{"product_id":"qmsr-iso-13485-gap-audit-510k","title":"QMSR \u0026 ISO 13485 Gap Audit","description":"\u003cstyle\u003e\n  .cn-service-content {\n    color: #000000;\n    font-size: 16px;\n    line-height: 1.75;\n  }\n\n  .cn-service-content h2,\n  .cn-service-content h3,\n  .cn-service-content p,\n  .cn-service-content li,\n  .cn-service-content strong {\n    color: #000000;\n  }\n\n  .cn-service-content h2 {\n    font-size: 25px;\n    line-height: 1.4;\n    margin: 30px 0 14px;\n  }\n\n  .cn-service-content h3 {\n    font-size: 19px;\n    margin: 22px 0 10px;\n  }\n\n  .cn-service-content p {\n    margin: 0 0 16px;\n  }\n\n  .cn-service-content ul,\n  .cn-service-content ol {\n    padding-left: 24px;\n    margin: 0 0 22px;\n  }\n\n  .cn-service-content li {\n    margin-bottom: 9px;\n  }\n\n  .cn-service-content .cn-note {\n    border: 1px solid #dddddd;\n    padding: 18px;\n    margin-top: 24px;\n  }\n\n  @media (max-width: 600px) {\n    .cn-service-content h2 {\n      font-size: 22px;\n    }\n  }\n\u003c\/style\u003e\n\u003cdiv class=\"cn-service-content\"\u003e\n\u003ch2\u003eQMSR \u0026amp; ISO 13485 Gap Audit for Medical Device Manufacturers\u003c\/h2\u003e\n\u003cp\u003eIs your medical device quality management system ready for the US FDA's Quality Management System Regulation (QMSR) and ISO 13485:2016 requirements? The QMSR \u0026amp; ISO 13485 Gap Audit from Cosmetic Compliance Nest helps medical device businesses evaluate their existing quality management processes, identify potential compliance gaps, and plan corrective improvements.\u003c\/p\u003e\n\u003cp\u003eEffective February 2, 2026, the FDA's QMSR incorporates ISO 13485:2016 by reference, with additional FDA-specific requirements and provisions. Medical device manufacturers need to understand how these requirements apply to their operations, documentation, and quality processes.\u003c\/p\u003e\n\u003cp\u003eOur gap audit service provides a structured review of your existing quality management system against the applicable requirements, helping you identify areas that may need attention before an FDA inspection, internal audit, or other quality compliance activity.\u003c\/p\u003e\n\u003ch2\u003eWhat Is a QMSR \u0026amp; ISO 13485 Gap Audit?\u003c\/h2\u003e\n\u003cp\u003eA QMSR and ISO 13485 gap audit is a systematic assessment of an organisation's existing quality management system against selected applicable regulatory and quality management requirements.\u003c\/p\u003e\n\u003cp\u003eThe review helps identify differences between your current procedures and the requirements relevant to your medical device operations. These may include document control, risk management, design and development, supplier controls, production processes, complaint handling, corrective and preventive action, and record management.\u003c\/p\u003e\n\u003cp\u003eThe objective is to provide a clearer picture of your current compliance position and support the development of a practical action plan to address identified gaps.\u003c\/p\u003e\n\u003ch2\u003eWhat Does the Gap Audit Cover?\u003c\/h2\u003e\n\u003cul\u003e\n\u003cli\u003e\n\u003cstrong\u003eQMSR Requirements Review:\u003c\/strong\u003e Assess relevant FDA Quality Management System Regulation requirements applicable to your organisation and activities.\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eISO 13485:2016 Assessment:\u003c\/strong\u003e Review relevant quality management system processes against the applicable ISO 13485 requirements.\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eDocument Control:\u003c\/strong\u003e Examine applicable procedures for document approval, revision control, distribution, and retention.\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eManagement Responsibility:\u003c\/strong\u003e Review relevant quality responsibilities, management oversight, and quality planning processes.\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eRisk Management:\u003c\/strong\u003e Assess how applicable risk management activities are integrated into relevant quality processes and product lifecycle activities.\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eDesign and Development Controls:\u003c\/strong\u003e Review applicable design planning, design inputs and outputs, verification, validation, and change control processes.\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eSupplier and Purchasing Controls:\u003c\/strong\u003e Assess relevant supplier evaluation, purchasing controls, and monitoring procedures.\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eProduction and Process Controls:\u003c\/strong\u003e Review applicable manufacturing controls, process validation, identification, traceability, and related records.\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eComplaint Handling and Feedback:\u003c\/strong\u003e Examine relevant procedures for customer feedback, complaint evaluation, investigation, and escalation.\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eNonconformity and Corrective Action:\u003c\/strong\u003e Assess processes for managing nonconforming products, investigating causes, implementing corrective actions, and checking effectiveness.\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eRecords and Regulatory Documentation:\u003c\/strong\u003e Review applicable quality records and documentation against the agreed audit scope.\u003c\/li\u003e\n\u003c\/ul\u003e\n\u003cp\u003eThe specific audit criteria depend on your organisation's activities, device types, existing quality management system, and applicable regulatory requirements.\u003c\/p\u003e\n\u003ch2\u003eWho Should Consider This Service?\u003c\/h2\u003e\n\u003cul\u003e\n\u003cli\u003eMedical device manufacturers supplying or planning to supply the US market.\u003c\/li\u003e\n\u003cli\u003eOrganisations reviewing their quality management system against the FDA's QMSR.\u003c\/li\u003e\n\u003cli\u003eBusinesses implementing or maintaining an ISO 13485:2016-based quality management system.\u003c\/li\u003e\n\u003cli\u003eManufacturers preparing for an internal audit or regulatory inspection.\u003c\/li\u003e\n\u003cli\u003eCompanies seeking to identify quality system weaknesses before implementing corrective improvements.\u003c\/li\u003e\n\u003cli\u003eMedical device businesses reviewing existing procedures following regulatory or operational changes.\u003c\/li\u003e\n\u003c\/ul\u003e\n\u003ch2\u003eOur QMSR \u0026amp; ISO 13485 Gap Audit Process\u003c\/h2\u003e\n\u003col\u003e\n\u003cli\u003e\n\u003cstrong\u003eInitial Assessment:\u003c\/strong\u003e Understand your organisation, device types, manufacturing or service activities, and existing quality management system.\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eScope Definition:\u003c\/strong\u003e Agree on the applicable audit criteria, processes, locations, and documentation to be reviewed.\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eDocumentation Review:\u003c\/strong\u003e Examine relevant quality manuals, procedures, records, and supporting documentation within the agreed scope.\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eRequirements Assessment:\u003c\/strong\u003e Compare the available evidence against applicable QMSR and ISO 13485:2016 requirements.\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eGap Identification:\u003c\/strong\u003e Identify potential nonconformities, documentation gaps, and processes that may need improvement.\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eFindings and Recommendations:\u003c\/strong\u003e Present the findings and practical recommendations in accordance with the agreed deliverables.\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eCorrective Action Planning:\u003c\/strong\u003e Help prioritise improvement activities and establish a plan for addressing the identified gaps.\u003c\/li\u003e\n\u003c\/ol\u003e\n\u003ch2\u003eWhat Are the Benefits of a Gap Audit?\u003c\/h2\u003e\n\u003cul\u003e\n\u003cli\u003e\n\u003cstrong\u003eImproved Regulatory Awareness:\u003c\/strong\u003e Understand the QMSR and ISO 13485 requirements relevant to your operations.\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eEarly Gap Identification:\u003c\/strong\u003e Identify potential weaknesses before they lead to more significant compliance issues.\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eStructured Improvement Planning:\u003c\/strong\u003e Use documented findings to organise corrective and preventive activities.\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eBetter Documentation Control:\u003c\/strong\u003e Identify areas where quality procedures and records may need to be reviewed or updated.\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eRisk-Based Prioritisation:\u003c\/strong\u003e Focus improvement efforts on issues relevant to product quality, patient safety, and regulatory compliance.\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eInspection Preparation:\u003c\/strong\u003e Support preparation for applicable regulatory inspections through improved awareness and organisation of quality system evidence.\u003c\/li\u003e\n\u003c\/ul\u003e\n\u003ch2\u003eDocuments and Information You May Need\u003c\/h2\u003e\n\u003cp\u003eDepending on the agreed audit scope, the following information may be requested:\u003c\/p\u003e\n\u003cul\u003e\n\u003cli\u003eQuality manual and quality management system overview.\u003c\/li\u003e\n\u003cli\u003eDocument control and record management procedures.\u003c\/li\u003e\n\u003cli\u003eRisk management procedures and relevant records.\u003c\/li\u003e\n\u003cli\u003eDesign and development documentation, where applicable.\u003c\/li\u003e\n\u003cli\u003eSupplier qualification and purchasing control records.\u003c\/li\u003e\n\u003cli\u003eProduction, process validation, and traceability records, where applicable.\u003c\/li\u003e\n\u003cli\u003eComplaint handling, nonconformity, and corrective action procedures.\u003c\/li\u003e\n\u003cli\u003eInternal audit records and management review documentation.\u003c\/li\u003e\n\u003cli\u003eApplicable regulatory procedures and previous audit findings.\u003c\/li\u003e\n\u003c\/ul\u003e\n\u003cp\u003eNot every document will apply to every organisation. The required evidence depends on the device, business activities, applicable exclusions or exceptions, and the agreed audit criteria.\u003c\/p\u003e\n\u003ch2\u003eQMSR and ISO 13485: Understanding the Relationship\u003c\/h2\u003e\n\u003cp\u003eISO 13485:2016 establishes quality management system requirements for organisations involved in medical devices and related services. The FDA's QMSR incorporates ISO 13485:2016 by reference while retaining additional FDA-specific requirements and provisions.\u003c\/p\u003e\n\u003cp\u003eMeeting ISO 13485 requirements should not automatically be treated as proof that every FDA obligation has been met. A suitable assessment must also consider the applicable provisions of the QMSR and other relevant FDA regulations.\u003c\/p\u003e\n\u003ch2\u003eFrequently Asked Questions About QMSR \u0026amp; ISO 13485 Gap Audits\u003c\/h2\u003e\n\u003cp\u003eVisit our dedicated Frequently Asked Questions page for further information about QMSR requirements, ISO 13485, audit preparation, documentation, and quality management system improvement.\u003c\/p\u003e\n\u003ch2\u003eAssess Your Quality Management System\u003c\/h2\u003e\n\u003cp\u003eTake a structured approach to reviewing your medical device quality management system. The QMSR \u0026amp; ISO 13485 Gap Audit from Cosmetic Compliance Nest can help your organisation identify potential gaps, understand applicable requirements, and plan the next steps towards improving its quality processes.\u003c\/p\u003e\n\u003cdiv class=\"cn-note\"\u003e\n\u003ch3\u003eImportant Disclaimer\u003c\/h3\u003e\n\u003cp\u003eCosmetic Compliance Nest provides independent quality and regulatory consultancy services and is not affiliated with or endorsed by the US Food and Drug Administration (FDA) or the International Organization for Standardization (ISO). A gap audit is an assessment against the agreed criteria and available evidence; it does not guarantee regulatory compliance, successful certification, or a favourable inspection outcome. Formal certification, where required, must be conducted by an appropriately accredited certification body. Audit scope, deliverables, and any follow-up support are subject to the agreed service terms.\u003c\/p\u003e\n\u003c\/div\u003e\n\u003c\/div\u003e","brand":"Nest Qual","offers":[{"title":"Default Title","offer_id":51539745374375,"sku":null,"price":728659.0,"currency_code":"PKR","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0768\/9496\/1831\/files\/laboratory_3.png?v=1792311981","url":"https:\/\/www.cosmeticcompliancenest.com\/products\/qmsr-iso-13485-gap-audit-510k","provider":"Nest Qual","version":"1.0","type":"link"}