School Accreditation Processes

Foundation FSSC officially released FSSC 22000 Version 7 on 1 May 2026, and the V7 documents highlight key updates such as the new ISO 22002-x:2025 PRP structure, alignment with GFSI Benchmarking Requirements 2024, clearer food chain categories, and strengthened additional requirements. FSSC 22000 Version 7 has been officially released on 1st May 2026. For food businesses, certified organizations, consultants, auditors, and food safety professionals, this update is important because Version 7 brings several changes compared to Version 6. Some key areas to review include: • New ISO 22002-x:2025 PRP structure • More detailed food chain categories and sub-categories • Strengthened product labelling and artwork controls • Updated food defense and food fraud expectations • Expanded PRP verification requirements • Stronger focus on food safety and quality culture • Measurable food loss and waste targets • New requirements related to certification process governance and AI usage Version 7 does not replace ISO 22000:2018. ISO 22000:2018 continues as the base standard. The major changes are in the supporting PRP standards, FSSC additional requirements, categorization, audit expectations, and certification controls. Organizations certified under FSSC 22000 should not wait until the transition deadline. This is the right time to review existing manuals, PRP checklists, food defense plans, food fraud assessments, allergen controls, labelling systems, and management review inputs. Refer to the attached infographic for a simplified comparison between FSSC 22000 Version 6 and Version 7. #FSSC22000 #FoodSafety #ISO22000 #FSSCV7 #FoodSafetyManagement #FSMS #FoodIndustry #FoodManufacturing #Audit #Compliance #CQAS

🚨 𝐌𝐀𝐉𝐎𝐑 𝐈𝐒𝐎 10993-1 𝐔𝐏𝐃𝐀𝐓𝐄𝐒 𝐈𝐌𝐌𝐈𝐍𝐄𝐍𝐓! 🚨 The 2025 revision of ISO 10993-1 is nearing publication, introducing significant changes to the evaluation of medical devices for biological safety. Manufacturers should prepare now, as many regions, particularly Europe, are expected to consider the new standard as State-of-the-Art immediately upon release. 𝐇𝐞𝐫𝐞 𝐚𝐫𝐞 𝐭𝐡𝐞 𝐤𝐞𝐲 𝐬𝐡𝐢𝐟𝐭𝐬 𝐢𝐧 𝐛𝐢𝐨𝐜𝐨𝐦𝐩𝐚𝐭𝐢𝐛𝐢𝐥𝐢𝐭𝐲 𝐞𝐯𝐚𝐥𝐮𝐚𝐭𝐢𝐨𝐧 𝐞𝐱𝐩𝐥𝐚𝐢𝐧𝐞𝐝 𝐟𝐨𝐫 𝐲𝐨𝐮𝐫 𝐢𝐧𝐟𝐨𝐠𝐫𝐚𝐩𝐡𝐢𝐜: 1️⃣ 𝑰𝒏𝒄𝒓𝒆𝒂𝒔𝒆𝒅 𝑭𝒐𝒄𝒖𝒔 𝒐𝒏 𝑹𝒊𝒔𝒌 𝑴𝒂𝒏𝒂𝒈𝒆𝒎𝒆𝒏𝒕 & 𝑬𝒙𝒑𝒆𝒓𝒕𝒊𝒔𝒆 🧐 The standard moves definitively away from a traditional "checkbox approach". • ISO 14971 Integration • Author Qualifications 2️⃣ 𝑹𝒆𝒄𝒂𝒕𝒆𝒈𝒐𝒓𝒊𝒛𝒂𝒕𝒊𝒐𝒏 𝒐𝒇 𝑪𝒐𝒏𝒕𝒂𝒄𝒕 𝑫𝒖𝒓𝒂𝒕𝒊𝒐𝒏 (𝑪𝒖𝒎𝒖𝒍𝒂𝒕𝒊𝒗𝒆 𝑼𝒔𝒆)  🔄 The approach to repeat-use devices has changed significantly, impacting categorisation and required testing. • Cumulative Contact. • Bioaccumulation. 3️⃣ 𝑴𝒂𝒏𝒅𝒂𝒕𝒆 𝒕𝒐 𝑬𝒗𝒂𝒍𝒖𝒂𝒕𝒆 𝑭𝒐𝒓𝒆𝒔𝒆𝒆𝒂𝒃𝒍𝒆 𝑴𝒊𝒔𝒖𝒔𝒆 🤔 Manufacturers must now consider foreseeable misuse—usage that may seem reasonable in a clinical setting but was not initially intended by the manufacturer. • This includes off-label use. • Failure to address foreseeable misuse can lead to regulatory pushback and necessitate reassessing endpoints and potentially repeating costly testing, especially chemical characterisation (ENL). 4️⃣ 𝑺𝒉𝒊𝒇𝒕𝒊𝒏𝒈 𝑩𝒊𝒐𝒍𝒐𝒈𝒊𝒄𝒂𝒍 𝑬𝒏𝒅𝒑𝒐𝒊𝒏𝒕𝒔 🔬 The requirements for specific tests are being adjusted: • Material Mediated Pyrogenicity (MMP) Removal. • Increased Genotoxicity. 5️⃣ 𝑳𝒊𝒇𝒆 𝑪𝒚𝒄𝒍𝒆 & 𝑫𝒆𝒈𝒓𝒂𝒅𝒂𝒕𝒊𝒐𝒏 𝑮𝒖𝒊𝒅𝒂𝒏𝒄𝒆 ♻️ The update includes new guidance on evaluating biocompatibility risks across the entire product life cycle (including prototyping) and clearer requirements for assessing device degradation risks over its useful life. What should you do now? You can start performing a Gap Assessment on your current Biological Evaluation documentation and Quality Management System procedures. This is crucial to identify and prioritise necessary updates before submission, especially if you are pursuing European markets. W̳a̳n̳t̳ ̳a̳ ̳d̳e̳e̳p̳e̳r̳ ̳d̳i̳v̳e̳?̳ 🎧 Listen to the discussion with expert Marina Daineko: https://lnkd.in/eNh8twiN #MedicalDevices #Biocompatibility #ISO10993 #RegulatoryAffairs #MedTech

FDA just updated their Recognized Standards list. Under Section B, FDA announces withdrawals and replacements of recognized standards in the biocompatibility category. These include: 1️⃣ ASTM F1984–25 Whole Complement Activation in Serum by Solid Materials → Updated version recognized   👉 Relevant to ISO 10993-4 effects (blood compatibility, complement activation) 2️⃣ ASTM F2147–01 (Reapproved 2016) Guinea Pig: Split Adjuvant and Closed Patch Testing for Contact Allergens → Withdrawn   👉 Sensitization method (historical method; withdrawal may reflect evolving regulatory approach) 3️⃣ ASTM F895–25 Agar Diffusion Cytotoxicity Screening → Updated version recognized   👉 Cytotoxicity (ISO 10993-5 alignment) 4️⃣ ASTM F748–25 Selecting Biological Test Methods for Materials and Devices → Updated version recognized   👉 Strategic biological evaluation planning (aligned with ISO 10993-1 philosophy) 5️⃣ ISO 10993-4:2017 + Amendment 1 (2025) Selection of tests for interactions with blood → Updated recognition   👉 Includes Amendment 1; blood compatibility guidance 6️⃣ ASTM F720–24 Guinea Pig Maximization Test (GPMT) → Updated version recognized   👉 Sensitization 🚫 𝐖𝐡𝐚𝐭 𝐢𝐬 𝐍𝐎𝐓 𝐢𝐧𝐜𝐥𝐮𝐝𝐞𝐝 →No new biocompatibility standards added in Table 2 →No changes to ISO 10993-1 in this specific notice →No new chemical characterization standards added Please share this with your audience! #ISO10993 #biocompatibility • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • If you’re currently working on biological evaluation and would value a second set of experienced eyes, feel free to reach out. I’d be glad to help.

🧩 Technical Standards every MedTech professionals should know! Whether you're dealing with a Class I device, Class III or building an AI-based SaMD, aligning with the right standards is critical for regulatory success and product quality. But where do you start? Which ones are essential for your compliance? Of course, specific standards depend on device type, intended use, and market. But today I decided to share those standards that form the foundation of regulatory expectations across the industry. 👇 Here's a selection of technical standards every MedTech or regulatory team should be aware of, with recent updates and what’s coming!   🛡️ 𝗚𝗲𝗻𝗲𝗿𝗮𝗹 𝘀𝗮𝗳𝗲𝘁𝘆 𝗮𝗻𝗱 𝗾𝘂𝗮𝗹𝗶𝘁𝘆 📌 ISO 13485 Medical Devices - Quality Management Systems 📌 ISO 14971 Medical Devices - Risk Management 📌 IEC 62366-1 Medical Devices - Usability Engineering 📌 ISO 10993 series Biological Evaluation for Medical Devices 📌 IEC 60601 Series Electrical Safety Requirements 📌 ISO 15223-1 Medical Devices - Labelling 💻 𝗦𝗼𝗳𝘁𝘄𝗮𝗿𝗲, 𝗜𝗻𝗳𝗼𝗿𝗺𝗮𝘁𝗶𝗼𝗻 𝗦𝗲𝗰𝘂𝗿𝗶𝘁𝘆 𝗮𝗻𝗱 𝗔𝗜 📌 IEC 62304 Software Life Cycle Processes 📌 ISO 27001 Information Security Management Systems 📌 ISO 42001 Information technology - Artificial intelligence - Management system 🧪 𝗖𝗹𝗶𝗻𝗶𝗰𝗮𝗹 𝗜𝗻𝘃𝗲𝘀𝘁𝗶𝗴𝗮𝘁𝗶𝗼𝗻, 𝗖𝗹𝗶𝗻𝗶𝗰𝗮𝗹 𝗣𝗲𝗿𝗳𝗼𝗿𝗺𝗮𝗻𝗰𝗲 𝗦𝘁𝘂𝗱𝗶𝗲𝘀 📌 ISO 14155 Medical Devices - Clinical Investigations 📌 ISO 20916 IVDs – Clinical performance studies 📣📣 What’s New: 📘 ISO 14155:2026 → Clinical investigation of medical devices for human subjects — Good clinical practice → Edition 4, 2026 published in March. 📘 ISO 10993-7:2026 → Biological evaluation of medical devices Part 7: Ethylene oxide sterilization residuals → Edition 3, 2026 just published. 📘 ISO 20417:2026 → Medical devices - Information to be supplied by the manufacturer → 2026 Edition published, and 2021 officially withdrawn. 📣 What’s Coming: 📘 ISO 18969 → A new standard for clinical evaluation of medical devices → Under development, now in Draft International Standard (DIS) stage. ⚠️ Staying up to date and monitor standards stage is not just good practice, it's essential to ensure compliance as expectations evolve.   New versions may change what's acceptable in risk management, testing, documentation, and more. This is why, on the MedBoard platform regulatory intelligence is not just about regulations and guidance. 👉 Real-time monitoring includes standards updates, adoptions, and country recognitions. So teams can stay informed, all in one place.   💬 Which of these do you use most?   #MedBoard #MedTech #MedicalDevices #RegulatoryAffairs #QualityManagement #RiskManagement  #ClinicalEvaluation #Compliance #ISO13485 #ISO14971 #MDSW #ClinicalAffairs #PostMarketSurveillance

TJC’s “NEW” Standards Just Dropped. Let’s Talk About It. On June 30th, the Joint Commission announced a massive overhaul. A full consolidation of its standards. This change takes effect January 2026, and while it might look new, here’s the truth. Nothing, and I mean NOTHING, is actually new! This isn’t about adding expectations. It’s about stripping away the fluff, aligning with CMS, and reducing confusion and redundancy. It’s a reset that forces us to return to the true sources: the codes, the standards, and the Conditions of Participation. And while the headlines are few, this is the kind of update that matters deeply to those of us working in compliance, operations, and education for the physical environment of care. Most people haven’t had time to dig into the details, but a few of us have. We have already reviewed the new standards and pre-publication content, and we’re working on practical resources to help healthcare facilities teams navigate the transition confidently. American Society for Health Care Engineering (ASHE) has already built courses to align and rolled out a super new cool tool called the Compliance Tracker. I put together a quick video to start the discussion, and we’ll be publishing an article on our website shortly to help frame what this means for survey prep, day-to-day operations, and future strategy. Until then, I’d love to hear from others in the field: ·  What questions do you have about the changes? ·  What’s your take on the changes? ·  How will this impact your facility documentation or survey prep? ·  Do you think this is the simplification we’ve been waiting for? Y'all let’s lead this change, not react to it. Legacy FM American Hospital Association Joint Commission Joint Commission Resources FM Reimagined, LLC NFPA Centers for Medicare & Medicaid Services #HealthCareFacilities #TJC #Accreditation #HospitalCompliance #EnvironmentOfCare #LifeSafety #LegacyFM #EmpowermentThroughEducation #CMS #FacilitiesManagement

Did you miss it? EVS-EN ISO 10993-12:2021 got Amendment A1:2025, and it tightens how sample preparation and extraction are justified. If your extractables and biological testing evidence depends on “standard” extraction ratios, this one is worth aligning on with your lab and your technical file owner. What changed: ↳ EVS-EN ISO 10993-12:2021+A1:2025 (consolidated) is active since 1 Oct 2025. ↳ Type: EN standard, Amendment | Region: EU ↳ Source: EVS standards catalogue entry (consolidated edition) 3 changes that matter most: 1. Normative alignment is tightened: the references list is updated and key clauses shift from “see” to “in accordance with” ISO 14971, ISO 10993-1, ISO 10993-18 and ISO/TS 10993-19. 2. Extraction planning gets more explicit: you must consider absorption capacity of absorbent materials when setting the overall extraction volume. 3. Table 1 is replaced with updated standard surface areas and extract volumes, including clearer handling for elastomeric materials, irregular solids and porous low-density materials, plus added notes for solvent-absorbing polymers and extraction-ratio justification for multilayer components. What this means for manufacturers: ↳ Your extraction rationale may need an update, especially for absorbent, porous, elastomeric, and multilayer devices where default ratios can under- or over-extract. ↳ CRO and lab work orders should be checked, because Table 1 and the extraction volume logic are now more prescriptive and easier to audit. ↳ Technical documentation may need clean-up: ensure your test plans and reports clearly show “in accordance with” alignment and the updated extraction set-up logic. What to do next: 1. Update your sample prep and extraction SOPs and templates to reflect the revised references, wording, and the new Table 1 structure. 2. Identify products with absorbent or porous components and confirm extraction volume calculations account for absorption capacity, not just nominal solvent volume. 3. Review recent biocompatibility and extractables packages for Table 1 alignment and document bridging where legacy extraction ratios or justifications differ. P.S. where do you see the biggest risk: absorbent materials, porous low-density polymers, or multilayer components with hard-to-justify extraction ratios? ⬡⬡⬡⬡⬡⬡⬡⬡⬡⬡⬡⬡⬡⬡⬡⬡⬡⬡⬡⬡⬡⬡⬡⬡⬡⬡⬡⬡⬡⬡⬡⬡⬡⬡⬡⬡⬡⬡⬡⬡⬡⬡ MedTech regulatory challenges can be complex, but smart strategies, cutting-edge tools, and expert insights can make all the difference. I'm Tibor, passionate about leveraging AI to transform how regulatory processes are automated and managed. Let's connect and collaborate to streamline regulatory work for everyone! #automation #regulatoryaffairs #medicaldevices

⛔ISO19011 Is Changing: What You Need to Know⛔ #ISO19011, the global standard for auditing management systems, is getting a significant update. The Draft International Standard (DIS) 19011:2025 introduces changes that will impact governance, risk, and compliance (GRC) professionals, particularly those overseeing audit functions. ➡️ What’s Changing in ISO19011? 1. Remote Auditing Is No Longer an Exception, It’s the Norm 🔷What’s new? 🔸The 2025 draft expands guidance on remote auditing, aligning with ISO/IEC TS 17012 (conformity assessment for remote audits). 🔸Organizations conducting virtual audits, hybrid audits, or remote compliance reviews will have clearer best practices. 🔷What this means for You: 🔸If your audit programs still treat remote auditing as a workaround, it’s time to formalize it. 🔸New policies and controls for virtual audits will be necessary to maintain audit credibility. 2. Stronger Risk-Based Approach to Auditing 🔷What’s new? 🔸The 2025 draft elevates risk assessment in audit planning and execution. 🔸Auditors will need to assess risks and opportunities within an audit program before conducting assessments. 🔷What this means for You: 🔸Risk-based auditing is becoming a requirement, not a best practice. 🔸Audit teams should prioritize high-risk areas, integrating audits with enterprise risk management (ERM). 3. Virtual Organizations & Digital Evidence Get Formal Recognition 🔷What’s new? 🔸The draft standard acknowledges “virtual locations”, organizations that operate without a physical footprint. 🔸New guidance covers auditing digital processes, AI-driven decisions, and cloud-based compliance programs. 🔷What this means for You: 🔸Compliance audits must adapt to digital businesses, especially in cloud security, AI governance, and fintech. 🔸Organizations will need new controls for validating digital records and automated compliance tools. 4. Auditor Competency Requirements Are Expanding 🔷What’s new? 🔸The 2025 revision strengthens competency requirements for auditors, including skills in cybersecurity, AI oversight, and remote auditing tools (Shea Brown). 🔸Training and evaluation criteria for audit teams will become more structured. 🔷What this means for You: 🔸Expect more rigorous requirements for internal and external auditors. 🔸Consider upskilling your audit teams now in digital auditing, cybersecurity compliance, and AI governance. ➡️How Should You Prepare? ◽Review Your Remote Auditing Policies – If virtual audits aren’t fully integrated into your audit program, now is the time to refine procedures. ◽Strengthen Risk-Based Audit Planning – Compliance is shifting from a checklist approach to a risk-prioritized strategy. Audit programs should align with enterprise risk frameworks. ◽Update Auditor Competency Requirements – The skills required to audit AI, cybersecurity, and remote environments will be increasingly scrutinized. Ensure your teams are trained and ready. A-LIGN #TheBusinessofCompliance

NCQA’s Latest Equity & Digital Quality Updates: What Every Value-Based Leader Should Know The next evolution of NCQA’s Health Equity & Digital Quality strategy is here — & it’s reshaping how we measure care, risk & performance across the VBC ecosystem. Here’s the short version 👇 1️⃣ Equity: Accessibility, Disability & Data Inclusion The 2026 Health Equity Accreditation (HEA & HEA Plus) standards expand what “equity” means in practice. 🔹 Disability & accommodation data collection is now a core requirement. 🔹 Geographic classification joins race/ethnicity as a disparity stratifier. 🔹 Community Health Worker (CHW) standards are formalized for training & supervision. 🔹 Focus expands from “cultural & linguistic” to appropriateness & accessibility for all populations. These shifts elevate equity from a program to a measurable system function — embedded in workflows, digital access & data infrastructure. 2️⃣ Digital Quality: From HEDIS to Real-Time Intelligence NCQA’s digital transition continues: 🔹 Digital HEDIS® moves quality reporting from annual to continuous. 🔹 Validation, test & parallel reporting pathways define readiness milestones. 🔹 New “dQM Implementation Validation” supports interoperability & trust in digital measures. Bottom line: manual abstraction & spreadsheet reporting won’t cut it in a digital quality era. 3️⃣ Why It Matters for Risk & Quality Leaders ✅ Equity is now quantified — you’ll need complete, stratified data to stay compliant. ✅ Digital readiness becomes a competitive advantage in payer & provider contracts. ✅ Success means blending analytics, accessibility & automation across the risk & quality continuum. What to Do Now ✔️ Audit how your org captures disability, accommodations & geographic data. ✔️ Check your portals & apps for accessibility — this is now an NCQA standard. ✔️ Engage with NCQA Digital Content Services & test your digital HEDIS readiness. ✔️ Educate stakeholders that “digital quality” = real-time & reliable performance. In short: These updates redefine equity & quality — moving us from reactive compliance to proactive, data-driven accountability. The leaders who prepare now will own the next generation of value-based care. At VBC One, we’re helping plans & provider partners navigate this exact transformation — aligning risk & quality in real-time. https://lnkd.in/gZRf9gU7 #NCQA #HealthEquity #DigitalQuality #HEDIS #ValueBasedCare #MSO #QualityImprovement #RiskAdjustment #PopulationHealth

On December 22, 2025, the 𝗙𝗗𝗔 updated its 𝗥𝗲𝗰𝗼𝗴𝗻𝗶𝘇𝗲𝗱 𝗖𝗼𝗻𝘀𝗲𝗻𝘀𝘂𝘀 𝗦𝘁𝗮𝗻𝗱𝗮𝗿𝗱𝘀 𝗗𝗮𝘁𝗮𝗯𝗮𝘀𝗲, adding 𝟭𝟬𝟬+ 𝗻𝗲𝘄 𝗼𝗿 𝗿𝗲𝘃𝗶𝘀𝗲𝗱 𝘀𝘁𝗮𝗻𝗱𝗮𝗿𝗱𝘀, with a subset eligible for use under the 𝗔𝗦𝗖𝗔 𝗣𝗿𝗼𝗴𝗿𝗮𝗺. For manufacturers working in the 𝗺𝗲𝗱𝗶𝗰𝗮𝗹 𝗲𝗹𝗲𝗰𝘁𝗿𝗶𝗰𝗮𝗹 𝗲𝗾𝘂𝗶𝗽𝗺𝗲𝗻𝘁 space, this update includes several 𝗜𝗘𝗖 𝟲𝟬𝟲𝟬𝟭 and 𝗜𝗘𝗖 𝟴𝟬𝟲𝟬𝟭 standards that are directly relevant and 𝗔𝗦𝗖𝗔-𝗲𝗹𝗶𝗴𝗶𝗯𝗹𝗲. The update also highlights how ASCA applies across a broader range of 𝗺𝗲𝗱𝗶𝗰𝗮𝗹 𝗱𝗲𝘃𝗶𝗰𝗲𝘀, including 𝗜𝗩𝗗𝘀, 𝗰𝗼𝗺𝗯𝗶𝗻𝗮𝘁𝗶𝗼𝗻 𝗽𝗿𝗼𝗱𝘂𝗰𝘁𝘀, and devices that are not based on medical electrical equipment. 𝗔𝗦𝗖𝗔 𝗲𝗹𝗶𝗴𝗶𝗯𝗶𝗹𝗶𝘁𝘆 𝗮𝗽𝗽𝗹𝗶𝗲𝘀 𝗶𝗻 𝗺𝘂𝗹𝘁𝗶𝗽𝗹𝗲 𝗮𝗿𝗲𝗮𝘀, but the impact can look very different depending on whether a product is evaluated under the 𝗜𝗘𝗖 𝟲𝟬𝟲𝟬𝟭 𝘀𝗲𝗿𝗶𝗲𝘀, 𝗜𝗘𝗖 𝟲𝟭𝟬𝟭𝟬 (𝗳𝗼𝗿 𝗲𝗹𝗲𝗰𝘁𝗿𝗶𝗰𝗮𝗹𝗹𝘆 𝗯𝗮𝘀𝗲𝗱 𝗜𝗩𝗗𝘀 𝗼𝗻𝗹𝘆), or 𝗼𝘂𝘁𝘀𝗶𝗱𝗲 𝘁𝗵𝗲 𝗲𝗹𝗲𝗰𝘁𝗿𝗶𝗰𝗮𝗹 𝘀𝗮𝗳𝗲𝘁𝘆 𝘀𝗽𝗮𝗰𝗲 𝗮𝗹𝘁𝗼𝗴𝗲𝘁𝗵𝗲𝗿, for example 𝗯𝗶𝗼𝗰𝗼𝗺𝗽𝗮𝘁𝗶𝗯𝗶𝗹𝗶𝘁𝘆. 𝗣𝗿𝗮𝗰𝘁𝗶𝗰𝗮𝗹 𝘄𝗮𝘁𝗰𝗵-𝗼𝘂𝘁 𝗳𝗼𝗿 𝗜𝗩𝗗 𝗘𝗠𝗖: 𝗜𝗘𝗖 𝟲𝟭𝟯𝟮𝟲-𝟮-𝟲 𝗘𝗱𝗶𝘁𝗶𝗼𝗻 𝟰 is now 𝗔𝗦𝗖𝗔-𝗹𝗶𝘀𝘁𝗲𝗱, but the real-world benefit depends on 𝗔𝗦𝗖𝗔-𝗮𝗰𝗰𝗿𝗲𝗱𝗶𝘁𝗲𝗱 𝗹𝗮𝗯𝘀 𝗵𝗮𝘃𝗶𝗻𝗴 𝘁𝗵𝗮𝘁 𝘀𝗽𝗲𝗰𝗶𝗳𝗶𝗰 𝘀𝗰𝗼𝗽𝗲. As of checking recently, that scope does not yet appear to be widely reflected, which can create a 𝘁𝗲𝗺𝗽𝗼𝗿𝗮𝗿𝘆 𝗯𝗼𝘁𝘁𝗹𝗲𝗻𝗲𝗰𝗸 𝗳𝗼𝗿 𝗺𝗮𝗻𝘂𝗳𝗮𝗰𝘁𝘂𝗿𝗲𝗿𝘀 planning to use the ASCA pathway. I’ve reached out to a couple of labs to better understand timing as this develops. Beyond medical electrical and IVD standards, the newly recognized list also spans areas such as 𝗺𝗲𝗱𝗶𝗰𝗮𝗹 𝗶𝗺𝗮𝗴𝗶𝗻𝗴 (𝗗𝗜𝗖𝗢𝗠), 𝗵𝗲𝗮𝗹𝘁𝗵 𝗶𝗻𝗳𝗼𝗿𝗺𝗮𝘁𝗶𝗰𝘀 𝗮𝗻𝗱 𝗶𝗻𝘁𝗲𝗿𝗼𝗽𝗲𝗿𝗮𝗯𝗶𝗹𝗶𝘁𝘆, and a wide range of 𝗱𝗲𝘃𝗶𝗰𝗲-𝘀𝗽𝗲𝗰𝗶𝗳𝗶𝗰 𝘁𝗲𝗰𝗵𝗻𝗼𝗹𝗼𝗴𝗶𝗲𝘀. I’ve published a deeper breakdown that covers • what changed in the FDA database • how 𝗔𝗦𝗖𝗔 𝗲𝗹𝗶𝗴𝗶𝗯𝗶𝗹𝗶𝘁𝘆 fits within FDA’s recognized standards framework • a focused look at the 𝗜𝗘𝗖 𝟲𝟬𝟲𝟬𝟭 and 𝗜𝗘𝗖 𝟴𝟬𝟲𝟬𝟭 standards included in this update The full article link is in the comments. A follow-on blog post with the 𝗰𝗼𝗺𝗽𝗹𝗲𝘁𝗲 𝗹𝗶𝘀𝘁 𝗼𝗳 𝗻𝗲𝘄𝗹𝘆 𝗿𝗲𝗰𝗼𝗴𝗻𝗶𝘇𝗲𝗱 𝘀𝘁𝗮𝗻𝗱𝗮𝗿𝗱𝘀 and additional analysis will follow.

If you're involved in Healthcare Facility Management, there have been a few major announcements in the last week. 1. The Joint Commission announced a major overhaul of its Life Safety and Environment of Care standards, aligning them more closely with CMS Conditions of Participation. This new structure, called “Accreditation 360: The New Standard,” merges the EC and LS chapters into one “Physical Environment” chapter and reduces the number of elements of performance by nearly half. This is more of a consolidation than a reduction or loosening of standards. In a move to increase transparency, The Joint Commission standards are now publicly searchable online! 2. ASHRAE and ASHE have officially released Guideline 43. Guideline 43 bridges the gap between design standards and operational standards by providing clear operational guidance that aligns with ASHRAE/ASHE 170. Its goal is to enhance patient, staff, and visitor safety, ensure consistency in HVAC system maintenance, and optimize system performance through a structured ventilation management program. This guideline is a big step toward safer, more efficient, and compliant healthcare facilities. Links to learn more are in the comments 👇 #guideline43 #HealthcareCompliance #FacilityManagement #JointCommission #Accreditation360 #ashe