The significance of an SOP (Standard Operating Procedure) Manual for Surgical Appliance and Supplies Manufacturing cannot be overstated. First and foremost, it plays a pivotal role in ensuring patient safety. Surgical appliances and supplies are critical components of healthcare, and adherence to standardized procedures is essential to produce products that meet stringent quality and safety standards. The manual provides a clear roadmap for every step in the manufacturing process, minimizing the risk of errors, contamination, and defects.
Furthermore, regulatory compliance is paramount in the healthcare industry. An SOP Manual assists manufacturers in meeting the stringent requirements of health authorities and quality standards, helping them avoid costly legal issues and product recalls.
Additionally, it aids in training and development of the workforce, ensuring that employees are well-versed in the precise manufacturing protocols. The manual is also a valuable resource for consistent and efficient operations, promoting product consistency and reliability. Ultimately, it upholds the integrity of surgical appliance and supplies manufacturing, safeguarding patient well-being and industry reputation.
CLICK HERE to download the List of SOPs Document in PDF format. Please share this document with your clients, colleagues and senior officers.
Top 50 SOPs for Standard Operating Procedures (SOPs) for Surgical Appliance and Supplies Manufacturing
SOP-788-001: Standard Operating Procedure for Raw Material Inspection
SOP-788-002: Standard Operating Procedure for Equipment Calibration
SOP-788-003: Standard Operating Procedure for Cleanroom Protocol
SOP-788-004: Standard Operating Procedure for Product Design and Development
SOP-788-005: Standard Operating Procedure for Prototype Testing
SOP-788-006: Standard Operating Procedure for Materials Handling
SOP-788-007: Standard Operating Procedure for Cutting and Machining
SOP-788-008: Standard Operating Procedure for Molding Processes
SOP-788-009: Standard Operating Procedure for Assembly Line Setup
SOP-788-010: Standard Operating Procedure for Quality Control Inspections
SOP-788-011: Standard Operating Procedure for Sterilization Processes
SOP-788-012: Standard Operating Procedure for Packaging and Labeling
SOP-788-013: Standard Operating Procedure for Inventory Management
SOP-788-014: Standard Operating Procedure for Order Processing
SOP-788-015: Standard Operating Procedure for Shipping and Logistics
SOP-788-016: Standard Operating Procedure for Environmental Health and Safety
SOP-788-017: Standard Operating Procedure for Facility Maintenance
SOP-788-018: Standard Operating Procedure for Waste Disposal
SOP-788-019: Standard Operating Procedure for Emergency Response
SOP-788-020: Standard Operating Procedure for Document Control
SOP-788-021: Standard Operating Procedure for Employee Training
SOP-788-022: Standard Operating Procedure for Performance Metrics Tracking
SOP-788-023: Standard Operating Procedure for Continuous Improvement
SOP-788-024: Standard Operating Procedure for Customer Complaints Handling
SOP-788-025: Standard Operating Procedure for Regulatory Compliance
SOP-788-026: Standard Operating Procedure for Audits and Inspections
SOP-788-027: Standard Operating Procedure for Product Recalls
SOP-788-028: Standard Operating Procedure for Risk Management
SOP-788-029: Standard Operating Procedure for Supplier Qualification
SOP-788-030: Standard Operating Procedure for Change Control
SOP-788-031: Standard Operating Procedure for Non-Conforming Product Handling
SOP-788-032: Standard Operating Procedure for Root Cause Analysis
SOP-788-033: Standard Operating Procedure for Corrective and Preventive Actions
SOP-788-034: Standard Operating Procedure for Calibration and Maintenance Records
SOP-788-035: Standard Operating Procedure for Design History File Maintenance
SOP-788-036: Standard Operating Procedure for Training Records Management
SOP-788-037: Standard Operating Procedure for Product Labeling Compliance
SOP-788-038: Standard Operating Procedure for Design Validation
SOP-788-039: Standard Operating Procedure for Process Validation
SOP-788-040: Standard Operating Procedure for Equipment Validation
SOP-788-042: Standard Operating Procedure for Computer Systems Validation
SOP-788-043: Standard Operating Procedure for Design Change Control
SOP-788-044: Standard Operating Procedure for Regulatory Submissions
SOP-788-045: Standard Operating Procedure for Post-Market Surveillance
SOP-788-046: Standard Operating Procedure for Product Lifecycle Management
SOP-788-047: Standard Operating Procedure for Intellectual Property Protection
SOP-788-048: Standard Operating Procedure for Crisis Management
SOP-788-049: Standard Operating Procedure for Business Continuity
SOP-788-050: Standard Operating Procedure for Records Retention
SOP ToolBox: If you are reading these lines, I am sure you are looking for Standard Operating Procedure guidelines or SOPs itself. In both the cases, searching in internet will not be yielding any great help. Because no company shares their SOP Development Process and certainly don’t share their SOP Documents. The best way to develop an SOP is creating one for yourself. At Fhyzics, we write SOPs day-in and day-out for companies across the globe including some of the Fortune 500 organisations. Our charge ranges from USD 5000 to USD 50000 depending upon the number of processes to be covered. Certainly, this is not affordable to small and mid-size organisations. Hence, we decided to create this SOP ToolBox to disseminate our 8-Step SOP Development Life-Cycle and best practices at an unbelievably low price.
I always say, writing an SOP is somewhere between art and science. So far you may be clueless on where to start and how to progress on an SOP? This will not be the case after you diligently go through this SOP ToolBox. We have summarised all our secrets here to get you started and to deliver a stunning SOP to your management.
- Adhesive tape, medical, manufacturing
- Arch supports, orthopedic, manufacturing
- Artificial limbs manufacturing
- Autoclaves, laboratory-type (except dental), manufacturing
- Bandages and dressings, surgical and orthopedic, manufacturing
- Beds, hospital, manufacturing
- Biohazard protective clothing and accessories manufacturing
- Biohazard protective clothing and accessory manufacturing
- Blood testing apparatus, laboratory-type, manufacturing
- Bulletproof vests manufacturing
- Bunsen burners manufacturing
- Cervical collars manufacturing
- Clean room suits and accessories manufacturing
- Clean room suits and accessory manufacturing
- Colostomy appliances manufacturing
- Corn remover and bunion pad manufacturing
- Corsets, surgical, manufacturing
- Cotton and cotton balls, absorbent, manufacturing
- Cotton tipped applicators manufacturing
- Crutches and walkers manufacturing
- Depressors, tongue, manufacturing
- Drapes, surgical, disposable, manufacturing
- Dressings, surgical, manufacturing
- Dryers, laboratory-type, manufacturing
- Elastic hosiery, orthopedic, manufacturing
- Firefighting suits and accessories manufacturing
- Firefighting suits and accessory manufacturing
- First-aid, snake bite, or burn kits manufacturing
- Foot appliances, orthopedic, manufacturing
- Furniture, hospital, specialized (e.g., hospital beds, operating room furniture), manufacturing
- Gas masks manufacturing
- Gauze, surgical, made from purchased fabric
- Gloves, rubber (e.g., electrician's, examination, household-type, surgeon's), manufacturing
- Gynecological supplies and appliances manufacturing
- Gynecological supply and appliances manufacturing
- Hard hats manufacturing
- Helmets (except athletic), safety (e.g., motorized vehicle crash helmets, space helmets), manufacturing
- Hosiery, orthopedic support, manufacturing
- Hospital beds manufacturing
- Hospital furniture, specialized (e.g., hospital beds, operating room furniture)
- Hydrotherapy equipment manufacturing
- Implants, surgical, manufacturing
- Incubators, infant, manufacturing
- Incubators, laboratory-type, manufacturing
- Infant incubators manufacturing
- Intra ocular lenses manufacturing
- Intrauterine devices manufacturing
- Iron lungs manufacturing
- Laboratory-type evaporation apparatus manufacturing
- Laboratory-type sample preparation apparatus manufacturing
- Life preservers manufacturing
- Limbs, artificial, manufacturing
- Metal fabric and mesh safety gloves manufacturing
- Noise protectors, personal, manufacturing
- Nose and ear plugs manufacturing
- Operating room tables manufacturing
- Orthopedic canes manufacturing
- Orthopedic device manufacturing and sale in retail environment
- Orthopedic devices manufacturing
- Orthopedic extension shoes manufacturing
- Orthopedic hosiery, elastic, manufacturing
- Personal safety devices, not specified elsewhere, manufacturing
- Prosthetic appliances and supplies manufacturing
- Prosthetic appliances and supply manufacturing
- Radiation shielding aprons, gloves, and sheeting manufacturing
- Respiratory protection mask manufacturing
- Restraints, patient, manufacturing
- Shoes, orthopedic extension, manufacturing
- Space suits manufacturing
- Splints manufacturing
- Sterilizers, hospital and surgical, manufacturing
- Sterilizers, laboratory-type (except dental), manufacturing
- Stretchers, medical, manufacturing
- Suits, firefighting, manufacturing
- Suits, space, manufacturing
- Supports, orthopedic (e.g., abdominal, ankle, arch, kneecap), manufacturing
- Surgical dressings manufacturing
- Surgical implants manufacturing
- Surgical supplies (except medical instruments) manufacturing
- Surgical supply (except medical instruments) manufacturing
- Sutures, surgical, manufacturing
- Tapes, medical adhesive, manufacturing
- Tongue depressors manufacturing
- Traction apparatus manufacturing
- Ultrasonic medical cleaning equipment manufacturing
- Vacuum pumps, laboratory-type, manufacturing
- Welder's hoods manufacturing
- Wheelchairs manufacturing
- Whirlpool baths (i.e., hydrotherapy equipment) manufacturing
2. Standard Operating Procedures (SOP) Manual for Finance Department
3. Standard Operating Procedures (SOP) Manual for Customer Service
4. Standard Operating Procedures (SOP) Manual for CRM Department
5. Standard Operating Procedures (SOP) Manual for Credit Department
6. Standard Operating Procedures (SOP) Manual for Treasury Department
7. Standard Operating Procedures (SOP) Manual for Human Resources (HR) Department
8. Standard Operating Procedures (SOP) Manual for Training Department
9. Standard Operating Procedures (SOP) Manual for Learning & Development Department
10. Standard Operating Procedures (SOP) Manual for Administration Department
11. Standard Operating Procedures (SOP) Manual for Front Office
12. Standard Operating Procedures (SOP) Manual for House Keeping
13. Standard Operating Procedures (SOP) Manual for Safety Department
14. Standard Operating Procedures (SOP) Manual for Security Department
15. Standard Operating Procedures (SOP) Manual for Facilities Management Department
16. Standard Operating Procedures (SOP) Manual for Vigilance Department
17. Standard Operating Procedures (SOP) Manual for Legal Department
18. Standard Operating Procedures (SOP) Manual for Information Technology (IT) Department
19. Standard Operating Procedures (SOP) Manual for Sales & Marketing Department
20. Standard Operating Procedures (SOP) Manual for Design & Engineering
21. Standard Operating Procedures (SOP) Manual for Procurement Department
22. Standard Operating Procedures (SOP) Manual for Production
23. Standard Operating Procedures (SOP) Manual for SRM Department
24. Standard Operating Procedures (SOP) Manual for Supply Chain Department
25. Standard Operating Procedures (SOP) Manual for Warehouse
26. Standard Operating Procedures (SOP) Manual for New Product Development Department
27. Standard Operating Procedures (SOP) Manual for Research and Development
28. Standard Operating Procedures (SOP) Manual for Quality Department
29. Standard Operating Procedures (SOP) Manual for Calibration Department
30. Standard Operating Procedures (SOP) Manual for Maintenance Department
Stainless steel, titanium, tantalum, platinum, palladium, fibre and hard plastics are the major raw materials involved in manufacturing surgical appliance and supplies. In this industry, the production process and raw materials gets differ based on the types of product. According to the requirement and usage, the designing process is been done. Then, the raw materials are involved in different steps of production process. After production, the products are undergone for cleaning process in various segments such as electro-polishing, ultrasonic cleaning, etc. Finally, the equipment’s are allowed for inspection to check its quality and standard.
- Raw Materials Preparation
- Designing
- Milling
- Drilling
- Bending
- Filing
- Grinding with Grinding Stone
- Sand Blasting Unit
- Electro- Polishing
- Ultrasonic Cleaning
- Gold Plating
- Etching- Chemical Etching/Laser itching
- Bar-coding system
- Quality Control and Packaging
- Adhesive-curing equipment
- Air compressors
- Analyzers
- Assembly systems
- Automation equipment
- Batch control systems
- Blowers
- Cleaning systems and chemicals
- Converting equipment
- Conveyors
- Cooling equipment
- Cutting machines
- Die-cutting machines
- Dipping equipment
- Dispensers/fillers
- Drilling machines
- Dryers
- Electrostatic meters
- Enclosures, humidity and temperature controlled
- Feeders
- Fluid-control equipment
- Grinding machines
- Heat-sealing machines
- Lamination systems
- Lasers
- Level sensors
- Machining systems
- Metal-fabrication equipment
- Nozzles
- Particle counters and particle-size classifiers
- Pick-and-place units
- Presses
- Pressure vessels and tanks
- Process-control equipment
- Rapid prototyping equipment
- Robotics
- Rotary-indexing assembly machines
- Scales
- Tip forming
- Tools and inserts, precision
- UV-curing systems
- Welders/sealers
- ISO 7153-1:2016(en)|International Organization for Standardization- https://www.iso.org/obp/ui/#iso:std:iso:7153:-1:ed-3:v1:en
- ISO 16142-1:2016(en)|International Organization for Standardization- https://www.iso.org/obp/ui#iso:std:iso:16142:-1:ed-1:v1:en
- ASTM International- https://www.astm.org/Standards/medical-device-and-implant-standards.html
- Medical Device Regulations| World Health Organization- http://www.who.int/medical_devices/publications/en/MD_Regulations.pdf
- Stryker Corporation| Michigan, United States| http://www.stryker.com/
- DePuy Synthes Companies| Indiana, United States|https://www.jnjmedicaldevices.com/enUS/companies/depuy-synthes
- Zimmer Biomet|Indiana, United States| http://www.zimmerbiomet.com/
- Smith & Nephew|London, United Kingdom| https://www.smith-nephew.com/about-us/
- Medtronic| Dublin, Ireland|https://www.medtronic.com/in-en/index.html
- GE Healthcare| Illinois, United States|https://www.gehealthcare.in/
- Fresenius Medical Care|Bad Homburg, Germany| https://www.freseniusmedicalcare.com/en/home/
- Ethicon Inc.|New Jersey, United States| https://www.jnjmedicaldevices.com/en-US/companies/ethicon
- Teleflex|Pennsylvania, United States| http://www.teleflex.com/
- Baxter International| Illinois, United States|http://www.baxter.com/
-
Medical Magazine India-https://www.medicalmagazine.in/
-
Medgadget| Medical Technology News- https://www.medgadget.com/
-
Medical and Surgical Appliances| Europe PMC- http://europepmc.org/articles/pmc2415323
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Orthopedic Prosthetic Appliance Journal- http://www.oandplibrary.org/op/pdf/1953_03.pdf
-
Open Access Journals| Remedy Publications LLC- http://www.remedypublications.com/open-access-journals.php
Research By : Udhay Sankar
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