ISO 9001 Audit Checklist

ISO certification can be an arduous journey, yet can bring immense business benefits. A key part of this process is internal audit.

An efficient internal audit will allow your company to enhance its processes, leading to improved products, higher profits and a stronger brand reputation.

Clause-by-Clause Checklist
Acquiring ISO certification for your products and services can bring many advantages, including increased efficiency, cost savings, customer satisfaction improvements and a competitive edge. But to gain this approval from an independent auditor requires your team to follow best practices and complete all required steps – this comprehensive ISO 9001 audit checklist can assist in accomplishing that task successfully.

As part of your preparations for an ISO 9001 audit, it’s essential that your quality management system (QMS) aligns with its requirements. Use this clause-by-clause checklist to quickly assess compliance levels against ISO 9001 standards and identify areas of non-compliance as well as ways to enhance processes.

This checklist encompasses all the main clauses of ISO 9001:2015, from creating your Quality Policy to documenting and communicating responsibilities and authorities within an enterprise. Additionally, this document discusses how your Quality Management System (QMS) is being managed, monitored, and improved; including how progress towards reaching objectives is reported to top management, and determining what needs auditing.

Process Auditing Checklist
ISO 9001 certification brings businesses numerous benefits. It can improve customer satisfaction and trust, increase brand value and open doors to global markets. Furthermore, ISO certification helps achieve operational excellence and boost financial performance – but attaining it requires hard work; conducting internal audits as well as third-party audits before documenting results are part of its requirements.

Perform internal audits regularly to ensure your QMS meets ISO 9001 requirements and can deliver products and services that satisfy customer, regulatory and other business requirements. When conducting an internal audit, gather documented information for each process – this includes process metrics, work instructions, turtle diagrams and process maps as these will become audit records.

If you need to review your Quality Management System (QMS) and determine that certain ISO 9001 requirements don’t apply, documentation detailing how you made this determination and the impact any changes might have had must also be made available as evidence of what happened must also be provided as evidence.

Gap Analysis Checklist
A gap analysis checklist is intended to assist an organization in comparing their current quality management system against ISO 9001 requirements, and planning improvements that will meet those standards. It involves identifying any differences between them and making plans to ensure your company satisfies them.

This checklist has been developed for use with multiple groups, such as senior management, middle management and operational staff. This allows an auditor to gain a wide array of perspectives on the current Quality Management System (QMS) as well as identify areas needing attention.

An auditor should make detailed notes as they inspect each area of a facility, paying particular attention to how each current system compares with ISO 9001 requirements and any gaps between current and target systems that may exist, so as to give a comprehensive view. Once complete, these notes should be put into a report for review by process owners and management teams.

Corrective Action Checklist
Corrective Action Checklist helps businesses whose ISO 9001 audit reveals nonconformities effectively close them off by creating an effective corrective action plan and taking effective corrective actions. With an actionable corrective plan in place, auditors are more likely to grant complete nonconformity closure.

This section’s questions focus on assessing how effectively the company’s management system handles health and safety issues, such as identifying hazards and implementing effective controls, while also looking at CTQ characteristics of human and technical resources.

The next section focuses on how a company manages its quality management systems, with particular attention being given to how performance is evaluated through client satisfaction surveys and internal audits. Furthermore, this checklist covers the way an organization evaluates and implements improvements through a documented process known as Gap Analysis performed by an outside provider to ensure objective results; this process helps identify any gaps in a business’s current QMS as well as any necessary remediation work required in order to comply with ISO standard compliance.