ISO 9001 Audit Checklists

Evaluate effectiveness of your organization's Quality Management System (QMS) through digital internal audits

Published 19 Aug 2022

What is an ISO Audit?

An ISO Audit is an official assessment sanctioned by the International Organization for Standardization (ISO) to determine if a company fulfills a set criteria, usually for developing a product, or rendering a service. An ISO certification gives merit to companies, and protects consumers by ensuring that international safety, reliability, and quality standards are met.

In this article we will answer the following questions: 

What is an ISO 9001 Audit?

An ISO 9001 audit is done to ensure that the existing Quality Management System (QMS) complies with ISO 9001 standards. The audit helps organizations identify and address issues, and discover potential improvements they can make with their QMS software to ensure that best practice processes are in place. An ISO 9001 audit is conducted in two methods:

Internal Audit

This type of audit is by an assigned member of the organization to compare existing QMS with ISO 9001 standards. Performing internal ISO 9001 audits help organizations prepare for the external audit by identifying signs of non-conformance, and see opportunities for improvement to ensure that QMS processes meet requirements for certification.

External Audit

This type of audit is performed prior to obtaining ISO certification. It is conducted with the help of an external auditor. The auditor will verify and ensure that the organization’s documentation meets the requirements of the ISO 9001 standard. At the end of the audit, the auditor will recommend whether you’ll be granted a certification or require corrective actions before you can be accredited.

ISO 9001: 2008 vs 2015 comparison

ISO 9001:2015 intends to focus on the PDCA (Plan, Do, Check, Act) management method; therefore, the updated version of any ISO 9001 template is structured according to PDCA. The purpose of this change was to guard against complacency and give momentum to continuous improvements in quality management systems.

Refer to the table below in order to spot the main differences between the ISO 9001:2008 and ISO 9001:2015 structures:

ISO 9001:2008 Structure

ISO 9001:2015 Structure

0. Introduction

0. Introduction

1. Scope

1. Scope

2. Normative Reference

2. Normative Reference

3. Terms and Definitions

3. Terms and Definitions

4. Quality Management Systems

4. Context of the Organization

5. Management Responsibility

5. Leadership

6. Resource Management

6. Planning

7. Product Realization

7. Support

8. Measurement, Analysis, and Improvement

8. Operation

9. Performance Evaluation

10. Improvement

Furthermore, ISO 9001:2015 focuses on risk-based thinking rather than preventative measures. Therefore, the most recent ISO 9001 checklist reflects this by focusing on analyzing situations that are specific to your organization and deciding individual actions based on that risk analysis.

ISO 9001 Audit Checklist Example PDF

Here is an example of an ISO 9001 PDF in the context of a QMS gap analysis. This upgrade in ISO 9001 form ensures that potential risks can be identified and acted on accordingly, long before preventative measures become apparent.

What is an ISO Audit Checklist?

An internal ISO 9001 Audit Checklists can help assess the effectiveness of an organization’s Quality Management System (QMS) and the achievement of ISO 9001 certification requirements. ISO checklists integrated with an Internal Audit Software are great tools to help implement a QMS and prepare for a third party ISO 9001:2015 certification audit.

How to Prepare the Checklist

Audit checklists assist internal audits in catching any issues that may cause non-conformity with ISO 9001 standards. Preparing an audit checklist doesn’t need to be difficult; you can either create from scratch or use a template. Below is a ISO 9001 audit checklist template example.

Regardless of what you choose, the ISO 9001 audit checklist must include the following clauses:

Clause 4: Context of the Organization

  • Understanding the organization and its context
  • Understanding the needs and expectations of interested parties
  • Determining the scope of the QMS
  • The Quality Management System and its processes

Clause 5: Leadership

  • Leadership and commitment
  • Quality policy
  • Organizational roles, responsibilities, and authorities

Clause 6: Planning

Clause 7: Support

  • Resources (general, people, infrastructures, environment for the operation of processes, monitoring and measuring resources, and organization knowledge)
  • Competence
  • Awareness
  • Communication
  • Documented information

Clause 8: Operation

  • Operational planning and control
  • Determination of requirements for products and services (market needs and interactions with customers)
  • Design and development of goods and services
  • Control of externally provided goods and services
  • Production of goods and provision of services
  • Release of goods and services
  • Control of nonconforming process outputs, products, and services

Clause 9: Performance Evaluation

  • Monitoring, measurement, analysis, and evaluation
  • Internal audit
  • Management review
  • ISO 9001 Clause 10: Improvement
  • Continual improvement
  • Nonconformity and corrective action

Get started with this ISO 9001:2015 Gap Analysis and Internal Audit Checklist built using iAuditor by SafetyCulture. Use iAuditor to assess your organization’s QMS and take note of gaps and areas of improvement, and assign actions to appropriate departments.

FAQs about ISO 9001

The latest revision of the ISO 9001 standard was published in September 2015. The current ISO 9001 standard is 9001:2015.

An ISO 9001 certification certifies that an organization’s Quality Management System (QMS) meets the standard. The organization is able to consistently provide products and services that meet customer satisfaction and regulatory requirements. 

ISO 9001 and AS 9100 are almost identical due to AS 9011 being founded around the ISO 9001 standard. However, the similarities end when it comes to the additional requirements of AS 9100 for the aerospace industry.

SafetyCulture staff writer

SafetyCulture staff writer

Erick Brent Francisco

Erick Brent Francisco is a content writer and researcher for SafetyCulture since 2018. As a content specialist, he is interested in learning and sharing how technology can improve work processes and workplace safety. His experience in logistics, banking and financial services, and retail helps enrich the quality of information in his articles.

Erick Brent Francisco is a content writer and researcher for SafetyCulture since 2018. As a content specialist, he is interested in learning and sharing how technology can improve work processes and workplace safety. His experience in logistics, banking and financial services, and retail helps enrich the quality of information in his articles.