Audit Checklist For the Running of ISO 9001 Version 2008

An audit checklist is an indispensable resource when performing internal audits, helping ensure all necessary information is included in the audit report.

Use this template with SafetyCulture internal audit software to perform an assessment of your Quality Management System (QMS). It features a process’status and importance’ tracker, helping plan an audit schedule.

Documentation
Documentation is key to any quality management system. It ensures processes remain consistent, meeting customer expectations. Documents should also be well organized so they’re easy to locate when required.

Documentation should contain clear descriptions of specifications and monitoring processes, along with clear identification for future reference and all necessary details (version control and creation or update date of documentation).

An auditor must also communicate areas for improvement to executive management in a way they understand, so that they may act upon its findings. Furthermore, noncompliance must be communicated in terms of real business implications for the company.

Processes
ISO 9001 is a quality management system standard based on several management principles, including Plan Do Check Act (PDCA), which requires organizations to develop procedures and processes leading to quality output.

Auditor’s will search for documentation that details how the business functions, such as quality objectives, customer needs and any changes that impact it. Furthermore, documented procedures must cover control of documents as well as storage, retention, protection disposition retrieval of records.

Auditor will want to verify that process flows and interactions among processes are documented accurately, such as turtle diagrams, flow charts, lists of processes or system maps. While documentation isn’t strictly required for audit purposes, having this knowledge will enable auditors to assess how effectively the processes function together.

Personnel
An effective audit checklist allows auditors to document essential details, enabling them to produce accurate, comprehensive, and impactful audit reports. It also ensures consistency by offering equal scrutiny and evaluation on each audit.

An effective audit checklist will assist in avoiding common pitfalls and guide the different stages of the audit process, from planning to execution to reporting and follow-up actions, while helping identify any weaknesses within internal processes.

An ISO 9001 audit checklist must be tailored specifically to your company’s individual needs. For instance, healthcare organizations will likely have different requirements than retail stores when creating their checklist. Furthermore, all relevant regulatory standards, orders, and notices should also be included within it and reviewed to assess if they meet audit objectives.

Training
ISO 9001 is the foundation of quality management systems used by companies from all industries worldwide, serving as an invaluable guideline for establishing best practices that form part of formal third-party ISO audits.

In 2015, a revised version of ISO 45001: 2015 was issued and released for general use. While its changes are minimal when compared with earlier editions, they do alter how businesses conduct business operations.

In this latest edition, physical work and its conditions are taken into account in addition to social and psychological conditions, external property is now included along with customer property in scope, document information is combined and there is less flexibility with regard to documentation directives; all this should allow greater emphasis to be put on adding value for customers.

Inspection
An internal quality audit checklist is an effective way of identifying potential risks and acting upon them before they become more serious, helping prevent issues before they worsen, while simultaneously increasing productivity and improving company morale.

An auditor will conduct an inspection to ascertain that processes comply with ISO 9001 standards, examine training manuals and assessments for job skills as well as inspect records and personnel to provide evidence that conformity has been achieved.

Audit checklists typically consist of five sections: scope, evidence collection, audit tests and methods, analysis of results and conclusion. While these elements are standard across audit types from financial to safety audits, their actual implementation may differ; an effective checklist will promote communication between both auditor and auditee.