ISO 13485 Audits: Definition, Types, Process, and How to Prepare

ISO 13485 is an internationally recognized standard that defines the quality management system (QMS) requirements for medical device manufacturers. The purpose of ISO 13485 is to provide medical devices and related services that consistently meet customer and regulatory requirements throughout the product lifecycle.

An ISO 13485 audit is a formal evaluation of an organization’s QMS to determine its conformity with ISO 13485:2016 and internal procedures.

ISO 13485:2016 requires internal audits per Clause 8.2.4 to evaluate QMS conformity, and supplier audits per Clause 7.4.1 to evaluate external providers. External audits may also be conducted by notified bodies or regulatory agencies to assess ISO 13485 certification or compliance.

The ISO 13485 audit process involves documented planning, auditor preparation, execution using clause-referenced checklists, supporting documentation, post-audit CAPA management, and integration into Management Review activities.

Effective audit preparation includes understanding the audit scope, verifying controlled documentation and training records, auditing high-risk QMS processes, for example, CAPA, change control, and organizing audit evidence by clause using audit checklists. To support these activities, a validated QMS software centralizes quality processes such as document control, audit management, training, CAPA, and change control. This ensures real-time traceability, version control, and ISO 13485 audit readiness.

SimplerQMS provides a cloud-based QMS software platform for medical device companies, supporting compliance with ISO 13485:2016, FDA 21 CFR Part 820, and EU MDR/IVDR requirements.

What Is an ISO 13485 Audit?

An ISO 13485 audit is a systematic, independent, and documented assessment to determine whether a medical device organization’s Quality Management System (QMS) meets ISO 13485:2016 requirements.

The purpose of an ISO 13485 audit is to verify QMS compliance, and effectiveness, and ensure that QMS processes consistently meet ISO 13485 requirements to support product quality and regulatory compliance.

ISO 13485 audits apply to manufacturers, suppliers, and service providers involved in the design, production, installation, or servicing of medical devices. These audits are conducted by accredited third-party certification bodies such as BSI or TÜV SÜD as part of initial certification, surveillance, and recertification.

What Are the Types of ISO 13485 Audits for Medical Devices?

 The different types of audits for medical devices under ISO 13485 are listed below.

• ISO 13485 Internal Audits: Internal audits are systematic, independent evaluations conducted by the organization according to Clause 8.2.4 to assess QMS conformity with ISO 13485:2016, and internal procedures.
• ISO 13485 Supplier Audits: Supplier audits are risk-based evaluations of external suppliers performed to verify compliance with ISO 13485 Clause 7.4.1 and verify the supplier’s ability to meet specific quality and regulatory requirements.
• ISO 13485 Certification Audits: Certification audits are conducted by accredited third-party bodies to determine that the QMS meets all ISO 13485:2016 requirements for initial certification, surveillance, or recertification.

ISO 13485 Internal Audits

An ISO 13485 internal audit is a systematic, independent, and documented process for evaluating whether the Quality Management System (QMS) meets ISO 13485:2016, internal procedures, and applicable regulatory requirements. Internal audits are required per ISO13485, Clause 8.2.4.

The purpose of an ISO 13485 internal audit is to verify the implementation and effectiveness of QMS processes, identify nonconformities, and ensure early detection of QMS deficiencies that could impact product safety, performance, or regulatory compliance.

ISO 13485 Internal Audits must assess the conformity of critical processes such as design and development per Clause 7.3, Corrective Action per Clause 8.5.2 and Preventive Action per Clause 8.5.3, production per Clause 7.5, and document control per Clause 4.2, using objective evidence to assess compliance. Examples of objective evidence include Device History Records (DHRs), audit trails, and validation records.

These audits are performed by trained, qualified personnel who are independent of the area being audited, with auditor competence documented per Clause 6.2.
Internal audit frequency must be risk-based and documented in an internal audit schedule that ensures full QMS coverage, prioritizing high-risk processes or processes where most nonconformities have occurred.

Internal audit results should be used as input into Management Review per Clause 5.6, and subsequent internal audits.

ISO 13485 Supplier Audits

An ISO 13485 supplier audit is a risk-based, documented evaluation of an external supplier’s Quality Management System. The purpose of ISO 13485 supplier audits is to verify compliance with Purchasing per Clause 7.4 and the supplier’s ability to meet quality, safety, and regulatory requirements.

A supplier audit applies to entities providing products or services that may impact device safety, performance, or conformity. It assesses compliance with approved specifications, quality agreements, and documented supplier procedures using objective evidence.

Unlike internal audits per Clause 8.2.4, which assess in-house QMS effectiveness, supplier audits extend QMS oversight to third parties. They are conducted by qualified QA personnel with expertise in procurement, quality, and regulatory compliance.

Supplier audits are essential for maintaining control over outsourced processes, ensuring suppliers consistently meet relevant specifications and regulatory requirements.

Key elements of ISO 13485 supplier audits include review of the supplier’s QMS documentation, certifications, DHRs, process validation, change control, complaint handling, and Corrective and Preventive Action (CAPA) systems.

Supplier audit results must be documented and used to update risk ratings, supplier scorecards, and the Approved Supplier List (ASL) as part of the supplier management cycle.

ISO 13485 Certification Audits

An ISO 13485 certification audit is a formal, third-party assessment of a medical device manufacturer’s Quality Management System to verify conformity with the ISO 13485:2016 standard.

The purpose of the certification audit is to confirm that the QMS is implemented, maintained, and capable of consistently meeting regulatory and product quality requirements supporting market access and regulatory compliance.

Certification audits are conducted by accredited registrars or Notified Bodies and involve a clause-by-clause evaluation of the QMS, supported by objective evidence such as records, SOPs, and validation reports.

These three phases in an ISO 13485 audit are.

• Initial Certification Audit: A two-stage process assessing QMS readiness (Stage 1) and full implementation (Stage 2).
• Surveillance Audits: Annual audits post-certification to verify ongoing compliance through risk-based sampling.
• Re-certification Audits: Full-scope audits are conducted every three years to renew certification and verify QMS effectiveness.

Certification audit findings are classified, and nonconformities must be addressed within defined timelines to achieve or maintain certification.

Audit outcomes are documented in a controlled audit report and stored in the QMS.

What is the ISO 13485 Audit Process?

The following process steps reflect the ISO 13485 internal audit process and are applicable to supplier and certification audits with some modifications to audit scope, responsibility, and applicable ISO 13485 requirements based on audit type. The differences are briefly explained in the relevant sections below.

1. Audit Planning and Scheduling: Define the audit scope, criteria, frequency, and responsible personnel based on process criticality, previous nonconformities, and regulatory priorities. The audit plan must ensure coverage of all applicable ISO 13485 clauses over the audit cycle and be documented within the QMS.
2. Audit Team Preparation: Assign competent, independent auditors per Clause 6.2, and equip them with clause-referenced checklists, prior audit results, and relevant QMS documentation.
3. Opening Meeting: Formally initiate the audit by presenting the scope, ISO 13485 clause coverage, audit criteria, and nonconformity classification. Confirm access to controlled records, electronic systems, and physical areas, and clearly define responsibilities. This ensures effective and compliant audit execution.
4. Conducting the Audit (On-Site or Remote): Evaluate QMS implementation and effectiveness using interviews, direct observation of activities, and review of objective evidence such as DHRs, CAPA records, and referencing applicable clauses.
5. Documenting Audit Findings: Record each finding with clause reference, evidence ID, and severity classification (major or minor nonconformity), where applicable in the audit findings log.
6. Closing Meeting: Present clause-referenced findings, confirm classification per internal criteria, assign responsible owners, and document required follow-up actions, including CAPA initiation if applicable.
7. Audit Report Issuance: A clause-referenced and controlled audit report detailing the scope, findings categorized by severity, and audit conclusion summarizing overall QMS conformity.
8. Corrective Actions and Follow-Up: Initiate and document CAPAs for applicable nonconformities, including root cause analysis, action implementation, and effectiveness verification.
9. Management Review and Continuous Improvement: Present audit outcomes and CAPA status during Management Review to assess QMS performance, assign actions, and drive continuous improvement.  Supplier and certification audit results may be reviewed if they impact QMS performance, supplier status

1. Audit Planning and Scheduling

Audit planning defines the scope, frequency, methods, and responsibilities of internal audits. The purpose of audit planning and scheduling is to ensure coverage of all applicable ISO 13485 clauses based on risk, CAPA history, and process criticality, among others.

The QA representative or the Audit Program Owner uses tools like the Nonconformity (NC) log, CAPA tracker, and product master files to generate a documented schedule. The schedule must cover all major QMS areas and be updated after significant changes in the QMS or regulatory environment. Maintaining an updated, risk-based audit schedule is essential to ensure compliance and ongoing audit program effectiveness. The approved audit schedule is maintained as a controlled document and is used to execute the audit.

2. Audit Team Preparation

Audit team preparation ensures auditors are competent, independent, and assigned per audit scope. The purpose of audit team preparation is to establish a team capable of executing an objective and compliant audit.

The QA representative verifies auditor training records and assigns roles based on auditor expertise. Tools to support audit team preparation include training matrices, process-specific checklists, and audit history. Auditor assignments should align with process complexity, and designated auditors should be familiar with previous findings relevant to their areas. The assembled audit team must be documented and meet the qualification requirements defined in Clause 6.2.

3. Opening Meeting

The opening meeting is a formal session to communicate the audit scope, ISO 13485 clauses covered, audit schedule, and access requirements such as availability of records, facilities, and personnel. The purpose of the opening meeting is to align process owners with audit objectives and confirm the availability of key records and personnel.

The Lead Auditor presents the agenda, and highlights focus areas, for example, CAPAs, and validation records. The Lead Auditor also documents any exclusions or constraints, such as QMS areas not in scope.

Best practices for the opening meeting include confirming access to electronic QMS systems, pre-identifying clause-referenced records for sampling, and verifying the availability of responsible personnel. When the opening meeting is concluded, the meeting minutes are signed by designated participants and retained as a controlled record within the audit file.

4. Conducting the Audit (On-Site or Remote)

Conducting the audit involves a systematic, clause-referenced review of controlled records and process activities to evaluate the implementation and effectiveness of QMS processes. The purpose of conducting the audit is to verify that the organization meets ISO 13485 requirements using verifiable documentation, interviews, and direct observations.

The audit team reviews documentation such as DHRs, Design History Files (DHFs), calibration logs, training records, and validation protocols while assessing alignment with documented procedures. Clause-by-clause audit checklists and risk-based sampling support compliant audit execution. Risk-based sampling could focus on higher-risk areas, unresolved findings, and critical quality system elements. Upon audit completion, the audit file includes documented checklists, a compiled evidence log, and a preliminary list of audit findings for review and classification.

Classification of audit findings is based on established internal criteria. Upon classification, audit findings are compiled into a clause-referenced log that supports subsequent review and follow-up by relevant personnel.

5. Documenting Audit Findings

Documenting audit findings involves recording nonconformities, observations, and Opportunities for Improvement (OFIs) with references to relevant clauses and supporting objective evidence, for example, incomplete training records. The purpose of documenting audit findings is to establish clear, traceable, factual findings for corrective action and compliance verification.

The Lead Auditor drafts each finding with supporting evidence and clause reference, while the QA representative verifies classification accuracy and ensures traceability to documented records where applicable. The required tools for documenting audit findings include NC report forms and severity classification criteria. Each finding must cite the applicable clause, document or record ID, and an objective, factual description of the finding. These audit findings are documented in the audit findings log.

6. Closing Meeting

The closing meeting is a formal review session where all audit findings are presented to process owners, their classifications are confirmed, and responsibility for follow-up actions is assigned. The purpose of the closing meeting is to ensure that each finding is fully understood, acknowledged by the responsible function, and documented in accordance with applicable procedures or work instructions.

The Lead Auditor presents each finding with the applicable ISO 13485 clause reference and supporting objective evidence, such as incomplete training logs. Process owners provide clarification or submit additional controlled documentation if needed. Observations and OFIs not requiring immediate attention may be recorded as input for Management Review, while systemic nonconformities or process-level failures must be escalated into the CAPA system. The meeting concludes with a signed audit summary that includes finalized classifications, designated action owners, and expected timelines. The audit summary is retained as a controlled audit record in the audit file.

7. Audit Report Issuance

The audit report is a version-controlled summary of the audit scope, methods, findings, and conclusions. The purpose of an audit report is to create a record of audit execution and outcomes, traceable to applicable ISO 13485 clauses.

The Lead Auditor is responsible for drafting the audit report, including the severity classification of each finding and its supporting evidence. The QA representative performs a review to ensure completeness, accuracy of clause references, and alignment with internal classification criteria before the report is formally released. The preparation of an audit report involves the use of several tools. This includes the audit checklist, NC log, and an ISO 13485 clause matrix. These ensure that each finding is clearly mapped to the corresponding ISO clause. These findings must also be supported by controlled documentation and records that demonstrate the nonconformity, for example,  incomplete training logs. For certification audits, the final audit report is issued by the certification body. For supplier audits, a supplier evaluation report is issued by the manufacturer or the organization conducting the supplier audit. Once approved, the signed audit report is retained in the QMS as a controlled record.  

8. Corrective Actions and Follow-Up

Corrective actions and follow-up involve the formal initiation, implementation, and closure of CAPAs linked to audit-identified nonconformities. The purpose of implementing corrective actions and follow-up is to address the determined root cause, restore compliance with applicable requirements, and prevent recurrence through risk-based follow-up actions. Process owners are responsible for executing corrective measures, which may include document revisions or training updates. QA independently verifies that the CAPA addresses the root cause, and meets predefined acceptance criteria to demonstrate effectiveness. Verification methods may include follow-up audits, review of objective evidence, and monitoring of key indicators such as reduced recurrence of related nonconformities.

Each CAPA must include a structured root cause analysis, a defined closure timeline, and clause-referenced traceability to the original audit finding. Evidence of CAPA implementation, such as revised SOPs or completed training logs, must be maintained as controlled records. CAPA closure is permitted only after QA verifies implementation and confirms effectiveness against defined criteria. In certification audits, CAPAs are submitted to the certification body for review and must be formally accepted to maintain or achieve certification. In supplier audits, corrective actions are issued to the supplier and monitored through the supplier evaluation and requalification process.

All supporting records must be traceable to the CAPA and retained within the QMS.

9. Management Review and Continuous Improvement

Management Review is a structured evaluation of QMS performance conducted in accordance with ISO 13485:2016 Clause 5.6. The purpose of Management Review is to evaluate QMS performance against defined objectives. Management Review also identifies recurring or cross-functional risks that could compromise QMS effectiveness and drive strategic actions for improvement.

The QA representative compiles clause-referenced audit reports, CAPA status data, and QMS metrics and submits them to the top management for their review.

Top management evaluates audit trends, nonconformance trends, and CAPA performance, defines follow-up actions, and adjusts quality objectives or resource plans as necessary. Supplier and certification audit results may be reviewed if they impact QMS performance or supplier status.

All review inputs must be current and linked to measurable QMS goals such as audit closure timelines or process-level KPIs. Outcomes are documented in approved, version-controlled Management Review minutes. This document is a controlled record with assigned responsibilities, decisions, and required updates to QMS procedures, objectives, or resource plans.

What Are the Post-Audit Activities After an ISO 13485 Internal Audit?

Post-audit activities following an ISO 13485 internal audit are outlined below.

1. Receive and Review the Audit Report: The designated QA representative, for example, the Quality Manager receives the final audit report and verifies the clause references, and classification of findings before initiating formal follow-up activities.
2. Communicate Audit Results Internally: Audit findings and classifications, for example, major, minor, or OFI are communicated to relevant process owners. Timelines and responsibilities for addressing audit findings are clearly defined and documented.
3. Perform Root Cause Analysis: For applicable nonconformities, process owners conduct documented root cause analysis using approved methodologies. For example, 5 Whys and Fishbone in accordance with the CAPA procedure.
4. Initiate Corrective Actions (CAPA): CAPAs are formally initiated for audit findings that require systemic correction. The initiated CAPAs must have a clear linkage to the nonconformity, for example, the audit NC ID, assigned owners, planned actions, due dates, and defined effectiveness criteria.
5. Implement Corrective Actions: Corrective actions are executed, including updates to controlled documents, retraining, process modifications, or system changes, with all changes recorded in the CAPA log.
6. Verify Effectiveness of Actions: The designated QA performs effectiveness checks using measurable criteria. For example, trend data. This ensures effectiveness of corrective actions is verified before CAPA closure.
7. Close Out Non-Conformities: Once effectiveness is verified, each nonconformity is formally closed in the audit tracking system with traceability to evidence, root causes, and associated corrective or preventive actions, where necessary.
8. Conduct Management Review: Management Review needs to be conducted as per clause 5.6. During the management review, audit metrics, for example, CAPA metrics are reviewed to evaluate QMS performance. This determines any resource adjustments or the authorization of decisions to ensure QMS effectiveness.
9. Update the Audit Program: The audit schedule is revised based on audit outcomes, for example, NCs, or changes in process risk. In addition, the audit program must also cover all applicable QMS processes within a defined audit cycle.
10. Promote Continuous Improvement: Data from audit findings, OFIs, and CAPA trends are analyzed for QMS improvements and input into quality objectives, driving continuous improvement. This ensures continued QMS effectiveness while meeting all applicable regulatory requirements.

How to Prepare for an ISO 13485 Audit?

The following steps outline how to prepare for an ISO 13485 audit. These steps apply to ISO 13485 internal, supplier, and certification audits. Depending on the type of ISO 13485 audit, adjustments are made to the audit scope, applicable ISO 13485 requirements, and process criticality, among other aspects.

1. Understand the Audit Scope and Requirements: Confirm which ISO 13485 clauses, processes, and locations are in scope. For example, confirming whether the audit is for certification, surveillance, or supplier qualification.
2. Assign Audit Roles and Responsibilities: Designate the audit program owner, area owner(s), and QA representatives, where necessary. Assigned responsibilities are documented in the audit plan. This ensures that roles and responsibilities are documented and understood across departments.
3. Ensure Documentation Is Current and Controlled: Verify that all SOPs, work instructions, forms, and records to be audited are approved, up-to-date, and version-controlled.
4. Review Previous Audits and CAPA Records: Assess closure status and effectiveness of prior CAPAs linked to audit findings. For example, delayed CAPA closure or QMS areas with a higher risk of non-compliance. This ensures focused preparation for inspection readiness.
5. Conduct a Mock Audit or Gap Assessment: Use a clause-referenced internal audit checklist to simulate audit conditions, assess compliance gaps, and document findings.
6. Verify Training and Competency Records: Ensure training matrices and individual records demonstrate current training and competency for all personnel performing QMS-related tasks.
7. Audit the CAPA, Change Control, and Risk Management Processes: Confirm these core systems are functioning effectively, with documented records of timely actions, traceability, and verified effectiveness.
8. Prepare Quality and Regulatory Reports: Ensure Management Review outputs, quality objectives, complaint metrics, and regulatory reports, for example, Post-Market Surveillance (PMS) reports are up to date and accurate.
9. Organize Audit Evidence and Files: Ensure that audit evidence such as DHRs, validation protocols, and calibration records are accessible per audit checklist requirements. Storage of audit files and evidence must ensure efficient retrieval during audits.
10. Brief and Train Staff on Audit Conduct: Train staff on how to respond to auditor questions factually, reference procedures, and retrieve requested records during the audit.
11. Schedule a Pre-Audit Walkthrough: Conduct a final readiness review of the facility, personnel, and documentation using the audit checklist to identify and correct any last-minute deficiencies. This confirms adequate preparedness before the actual audit.

What Are the Common ISO 13485 Audit Findings?

The common ISO 13485 audit findings are listed below.

• Outdated or Uncontrolled Documents: SOPs, work instructions, or forms are found in use without current approval status, lacking revision control or proper archival per Clause 4.2.4.
• Incomplete Training Records: Training records do not demonstrate training on current procedures or lack documented verification of training effectiveness for job-specific tasks per Clause 6.2.
• Ineffective Corrective and Preventive Actions (CAPA): CAPAs are initiated without documented root cause analysis, or closed without verifying effectiveness, resulting in repeat nonconformities. CAPA must meet Clauses 8.5.2., Corrective Action and 8.5.3., Preventive Action.
• Poor Change Control Practices: Change records often lack documented impact assessments, risk assessments, or required approvals before implementation, especially for changes affecting validated processes or controlled documents. This reflects noncompliance with Clause 4.1.4
• Non-Conformance Management Gaps: Nonconformities are inadequately recorded, investigated, or linked to specific product lots or processes, with missing evidence of containment, or correction required as per Clause 8.3.2.
• Supplier Control Deficiencies: Supplier control deficiencies occur when the Approved Supplier List (ASL) is outdated, supplier evaluations lack documented approval or re-evaluation criteria, or there is no traceable link between supplier-related nonconformities and requalification decisions. These issues indicate noncompliance with Clause 7.4.1
• Inadequate Risk Management: Risk management files often lack updates following design changes, or process modifications, and fail to maintain traceability between identified hazards, design inputs, implemented risk controls, and residual risk justifications. This reflects nonconformity with ISO 14971 and ISO 13485 Clause 7.1.
• Incomplete or Missing Design Control Records: DHFs lack required elements such as approved design inputs, verification and validation protocols, or documented design reviews. This does not sufficiently meet Clause 7.3.
• Audit Program Weaknesses: Audit programs may be missing required process audits, lack justification for audit frequency, or fail to demonstrate full coverage of ISO 13485 clauses within the audit cycle. This is a common nonconformity to Clause 8.2.4.
• Inadequate Management Review: Records exclude required inputs such as audit results, CAPA trends, and field data, or lack documented outputs like assigned actions and follow-up; in some cases, reviews are conducted without meaningful analysis, timely follow-up, or appropriate leadership involvement, compromising QMS oversight per Clause 5.6.
• Data Integrity and Traceability Issues: Missing signatures, uncontrolled revisions, and unverified edits compromise the integrity and reliability of quality records, undermining traceability to responsible personnel, product batches, and equipment. This is noncompliant with Clause 4.2.5.
• Validation and Calibration Shortcomings: Process validations may lack approved protocols or objective acceptance criteria, while calibration records often lack traceability to standards, calibration intervals, or results. These gaps do not sufficiently meet Clauses 7.5.6 and 7.6.

What Are the Best Practices to Ensure ISO 13485 Compliance and Audit Readiness?

The best practices to ensure ISO 13485 compliance are listed below.

1. Establish a Robust Document Control System: All SOPs, work instructions, and forms must be revision-controlled, with documented approvals, and change logs per Clause 4.2.4. Obsolete documents must be archived and removed from use.
2.  Automate and Track Employee Training: Use training management tools that link training requirements to current SOP versions and document completion of role-based training with effectiveness assessments. Training gaps must be traceable to individual employee records and closed prior to performing the relevant tasks.
3. Implement a Closed-Loop CAPA Process: Each CAPA must document the root cause using structured tools such as 5 Whys or Fishbone. Each CAPA must include action plans, and undergo effectiveness checks based on predefined, measurable criteria. CAPAs must also be traceable to audit findings, complaints, or NCs as applicable to ensure traceability.
4. Use Integrated QMS Software: Validated platforms provide real-time control of documents, training, CAPAs, and audits with time-stamped audit trails and version-controlled records. This reduces compliance risk by preventing outdated documents, ensuring timely training, maintaining CAPA traceability, and supporting audit readiness per ISO 13485.
5. Maintain a Proactive Internal Audit Program: Audit schedules must be risk-based, ensure full coverage of ISO 13485 clauses, and include documented audit plans, findings, and follow-ups per Clause 8.2.4. Audit frequency must be justified by process criticality, past NCs, and change activity.
6. Conduct Regular Management Reviews: Management Reviews must be conducted as per Clause 5.6 and evaluate QMS effectiveness based on inputs such as audit results, CAPA status, complaints, and quality objectives. Based on these inputs, top management must document decisions, assign actions with due dates, and adjust QMS priorities or resources as needed.
7. Ensure Comprehensive Supplier Management: Maintain an up-to-date Approved Supplier List supported by documented selection, evaluation, and re-evaluation activities per Clause 7.4.1. Supplier qualification records must include Supplier audit results, Supplier Corrective Action Request & Report (SCAR), and performance reviews. Each of these must be traceable to purchasing decisions and supplier status within the QMS.
8. Keep Risk Management Files Current: Risk files must reflect current product configurations, process changes, and post-market data, and be traceable to design controls and residual risk justifications. Risk assessments must be updated in accordance with ISO 14971 requirements and traceable to design inputs, control measures, and change control records where applicable.
9. Validate and Maintain Equipment and Software: All software affecting product quality or QMS processes must be validated with documented protocols, and acceptance criteria, where relevant. Equipment used for monitoring or measuring must be calibrated at defined intervals, and compliant with Clause 7.6.
10. Prepare and Organize Audit Evidence Continuously: Maintain readily accessible, clause-referenced evidence such as DHRs, DHFs, training logs, CAPA files, and validation reports. Documentation must be organized by audit checklist category to ensure traceability and readiness during internal or external audits.

How Does QMS Software Help Ensure ISO 13485 Audit Readiness?

QMS software provides a centralized, validated system to manage, track, and document all audit-related activities aligned with ISO 13485:2016 requirements.

QMS software ensures that audit evidence, such as training records, CAPA records, and controlled documents, are readily accessible, up to date, and traceable to specific clauses. This significantly streamlines audit preparation. QMS software also streamlines audit readiness by automating audit scheduling, assigning responsible roles, and tracking the completion of tasks through a dedicated audit management module. Integrated capabilities including change control, and CAPA workflows enable real-time visibility into the audit status.

Manual QMS systems often result in version control errors, missed deadlines for SOP training, undocumented changes, and fragmented audit trails. This leads to insufficient audit readiness. These deficiencies compromise traceability, document control, and record control required to demonstrate conformity during ISO 13485. Digital solutions overcome these deficiencies by ensuring access-controlled workflows, time-stamped audit logs, automatic task reminders, and centralized repositories for all audit records, ensuring data integrity and compliance with ISO 13485 and 21 CFR Part 11.

QMS software automates recurring tasks such as audit planning, task assignment to a responsible person(s), and deadline tracking. It supports training management, SOP release, and the storage and retrieval of reference documents and records to support audit findings. QMS software improves audit activities by linking audit findings directly to applicable clauses, CAPA records, training logs, and controlled documents, where necessary. This is done while maintaining a secure and complete audit trail that is accessible during internal or regulatory audits.

SimplerQMS provides a medical device QMS software purpose-built for companies operating in regulated environments. SimplerQMS has an intuitive interface. This ensures quality and regulatory teams manage audits and related processes in compliance with global standards easily.

The SimplerQMS platform supports a wide range of interconnected quality processes including audit management, CAPA, nonconformance handling, change control, document management, training, supplier management, and complaint handling within a single validated system.

SimplerQMS helps ensure efficient management of quality management processes, supporting compliance with standards and regulations, including ISO 13485:2016, FDA 21 CFR Part 820, 21 CFR Part 11, EU MDR 2017/745, and IVDR 2017/746. SimplerQMS is a fully validated software in accordance with GAMP 5, significantly reducing the validation burden, and is also compliant with software validation requirements as per ISO 13485 and 21 CFR 820.