School Accreditation Processes

ISO 45001:2018 Checklist – Are You Ready for the Audit? Getting ready for a certification or surveillance audit for ISO 45001? Here’s a concise checklist to help you assess the essentials: 1. Organizational Context Analysis of interested parties Identification of internal/external issues 2. Leadership & Worker Participation H&S policy communicated Roles and responsibilities defined Worker consultation & participation in place 3. Planning Risk & opportunity assessment SMART H&S objectives Action plan implemented 4. Support H&S training and competence Internal and external communication Documented information available 5. Operation Effective operational control Management of change Emergency preparedness and response 6. Performance Evaluation Monitoring and measurement of H&S performance Internal audits conducted Management review held 7. Improvement Nonconformity handling Corrective actions tracked Continuous improvement demonstrated #ISO45001 #OHSMS #QHSE #InternalAudit #WorkplaceSafety #HSE #ManagementSystem

I just read the Trump administration's 151-page accreditation overhaul. My first reaction: finally. Someone's holding schools accountable for what happens after the diploma. My second reaction: most schools have no idea they're already exposed. Here's what I mean. I talk to career services and higher ed leaders every week. When I ask them "can you prove student outcomes to your accreditor right now?", I get one of three answers: "We think we're fine." "We have a 5% survey response rate." Silence. The new rules change everything. Accreditors now have to set minimum student achievement standards. Cost efficiency matters now. Outcome data, not surveys that 95% of students ignore, will determine who qualifies for federal funding. To be clear, I DO have issues with how earnings data drives policy. It ignores geography. It punishes apprenticeships. It penalizes the student who took a lower-wage job to break into their field. That first-year window is a flawed proxy for long-term success. But here is what is not optional: you need to know where you stand before someone else tells you. If you're a higher ed leader, ask yourself three questions this week: 1. If your accreditor asked to see your outcomes data tomorrow, could you produce it? I am not talking about anecdotal placement rates. I mean verified outcomes with salary, timeframe, and source. 2. What is your actual survey response rate? If it is under 50%, you do not have data. You have a confidence trick you are running on yourself. 3. Can you track a student five years out? Because first-year earnings data misses the career pivot, the certification that doubled someone's salary, the apprenticeship that started low and went high. Schools that can answer this don't have to worry about waiting for the fine, the bad press, the accreditation review that ends with a letter no school wants to receive. The ones who cannot answer? They are about to have a very uncomfortable year. You do not need to panic. But you do need to move.

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.

Preparing for a Successful HSE Audit: Health, Safety, and Environment (HSE) audits are crucial for ensuring compliance, identifying areas for improvement, and fostering a strong safety culture within an organization. Proper preparation is key to a smooth and successful audit. How to effectively prepare: 1. Understand the Audit Scope and Criteria The first step is to clearly understand the scope of the audit – what specific areas of your HSE management system will be reviewed? Also, identify the audit criteria – the standards, regulations, and internal policies against which your system will be assessed. This information is usually provided by the auditing body. 2. Review Your HSE Documentation Review all relevant HSE documentation. This includes: Policies and Procedures, Risk Assessments, Training Records, Incident Reports and Investigations, Permits and Licenses, Monitoring and Measurement Records. 3. Conduct a Pre-Audit Self-Assessment Perform a thorough internal audit against the same criteria the external auditors will use. This helps identify potential gaps and areas needing improvement before the official audit. Assign responsibilities for addressing any identified non-conformities. 4. Prepare Your Team Inform relevant personnel about the upcoming audit, its scope, and their potential roles. Ensure they understand the importance of the audit and are prepared to answer questions honestly and provide necessary documentation. Conduct briefing sessions to review key procedures and expected responses. 5. Organize and Ensure Accessibility Organize all documentation in a logical and easily accessible manner. Designate a point person to coordinate the audit process and facilitate access to information for the auditors. Prepare a dedicated audit room with necessary resources. 6. Focus on Evidence of Implementation Auditors will not only look at your documentation but also seek evidence that your HSE management system is effectively implemented in practice. This includes observing work activities, interviewing employees, and reviewing records of implementation. 7. Be Proactive and Transparent During the audit, be proactive in providing information and address any questions openly and honestly. If non-conformities are identified, acknowledge them and demonstrate a commitment to taking corrective actions. By following these steps, organizations can significantly enhance their preparedness for an HSE audit, leading to a more efficient and positive experience and ultimately contributing to a safer and healthier workplace.

𝗞𝗲𝘆 𝗨𝗽𝗱𝗮𝘁𝗲𝘀 𝗳𝗿𝗼𝗺 𝘁𝗵𝗲 𝟮𝟬𝟮𝟰 𝗤𝘂𝗮𝗹𝗶𝘁𝘆 𝗔𝘀𝘀𝗲𝘀𝘀𝗺𝗲𝗻𝘁 𝗠𝗮𝗻𝘂𝗮𝗹 I have reviewed the Quality Assessment Manual 2024 and wanted to share some insights and key updates. 1️⃣ 𝗕𝗿𝗼𝗮𝗱𝗲𝗻𝗶𝗻𝗴 𝘁𝗵𝗲 𝗦𝗰𝗼𝗽𝗲: 𝗖𝗼𝗻𝗳𝗼𝗿𝗺𝗮𝗻𝗰𝗲 𝗮𝗻𝗱 𝗣𝗲𝗿𝗳𝗼𝗿𝗺𝗮𝗻𝗰𝗲 𝗘𝘃𝗮𝗹𝘂𝗮𝘁𝗶𝗼𝗻 The Quality Assessment will now evaluate not only conformance with standards but also the 𝗽𝗲𝗿𝗳𝗼𝗿𝗺𝗮𝗻𝗰𝗲 of the internal audit function in achieving agreed objectives. The chief audit executive must develop 𝗼𝗯𝗷𝗲𝗰𝘁𝗶𝘃𝗲𝘀, performance criteria, and measurable metrics (e.g., KPIs) with inputs from the board and senior management. 2️⃣ 𝗜𝗻𝘁𝗿𝗼𝗱𝘂𝗰𝗶𝗻𝗴 𝘁𝗵𝗲 𝗙𝗼𝘂𝗿-𝗣𝗼𝗶𝗻𝘁 𝗤𝘂𝗮𝗹𝗶𝘁𝘆 𝗥𝗮𝘁𝗶𝗻𝗴 𝗮𝗻𝗱 𝗖𝗼𝗻𝗰𝗹𝘂𝘀𝗶𝗼𝗻 𝗠𝗼𝗱𝗲𝗹 A revised Four-Point Quality Rating Model has been introduced for more nuanced evaluations. 𝗧𝗵𝗲 𝗿𝗮𝘁𝗶𝗻𝗴𝘀 include: -> Full Achievement (Pass) -> General Achievement (Pass) -> Partial Achievement (No Pass) -> Nonachievement (No Pass) These ratings will be applied for each Standard, Principle and Overall Conformance. 3️⃣ 𝗢𝗽𝘁𝗶𝗼𝗻𝗮𝗹 𝗠𝗮𝘁𝘂𝗿𝗶𝘁𝘆 𝗥𝗮𝘁𝗶𝗻𝗴𝘀 𝗳𝗼𝗿 𝗦𝘁𝗿𝗮𝘁𝗲𝗴𝗶𝗰 𝗜𝗻𝘀𝗶𝗴𝗵𝘁𝘀 For organizations seeking to benchmark and evolve their audit maturity, the manual introduces an 𝗼𝗽𝘁𝗶𝗼𝗻𝗮𝗹 𝗠𝗮𝘁𝘂𝗿𝗶𝘁𝘆 𝗥𝗮𝘁𝗶𝗻𝗴. 𝗧𝗵𝗶𝘀 𝗳𝗶𝘃𝗲-𝘁𝗶𝗲𝗿 𝗳𝗿𝗮𝗺𝗲𝘄𝗼𝗿𝗸 is as follows: ➤ Optimizing (highest level) ➤ Managed ➤ Integrated ➤ Infrastructure ➤ Initial (lowest level) It allows teams to assess their current maturity level and identify areas for growth. 4️⃣ 𝗣𝗲𝗲𝗿 𝗥𝗲𝘃𝗶𝗲𝘄: 𝗔 𝗖𝗼𝘀𝘁-𝗘𝗳𝗳𝗲𝗰𝘁𝗶𝘃𝗲 𝗦𝗼𝗹𝘂𝘁𝗶𝗼𝗻 Peer reviews involve internal auditors from multiple organizations pooling resources to conduct independent assessments. A minimum of three organizations is required to ensure reviewer independence and objectivity. This alternative is cost-effective compared to hiring external service providers. 𝙄’𝙙 𝙡𝙤𝙫𝙚 𝙩𝙤 𝙝𝙚𝙖𝙧 𝙮𝙤𝙪𝙧 𝙩𝙝𝙤𝙪𝙜𝙝𝙩𝙨 𝙤𝙣 𝙩𝙝𝙚𝙨𝙚 𝙠𝙚𝙮 𝙘𝙝𝙖𝙣𝙜𝙚𝙨!

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

Amendments in NABL 153 ( as released on 23.06.2023) - Application form for Medical Testing Laboratories -- As per the revised standard ISO 15189:2022 released in Dec 2022 NABL has incorporated changes on 23/06/2023 in application form for medical testing laboratories- NABL 153 ·         ISO 15189:2012 is changed to ISO 15189:2022. ·        For one person company instead of Pan NO registration certificate registration as per Companies Act, 2013 is required. ·        Requirements & instructions while applying for NABL Accreditation is added new & explained in detail. ·        Management system document (howsoever named) is still there but not in the name of Quality Manual. ·        Declaration form to be provided ·        15 days’ time frame is given for informing to NABL in case of any significant changes  such as: 1.its legal, commercial, ownership or organizational status, 2. personnel, facilities, equipment, authorized personnel  to review the results of examinations, premises, scope of accreditation. 3.any other change in information submitted in application. ·        Request for any change in applied scope of accreditation, equipment and personnel including personnel to report, review and authorize the results during ongoing onsite assessment will not be entertained now at the time of assessment. ·        How the name/Identification of the Laboratory to be mentioned in application form. Instructions are clearly defined in NABL 153. ·        Point of Care testing (POCT) added in scope. ·        Scope of accreditation --- new column is added for Facility (Permanent/ Mobile/ POCT/ Site facility) ·         chief executive of the laboratory  is changed to Head of the laboratory. ·        If any  specific government regulation applicable then provide the complete list of applicable regulations. ·        For parent organization -- If the laboratory is a defined part of a legal entity, then the organization structure of the Legal entity, with place of the laboratory within the larger structure (legal entity/parent organization) shall also be submitted, clearly identifying the other activities performed by the legal entity. If the laboratory is one of the laboratories in a chain of laboratories, then the name and address of the main laboratory (however named, if applicable) and the relationship between the two shall also be described. ·        List of employees – support function staff  to be included. ·        For imaging services one table is added for details of radiological safety officer. ·        For list of reference material – renamed as list of reference standards. ·        One more list is added as list of Phantom for imaging laboratories. ·        EQA requirements – this is divided in to two. One list is only for EQA participation and another is for ILC. CA to be mentioned  only in ILC table. ·      Signature of head of the laboratory are required not of lab director in form #medical #change #quality #management   ·         

Draft USP <1058> Posted Today for Industry Comment! A proposed update to USP <1058> on Analytical Instrument and System Qualification has been published on-line in Pharmacopoeial Forum today. There are major changes here. The 4Qs model, beloved of pharma and industry suppliers, still staggers along. However, there is a new 3 phase approach to instrument qualification and system validation: 1. Specification and selection 2. Installation, Performance Qualification (what?!) and Validation 3. Ongoing Performance Verification This approach aligns with USP <1220> Analytical Procedure Lifecycle. You'll have to register (free) to access PF and issue 51(2) where you will find the draft. Please comment about this proposal. https://lnkd.in/gTipywi5

🔐 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.