enter some basic details using the form fields below.
