What Is a Quality Audit?

Quality auditing is the systematic, independent, and recorded examination and evaluation of an institution’s quality management system (QMS) to specify whether quality activities and results conform to a strategic arrangement that is effectively implemented and appropriate for achieving the organization’s objectives. A quality audit is often undertaken at predetermined intervals by an internal or external quality auditor or audit team to ensure a business has a well-defined quality monitoring system. It is a critical component of the ISO 9001 quality management system standard. According to the Institute of Internal Auditors, confidence levels typically range between 90% and 95%. The word “confidence level” refers to an auditor’s degree of assurance that the sample will accurately reflect the population’s actual values. The greater the needed level of confidence, the larger the sample size.

Benefits of Quality Audits

Each organization has written and documented policies and standards. Thus, does every business prioritize internal quality standards first? However, is everyone genuinely concerned about the importance of quality reviews? “Quality” is a broad concept. The quality of organizational procedures has a more significant impact on functional areas than we may realize. In today’s world, corporations strive to enforce internal audits holistically. The pertinent question is “why?” Why do we require monthly internal audits? Do we need to repeat the same technique regularly? If you’re still interested, here are the answers.

Alignment of Policies and Procedures in the Real World: First, we are all aware that specific policies, standards, and techniques must be followed organization-wide while developing a software product. However, what is available is essentially paperwork. It becomes tough to reconcile real-world daily issues, quality management methods, and established policies and procedures by reading the same. Internal Quality Audits link these two, ensuring that we perform what we are supposed to do – the proper manner, adhering to all applicable standards.Gap Analysis and Internal Process Evaluation Tool: You can use a quality audit tool to determine how well things work at your company. We find this out if we look deeper into why we do quality audits. When an organization follows quality standards, they don’t always meet the standards that people expect them to follow. A quality audit is a way to look at how an organization manages quality and find ways to make things more practical and save money.Contribute to Optimization and Track Serious Issues Before They Occur: Organizations today desire lean processes and high-quality standards. Quality audits can assist in identifying opportunities for waste elimination and establishing a lean and controllable Quality Management System inside a business. Also, various checkpoints and criteria must be verified during periodic quality audits. For example, an auditor examines for proof of client or reviewer reviews/signoffs before deploying the system into the client’s production environment. This can reveal serious issues/risks resulting in a penalty or significant business loss.This results in a high level of business satisfaction: During quality audits, non-conformances are identified. Naturally, teams gravitate toward rejecting, arguing, or avoiding these. The critical aspect to grasp is that this is not merely a fault-finding system. It is simple to identify prospective gaps and examine corrective and preventive action based on non-conformances. This can result in increased customer satisfaction with the product’s quality. Additionally, periodic audits are required to ensure that corrective and preventive activities are carried out successfully and on schedule.Contributes to Cost-Effective Quality: It is argued that methods that are not quantifiable are ineffective. Quality audits assist in quantifying the many aspects of a quality management system, recording those measures, and converting the analytical results into possibilities for optimizing quality standards and processes. They also offer value to the organization’s core business. We automatically build an internal quality excellence environment with quantifiable data to examine, established corrective and preventive measures, and a system to track everything from defects to possible risks and issues.

Types of Quality Audits

At the most fundamental level, quality audits elicit objective proof of operational conformity. There are numerous sorts of audits that can be undertaken to determine conformance. Audits might be conducted internally, by a supplier, or by an independent third-party auditor. Audits can cover processes, systems, or products, but they are always compared to a predefined set of criteria. The following is a list of ten types of quality audits that are frequently performed:

Internal Quality System Audit: This sort of audit examines the method used to assess quality. Internal quality audits are conducted to determine the effectiveness of an organization’s Electronic Quality Management System (EQMS). The software solution’s quality documentation and processes are examined to ensure optimal efficiency and high-quality product outcomes. The software handbook is audited to ensure that it covers all crucial sections of the solution and is easily accessible to all relevant workers. Audits of work instructions are conducted to guarantee compliance with standard operating procedures and to check that quality processes are reaching targets.Supplier Audit: Supplier audits allow an organization to work with its suppliers in real-time. Companies can control the quality of their suppliers and sub-tier suppliers by auditing the supply chain. They can also hold people who don’t do well accountable. Key performance indicators (KPIs) quickly show where things need to be better. With this level of transparency, suppliers can see purchase order activity, like when the order was received and inspected, so they can work together to find problems and fix them.Production Team Audit: A production team member is often audited when Operator Acceptance and Certified Operator programs or skills management re-qualifications are needed to be done again. There are many things that auditors examine when they re-qualify an operator. They look at changes in processes, evidence that they’ve been trained, and proof that they’ve done things that didn’t meet the standards.Safety Audit: There are safety plans and procedures to keep employees safe at work. A safety audit looks at these plans and strategies. This type of audit can look at how the equipment works or how organizations run to ensure they stay safe regularly. Successful safety policies keep injuries and accidents from happening and improve the overall well-being of employees.Facilities Audit: A facility audit addresses issues about the quality of a corporation’s assets. A facility audit may include examining building systems such as heating, ventilation, air conditioning, and industrial equipment and technology. Processes linked with these facilities are analyzed to guarantee their safety and find opportunities for change to improve quality results.Environmental Audit: Environmental audits are aimed to assist businesses in creating a safer work environment by identifying areas of workplace risk and developing a strategy to comply with OSHA other laws. An audit is undertaken to check that staff comply with regulatory requirements and wear the proper personal protective equipment.Risk Assessment Audit: A risk assessment is a procedure that determines potential workplace dangers and categorizes them to implement preventative actions. This type of audit enables businesses to implement an effective risk reduction strategy. After identifying all hazards, preventative steps can be prioritized to avoid hostile workplace and economic effects.Design Control Audit: Within highly regulated industries, design control audits are conducted to guarantee that manufacturers adhere to a defined process that results in an end product that fulfills acceptable quality and safety standards and appropriately serves user needs. The design plan and the design inputs and outputs are examined for compliance with the appropriate acceptance criteria, and risk analysis is conducted.Regulatory Audit: Regulatory audits follow a specific set of regulations or standards. Quality methods are scrutinized, and the data collection process is thoroughly analyzed for probable nonconformance.Method Validation Audit: The FDA or other regulatory agencies conduct method validation audits to ensure that the analytical test procedures employed during the manufacturing process are standardized reproducible, and documented. This practice is used when testing for consistency and precision is required, as is the case with products created for human consumption.

How to Conduct an Internal Quality Audit

Few businesses recognize the value of internal quality audits. Auditing is frequently regarded as an undesirable but essential disruption. This requires time and effort and may cause employees to feel intimidated. And, once accomplished, minor changes. This is unfortunate, as internal audits are highly effective instruments. They can assist organizations in preparing for regulatory audits and external audits in identifying natural areas for development. Follow these six fundamental steps to conduct more effective internal quality audits.

  • 1. Conduct routine audits

    An audit should not be unexpected. Internal audits should be conducted regularly. How frequently should it depend on the type of your firm and the risk level associated with its activities? Additionally, avoid scheduling audits during peak work hours. This can result in unnecessarily high levels of tension and resentment. Include dates for internal quality audits in the annual calendar of the organization. Send reminders to staff as the audit date approaches. This allows individuals to prepare by gathering documentation, preparing for interviews, and verifying their bookkeeping.

2. Define the audit’s scope

Typically, in cooperation with team experts, the quality manager is most equipped to develop internal audit criteria. These should be concentrated on high-risk regions throughout the process or company lifecycle. They should also include the entire workflow to discover inefficiencies. It is critical to keep consistency in the criteria across time to the extent that this is possible and makes sense. This provides team members with specific objectives to work toward between audits. Additionally, it enables the evaluation of performance over time. However, criteria must be adaptable to your organization’s growing procedures.

3. Prepare for the audit

An internal quality audit must be planned before it can happen. You will need to hire an auditor. This could be an employee who knows about the process but isn’t directly involved. It could also be someone who is not from the company but knows about business and industry rules. Employees from different departments usually help with the audit. Suppose they see what will be audited and how the process is less scary. Set the format for the audit. The interviews could be about the process, the documentation, or the workflows. This could also include a demonstration of how the workflows work. A good audit includes clear communication about what the audit is about and how it will be done. Another thing that can help is if employees have a set amount of time to prepare for the audit.

4. Perform the audit

To guarantee maximum participation and cooperation, begin by convening a meeting to inform staff about the audit’s objectives. Additionally, work to dispel worries of a witch hunt targeting underperforming team members. Encourage participants to submit their observations and enhancement suggestions. Allow sufficient time for the auditor to obtain a thorough understanding of your company’s business life cycle and workflows once the auditing process begins. Additionally, it is beneficial to analyze the organization’s quality management system to discover any irregularities.

5. Report on the audit

The auditor’s final report lays out the audit findings and recommends what to do next. It should help managers keep track of quality and performance over time and look for ways to improve. Often, these reports aren’t shown to anyone else in the company. Instead, it should be communicated to the workforce in a summary form with clear areas for improvement. At the same time, point out how well the team has worked since the last review. This can help keep workers excited.

6. Take appropriate action on recommendations

This is the critical phase. Demonstrate to employees that quality and the auditing process are important by acting on the findings. Concentrate on one or two enhancements at a time. Conduct regular evaluations of the outcomes of implemented modifications and their impact. Additionally, strive to involve employees in resolving the auditor’s recommendations. Everyone must take an active role in any effort to develop continuously. Additionally, it is critical for maintaining long-term compliance with quality standards.


What is a quality auditor’s role?

Quality auditors keep an eye on the products and services of a business. They define parameters for testing products and services, devise quality control methods, conduct audits, and supervise quality control teams. They may work in various industries, including manufacturing and supply, food & beverage, and information technology.

What is a quality management system checklist?

A quality management system is a software application used to formally document processes and procedures inside a company. Having defined processes and procedures enables a business to benchmark and measure its quality and give metrics to improve the business’s quality.

Do you double-check your checklist?

When team members utilize a Do-Confirm checklist, they accomplish their tasks from memory. Then they pause and go over the list, confirming that they completed each thing. When using a Read-Do list, individuals do each action as they check them off, much like a recipe.

What purpose does a checklist serve?

Checklists detail each stage of a procedure, which helps keep things organized. It can be used as a visual reminder, a method for prioritizing chore lists, and a means to schedule all that has to be done to avoid missing deadlines. Simple to use and highly effective at ensuring that all procedures are completed.

Quality auditing is an effective management tool for determining the root reasons for poor quality, corrective actions, and quality-related confirmation or verification activities. It identifies quality management system flaws and errors and assists in improving and resolving them based on comprehensive findings and recommendations. Are you prepared to build your quality audit checklist based on the above facts? If you are, there are downloadable templates accessible for you!