ISO CERTIFICATION
Certification Code

Quality Management System (QMS)/Environmental Management System (EMS)

  • Code Certification Area Quality Environment
    03 Food & Beverages and Tobacco ○ ○
    04 Textile and Textile Products ○ ○
    05 Leather and Leather Products ○ ○
    06 Timber and Timber Products ○ ○
    07 Pulp, Paper and Paper Products ○ ○
    08 Publishing Business ○ ○
    09 Printing Business ○ ○
    10 Coking and Petroleum Refining Products ○ ○
    12 The Manufacture of Chemicals, Chemicals, and Chemical Fibers ○ ○
    13 Pharmaceutical Products ○ ○
    14 Rubber and Plastic Products ○ ○
    15 Nonmetallic Mineral Products ○ ○
    16 Concrete, Cement, Lime, Plaster, etc. ○ ○
    17 Base Metal and Fabricated Metal Products ○ ○
    18 Machinery and Equipment ○ ○
    19 Electric and Optical Instrument ○ ○
  • Code Certification Area Quality Environment
    20 Shipping ○ ○
    21 Aviation ○ ○
    22 Other Transport Equipment ○ ○
    23 Other Manufacturing Business ○ ○
    24 Recycle and Renew ○ ○
    28 Construction ○ ○
    29 Wholesale/Retail Trade and Repair ○ ○
    30 Accommodation and Food Industry ○ ○
    31 Transport, Warehouse and Communication ○ ○
    32 Finance, Insurance, Real Estate, Rental, Asset Management Service ○ ○
    33 Information Technology ○ ○
    34 Engineering Service ○ ○
    35 Other Services ○ ○
    37 Education ○ ○
    38 Health and Social Welfare ○ ○
    39 Other Social Services ○ ○

Food Safety Management System (FSMS)

Section Division Group Activities may include:
Food and
Animal Feed
Processing		 C Food
Manufacturing		 C₁ Perishable meat product processing Production of animal products including fish, aquatic products, meat, egg, milk products and processed fish products
C₂ Perishable plant product processing Production of plant product including fruit, fresh juice, vegetable, crops, nuts and beans
C₃ Perishable animal and plant product processing
(combined food product)		 Production of combined food product, including pizza, lasagna, sandwich, dumpling and instant food
C₄ Room temperature distributed product processing Production of any food type distributed at room temperature, including canned food, biscuit, snacks, cooking oil, drinking water, beverage, pasta, flour, sugar and edible salt
D Animal Feed
Production		 D₁ Animal feed production Production of animal feed with one or several food ingredients for animals producing meat
D₂ Pet food production Production of pet food with one or several food ingredients for animals that do not produce meat

Quality Management System for Medical Devices

Main Category Middle category Subclass
Manual medical device Manual non-implantable general medical device
  • Manual anesthesia, emergency and intensive care equipment
  • Manual injection, infusion, blood transfusion and dialysis equipment
  • Manual orthopedics and function recovery equipment
  • Medical equipment with manual measurement function
  • Manual ophthalmic equipment
  • Manual equipment
  • Contraception medical equipment
  • Manual washing, disinfection, washing, rinsing medical equipment
  • Manual in vitro fertilization and auxiliary reproductive technology equipment
  • Manual ingestion medical equipment
Manual implant
  • Manual cardiovascular implant
  • Manual orthopedic implant
  • Manual functional implant
  • Manual soft tissue implant
Device for wound treatment
  • Bandages and wound dressings
  • Sealing materials and clamps
  • Other wound treatment medical devices
Manual dental instruments and accessories
  • Manual dental equipment and instruments
  • Dental materials
  • Dental implants
Manual medical devices other than the above -----
Electric medical equipment
(non-implantable)
Electric general medical device
  • Devices for extracorporeal circulation, infusion and blood coagulation
  • Respiratory devices, oxygen therapy including high-pressure chambers, devices for inhalation anesthesia
  • Stimulation and suppression devices
  • Motorized surgical devices
  • Motorized ophthalmic devices
  • Motorized dental devices
  • Motorized cleaning and disinfection and sterilization devices
  • Motorized rehabilitation Equipment and electric prosthesis
  • Electric patient posture maintenance and transport equipment
  • Electric IVF and assisted reproductive technology equipment
  • Medical gas supply system and its parts
  • Software
Device for image
  • Ionizing radiation Device
  • Non-ionizing radiation
Monitoring device
  • Insignificant biological phenomena monitoring device
  • Important biological phenomena monitoring device
Devices for radiation and heat therapy
  • Ionizing radiation equipment
  • Non-ionizing radiation equipment
  • High-body temperature and low-body temperature equipment
  • Extracorporeal shock wave therapy
Electric (non-implantable) medical devices other than regular -----
Electric medical device
(Implantable type)
Electric implantable general medical device
  • Electric implantable stimulation / suppression medical device
Implantable medical devices other than the above -----
Medical device for in vitro diagnosis
Reagents and reagent products, calibrators and management materials for
  • Clinical Chemistry
  • Immunochemistry (Immunology)
  • Hematology/Hemostatic/Immune Hematology
  • Microbiology
  • Infection Immunology
  • Histology/Cytology
  • Genetic testing
 -----
In vitro diagnostic equipment and software -----
In vitro diagnostic medical devices other than the above -----
Medical device sterilization method
Ethylene oxide gas sterilization -----
Moist heat -----
Aseptic treatment -----
Radiation sterilization (EX: gamma ray, X-ray, electron beam) -----
Sterilization methods other than the above -----
Equipment that combines/utilizes specific substances and technologies
Medical devices incorporating medical substances -----
Medical device using animal-derived tissue -----
Medical device incorporating derivatives of human blood -----
Medical device using micro mechanics -----
Medical devices using nanomaterials -----
Medical devices utilizing biologically active coatings and materials, or full or predominantly absorbent properties -----
Medical devices that combine or utilize specific substances/technology/elements other than the above -----
Parts and service
Raw materials
  • Raw materials, plastics, wood, ceramics
Components
  • Electrical components, fixtures, molded raw materials, machined raw materials, plastic injection products
Subassembly
  • Electronic sub-assembly, mechanical sub-assembly created by design drawings or work orders
Calibration service
  • Service to verify/confirm measuring instruments, tools or test facilities
Distribution service
  • Distributors storing and shipping medical devices, not being a legal manufacturer of medical devices
Maintenance service
  • Electrical or mechanical repair services, facility cleaning and maintenance services, uniform cleaning and testing of ESD coveralls
Transport service
  • General truck, ship, and air transport services
Other services
  • Consulting services related to medical devices and packaging services