What is a Quality Audit?

Any business or organization must ensure the quality of products or services to be efficient and competitive. In the highly regulated field of medical devices, ensuring product quality and safety is one key to success. Quality audits are critical tools for verifying compliance with predefined standards and identifying opportunities for improvement.

What is a quality audit?

A quality audit is a systematic and independent examination of an organization's QMS to evaluate the degree of conformance to meet a specification or procedure of the product, design, process, or system.

A quality audit in the medical device industry systematically examines a company's quality management system, processes, and products to ensure compliance with regulatory requirements and industry standards such as ISO 13485.

Its primary goal is to uphold product safety, efficacy, and quality throughout the device lifecycle. It aims to find weaknesses, discover improvement opportunities, and assess the effectiveness of corrective actions.

In nutshell, it evaluates the effectiveness of an organization's quality controls, identifies areas for improvement, and ensures quality compliance in all areas.

The primary classifications of quality audits include internal (first-party) and external (second- and third-party) audits. However, additional classifications exist based on different criteria, such as scope (product, process, and system audit) or method (remote, hybrid, and on-site).

What is the difference between first, second, and third-party audits?

There are some differences between first, second and third-party audits of management systems. The roles of internal and external audits differ in some subtle aspects, such as approach, duration, formality, and purpose. These differences place limitations on the auditor and require different skills. The level of formality varies along a spectrum, where a first-party audit is less formal, and a third-party audit is typically the most formal, particularly when certification is at stake. Let's take a closer look.

First-party audit

A first-party audit is conducted by or on behalf of the organization itself. The primary purpose is to assess and improve the organization's internal processes, systems, and compliance. It focuses on enhancing efficiency, effectiveness, and adherence to internal policies and procedures. Internal audits are a requirement of ISO 13485 (clause 8.2.4). At the same time, internal auditors may need more objectivity due to their familiarity with the organization's operations and stakeholders. Their assessments might be influenced by internal biases or organizational culture. The organization being audited has complete control over the audit process, including planning, execution, and follow-up actions. They are responsible for implementing any corrective actions identified during the audit.

Second-party audit

A second-party audit involves an examination conducted by external parties with a vested interest in the organization, such as clients, customers, suppliers, or partners. The auditing party may impose specific criteria, scope, and requirements on the audited organization. These audits aim to evaluate the capabilities, performance, and compliance of suppliers, contractors, or business partners. Contractual agreements or specific customer requirements often drive them.

This is just one method of compliance with ISO 13485 clause 7.4.1. Buyers should consider how necessary a warranty is for a particular product, service, or project. Several factors can be considered to decide the relative importance of having an external supplier provide a fully compliant system. This may mean that even if an external supplier offers an attractive price and delivery terms, it will not be awarded the risky contract due to deficiencies in its QMS.

Third-party audit

These audits are conducted by independent entities or certification bodies that have no affiliation with the organization being audited. They are typically engaged to provide an unbiased assessment of compliance with standards or regulations. The primary purpose is usually certification, regulatory compliance, or providing an impartial assessment of an organization's adherence to standards or rules set by external bodies. Independent auditors maintain a higher level of objectivity and impartiality since they have no direct affiliation with the organization being audited.

Why is conducting a quality audit important?

Regardless of the type, a quality audit aims to identify areas requiring improvement in an organization's performance. Whether it's improving internal processes, supplier performance, or overall compliance, audits provide opportunities for continuous improvement and optimization.

Audits identify non-conformities or areas where processes may not meet established standards. Organizations can take corrective actions to prevent errors, defects, or regulatory violations by identifying these issues.

Improving product quality is a main aim of the audit. A quality audit helps ensure that products or services meet or exceed customer expectations regarding quality, reliability and safety. By maintaining high standards through regular reviews, organizations can increase customer satisfaction and loyalty.

In addition, auditing helps organizations mitigate risks. By proactively addressing potential risks through audits, organizations can minimize the likelihood of costly recalls, legal issues or damage to their reputation.

The results of all types of audits can have significant implications for an organization's reputation, customer satisfaction, regulatory compliance and overall success. Whether resolving non-conformities, improving processes, or achieving certification, audit results are essential to driving positive change and ensuring organizational effectiveness.

What are the steps to conduct a quality audit?

Regarding the stages of a quality audit, the acronym PERC can be helpful. It stands for Planning, Executing, Reporting, Closing (Follow-up).

Planning

Preparation is everything. During the planning stage, auditors decide what needs to be checked and who will perform the checking.

First, the purpose and scope of the audit are determined. Then, the quality aspects, including processes, products, services, or a combination of these, will be examined and determined.

Assembling a team of qualified auditors with relevant experience in the area being audited is also part of the planning phase. It is important to always remember that team members are impartial and independent of the processes being checked.

The detailed plan should describe the audit approach, including criteria, methodology, schedule and required resources. It should also include specific audit activities and assign responsibilities among team members.

Execution

After planning, auditors check everything thoroughly, including how things are done and the documents that go with them.

This stage involves collecting relevant documents, records, and data related to the processes, products, or services being audited. These may include quality manuals, procedures, specifications, and performance indicators.

The audit must be carried out according to an established plan. This typically involves a combination of document review, staff interviews, process observation, and product or service sampling. The results allow for assessing compliance with established criteria and identifying areas for improvement.

At the end of this phase, a record of all audit findings, including observations, non-conformities, and opportunities for improvement, should be made. Ensuring that the results are clear, objective, and supported by evidence is essential.

Report

Next, auditors write down what they found and suggest ways to make things better.

The formal audit report includes a summary of the findings, conclusions and recommendations. Auditors should communicate to stakeholders any non-conformities or areas of concern, as well as proposed corrective actions and timelines for implementation.

Closing (Follow-up)

Last but not least, follow up. Auditors must monitor whether proposed improvements are implemented.

It may include:

• monitoring the implementation of corrective actions to eliminate identified non-conformities;

• checking that actions taken are effective in solving problems and improving quality;

• updating audit documentation and records.

Choose a Quality Audit with Matrix Requirements

The quality audit process might seem complex, but it's straightforward with good planning and preparation. Professionals who understand the rules and challenges specific to the field are key. Alongside having high-quality SaMD solutions for quality management systems (QMS), the Matrix team has professionals with expertise in medical device quality management systems and regulatory compliance who will help your organization meet certification standards through services like quality audits.

Are you ready to elevate your organization to new heights of excellence and ensure the audit meets the needs of the medical device industry? Contact us!