Quality Audit: Definition, Types, Process, and Requirements

A quality audit is a systematic and independent process used to evaluate the effectiveness and conformance of a Quality Management System (QMS) against internal procedures, external standards, and regulatory requirements. A quality audit involves collecting objective audit evidence to assess whether quality objectives are being achieved.

The purpose and importance of quality audits include ensuring compliance, identifying nonconformities, and supporting continual improvement. Quality audits help organizations strengthen internal controls, mitigate quality risks, and maintain trust with customers and regulators.

Types of quality audits include internal (first-party) and external (second- and third-party) audits. Each audit type plays a distinct role in assessing and maintaining QMS effectiveness.

In terms of scope, quality audits may target specific processes, products, or the entire QMS. Process audits evaluate workflows, product audits assess compliance with specifications, and system audits review the QMS holistically.

The main phases of a quality audit process include planning and scheduling, execution, documentation and reporting, and follow-up and closure. Each phase ensures that findings lead to actionable improvements and ongoing audit readiness.

Regulatory requirements and standards that apply to quality audits include ISO 9001:2015, ISO 19011:2018, ISO 13485:2016, FDA 21 CFR Part 820, ICH Q10, GMP, AS9100, IATF 16949, and others. These requirements and standards define expectations for audit frequency, auditor competence, documentation, and corrective action procedures.

QMS software plays a vital role in supporting audit readiness by enabling audit scheduling, document control, nonconformance tracking, and corrective and preventive actions (CAPA) integration. QMS software enhances audit efficiency and helps ensure compliance.

SimplerQMS is a fully validated life science QMS software with integrated audit management capabilities. SimplerQMS software supports compliance with regulatory requirements and streamlines audit planning, documentation, execution, and follow-up in a centralized, digital environment.

What Is a Quality Audit?

A quality audit is a systematic, independent, and documented process for obtaining audit evidence and evaluating it objectively to determine the extent to which audit criteria are fulfilled. Audit evidence refers to verifiable records, statements of fact, or data. Audit criteria include applicable policies, procedures, standards, or regulatory requirements used as benchmarks.

The primary purpose of a quality audit within an organization is to verify whether the QMS is effectively implemented and maintained. It also assesses whether the system meets internal requirements, customer expectations, and regulatory standards.

A quality audit evaluates both conformance, which refers to adherence to procedures and standards, and effectiveness, which refers to the achievement of intended outcomes. A quality audit also helps identify opportunities for continual improvement and ensures sustained compliance with applicable requirements.

Several different types of audits exist. Financial audits focus on the accuracy of financial statements, while compliance audits focus on legal adherence. In contrast, quality audits emphasize operational performance, process effectiveness, and product or service conformance. Quality audits help organizations proactively manage risks, increase customer satisfaction, drive continuous improvement, and optimize process outcomes.

Quality audits may be conducted by internal or external auditors. Internal auditors are trained individuals within the organization who are independent of the processes they audit. External auditors may represent customers (second-party audits), or certification bodies and regulatory authorities (third-party audits).

According to ISO 19011:2018, an auditor is a person with the competence to perform audit tasks objectively and systematically. Auditors should possess the training and experience necessary to conduct audits impartially and effectively.

A quality audit typically assesses multiple key elements such as conformance to requirements, compliance with regulations, effectiveness of QMS processes, and the organization’s ability to achieve defined quality objectives.

Quality audits can be conducted in various formats depending on organizational needs and logistical considerations. On-site audits involve the auditor’s physical presence at the facility, allowing direct observation of operations, interviews with staff, and review of physical records. Remote audits are conducted digitally using video conferencing, screen sharing, and cloud-based documentation platforms, offering efficiency when physical access is limited. Hybrid audits combine both on-site and remote elements, providing added flexibility and effectiveness, particularly for organizations where full on-site auditing may be impractical.

What Is the Importance of Quality Audits in Quality Management Systems (QMS)?

Quality audits are important for maintaining the effectiveness, compliance, and continuous improvement of a QMS. Quality audits provide a structured method to evaluate whether quality processes are operating as intended and in accordance with internal procedures and external regulatory requirements.

Quality audits confirm that quality processes are being implemented correctly and consistently across the organization. Quality audits help identify nonconformities, gaps, or deviations that may impact product or service quality, patient safety, or regulatory compliance. Conducting regular quality audits supports quality management system certification, regulatory readiness, internal accountability, and long-term customer satisfaction.

Quality audits also act as a driver for continuous improvement. Organizations use audit findings to support CAPA, enhance process controls, and refine quality objectives. Over time, improvement actions drive higher operational efficiency, reduce errors, and promote a culture of accountability and excellence across the organization.

Quality audits are not just regulatory checkpoints; they are strategic tools that ensure the QMS evolves with business needs, regulatory changes, and customer expectations.

What Are the Objectives of a Quality Audit?

A quality audit serves multiple purposes, each contributing to the overall strength and effectiveness of the QMS.

Below are the key objectives that organizations aim to achieve through quality audits.

• Ensuring Compliance with Applicable Requirements: Quality audits verify alignment with internal procedures, industry standards, and regulatory frameworks. Ensuring compliance with applicable requirements minimizes the risk of nonconformance and supports certification and regulatory approval.
• Identifying Non-Conformities and Areas for Improvement: Quality audits help detect process deviations, documentation gaps, and process inefficiencies that may impact the quality of products or services. Findings are addressed through CAPA to strengthen the QMS and reduce recurrence.
• Verifying the Effectiveness of the Quality Management System: Quality audits assess whether QMS processes function as intended and deliver expected outcomes. This includes evaluating performance against quality objectives, process controls, and documented procedures.
• Supporting Continuous Improvement Initiatives: Quality audit results support improvement strategies by highlighting recurring issues, process inefficiencies, or quality risks. Organizations can utilize this data to refine their workflows and enhance outcomes.
• Evaluating Risk Management Practices: Quality audits assess how well risk-based thinking is implemented within the QMS, as required by standards such as ISO 9001:2015, ISO 13485:2016, and others. Quality audits ensure that risks are identified, documented, monitored, and effectively mitigated.

What Are the Different Types of Quality Audits?

Quality audits are typically categorized into the following types.

• Internal Audits: Internal audits, also known as first-party audits, are conducted by employees within the organization who are independent of the processes being audited. They evaluate compliance with internal procedures and applicable requirements and help identify areas for improvement before external assessments.
• External Audits: External audits are audits performed by outside entities and include second-party and third-party audits. Second-party audits are carried out by customers or stakeholders, while third-party audits are conducted by independent certification bodies.

Internal Audits

An internal audit is a systematic evaluation of an organization’s QMS. An internal audit is conducted to determine whether processes comply with internal procedures and applicable requirements. Internal audit is referred to as a first-party audit or self-inspection because it is initiated and performed by the organization itself.

Internal audits are typically performed by internal auditors who are employees of the organization but independent of the area being audited to ensure objectivity. These auditors should be trained in audit methodology, familiar with relevant standards, and competent in process evaluation, risk analysis, and QMS principles.

The scope of internal audits may cover specific processes, products, departments, or the entire QMS. Internal audits assess whether documented procedures, policies, and practices align with internal quality objectives, customer requirements, and external requirements.

Internal audits are a core part of an organization’s quality strategy. They help identify weaknesses, monitor process effectiveness, maintain regulatory readiness, and support continual improvement initiatives.

ISO 9001:2015 Clause 9.2 outlines internal audit requirements. Clause 9.2 mandates that organizations plan, implement, and maintain an audit program that considers the importance of processes, organizational changes, and results from previous audits.

The frequency of internal audits depends on risk levels, regulatory obligations, changes within the organization, and past audit performance. Most organizations perform internal audits annually or semi-annually, while areas with higher risk or critical processes may require more frequent assessments.

Key benefits of conducting regular internal quality audits include increased accountability, strengthened process controls, early detection and correction of nonconformities, enhanced customer satisfaction, and improved readiness for external or certification audits.

External Audits

An external audit is a formal, independent evaluation of an organization’s QMS, performed by an outside entity. External audits may assess the entire QMS or focus on specific processes, products, or operational sites, depending on the audit scope and objectives.

They may be categorized as a second-party or third-party audit.

Third-party external audits are conducted by an independent organization with no direct interest in the organization’s operations, such as a certification body or regulatory authority.

These audits are performed by certified and accredited auditors who represent bodies such as ISO registrars or regulatory agencies (e.g., FDA or notified bodies).

In contrast, second-party audits are performed by customers or other contractual partners, who do have a vested interest in the organization’s performance. These auditors are typically trained by the customer organization but may not always hold formal certification. Second-party audits focus on verifying that contractual, regulatory, and quality expectations within the supply chain are being met.

Common types of external audits include certification audits, surveillance audits, recertification audits, and regulatory audits. Certification audits assess conformity to standards such as ISO 9001 or ISO 13485 to issue or renew quality certifications. Surveillance audits are performed periodically, usually on an annual basis, to verify ongoing compliance between certification cycles. Recertification audits are conducted every three years to evaluate the entire QMS and renew the organization’s certification. Regulatory audits are performed by government or regulatory authorities to confirm compliance with applicable laws and industry-specific regulations, such as FDA inspections or EU MDR conformity assessments.

Certification programs generally include annual surveillance audits and a recertification audit every three years. Regulatory audits may be scheduled, risk-based, or triggered by specific events, depending on the organization’s history and risk profile.

External audits are governed by globally recognized standards and regulations. These standards and regulations include ISO 9001 for quality management systems, ISO 19011 for auditing principles, ISO 13485 for medical device QMS, FDA 21 CFR Part 820 for Quality System Regulation (QSR) compliance, and others.

The outcomes of external audits include a formal audit report detailing conformities, nonconformities, and recommendations for improvement. Positive outcomes can result in certification approval, market access, and enhanced credibility with customers and regulators. Negative audit results may lead to required corrective actions, suspension or revocation of certification, or regulatory sanctions.

What Are the Different Scopes of Quality Audits?

In the context of a quality audit, scope refers to the specific area or focus being evaluated. Based on the scope, quality audits can be categorized into three main types listed below.

• Process Audit: A process audit evaluates whether a specific process operates according to predefined procedures, regulatory requirements, and quality standards. A process audit focuses on reviewing inputs, controls, and outputs, and examining documents such as procedures, work instructions, training logs, and job descriptions to ensure consistency, effectiveness, and compliance.
• Product Audit: A product audit evaluates whether a finished product or in-process item meets defined specifications, safety standards, and customer requirements. A product audit typically involves physical inspection, functional testing, and verification activities to confirm the product meets documented performance criteria and intended outcomes.
• System Audit: A system audit reviews the entire QMS to determine whether all elements are effectively developed, implemented, and maintained following applicable requirements and contractual commitments. A system audit evaluates how processes interact, whether documentation aligns with regulatory and customer expectations, and how well the system supports overall quality objectives.

What Are First, Second, and Third-Party Quality Audits?

Quality audits are classified based on the relationship between the auditor and the organization being audited. The most common formats of quality audits are listed below.

• First-Party Audits: First-party audits are conducted internally by an organization’s own employees or internal audit team to evaluate its processes, products, or systems. First-party audits assess compliance with internal procedures or external requirements and help identify strengths, weaknesses, and improvement opportunities before external reviews.
• Second-Party Audits: Second-party audits are performed by a customer or other external stakeholder, such as a contractor, business partner, or service provider. Second-party audits ensure that products or services meet contractual obligations, specified standards, and quality expectations within the supply chain.
• Third-Party Audits: Third-party audits are conducted by independent, certified, and competent organizations, such as accredited certification bodies or regulatory authorities. Third-party audits assess conformity with external standards and regulations such as ISO 9001, ISO 13485, or FDA 21 CFR Part 820 and are typically required for quality certification or regulatory approval.

What Are the Key Phases of a Quality Audit Process?

The key phases of a quality audit process include the steps listed below.

1. Audit Planning and Scheduling: This phase involves defining the audit scope, objectives, and criteria, as well as selecting qualified and impartial auditors. A clear audit plan ensures that audits are risk-based, resource-efficient, and aligned with regulatory requirements and organizational priorities.
2. Audit Execution: The execution phase includes collecting objective evidence through interviews, observations, and document reviews. The goal is to assess conformity with documented procedures and applicable requirements, and to identify nonconformities or opportunities for improvement.
3. Documentation and Reporting: Audit findings are documented in a formal audit report, which includes identified nonconformities, observations, and examples of positive practices. The report is shared with relevant stakeholders for review, management action, and quality improvement planning.
4. Follow-Up and Closure: The follow-up of the audit includes implementing and verifying corrective actions to address identified findings. The audit is officially closed once all actions are confirmed effective, supporting the continual improvement of the QMS.

1. Audit Planning and Scheduling

Audit planning and scheduling is the first critical step in the quality audit process. Audit planning and scheduling ensure that audits are conducted in a systematic, objective, and efficient manner aligned with the organization’s quality goals and compliance requirements.

Audit planning involves defining the audit objectives, scope, and criteria. Objectives clarify what the audit aims to accomplish, such as verifying compliance with internal procedures or external regulations, assessing the effectiveness of specific processes, or identifying areas for improvement. The scope outlines the boundaries of the audit, including which departments, processes, products, or locations will be assessed. Criteria define the standards, regulations, policies, or documented procedures against which the audit evidence will be compared.

Audit planning also involves identifying required resources and coordinating logistics, such as access requirements.

Responsibilities for planning are typically assigned to the Lead Auditor or Quality Manager. This person selects competent, impartial auditors and ensures they are independent of the areas being audited to maintain objectivity.

The audit schedule defines the timing, frequency, and method of audits. The audit schedule typically includes the processes or departments to be reviewed, assigned auditors, and the duration of each audit activity. The schedule is communicated in advance, often via the QMS platform or email, to ensure preparedness and minimize disruption. Audit frequency and priorities are determined based on process criticality, recent changes, and results from previous audits.

2. Audit Execution

The audit execution phase involves performing the actual audit activities according to the predefined audit plan. Audit execution activities typically include opening meetings, process walk-throughs, document reviews, employee interviews, sampling, and on-site observations.

Based on this process, auditors gather objective evidence, evaluate conformity, and assess whether the audited processes meet the defined audit criteria.

As part of this phase, auditors review the effectiveness of corrective actions from previously identified nonconformities to ensure that issues have been adequately addressed and have not recurred.

Auditors use a range of tools and techniques, such as checklists, interviews, observations, digital forms, and sampling of records, to collect objective evidence.

Professional conduct is essential during this phase to maintain impartiality, confidentiality, and consistency in audit execution. Auditors should remain independent, respectful, and focused on evidence-based evaluation.

Nonconformities are identified by comparing observed practices against audit criteria. Nonconformities are documented with supporting evidence in audit records to facilitate later analysis. Audit findings are typically discussed with the auditee during the audit to ensure mutual understanding before being formally documented for reporting and follow-up actions.

3. Documentation and Reporting

Documentation and reporting transform raw audit evidence into structured, actionable information in the form of an audit report. This phase ensures that all audit findings are formally recorded and communicated to support traceability, transparency, and effective follow-up.

An audit report typically includes the audit objectives, scope, criteria, audit team, evidence reviewed, detailed findings, nonconformities, and recommendations for CAPA. The report needs to be clear, factual, and complete in order to serve as a reliable reference for decision-making, compliance verification, and future audits.

The draft audit report is usually reviewed and approved by the lead auditor or audit team before being shared with relevant stakeholders. Results are communicated to stakeholders via email summaries or executive meetings, ensuring that decision-makers are informed and able to take timely action.

Best practices for audit documentation and reporting include using standardized templates, maintaining consistency in formatting and terminology, and ensuring that all documentation aligns with quality objectives and applicable requirements. High-quality audit reports are clear, complete, and traceable, with each finding linked to specific requirements and supported by objective evidence to facilitate effective follow-up and corrective action.

4. Follow-Up and Closure

The follow-up and closure phase ensures that audit findings result in effective actions and measurable improvements within the QMS. After the audit report is issued, process owners are responsible for creating CAPA plans that clearly define root causes, action steps, responsible individuals, and deadlines.

Auditors or quality teams verify the implementation and effectiveness of these actions by reviewing objective evidence such as updated SOPs, training records, or performance metrics. Follow-up may also involve interviews with staff or scheduling additional audits.

An audit is officially closed only when all identified nonconformities have been resolved and formally approved in the CAPA log.

This phase is critical for strengthening the QMS and embedding a culture of continuous improvement by ensuring that lessons learned from the audit are implemented effectively and sustainably.

What Are Post Quality Audit Activities?

Post-audit activities are the actions taken after an audit to address findings, verify corrective measures, and strengthen the quality management system.

Below are listed common post-audit activities.

• Audit Report Distribution: Final audit reports are shared with relevant stakeholders, such as department heads, quality leadership, or external parties, when required. Proper distribution ensures visibility, transparency, and accountability of the audit results.
• Management Review: Audit results and trends are discussed during management review meetings to evaluate systemic risks and overall quality performance. These reviews support strategic decision-making and demonstrate leadership engagement in continuous improvement.
• Corrective Action Implementation: Identified nonconformities are addressed through documented corrective actions to prevent recurrence. Responsibilities, deadlines, and action plans are clearly defined to ensure accountability.
• Updating Procedures or Documentation: Relevant SOPs, work instructions, or QMS documentation are revised if the audit reveals gaps or outdated materials. Updates ensure continued accuracy, compliance, and operational clarity.
• Corrective Action Verification: The quality or audit team confirms that the implemented corrective actions have been properly implemented and are effective in addressing the identified issues. Verification activities may include reviewing updated procedures, conducting interviews, or analyzing process performance data to ensure sustained improvement.
• Closing Nonconformance Records: Nonconformity records are officially closed once corrective actions are implemented, verified, and documented. Closure indicates audit resolution and compliance with requirements.
• Audit Record Archiving: All audit-related documentation, including checklists, reports, and CAPA logs, is archived according to the organization’s document retention policies. Proper archiving ensures traceability and supports future audits and regulatory inspections by providing accessible, verifiable evidence of past audit activities and corrective actions.
• Audit Effectiveness Assessment: An audit evaluation is conducted to determine whether the audit process and corrective actions achieved the intended improvements. This analysis helps enhance future audit planning and execution.
• Trend Analysis of Audit Findings: Audit data is analyzed over time to identify recurring issues, systemic weaknesses, or emerging risks. These insights support proactive risk management and continuous quality improvement.
• Employee Feedback and Lessons Learned: Feedback from auditors and auditees is collected to improve audit methodology, communication, and efficiency. Lessons learned are incorporated into future audit cycles to enhance performance.
• Training and Competency Refreshers: Targeted training is conducted to address knowledge gaps or reinforce regulatory and procedural expectations revealed during the audit. Such training ensures workforce readiness and compliance.
• Integration into Risk Management Processes: Audit results are incorporated into the organization’s risk register or risk-based thinking strategy. Incorporating audit results into risk management ensures that nonconformities inform broader risk assessments and mitigation planning.
• Supplier or Contractor Notification (if applicable): Relevant partners are notified when audit findings affect suppliers or outsourced services. Notifying affected partners encourages joint responsibility and drives corrective actions across the supply chain.
• Regulatory Notification (if required): The organization may need to notify regulatory authorities such as the FDA, EMA, or notified bodies if serious compliance issues are uncovered. Transparency ensures ongoing regulatory alignment and trust.
• Audit Program Review and Refinement: Insights from completed audits are used to evaluate and improve the audit program’s structure, scope, frequency, and auditor performance. Continuous improvement of the program ensures relevance and effectiveness.
• Digital System Updates (for eQMS Users): For organizations using QMS software, audit outcomes may lead to updates in digital workflows, audit templates, and document control systems.

How Does a Quality Audit Cycle Support Continuous Improvement?

The quality audit cycle supports continuous improvement by providing a structured and repeatable process for evaluating and enhancing quality systems.

Quality audit cycle typically includes four key phases: planning, execution, reporting, and follow-up. Each phase contributes unique value by identifying quality gaps, correcting deficiencies, and driving ongoing organizational performance.

During the audit planning phase, the organization defines the audit scope, objectives, and criteria based on quality goals, risk factors, and previous audit results. This strategic alignment ensures that audits are aligned with strategic priorities.

In the execution phase, auditors gather objective evidence through observations, interviews, and document reviews to assess compliance and identify nonconformities or continuous quality improvement opportunities.

The reporting phase translates audit findings into actionable insights. Audit reports summarize nonconformities, observations, and best practices in a clear, traceable format to support corrective and preventive action.

The follow-up and closure phase ensures that CAPA actions are properly implemented, verified for effectiveness, and documented. This final step confirms that issues are resolved effectively and helps prevent recurrence.

The audit process includes mechanisms for identifying and resolving systemic issues. These include root cause analysis, trend evaluation, risk assessments, and categorizing nonconformities by severity and frequency. Integration with CAPA systems ensures that problems are addressed systematically. Management review meetings use audit data to drive strategic quality decisions, and audit findings are linked with performance metrics to support process optimization.

Audit results are often incorporated into broader continuous improvement initiatives such as CAPA programs, Lean methodologies, and Six Sigma frameworks. These programs rely on audit data to streamline processes, eliminate root causes of recurring problems, reduce waste, and boost overall efficiency.

The quality audit cycle not only reinforces regulatory compliance but also fosters a proactive quality culture and supports long-term organizational improvement.

What Regulatory Requirements and Standards Apply to Quality Audits?

Quality audits are expected to align with various regulatory requirements and international standards, depending on the industry and jurisdiction. These frameworks define the expectations for how audits should be conducted, documented, and used to maintain and improve a QMS.

Below are listed key regulatory requirements and standards that define the expectations for quality audits.

• ISO 9001:2015: ISO 9001:2015 is an international standard for quality management systems applicable to organizations in any industry. Clause 9.2 of ISO 9001:2015 requires organizations to conduct internal audits at planned intervals. These audits ensure that the QMS conforms to both internal requirements and the ISO 9001 standard, and that it is effectively implemented and maintained. Clause 9.2 mandates the establishment of an audit program. This program includes defined audit frequency, methods, responsibilities, criteria, and scope. The audit program ensures auditor objectivity, provides for the reporting of results to management, outlines the implementation of corrective actions, and includes the retention of documented evidence.
• ISO 19011:2018: ISO 19011:2018 is a guidance standard for auditing management systems. Clause 5 outlines the management of an audit program, Clause 6 details the conduct of an audit, and Clause 7specifies auditor competence. This standard also provides audit principles, program planning, audit execution steps, and practical guidance for performing effective audits.
• 21 CFR Part 820 (Quality System Regulation): 21 CFR Part 820 is a U.S. FDA regulation governing medical device manufacturers’ quality systems. Section 21 CFR § 820.22 requires medical device manufacturers to establish and perform quality audits to verify compliance with their quality system and assess its effectiveness. Audits have to be conducted by personnel without direct responsibility for the audited areas, documented thoroughly (including reaudits and corrective actions), and reviewed by responsible management.
• ISO 13485:2016: ISO 13485:2016 is an international standard for quality management systems in the medical device industry. Clause 8.2.4 requires organizations to conduct internal audits at planned intervals to verify QMS conformity to the standard and applicable regulatory requirements, and to ensure effective implementation and maintenance. ISO 13485:2016 mandates documented audit procedures, objective and impartial auditors, records of results, and timely corrections or corrective actions with follow-up verification to address any identified nonconformities.
• ICH Q10: ICH Q10 is an international guideline for pharmaceutical quality systems. Section 4.1 requires companies to establish a formal, periodic management review process to evaluate the effectiveness of the Pharmaceutical Quality System (PQS). The review outlined in ICH Q10 shall evaluate self-assessment processes, including internal audits, risk assessments, and trending analyses, to identify systemic issues and support proactive improvement of the pharmaceutical quality system.
• Good Manufacturing Practices (GMP): GMP is a set of guidelines ensuring pharmaceutical products are consistently produced and controlled to quality standards. EU GMP Part I, Chapter 9 requires manufacturers to implement self-inspections or quality audits that regularly evaluate the effectiveness and applicability of the Pharmaceutical Quality System to maintain compliance, product quality, and patient safety.
• AS9100D:2016: AS9100D is an international quality management standard for the aerospace industry. Clause 9.2 requires organizations to conduct internal audits at planned intervals to determine whether their QMS conforms to internal requirements and the AS9100 standard, and whether it is effectively implemented and maintained. Clause 9.2 also mandates the establishment and maintenance of an audit program that defines audit frequency, methods, responsibilities, scope, and criteria. The program should ensure objectivity, timely corrective actions, management reporting, and retention of documented evidence of audit results.
• IATF 16949 (previously ISO/TS 16949): IATF 16949:2016 is an international quality management standard for the automotive industry. Clause 9.2 outlines comprehensive internal audit requirements tailored to the automotive industry. Clause 9.2 requires organizations to conduct internal audits at planned intervals to assess whether their QMS conforms to both ISO 9001:2015 and IATF 16949 requirements, and to verify that the QMS is effectively implemented and maintained. Organizations should establish and maintain a documented audit program that defines frequency, methods, responsibilities, planning, and reporting. This program shall consider process importance, organizational changes, and previous audit results, ensuring objectivity, impartiality, and timely corrective actions.

What Are the Requirements for Quality Audit Auditors?

Quality audit auditors require a combination of technical expertise, industry knowledge, and professional integrity to ensure audits are conducted competently and impartially. The core qualifications and competencies are outlined below.

• Foundational Audit Knowledge and ISO 19011 Alignment: Auditors should possess a strong understanding of auditing principles and practices, particularly those outlined in ISO 19011, which provides guidelines for auditing management systems.
• Industry and Technical Competence: Auditors need to have knowledge of the industry they are auditing. This includes understanding applicable standards (such as ISO 9001, ISO 13485, or FDA regulations), products, and relevant processes.
• Certification and Professional Recognition: Auditors should possess formal certifications to enhance their credibility and demonstrate a verified level of competence. Common certifications include Certified Quality Auditor (CQA), Chartered Quality Institute (CQI), International Register of Certificated Auditors (IRCA) Certified Auditor, and Exemplar Global Certified Auditor.
• Objectivity, Independence, and Ethical Conduct: Auditors should remain impartial, avoid conflicts of interest, and uphold ethical standards. Independence from the audited area is essential to maintaining the integrity of the audit.
• Analytical, Communication, and Observational Skills: Auditors require strong analytical skills to identify root causes and evaluate objective evidence. Effective communication and keen observation are vital for conducting interviews, interpreting documents, and reporting findings.
• Training and Continuous Professional Development: Auditors should regularly update their knowledge through ongoing training and professional development. This ensures auditors stay current with evolving standards, regulatory updates, and auditing techniques.
• Time Management and Organizational Skills: Auditors need to manage time effectively, allowing each audit phase, from planning to closure, to stay within expected timelines. Good organizational skills support the coordination of audit activities and the handling of documentation.
• Understanding of Continuous Improvement Methodologies: Auditors have to be familiar with continuous improvement tools such as CAPA systems, Lean principles, Six Sigma, and the Plan-Do-Check-Act (PDCA) cycle. This knowledge enables them to evaluate how effectively improvement initiatives are implemented across the organization.

How to Prepare for a Quality Audit?

To prepare for a quality audit, auditees should proactively organize their systems, documentation, and personnel to demonstrate conformance and readiness.
The following steps outline a structured approach to achieving audit readiness from the auditee’s perspective.

1. Review Quality Documentation: Verify that quality manuals, procedures, work instructions, and policies are current, approved, and reflect actual practices. Ensuring documentation accuracy reduces the risk of findings during the audit.
2. Organize Records and Evidence: Collect relevant records, such as CAPA logs, training records, and calibration certificates, in an accessible, well-organized format. Organizing records and evidence helps demonstrate compliance and supports efficient evidence retrieval, depending on the audit scope.
3. Assign Roles and Responsibilities: Identify key personnel responsible for supporting the audit process, including document retrieval and auditor communication. Assigning clear roles minimizes confusion and ensures smooth coordination.
4. Conduct Internal Pre-Audit Checks: Perform internal audits or mock audits to identify and resolve potential nonconformities in advance. Carrying out pre-audit checks helps improve conformance and audit confidence.
5. Train and Brief Employees: Educate staff on their roles, responsibilities, and relevant procedures they may be questioned on during the audit. Well-informed employees increase transparency and demonstrate process ownership.
6. Clarify Audit Scope and Objectives: Understand the scope, criteria, and objectives of the upcoming audit by reviewing the audit plan. Align internal resources and expectations to ensure accurate preparation.
7. Ensure Access and Logistics: Confirm that physical areas, systems, and documents required for the audit are accessible to auditors. Arrange necessary logistics for on-site or remote audit formats.
8. Review Previous Audit Findings: Assess the status of corrective actions from prior audits to verify they have been effectively implemented. Ensuring closure of past findings demonstrates accountability, prevents recurrence, and strengthens compliance readiness.
9. Address Known Issues Proactively: Resolve outstanding nonconformities, CAPAs, or system gaps before the audit. Taking corrective actions in advance demonstrates a commitment to continuous improvement.

What Tools Are Used in Quality Auditing?

Conducting an effective quality audit relies on the use of structured tools that promote consistency and accuracy.

Listed below are some of the most commonly used tools that support the audit process.

1. Audit Checklists: Audit checklists are structured forms used to guide auditors through predefined audit criteria, such as regulatory requirements, internal procedures, or ISO standards. They promote consistency, ensure thorough coverage of audit areas, and help auditors collect objective evidence efficiently.
2. Audit Report Templates: Audit report templates offer a standardized format for recording audit findings, including nonconformities, observations, and best practices. These templates help ensure clarity, traceability, and alignment with quality and regulatory reporting requirements.
3. Audit Management Software: Audit management software is a specialized digital solution designed to plan, schedule, conduct, and follow up on audits. The software enables centralized oversight of audit activities, automates task tracking, and integrates CAPA workflows for improved audit lifecycle control.
4. QMS Software: Many QMS platforms include built-in audit management features. These systems streamline the connection between audits and other quality processes such as document control, training, nonconformance management, and risk assessments.
5. Risk Assessment Tools: Tools such as risk matrices, Failure Modes and Effects Analysis (FMEA), or hazard analysis checklists are used to evaluate the risk level associated with audit findings or processes. Integrating risk-based thinking supports prioritization and strategic decision-making in audits.

How Does QMS Software Support Audit Readiness?

QMS software is a digital solution designed to manage, streamline, and automate quality-related processes in alignment with regulatory requirements. QMS software plays a key role in supporting audit readiness by enabling efficient document control, compliance monitoring, and data traceability across an organization.

QMS software solutions provide a range of features that directly support audit readiness and regulatory compliance. The list below outlines key functionalities of QMS software and how they help organizations prepare for audits.

• Version-controlled Document Management: Ensures easy retrieval of the latest approved versions of procedures, SOPs, records, and policies, reducing the risk of outdated documentation during audits.
• Linkage Across Processes and Documents: Connects related quality documentation and records (e.g., SOPs, CAPAs, training logs) to provide complete traceability and context for quality activities.
• Audit Trails and Full Record History: Maintains detailed logs of document revisions, approvals, and user activities to ensure accountability and transparency.
• Audit Planning, Scheduling, and Tracking: Supports structured audit programs with streamlined audit scheduling, reminders, and status tracking to ensure timely execution.
• Integrated CAPA and Nonconformance Management: Enables seamless identification, documentation, and resolution of audit findings, linking them with corrective and preventive actions.
• Training Management Integration: Links training records to procedures and roles, helping demonstrate personnel competence and regulatory compliance during audits. As a result of corrective actions or process changes, updating training assignments and maintaining these links can further support compliance and workforce competence.
• Selective Access for Auditors: Allows secure, role-based access to audit-relevant documents only. The auditors can be granted view-only access to specific files without compromising sensitive information.

SimplerQMS is a fully validated life science QMS software. SimplerQMS supports end-to-end quality processes in regulated life-science industries. The QMS software includes a built-in audit management module, providing centralized control over audit documentation, planning, findings, and follow-up actions.

By integrating document control, CAPA, audit, and training modules, SimplerQMS helps life science companies maintain continuous audit readiness and supports compliance with requirements such as ISO 13485, FDA 21 CFR Part 820, EU MDR/IVDR, and others.