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Have you considered these factors when determining the scope of the organization? How?.How have you used the boundaries and applicability of the QMS to establish the scope for your ISO 9001 audit?.Determining the scope of the quality management system.How do you monitor and review the information about interested parties and their relevant requirements?.

How have you determined which interested parties are relevant to your QMS? How have you determined which relevant requirements those parties must meet? How have you determined their potential impact?.

Understanding the needs and expectations of interested parties:.

How do you monitor and review the information about these external and internal issues?.

How has your organization determined the external and internal issues affecting its purpose and strategic direction? How do these affect your QMS’s ability to achieve its intended result?.

Understanding the organization and its context:.

Here, modified from ISO 9001:2015, is a list of questions that should be considered in an internal audit for compliance with the standard: Internal Quality Management System Audit Checklist (ISO 9001:2015) The ISO 9001 audit checklist contains seven main categories:Īn ISO 9001 audit checklist helps the auditor to gather documentation and information about quality objectives, corrective action, internal issues, and customer satisfaction.Ī typical audit checklist might look like this: Question #Įxplain the question and provide more detail Or, if you want to achieve certification the easy way, try a GRC tool that conducts unlimited internal audits for you with just a few clicks. We’ve also compiled a comprehensive guide to all things ISO. In this post we will outline clause by clause, the questions your internal auditor should ask to assess your compliance with ISO 9001. Internal audits can help to maintain the integrity of your QMS between external audits, as well. Before hiring an outside auditor to determine your organization’s eligibility, you may want to conduct an internal audit to lay the foundation for a smooth process. That said, certifying ISO 9001 compliance is not easy.

Taking a “process approach” to managing qualityĪny organization can use ISO 9001 (specifically the ISO 9001:2015 framework), and more than 1 million organizations in 170 countries have already been certified as ISO 9001-compliant.

Top management’s commitment and involvement to quality.

The standard itself is based on several underlying quality management principles, such as: ISO 9001 provides the criteria that quality management systems should meet to help companies improve the quality of their systems, operations, goods, and services. ISO 9001 is an international standard for quality management systems (QMS), published by the International Organization for Standardization (ISO).