Documents for Quality Management Audits

In our recent article on ISO 9001 we provided an introduction to the standard, what 9001 is, how to get certified and what help you might need along the way.

In today’s article we’ll be looking at a complimentary activity – that of audits, we’ll be looking at whay sort of documents you’ll be looking to use, what they are and how they fit into your QMS and audit plans.

We’ll be covering:

  • What is ISO 9001
  • What’s an audit
  • Documentation
    • Quality Manual
    • Procedures and work instructions
    • Quality Records
    • Internal Audit reports
    • Non Conformance reports (NCRs)
    • Training records
    • Suppliier documentaiton
    • Customer feedback and/or Complaints
    • Regulatory Compliance documentation

What is ISO 9001

We’re not going to dwell too much on this; please check out our  Introduction to ISO 9001 article for more information.

In brief, ISO 9001 is an internationally recognized standard for quality management. 9001’s “clauses” lay out the guidelines for establishing a quality management system (QMS). Want to know more? Check the article in the link above.


In quality management, an audit refers to a systematic examination of processes, procedures, and records to verify compliance with established quality standards and requirements.

These could be outlined in a standard such as ISO 9001 or another defined method. 

It will typically involve evaluating the effectiveness of the organization’s quality management system against what it has set out to achieve, identifying areas for improvement, and ensuring adherence to any regulatory or industry specific guidelines. 

Audits may be conducted internally (by the company themselves) or externally by independent parties, such as certification bodies or other 3rd parties (customers perhaps).

Audits are an indispensable tool for quality management. They are necessary to ensure that processes within a company function effectively and comply with relevant standards and regulations. 

As the above describes, audits generally require access to a range of the organization’s documentation, be that manuals or other forms. Let’s take a look at some examples of these below:

1. Quality Manual

The Quality Manual is often considered the cornerstone of a company’s Quality Management System (QMS). It outlines a range of the company’s characteristics, including quality policies, objectives, organizational structure, and the processes it follows to ensure quality. 

During an audit, the quality manual is likely to be reviewed, primarily to provide an understanding of the company’s quality management framework and business context.

2. Procedures and Work Instructions

Procedures and work instructions provide detailed guidelines on how specific tasks and processes are to be carried out within the organization. These documents outline responsibilities, information to be recorded, and how processes are to be executed. 

These documents can be evaluated to ensure consistency and effectiveness of processes across different departments. Discrepancies between documented procedures and actual practices may indicate areas where corrective action is needed.

3. Quality Records

Quality records encompass documentation related to various quality-related activities such as inspections, tests, audits, and non-conformances. These records serve as evidence of compliance with quality standards and regulatory requirements. 

Auditors scrutinize quality records to assess completeness, accuracy, and traceability of information. 

They may also verify the implementation of corrective and preventive actions based on the findings recorded in these documents.

4. Internal Audit Reports

Internal audits are conducted by the company’s own personnel to evaluate the effectiveness of its quality management system. Internal audit reports document findings, observations, and recommendations resulting from these audits. 

Internal Audit Reports can provide insight into the company’s self-assessment processes and identify recurring issues or trends. 

Understanding post audit activities (such as solving NCR’s) can also demonstrate an organization’s commitment to continuous improvement.

5. Non-Conformance Reports (NCRs)

NCRs document instances where products, processes, or systems deviate from specified requirements or standards. These reports capture details of non-conformities identified during inspections, audits, or customer complaints. 

Auditors analyze NCRs to assess the frequency and severity of non-conformances, as well as how effective corrective and preventive actions (CAPA) have been taken by the organization. 

Addressing root causes and preventing the recurrence of non-conformities is crucial for maintaining product quality and customer satisfaction, and it demonstrates a commitment to quality.

6. Training Records

Training records document training activities undertaken by employees to ensure competency in performing their assigned tasks. 

Training records may capture information such as training objectives, content, attendees, and dates. 

Training records can be assessed to verify that employees have received adequate training related to procedures and processes. 

It can help in assessing the organization’s commitment to ensuring that personnel possess the necessary skills and knowledge to contribute to quality objectives.

7. Supplier Documentation

Suppliers are often used by businesses for a variety of products and services, from components to professional services.

Associated Supplier documentation may include contracts, agreements, specifications, quality certifications, and performance records. 

By evaluating supplier documentation we can determine the effectiveness of the company’s supplier management processes and how this supports the business in providing products that meet the customers requirements.

8. Customer Feedback and Complaints

Customer feedback and complaints provide valuable insights into the satisfaction levels of customers and the performance of processes that produce products or services. 

Audits will typically review customer feedback mechanisms. These may range from surveys, non conformance reports, complaints and other associated metrics.

Analyzing associated trends helps identify weaknesses (and improvement opportunities) and can aide decision-making aimed at improving customer satisfaction.

9. Regulatory Compliance Documentation

Depending on certain specifics (i.e. the industry and geographical location for example), companies are likely to be subject to various regulatory requirements pertaining to quality, safety, and environmental standards. 

Regulatory compliance documentation which can be assessed may include permits, licenses, certifications, and regulatory audit reports. 

Audits verify the organization’s adherence to applicable regulations and standards by reviewing these documents. Non-compliance may lead to various issues, from legal consequences to impacting the customer.


Audits may require a range of documentation from the company’s management system and operating processes. 

Each of these will be carefully reviewed, providing insight into its quality management practices. Each document plays a crucial role in evaluating the effectiveness and compliance of the organization’s processes. 

By meticulously reviewing these documents, Auditors can identify areas for improvement, ensure regulatory compliance, and participate in enhancing product quality and customer satisfaction.

Are you an auditor or perhaps help manage your organizations quality management system? What are your thoughts on documentation? As always, we’d love your feedback in the comments section below.