## [Quality Management System (QMS) Audit Service](/services/quality-management-system-qms-audit-service) Service # Quality Management System (QMS) Audit Service Evaluate your medical-device quality management system (QMS) for compliance with ISO 13485 requirements. [ Contact us ](#form) ![Shot of Caucasian Engineers using digital tablet for inspection quality of producing protective face mask in automated production line.](https://delivery-p133222-e1298791.adobeaemcloud.com/adobe/assets/urn:aaid:aem:ae28a15c-5a23-4468-b908-51dc6c9d28eb/as/ae28a15c-5a23-4468-b908-51dc6c9d28eb.webp?&smartcrop=Landscape&max-quality=90&width=400) *play\_arrow* *pause* ## Breadcrumb - [ *keyboard\_arrow\_left* Services ](/services) - [ Home ](/) *pen\_size\_1* - [ Services ](/services) *pen\_size\_1* - Quality Management System (QMS) Audit Service ## QMS audit for ISO 13485 compliance UL Solutions delivers ISO 13485 quality management system audits that help medical device manufacturers demonstrate compliance, manage regulatory risk and maintain confidence across the entire product lifecycle. Our quality management system audit supports organizations seeking ISO 13485 certification and and can be combined with ISO 9001 or MDSAP to reduce duplicate audits and streamline your compliance plan. ### What a quality management system audit covers Your audit assesses readiness and conformity of documented procedures and processes to ISO 13485 requirements, with clear reporting of any nonconformities and next steps. ### ISO 13485 audits with combined options To help minimize multiple audits, you can schedule combined ISO 13485 audits with ISO 9001 and/or MDSAP, aligning activities and timelines for efficiency. ## Our ISO 13485 Certification Audit Process and Timeline We follow a structured, step-by-step approach to verify the medical device quality management system (QMS), evaluate compliance, and maintain certification over time. ### Registration (Stage 1 and Stage 2) - **Stage 1 (readiness):** On‑site review of documentation and preparedness; you’ll receive a written report including any nonconformities. - **Stage 2 (certification):** Typically scheduled one to six months after Stage 1; at closing, the audit team advises on the recommendation toward registration. ### Surveillance audits and triennial recertification - **Surveillance audits** (annual) confirm continued conformance. - **Triennial recertification** performed every three years to evaluate overall progress and renew your certification cycle. ## Extend market access with MDSAP When your growth strategy requires broader market acceptance, MDSAP combines ISO 13485 with the regulatory requirements of five jurisdictions (U.S., Canada, Australia, Japan and Brazil), helping reduce the number of separate audits. In Canada, the MDSAP certificate has replaced the ISO 13485 certificate in the medical device license process; participating authorities leverage MDSAP audit reports in various ways to streamline oversight. [ Learn more ](/services/medical-device-single-audit-program) ![Shot of a scientist recording his findings on a digital tablet](https://delivery-p133222-e1298791.adobeaemcloud.com/adobe/assets/urn:aaid:aem:fa02e87e-df7f-4d20-adbc-e4eafc744fcd/as/fa02e87e-df7f-4d20-adbc-e4eafc744fcd.webp?&smartcrop=Landscape&max-quality=90&width=400) ### One audit, multiple regulators MDSAP audits, conducted by an approved auditing organization like UL Solutions, follow a three‑year cycle (Stage 1, Stage 2, annual surveillance, recertification). ### When MDSAP fits your strategy If you’re targeting multiple MDSAP markets, a single QMS certificate can save time, reduce audit fatigue and minimize operational disruption compared to separate audits. ## Related medical device services Support your certification program with adjacent services that help verify product safety and performance while navigating global regulatory pathways. ### Testing and regulatory certification UL Solutions provides medical device performance and safety testing (e.g., EMC, wireless, cybersecurity, biocompatibility) and regulatory support across standards such as IEC 60601, IEC 62304 and ISO 14971. Explore Medical Device Regulatory Testing and Certification to plan an integrated route from testing to market access. ## Why UL Solutions ### Accreditation, expertise and global reach UL Solutions is a UKAS‑accredited Registrar under ISO 17021 offering QMS registration to ISO 13485 and ISO 9001, with all auditors conducting these services employed full‑time by UL Solutions for consistent experiences. Our regulatory auditors are part of 15,000 mission‑driven employees in 40+ countries serving customers in 100+ countries. ### Impartiality you can rely on UL Solutions does **not** design QMSs or provide consulting related to systems we certify, maintaining impartiality as an ISO 17000‑series accredited certification body and MDSAP Recognized Auditing Organization. ![UL Solutions Abstract Graphics - Full Circuit](https://delivery-p133222-e1298791.adobeaemcloud.com/adobe/assets/urn:aaid:aem:32ecb06c-71b5-4dab-9963-748f891ed6a2/as/32ecb06c-71b5-4dab-9963-748f891ed6a2.webp?&max-quality=90&width=400) ![UL Solutions](/modules/custom/ul_component/components/brand_element/assets/brand-element-positive/mobius.svg) ![UL Solutions](/modules/custom/ul_component/components/brand_element/assets/brand-element-reverse/mobius.svg) ## Ready to start your QMS audit? Get in touch to schedule your ISO 13485 audit or discuss combined options (ISO 9001 and MDSAP) that align to your regulatory roadmap. Our team helps you streamline audits while supporting long‑term compliance. [ Contact us ](#form) Close *cancel* ### Get in touch Have questions, need specifics? Let's get this conversation started. \* By ticking this box, I confirm that I have read and understood the [Online Policy](https://www.ul.com/resources/online-policies) and consent to the processing of my personal data as described therein. \* By ticking this box, I consent to the cross-border transfer of my personal data as described in the [Online Policy](https://www.ul.com/resources/online-policies). I agree to receive UL Solutions marketing communications and understand that I can opt out at any time without affecting other services by visiting our [Preference Center](https://www.ul.com/preference-center). ##### Thank you! One of our team members will respond to your request as soon as possible. Close ## Related services ![Medical device testing](https://delivery-p133222-e1298791.adobeaemcloud.com/adobe/assets/urn:aaid:aem:c0b91680-61da-4d57-8547-edbf818fe395/as/c0b91680-61da-4d57-8547-edbf818fe395.webp?&max-quality=90&width=400) Service ### IEC 61010 Testing, Assessment and Certification Services for electrical equipment used in testing, measurement and laboratories. [ Learn more *arrow\_forward* ](/services/iec-61010-testing-assessment-and-certification) ![Medical Devices and Products](https://delivery-p133222-e1298791.adobeaemcloud.com/adobe/assets/urn:aaid:aem:bae41a82-8b82-4bd4-9e71-3c691064c855/as/bae41a82-8b82-4bd4-9e71-3c691064c855.webp?&max-quality=90&width=400) Service ### Medical Device Performance and Safety Testing UL Solutions provides medical device testing for safety and performance, as well as certification and regulatory compliance support for medical product manufacturers and healthcare companies. [ Learn more *arrow\_forward* ](/services/medical-device-performance-and-safety-testing) ![Hospital health care and medicine.](https://delivery-p133222-e1298791.adobeaemcloud.com/adobe/assets/urn:aaid:aem:89436a47-a661-4c53-b7ac-f8360be2a446/as/89436a47-a661-4c53-b7ac-f8360be2a446.webp?&max-quality=90&width=400) Service ### IEC 60601 Testing and Certification Evaluate compliance to IEC 60601, the standard for the basic safety and essential performance of medical electrical equipment. [ Learn more *arrow\_forward* ](/services/iec-60601-testing-and-certification) ![Test tubes with dropper](https://delivery-p133222-e1298791.adobeaemcloud.com/adobe/assets/urn:aaid:aem:2a665c8b-f76a-4405-8f0b-a9644cf4d5bf/as/2a665c8b-f76a-4405-8f0b-a9644cf4d5bf.webp?&max-quality=90&width=400) Service ### INMETRO Certification Requirements for Medical Devices UL Solutions is an INMETRO-accredited certification body for medical devices, providing mandatory certification and factory inspections. We can help you streamline access to the Brazilian market. [ Learn more *arrow\_forward* ](/services/inmetro-certification-requirements-medical-devices) ![Doctor using electrode on patient in operating theatre.](https://delivery-p133222-e1298791.adobeaemcloud.com/adobe/assets/urn:aaid:aem:18062eb6-f3a4-415c-9f35-7e7caa97b2ab/as/18062eb6-f3a4-415c-9f35-7e7caa97b2ab.webp?&max-quality=90&width=400) Service ### CE Marking Certification for Medical Devices and IVDs Our deep expertise and extensive presence in Europe enable us to help medical device manufacturers with CE marking compliance for the EU market. [ Learn more *arrow\_forward* ](/services/ce-marking-certification-medical-devices-and-ivds) ## Related resources ![Video](/modules/custom/ul_component/components/brand_icon/assets/brand-icons-positive/video.svg) ### IVDR Class C Transition Period and Certification Readiness Are you ready to meet IVDR Class C deadline? Watch our webinar to learn how to prepare for certification before the window closes. [ Watch webinar *arrow\_forward* ](/resources/ivdr-class-c-transition-period-and-certification-readiness) ![Video](/modules/custom/ul_component/components/brand_icon/assets/brand-icons-positive/video.svg) ### Harmonization of QSR 21 CFR Part 820 with ISO 13485:2016 This on-demand webinar reviews updates and considerations for U.S. medical device manufacturers ahead of the FDA’s issuance of a Final Rule on QSR 21 CFR Part 820, harmonizing with ISO 13485:2016. [ Watch webinar *arrow\_forward* ](/resources/harmonization-qsr-21-cfr-part-820-iso-134852016) ![Notebook and pencil](/modules/custom/ul_component/components/brand_icon/assets/brand-icons-positive/notebook_and_pencil.svg) ### In Vitro Diagnostic Medical Devices Regulation (IVDR) Certification We have expanded our service offering to include IVDR certification, supporting in vitro diagnostic medical device (IVD) manufacturers to streamline market access to the European Union. [ Read article *arrow\_forward* ](/insights/in-vitro-diagnostic-medical-devices-regulation-ivdr-certification) ![Notebook and pencil](/modules/custom/ul_component/components/brand_icon/assets/brand-icons-positive/notebook_and_pencil.svg) ### Key Considerations for Successful MDSAP Audit Our expert provides insights into the preparation process for MDSAP audits for medical device manufacturers. Read our article to learn about best practices to meet compliance requirements. [ Read article *arrow\_forward* ](/insights/key-considerations-successful-mdsap-audit) ![Online promotion](/modules/custom/ul_component/components/brand_icon/assets/brand-icons-positive/online_promotion.svg) ### UKCA: UL Solutions Expands Scope for Medical Devices UL International (UK) Ltd. was recently designated as an Approved Body for medical devices, to support the needs of connected medical device manufacturers seeking market access in Great Britain. [ Read news story *arrow\_forward* ](/news/ukca-ul-solutions-expands-scope-medical-devices) ![Video](/modules/custom/ul_component/components/brand_icon/assets/brand-icons-positive/video.svg) ### Mastering the Medical Device Single Audit Program (MDSAP) The Medical Device Single Audit Program (MDSAP) streamlines the regulatory process for medical device manufacturers by allowing a single audit to satisfy quality management system (QMS) requirements of multiple regulatory authorities. [ Watch webinar *arrow\_forward* ](/resources/mastering-medical-device-single-audit-program-mdsap) ![Video](/modules/custom/ul_component/components/brand_icon/assets/brand-icons-positive/video.svg) ### Mastering IVDR in 2025: Challenges and Strategies Across the Full Compliance Spectrum The In Vitro Diagnostic Regulation (IVDR) continues to reshape the regulatory landscape in the EU, and 2025 marks a key year for manufacturers. [ Watch webinar *arrow\_forward* ](/resources/mastering-ivdr-2025-challenges-and-strategies-across-full-compliance-spectrum) ![Round talk bubble 1](/modules/custom/ul_component/components/brand_icon/assets/brand-icons-positive/round_talk_bubble_1.svg) ### U.S. FDA Harmonization of 21 CFR Part 820 with ISO 13485:2016 Get tips and updates for the adoption of ISO 13485:2016 requirements under the Quality Management System Regulation for medical devices marketed in the U.S. [ Read FAQs *arrow\_forward* ](/resources/us-fda-harmonization-21-cfr-part-820-iso-134852016) ## Related solution ![Portrait of young woman with colored hair consulting with prosthetist in orthology clinic](https://delivery-p133222-e1298791.adobeaemcloud.com/adobe/assets/urn:aaid:aem:600a7988-9f92-4139-b6be-a4723b4e099c/as/600a7988-9f92-4139-b6be-a4723b4e099c.webp?&max-quality=90&width=400) ### Health and Life Sciences Our safety science expertise and software enable industry innovators to overcome critical challenges across the medical product life cycle and deliver safer, more effective and more sustainable products*. [ Learn more ](/industries/healthcare-and-life-sciences) ## UL MMS Program Requirements PDF ### ULS-Medical-Regulatory-Services-Program UL.com Document [ Download PDF *arrow\_forward* ](https://delivery-p133222-e1298791.adobeaemcloud.com/adobe/assets/urn:aaid:aem:b0d6849b-9d41-443d-8cc9-8bba5614a5d7/original/as/ULS-Medical-Regulatory-Services-Program-Reqs-Issue-17.0.pdf) [ Download PDF *download* ](https://delivery-p133222-e1298791.adobeaemcloud.com/adobe/assets/urn:aaid:aem:b0d6849b-9d41-443d-8cc9-8bba5614a5d7/original/as/ULS-Medical-Regulatory-Services-Program-Reqs-Issue-17.0.pdf) ## Frequently asked questions ### What is a QMS audit for medical devices? *add* *remove* A QMS audit is an independent assessment of your documented procedures and processes against applicable standards (such as ISO 13485) to system’s readiness and conformity with regulatory and quality requirements. ### What is ISO 13485? *add* *remove* ISO 13485 is the internationally recognized Quality Management System standard for medical devices, use by organizations throughout the device lifecycle to demonstrate their commitment to product safety, quality, and regulatory compliance. ### How to get ISO 13485 certification? *add* *remove* With UL Solutions, you undergo Stage 1 (readiness) and Stage 2 (certification) audits; after successful registration, you undergo annual surveillance audits and triennial recertification to maintain your certificate. Combined audits (e.g., with ISO 9001 or MDSAP) are available to improve operational efficiency. ### What is the difference between a QMS and MDSAP? *add* *remove* Your QMS is the system you implement to meet ISO 13485 and related requirements. MDSAP (Medical Device Single Audit Program) is a regulatory audit program that evaluates your QMS to ISO 13485 plus specific requirements of five authorities (U.S., Canada, Australia, Japan, Brazil), allowing single audit to serve multiple global markets. ### How long does a UL QMS audit take? *add* *remove* Timing varies by organization’s size and complexity. Typically, Stage 2 follows one to six months after Stage 1, with surveillance audits conducted annually and a recertification audit every three years. ### Does UL Solutions perform QMS internal audits or consulting? *add* *remove* No. To protect impartiality, UL Solutions **does not** design QMSs or provide consulting tied to certification. ### What documents are reviewed first or is there a QMS audit checklist? *add* *remove* During Stage 1, auditors focus on documented procedures (SOPs) and preparedness per ISO 13485 and, when applicable, MDSAP audit criteria. The written findings from this review guide your readiness assessment and help identify any current gaps to be addressed before Stage 2. While UL Solutions does not publish a generic audit checklist, these findings provide a clear framework for the readiness evaluation. ### Is ISO 13485 relevant in the U.S. with FDA’s QMSR? *add* *remove* Yes. FDA’s QMSR incorporates ISO 13485:2016 by reference (final rule issued Jan. 31, 2024; effective Feb. 2, 2026). This alignment harmonizes U.S. QMS regulatory expectations with the international ISO 13485 standard.