ISO 9001 Internal Audit Checklist Template

Establishing regular internal audits on your quality management system is an integral component of compliance and performance improvement, but pre-packaged checklists may not be the most efficient method.

These comprehensive ISO 9001 audit checklists were created in compliance with ISO 19011:2018 Guidelines for Auditing Management Systems, to minimize risks during crucial implementation, gap analysis or certification audits.

Processes
This clause-by-clause ISO audit checklist template makes it easy for you to conduct internal audits of your quality management system (QMS) in accordance with ISO standard to assess compliance and build an efficient foundation for managing quality processes, satisfying customers and continuously improving performance over time.

Process auditing involves asking a variety of questions regarding inputs, outputs, risks, controls, activities, materials equipment personnel involved with your processes. The questions aim to ensure your company employs a process approach compatible with ISO 9001 requirements.

This template also includes a table with questions covering supplier audits to assess compliance of their QMS with ISO 9001 standards. These audits involve reviewing operating procedures, work instructions, policies, plans contracts and organizations charts as well as effectiveness of interfaces between departments; auditors will use an audit plan form when scheduling these internal audits.

Documentation
An ISO internal audit will examine the documentation associated with its quality management system (QMS). This may include everything from training records and certification documentation, to how these documents are utilized by the company itself. Additionally, an internal auditor will observe their use.

These templates provide an effective starting point for companies just embarking on their ISO 9001 journey and conducting their initial gap analysis or process audit. They serve as an indispensable guide that outlines exactly what should be observed, as well as any questions that should be raised.

This audit template is a clause-by-clause checklist covering every requirement of the ISO standard, designed to assist companies in assessing whether their processes comply with its specifications and identify areas for potential improvement. Furthermore, this editable template comes complete with notes sections so it can easily meet individual organization’s unique needs – saving both time and effort! Using it will save organizations both time and effort when conducting an ISO standard audit.

Corrective and Preventive Actions (CAPAs)
A quality management system (QMS) should include processes for identifying risks and preventing nonconformities from happening, as well as conducting regular internal audits to assess its efficacy.

ISO 9001 requires companies to put into place a CAPA structure in order to prevent issues and address them quickly. An audit checklist for ISO 9001 should include questions that explore how CAPAs are initiated, documented, and monitored as well as whether or not these measures have proven successful at preventing further issues and strengthening the QMS.

At the same time, an ISO 9001 audit checklist should include questions that examine the management review process to ensure that an organization is regularly and thoroughly reviewing its own Quality Management System (QMS). Such questions might address whether management reviews meet frequency requirements; how well they assessed key issues and problems impacting QMS; or whether quality assurance managers frequently reviewed results of the QMS.

Non-Conformities
An effective ISO 9001 audit checklist helps organizations identify areas of noncompliance or inefficiency within their organisation. It promotes thorough documentation review, encourages consistency and objectivity across processes, and allows efficient resolution of problems related to nonconformities.

Businesses looking to implement ISO 9001:2015 for the first time must use a gap analysis checklist in order to quickly and accurately assess where there may be gaps between an existing quality management system and those required by ISO 9001:2015. This will allow businesses to take appropriate measures.

Templates must include clear and precise guidance on how to collect data, so anyone trained in conducting an internal audit will be able to use it without issue. Furthermore, they should adhere to PDCA management methods which help prevent complacency while driving continuous improvement efforts forward. Lastly, templates should include instructions on how to address nonconformities identified during audits such as identifying, segmenting, returning or suspending products or services that don’t meet requirements – this might involve identifying products or services not meeting expectations as well as returning or suspending provision if needed.