--- title: "QMS Templates and SOPs for Life Sciences | Qualio" canonical: "https://www.qualio.com/compliance-platform/qms-templates" updatedDate: "2026-11-02T21:15:02.000Z" description: "Quality procedures, templates and workflows for medical devices, SaMD, IVD, therapeutics, labs and ISO 27001, about 90% written, loaded into Qualio and mapped to the regulation." --- # QMS Templates and SOPs for Life Sciences | Qualio Quality procedures, templates and workflows for medical devices, SaMD, IVD, therapeutics, labs and ISO 27001, about 90% written, loaded into Qualio and mapped to the regulation. ## Your quality procedures, already written Procedures, document templates and event templates for 15 regulatory pathways, about 90% written and loaded into your Qualio library. ## What the pathways hold Every pathway is built on the same shared processes, then adds what its regulations ask for. Written, with the roles and products left for your team. Documents and templates across every pathway. Pathways, from medical devices to ISO 27001. ## What's in a pathway Each pathway holds the procedures, document templates and event templates for one regulatory requirement, with a work instruction for running each process in Qualio. The procedures are about 90% written. The steps, responsibilities and records are set out, and your team tailors the rest to your products, processes and risk profile, then approves each one. ## How it gets into Qualio - Choose the pathway for what you make and where you sell it. - Our support team loads the procedures and templates into your document library and sets up the event templates as the workflows that run them. - Your team tailors each procedure and approves it through your own document control. ## What it maps to Each pathway includes a matrix that maps its documents to the clauses of the regulation it answers. Once the procedures are approved, Compliance Frameworks assesses them clause by clause against the standards you run. ## Hear from our customers ## The processes every pathway starts with Each card lists what comes with the process and where to see it run in Qualio. ### Document control The document control, good documentation practice and records procedures, with templates for SOPs, work instructions and quality records. Each document runs through Qualio's own review and approval. See [Document control](/compliance-platform/document-control). ### Change control The general change procedure and a design and process change review, with the change request workflow and a guide to raising one in Qualio. See [Change control](/compliance-platform/change-control). ### Training The training procedure, with training record and employee file templates and a guide to building training plans in Qualio, so a revised procedure goes out with its retraining. See [Training](/compliance-platform/training). ### CAPA The CAPA procedure with the CAPA and extension request workflows, and a guide to raising and extending a CAPA in Qualio. See [Quality events](/compliance-platform/quality-events). ### Nonconformance and deviation Procedures for nonconformances and deviations, each with its own workflow and a guide to raising one in Qualio. ### Complaints and feedback Procedures for customer feedback and complaints, with a feedback form and the complaint and incident report workflows. See [Post-market surveillance](/compliance-platform/post-market-surveillance). ### Suppliers The purchasing and supplier control procedure, with supplier audit forms and schedules, the supplier corrective action workflow and a guide to keeping supplier files in Qualio. See [Suppliers](/compliance-platform/suppliers). ### Audits Procedures for internal and external audits, with an audit schedule, an audit file and the internal audit report workflow. See [Audits](/compliance-platform/audits). ### Risk management The risk management procedure, with templates for the plan, the analysis, the risk management file and the report. See [Risk management](/compliance-platform/risk-management). ### Quality manual and management responsibility The quality manual and quality policy, quality objectives, the organisation chart, and the management review and data analysis procedures with review minutes and actions. ### Electronic records and validation Procedures for electronic records and signatures and for validating software and spreadsheets, with a signature matrix and Qualio's validation document. See [Validation](/compliance-platform/validation). ### Equipment and calibration The calibration and maintenance procedure, with equipment list and equipment record templates. ## What your pathway adds ### Medical device (hardware) Design controls, production and device history records, labelling and sterilisation, the EU MDR and UK MDR technical files, and post-market surveillance with vigilance and recalls. ### Software as a medical device The medical device processes plus the software lifecycle: development, verification and validation, coding practice, IQ/OQ/PQ, requirements and design specifications, and cybersecurity. ### In vitro diagnostic device The medical device processes plus performance evaluation and the EU IVDR technical documentation. ### Therapeutics Laboratory control and out-of-specification results, stability, production and batch release, annual product review, field alerts and recalls, and supply chain and outsourced operations. ### Combination products The medical device and therapeutics processes in one system, with a regulation matrix for each side. ### Cosmetics and nutraceuticals Production and release, quality control, stability and out-of-specification results, supply chain and subcontracting, and post-market adverse event reporting. ### ISO 9001 The shared processes mapped to ISO 9001, with design and development and the release of products and services. ### Laboratories (ISO 15189 and ISO 17025) Examination and test methods, method validation, measurement uncertainty and decision rules, sampling and reagents, and the release of results and certificates of analysis. ### ISO 27001 The shared processes plus an information security management system: security policies, incident response, business continuity, privacy and data protection, the statement of applicability and a security risk register. ### Combined pathways Hardware with SaMD, SaMD with ISO 27001, hardware with SaMD and ISO 27001, or ISO 9001 with ISO 27001, each set up as one quality system. ### Clinical Good clinical practice on top of any pathway: study set-up, monitoring, serious adverse events, investigational product, the trial master file, clinical data and trial closure. ## Frequently Asked Questions ### Are these templates or finished procedures? Finished procedures, about 90% written. Each one sets out the steps, the responsibilities and the records, and leaves the parts only your company can fill in, such as your roles and your products. Your team tailors each one and approves it through your own document control. ### Which pathways do I need, and how are they sold? Pathways come in four packages. Core fits a company with one regulatory requirement, such as medical device hardware or ISO 9001: 60+ documents, 60 document templates and 9 event templates. Premier fits a company with several, such as SaMD with ISO 27001: 80+ documents, 80+ document templates and 10 event templates. The clinical add-on brings 25 documents, 6 document templates and 1 event template. All Access holds every pathway, 1000+ documents and 130+ event templates, for teams serving clients with different requirements. ### How much time does it save? Our customers estimate six months, the time it takes to write a quality system, review it and put it into use. ### How do the templates relate to the frameworks? Each pathway's matrix maps its documents to the regulation's clauses. Once your team has tailored and approved the procedures, Compliance Frameworks assesses them clause by clause against the standards you run and recommends a fix for any gap. ## Which regulations does your quality system answer to? Tell us what you make and where you sell it, and we will show you the processes your pathway brings, loaded in Qualio.