Accreditation Application Procedures

If you are applying for JCI (Joint Commission International) accreditation for your hospital facility, the following key areas must be fully considered and aligned: JCI Readiness | Facility Management & Engineering 1. FMS Governance & Documentation •FMS program charter approved and implemented • Roles and responsibilities for engineering and safety defined • Risk assessments completed and reviewed annually • Policies, SOPs, and PM plans under document control 2. Safety & Security Management • Environmental safety risk assessment conducted • Security plan covering access control, CCTV, incident response • Security incidents logged, analyzed, and closed • Staff aware of emergency codes and response 3. Fire Safety Management •Fire risk assessment and fire safety plan approved •Fire detection, alarm, and suppression systems tested •Fire drills conducted for all shifts and areas •Fire exits, fire doors, signage, and emergency lighting compliant 4. Utilities & Critical Systems • Preventive maintenance program for critical systems ≥95% compliance • Emergency generators tested and logs maintained • UPS, ATS, and electrical panels labeled and inspected • HVAC systems monitored for temperature, pressure, and airflow 5. Medical Gas Systems • Medical gas inventory and system drawings available • Manifolds, alarms, and shut-off valves labeled and functional • Cylinder storage compliant with segregation and signage • Medical gas maintenance and testing records available 6. Water Safety & Environment • Water management plan implemented • Water quality testing and results documented •Legionella and contamination controls in place • Drainage and wastewater systems inspected 7. Hazardous Materials & Waste • Chemical inventory with SDS at point of use • Hazardous material storage compliant • Spill kits available and staff trained • Clinical and hazardous waste segregation monitored 8. Medical Equipment Management • Medical equipment inventory with risk classification • Preventive maintenance and calibration schedules followed • Acceptance testing for new equipment completed • Equipment recalls and alerts managed and documented 9. Emergency Preparedness & Business Continuity • Hazard Vulnerability Analysis (HVA) completed • Emergency response and evacuation plans tested • Utility failure drills conducted and evaluated • Emergency supplies inspected and available 10. Survey & Tracer Readiness (Engineering) • Engineering staff can explain fire, power, and water failure response • PM records immediately retrievable during tracers • No expired inspection certificates or overdue PMs • Open risks tracked with mitigation plans Use this checklist as a live compliance tool. Surveyors will verify documentation, inspect systems physically, and interview engineering staff on site. Good luck! 🙂

How to Achieve Your Product Certification Body ISO/IEC 17065 Accreditation If you are a certification body whether you are certifying organic food, electronics, cosmetics, or cables, ISO/IEC 17065 is the global benchmark. It tells: ↳ “We certify products with competence, impartiality, and integrity.” So how do you actually achieve accreditation? Here’s a step-by-step breakdown: Step 1: Understand What ISO/IEC 17065 Is This standard lays down the requirements for product certification bodies. It is not about your product. It is about how you certify others’ products. It focuses on: ↳ Impartiality ↳ Competence ↳ Transparent decision-making Step 2: Set Up a Documented Management System You will need policies and procedures that show: ↳ How you manage impartiality ↳ How you handle complaints and appeals ↳ How decisions are made independently ↳ How you evaluate product compliance Start with a system manual and process maps. Step 3: Build a Competent Team Accreditation bodies will check that your staff: ↳ Understand the products and applicable standards ↳ Have sector-specific knowledge, authorized, trained, evaluated, and authorized to make decisions Step 4: Identify and Manage Conflicts of Interest You must show that: ↳ Your decision-makers are not involved in consulting ↳ You are not being influenced by clients or money ↳ All potential risks to impartiality are assessed and acted upon Step 5: Apply for Accreditation Find an IAF-recognized accreditation body in your region. ↳ Submit your application, ↳ Submit documented system,  ↳ Get audited,  ↳ Close nonconformities, and  ↳ Final decision. Pro tip: Make sure you are already operating your system before applying most accreditation bodies want at least 1–2 real certifications completed. There is an irony in the accreditation process; you need accreditation to certify products, but to get accredited, you must show you have already certified products. The practical solution? Start with a non-mandatory certification scheme or work with a willing client to run your system on real cases. This proves to the accreditation body that your certification process isn’t just documented; it is functional and implemented. Step 6: Maintain & Improve ISO/IEC 17065 is not a one-time deal. You will face surveillance audits, periodic reviews, and continual improvement expectations. As they say: "Excellence is not a destination; it’s a continuous journey." Why It is Worth It? ↳ Proves your credibility globally ↳ Builds buyer trust in certified products ↳ Opens doors to regulated and export markets ↳ Shields your brand from legal or reputational risks If you are unsure where to start or want help getting ready follow Jasmin Dhakaan and drop a message. #ISO17065 #HowToGuide #Accreditation #CertificationBody #ProductCertification #QualityMatters #JasminDhakaan #Compliance #GlobalTrade #ISOStandards #TICIndustry #AccreditationExpert

TEAM NB MDR Certification Process (including Pre-application, Application and Post Application phases) – Consensus document 18 december 2024 Purpose and Scope The purpose of this consensus document is to describe in detail the pre-application, application processes through which manufacturers may apply to Notified Bodies (NBs) for the certification of medical devices under the regulation (EU) 2017/745 (MDR). The document was developed by reviewing the application process and associated documents of individual Team-NB members and harmonising the processes where possible. This document is applicable to both legacy devices (pursuant to Article 120) transitioning to MDR, and devices that are new to the market and have not been certified under the Directives before. The document also briefly describes the certification activities that are undertaken after the application process is concluded. This consensus guidance document is aligned to the requirements of Medical Devices Regulation [MDR] (EU) 2017/745, described in detail in Annex VII §4.2, §4.3 for pre-application and application requirements. The following are outside the scope of this document: - Application process for a NB certificate as per Article 16 of MDR. - Application process for a NB opinion for devices as per Article 117 of MDR. - Application process for Recertification as per Annex VII §4.11 of MDR.