ISO 9001:2015 Audit Checklist

The ISO 9001 standard defines requirements for your Quality Management System, consisting of 10 sections or clauses. An auditor will evaluate your QMS against these requirements; however, only clauses 4-10 can be directly audited.

This ISO9001:2015 audit checklist simplifies audit planning and preparation by offering both process auditing as well as clause-by-clause checklists.

Review of documented processes
Documented processes are an essential component of an ISO audit checklist, including reviewing their adequacy, completeness and alignment as well as their effectiveness in meeting intended results and organizational goals. This assessment takes place utilizing ISO’s PDCA management methodology by considering suppliers, steps outputs and customers.

Review of documented procedures is an integral component of an ISO audit checklist and involves assessing whether an organization’s processes are effective at providing quality products and services, along with their implementation of key quality management principles and compliance to specific clauses within ISO standard. This assessment is essential in attaining ISO certification as it helps establish trust with customers while showing commitment to continuous improvement through certification.

Review of documented procedures
Audits conducted using the ISO 9001 audit checklist allow auditors to examine an organisation’s documented processes to ensure they comply with this international standard and discover areas for improvement while encouraging an ongoing cycle of continuous improvement within an organisation.

Auditor must assess an organization’s documentation – including quality manuals, procedures, work instructions and records – for appropriateness, accuracy and compliance with ISO 9001 requirements.

An audit should assess the effectiveness of key processes by assessing output quality and performance indicators. Any non-conformities must be documented and addressed promptly; using an audit checklist helps simplify this process while decreasing subjective interpretations and biases to make it more reliable and efficient; furthermore it enables organisations to maintain consistent assessments with better quality results.

Review of documented records
As part of your audit process, it is essential that you review any documentation relevant to the processes being assessed, such as process metrics, work instructions, turtle diagrams and process maps/flowcharts. Furthermore, review control plans or failure mode effects analysis work sheets as appropriate.

This review is designed to ensure that documented processes comply with ISO 9001 requirements and reflect actual practices within an organisation. Furthermore, this will allow you to evaluate each process’s effectiveness by observing it, reviewing performance indicators, and interviewing personnel.

Review of documents is key to conducting a successful internal quality audit. This step allows you to detect any non-conformities that need to be addressed and maintain objectivity during evaluation processes, leading to more accurate and reliable assessments that save both time and resources. Use of checklists promote consistency while helping maintain objectivity during evaluation processes for greater objectivity that ultimately saves time and resources.

Review of internal audits
As part of an ISO 9001:2015 audit checklist, the audit team should conduct an internal review to evaluate their own performance. This can be accomplished by creating a formal audit report which can be shared with senior management. This report should contain details about both internal audit results and how these have helped strengthen quality systems within companies.

An auditing firm with experience can perform this review, commonly known as Quality Assurance Review (QAR), to assess and ensure the efficiency of an internal audit department.

Certified auditors should be available not only to perform internal audits but also provide services like Gap Analysis and Certification Audit. Furthermore, certified auditors can help with developing your quality management system and ensuring your products and services comply with customer and regulatory requirements – which will lead to long-term success and financial gain as customers trust businesses that focus on quality.