School Accreditation Processes

🚨 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.

𝐇𝐨𝐰 𝐓𝐨 𝐏𝐫𝐞𝐩𝐚𝐫𝐞 𝐟𝐨𝐫 𝐚 𝐒𝐮𝐜𝐜𝐞𝐬𝐬𝐟𝐮𝐥 𝐀𝐜𝐜𝐫𝐞𝐝𝐢𝐭𝐚𝐭𝐢𝐨𝐧 𝐏𝐞𝐞𝐫 𝐑𝐞𝐯𝐢𝐞𝐰 𝐓𝐞𝐚𝐦 𝐕𝐢𝐬𝐢𝐭 𝐚𝐭 𝐘𝐨𝐮𝐫 𝐒𝐜𝐡𝐨𝐨𝐥 𝐨𝐟 𝐁𝐮𝐬𝐢𝐧𝐞𝐬𝐬 Accreditation matters as a sign for quality, connection to an international body that adopts rigorous standards. It provides opportunities to engage with peer institutions, learn from best practices, and avoid pitfalls. This connection to the accreditation body and to other schools of business provides a platform for collaboration. At the recent AACSB conference in a very rainy, but still beautiful, Tunis, at the Mediterranean School of Business, my colleague Thami Ghorfi and I had the chance to share insights regarding peer review visits. Among the main points we discussed: 1-    𝐓𝐡𝐞 𝐏𝐞𝐞𝐫 𝐑𝐞𝐯𝐢𝐞𝐰 𝐓𝐞𝐚𝐦 (𝐏𝐑𝐓) 𝐢𝐬 𝐧𝐨𝐭 𝐚𝐧 𝐚𝐮𝐝𝐢𝐭𝐢𝐧𝐠 𝐛𝐨𝐝𝐲 𝐚𝐧𝐝 𝐝𝐨𝐞𝐬 𝐧𝐨𝐭 𝐩𝐨𝐥𝐢𝐜𝐞 𝐲𝐨𝐮𝐫 𝐨𝐩𝐞𝐫𝐚𝐭𝐢𝐨𝐧𝐬. Their role is to verify, clarify, and offer you advice on how to meet accreditation standards and not fall off. They normally evaluate the school’s mission, review the strategic plans, and ask for clarification and offer guidance on educational quality, assurance of learning, and faculty qualifications. They offer “expert consultative advice” not policing. 2-     𝐁𝐞𝐢𝐧𝐠 𝐜𝐨𝐦𝐩𝐨𝐬𝐞𝐝 𝐨𝐟 𝐞𝐱𝐭𝐞𝐫𝐧𝐚𝐥 𝐦𝐞𝐦𝐛𝐞𝐫𝐬 𝐡𝐞𝐥𝐩𝐬 𝐚 𝐥𝐨𝐭. It is often the case that internal members, by the very fact that they are absorbed by the day-to-day operations, may suffer from normative myopia unable to see issues that require their attention. A fresh set of eyes always helps. 3-    𝐄𝐚𝐫𝐥𝐲 𝐩𝐫𝐞𝐩𝐚𝐫𝐚𝐭𝐢𝐨𝐧 𝐢𝐬 𝐜𝐫𝐮𝐜𝐢𝐚𝐥.  Deans should be able to rely on a core team of experienced staff who are able to provide timely and essential internal advice and prepare well in advance. Deans should never attempt to do everything themselves because they aspire to do everything in a "perfect" manner. Doing this, ironically, would almost invariably ensure imperfect preparation. 4-    𝐀 𝐏𝐑𝐓 𝐭𝐞𝐚𝐦 𝐝𝐨𝐞𝐬 𝐧𝐨𝐭 𝐞𝐱𝐩𝐞𝐜𝐭 𝐚 “𝐩𝐞𝐫𝐟𝐞𝐜𝐭” 𝐬𝐜𝐡𝐨𝐨𝐥. Be willing to acknowledge challenges and risks. In my experience a PRT member does not expect that any school would be running without challenges or risks. What is more important is demonstrating that you are aware of those risks and that you have a plan to mitigate them rather than trying to sweep them under the rug. 5-    Make sure your faculty, staff, students, external board members, and other stakeholders 𝐚𝐫𝐞 𝐚𝐥𝐥 𝐚𝐥𝐢𝐠𝐧𝐞𝐝, to the extent possible, in terms of understanding your mission, your positioning, and the value your school offers. Make them aware of the importance of this visit and the positive implications of a successful outcome. Wishing the best of luck to all my colleagues whose schools are undergoing their initial accreditation or reaccreditation! Suliman S. Olayan School of Business at AUB American University of Beirut Ihsan Zakri Leila Triki

🧩 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

How a company should proceed professionally for getting ISO certification, Step by step.. Step 1: 1. Hire a Management Representative , who will oversee the ISO certification process and keep management in loop for progress. 2. Hire an experienced QA/QC Manager who will develop and implement the Quality Management System (QMS). 3. Assemble a team of qualified professionals to support the ISO certification process. Step 2: 1. Develop a Quality Policy that outlines the organization's commitment to quality. 2. Establish Quality Objectives that are measurable and achievable. 3. Develop a QMS manual that outlines the organization's quality policies, procedures, and processes. Step 3: 1. Perform a gap analysis to identify areas where the organization's current processes and systems do not meet the requirements of the ISO standard. 2. Use tools such as checklists, questionnaires, and process mapping to identify gaps. 3. Prioritize the identified gaps based on their impact on the organization. Step 4: 1. Create an implementation plan that outlines the steps needed to address the gaps identified in the gap analysis. 2. Establish a project timeline and milestones. 3. Define roles and responsibilities for each team member. Step 5: 1. Provide training and awareness to employees on the ISO standard, its requirements, and the organization's QMS. 2. Use training methods such as workshops, seminars, and online training. 3. Ensure that employees understand their roles and responsibilities in the QMS. Step 6: 1. Implement the changes and controls identified in the implementation plan. 2. Develop new policies, procedures, and documentation as needed. 3. Establish a document control system to manage documents and records. 4. Implement a records management system to manage records and data. Step 7: 1. Conduct an internal audit to ensure that the organization's QMS meets the requirements of the ISO standard. 2. Use audit tools such as checklists and questionnaires. 3. Identify areas for improvement and develop a plan to address them. Step 8: 1. Research and select a certification body that is accredited by a recognized accreditation body, such as the International Accreditation Forum (IAF). 2. Ensure that the certification body has experience in certifying organizations in your industry. Step 9: 1. Submit an application to the selected certification body, providing documentation and evidence of the organization's conformity to the ISO standard. 2. Ensure that the application includes all required documentation and information. 3. Pay the certification fees. Step 10: 1. The certification body will conduct a Stage 1 audit to review the organization's documentation and systems. 2. The certification body will conduct a Stage 2 audit to assess the organization's implementation of the ISO standard. Step 12: Receive Certification Step 13: Maintain certification through regular surveillance audits and recertification audits.

-Introduction to ISO 9001:2015 Audit An ISO 9001:2015 audit is a systematic and independent evaluation of an organization’s Quality Management System (QMS) to verify that it: Meets customer and stakeholder expectations Complies with applicable statutory and regulatory requirements Promotes and sustains continuous improvement --- Principles and Clauses of ISO 9001:2015 Seven Quality Management Principles The ISO 9001:2015 standard is founded upon the following seven quality management principles: 1. Customer Focus 2. Leadership 3. Engagement of People 4. Process Approach 5. Improvement 6. Evidence-Based Decision Making 7. Relationship Management Ten Clauses of ISO 9001:2015 The standard is structured into ten key clauses, which provide a comprehensive framework for implementing and maintaining an effective QMS: 1. Scope 2. Normative References 3. Terms and Definitions 4. Context of the Organization 5. Leadership 6. Planning 7. Support 8. Operation 9. Performance Evaluation 10. Improvement --- Objectives of the Audit The primary objectives of an ISO 9001:2015 audit are to: 1. Verify compliance with ISO 9001 requirements 2. Assess QMS effectiveness, identify nonconformities, evaluate risk management, and ensure employee awareness 3. Support and reinforce a culture of continuous improvement --- Preparing for an Audit Key preparation steps include: 1. Defining audit objectives and scope – Establish the purpose, coverage, and boundaries of the audit. 2. Developing an audit plan – Determine the schedule, methodology, and reference documentation. 3. Assembling the audit team – Ensure auditors possess the necessary competence, independence, and impartiality. --- Conducting the Audit 1. Opening Meeting – Clarify the audit scope, objectives, methodology, and expectations. 2. Document Review – Examine QMS documentation, standard operating procedures (SOPs), training records, previous audit reports, and customer feedback. 3. Interviews and Observations – Assess employee competence, process adherence, and operational practices. 4. Process Audit – Evaluate workflows, key performance indicators (KPIs), resource utilization, and process efficiency. 5. Risk and Nonconformance Assessment – Identify deviations, classify them as major or minor, and record objective evidence. --- Reporting and Follow-Up 1. Audit Report – Summarize audit scope, criteria, findings, supporting evidence, nonconformities, and opportunities for improvement. 2. Closing Meeting – Present audit results to management and agree on corrective actions. 3. Corrective Action and Root Cause Analysis – Define corrective and preventive measures to eliminate causes of nonconformities. 4. Follow-Up Audit – Verify implementation and evaluate the effectiveness of corrective actions.

🔐 ISO 27001: Preparing for the Certification Audit After implementing an Information Security Management System (ISMS), many organisations ask the same question: “What actually happens during the ISO 27001 certification audit?” In this presentation, I walk through the journey from ISMS implementation to external certification, explaining what organisations should expect and how to prepare effectively. The presentation covers several practical topics, including: • Where the external certification audit fits within the ISO 27001 lifecycle • How to select an accredited certification body and qualified auditors • The difference between Stage 1 (readiness review) and Stage 2 (certification audit) • Typical roles involved during the audit • How auditors sample evidence and interview staff • Common audit findings and red flags organisations should avoid I also explain what auditors are really evaluating during the certification audit: • Whether the ISMS is implemented • Whether controls are operating effectively • Whether risks are properly managed • Whether the organisation monitors performance and improves the ISMS One important point I highlight is that ISO 27001 certification is not about perfection. It is about demonstrating that the organisation has a structured, risk-based approach to managing information security and continually improving its security posture. If you are preparing for an ISO 27001 audit, this presentation provides a practical overview of what auditors expect and how organisations can approach certification with confidence. 📺 The full presentation is available(video): https://lnkd.in/dc-Y-KGa #ISO27001 #InformationSecurity #ISMS #CyberSecurity #RiskManagement #Audit #Compliance #SecurityGovernance #ISOStandards ⚠️ Disclaimer: The views and guidance shared in this presentation are based on my professional experience working with organisations implementing and auditing ISO 27001 Information Security Management Systems. They are intended for educational and informational purposes and should not be interpreted as official guidance from ISO or any certification body.

2026 - First post ! Happy learning !! The mini-review highlights the significant impact of ISO 15189 accreditation-on clinical laboratories,emphasizing its role in improving-laboratory performance,enhancing patient safety, and-strengthening personnel-competence. The article provides evidence from various international studies and real-world experiences, demonstrating the benefits of implementing ISO15189-based quality managementsystems (QMS). Key Points: 1. Laboratory Performance: * ISO 15189 accreditation improves analytical accuracy,operational efficiency, and reliability. * Accredited laboratories show lower error rates, reducedsample rejection, and faster turnaround times compared to non-accredited laboratories. * Specific studies report significant reductions in errorrates, contamination, and-diagnostic inaccuracies after implementing ISO 15189. 2.Patient Safety: * ISO 15189 contributes to enhanced patient safety byreducing laboratory incidents and their severity. * Longitudinal monitoring in accredited laboratories shows a consistent decline in incidents, particularly duringnight shifts. * Accreditation fosters a culture of safety and accountability,improving medical safety andpatient care. 3. Personnel Competence: * ISO 15189 emphasises structured training and competency assessment programs, which improve staff skills, professional ethics, and testing capabilities. * Surveys indicate positive attitudes among laboratoryprofessionals toward accreditation, though challenges such as increased workload and paperworkremain. ISO 15189:2022 Updates: * The 2022 revision introduces structural changes, including alignment with ISO/IEC17025:2017, integration of point-of-care testing (POCT)requirements, and a stronger focus on risk-based approaches and patient-centered care. * Ethical considerations, such as in partiality and confidentiality, have been strengthened. Conclusion: ISO 15189 accreditation establishes a robust framework for clinical laboratories, leading to improved performance, safety, and staff competence.The 2022 revision further emphasizes risk management and patient-centered care, supporting continuous improvement in laboratory practices.

The quality, effectiveness, and maintenance of medical equipment are crucial components in hospital accreditation processes like Joint Commission International (JCI). ✔️Quality of Medical Equipment ✅️Patient Safety & Clinical Outcomes: High-quality equipment ensures accurate diagnoses, effective treatment, and patient safety—core principles of JCI. ✅️Compliance with Standards: JCI requires hospitals to use equipment that meets international quality and safety standards, including CE marking, FDA approval, or equivalent certifications. ✅️Technology Management Program: JCI evaluates whether a hospital has a structured program to assess, select, and evaluate the quality of medical technologies. ✔️Effectiveness of Medical Equipment ✅️Operational Readiness: Equipment must function correctly and be available when needed. JCI assesses whether devices are suitable for their intended clinical use and deliver expected outcomes. ✅️User Training & Competency: Effective equipment is also about appropriate use—JCI checks for documented staff training and competency assessments related to each device. ✔️Maintenance of Medical Equipment ✅️Preventive Maintenance (PM) & Calibration: JCI emphasizes documented schedules for PM, calibration, and performance verification. This ensures reliability and reduces the risk of failure during critical procedures. ✅️Corrective Maintenance & Incident Reporting: Hospitals must track repairs and equipment failures. JCI reviews how maintenance logs, service reports, and incident investigations are managed. ✅️Life Cycle Management: From acquisition to decommissioning, JCI evaluates how well hospitals manage their equipment life cycle, including end-of-life disposal. ✔️Relevant JCI Standards (Examples) ✅️FMS.8 and FMS.8.1: Focus on facility management and safety, including inspection, testing, and maintenance of medical equipment. ✅️FMS.9: Requires a written plan for equipment management, including inventory, performance testing, and documentation. ✅️GLD & IPS Standards: Related to leadership and infection control, also reference the safe and effective use of medical devices. Medical equipment quality, effectiveness, and maintenance are foundational to achieving and maintaining JCI accreditation. They are tied directly to patient safety, risk reduction, and clinical excellence, all of which JCI rigorously evaluates during audits and surveys. #Biomedical #Engineering #Medical #Technology #Healthcare #Technology #Management #JCI #Accreditation 💙