NCC Group - Gestão da Qualidade NCC Group - Atuação

Acting

NCC stands out for its competence and technical expertise in all conformity assessment activities, ensuring quality and safety.

Management System Anatel Inmetro MDSAP IECEx ONA ECOK

Management System

Certification for Management Systems Applied to Products

Health Products Management System
ABNT NBR ISO 13485:2016

The certification for Health Products Management Systems ABNT NBR ISO 13485:2016 is derived from the internationally accepted ISO 9001, with specific adaptations for medical device processes. This certification ensures compliance throughout the entire product lifecycle, covering design, production, installation, maintenance, and sales.

Accredited Scopes ABNT NBR ISO 13485:2016

Active Medical Devices (Non-implantable)

  • Imaging Devices
  • Monitoring Devices
  • General-purpose Active Medical Devices
  • Devices for Radiotherapy and Thermotherapy

Non-active Medical Devices

  • Non-active Dental Devices and Accessories
  • General-purpose Non-active, Non-implantable Medical Devices
  • Devices for Wound Treatment
  • Non-active Implants

Sterilization Methods for Medical Materials

  • Aldehydes (Formaldehyde and Glutaraldehyde), Dry Heat (Ovens and Sterilizers)
  • Moist Heat
  • Radiation Sterilization (Gamma Radiation, Alpha Radiation, Electron Beam)
  • Ethylene Oxide (ETO)
  • Aseptic Processing

Active Implantable Medical Devices

  • General Active Implantable Medical Devices
  • Other Active Implantable Medical Devices

Devices Incorporating/Utilizing Specific Substances/Technologies

  • Medical Devices Incorporating Medicinal Substances
  • Medical Devices Utilizing Animal-Origin Tissues
  • Medical Devices Incorporating Human Blood Derivatives
  • Medical Devices Utilizing Micromechanics
  • Medical Devices Utilizing Nanomaterials
  • Medical Devices Utilizing Biological Coatings
  • Medical Devices Incorporating or Utilizing Specific Substances/Technologies/Elements Beyond Those Specified Above

Management System
ABNT NBR ISO 9001:2015

The ABNT NBR ISO 9001:2015 certification provides companies with numerous benefits, ensuring not only quality standards but also a continuous pursuit of customer satisfaction. Implementing a management system is a strategic decision that enables the identification and correction of inefficient processes, promoting continuous improvement.

Accredited scopes of ABNT NBR ISO 9001:2015

Rubber and Plastic Products

  • 22.11 Manufacture of tires and inner tubes; tire retreading
  • 22.19 Manufacture of other rubber products
  • 22.21 Manufacture of plastic sheets, plates, tubes, and profiles
  • 22.22 Manufacture of plastic packaging
  • 22.23 Manufacture of plastic articles for construction
  • 22.29 Manufacture of other plastic articles

Basic Metals and Manufactured Metal Products

  • 24.10 Steelmaking and ferroalloy production
  • 24.20 Manufacture of steel tubes, pipes, hollow profiles, and related fittings
  • 24.31 Cold drawing of bars
  • 24.32 Cold rolling of narrow strip
  • 24.33 Cold forming or folding
  • 24.34 Cold drawing of wire
  • 24.41 Production and primary processing of precious metals
  • 24.42 Production and primary processing of aluminum
  • 24.43 Production and primary processing of lead, zinc, and tin
  • 24.44 Production and primary processing of copper
  • 24.45 Production and primary processing of other non-ferrous metals, n.e.c.
  • 24.51 Casting of iron
  • 24.52 Casting of steel
  • 24.53 Casting of light metals
  • 24.54 Casting of other non-ferrous metals, n.e.c.
  • 25.11 Manufacture of metal structures for construction
  • 25.12 Manufacture of metal doors and windows
  • 25.21 Manufacture of boilers and radiators for central heating
  • 25.29 Manufacture of other metal tanks and containers
  • 25.30 Manufacture of steam generators (except central heating boilers)
  • 25.50 Manufacture of forged, stamped, and rolled products; powder metallurgy
  • 25.61 Metal treatment and coating
  • 25.62 General mechanical engineering activities
  • 25.71 Manufacture of cutlery
  • 25.72 Manufacture of locks, hinges, and other hardware
  • 25.73 Manufacture of tools
  • 25.91 Manufacture of heavy metal packaging
  • 25.92 Manufacture of light metal packaging
  • 25.93 Manufacture of wire products, chains, and springs
  • 25.94 Manufacture of rivets, screws, and nuts
  • 25.99 Manufacture of other metal products, n.e.c.
  • 33.11 Repair of metal products

Machinery and Equipment

  • 25.40 Manufacture of weapons and ammunition
  • 28.11 Manufacture of engines and turbines (except for aircraft, automobiles, and motorcycles)
  • 28.12 Manufacture of hydraulic and pneumatic equipment
  • 28.13 Manufacture of other pumps and compressors
  • 28.14 Manufacture of other taps and valves
  • 28.15 Manufacture of bearings, gears, and other transmission components
  • 28.21 Manufacture of furnaces and burners
  • 28.22 Manufacture of lifting and handling equipment
  • 28.23 Manufacture of office machinery and equipment (except computers and peripheral equipment)
  • 28.24 Manufacture of portable power tools
  • 28.25 Manufacture of non-domestic refrigeration and ventilation equipment
  • 28.29 Manufacture of other general-purpose machinery, n.e.c.
  • 28.30 Manufacture of agricultural, livestock, and forestry machinery and tractors
  • 28.41 Manufacture of metallurgy machinery
  • 28.49 Manufacture of other machine tools
  • 28.91 Manufacture of machinery for metallurgy
  • 28.92 Manufacture of machinery for extractive industries and construction
  • 28.93 Manufacture of machinery for the food, beverage, and tobacco industries
  • 28.94 Manufacture of machinery for the textile, apparel, and leather industries
  • 28.95 Manufacture of machinery for the paper and cardboard industries
  • 28.96 Manufacture of machinery for the plastics and rubber industries
  • 28.99 Manufacture of other special-purpose machinery and equipment, n.e.c.
  • 30.40 Manufacture of military combat vehicles
  • 33.12 Repair of machinery
  • 33.20 Installation of industrial machinery and equipment

Optical and Electrical Equipment

  • 26.11 Manufacture of electronic components
  • 26.12 Manufacture of printed circuit boards
  • 26.20 Manufacture of computers and peripheral equipment
  • 26.30 Manufacture of communication devices and equipment
  • 26.40 Manufacture of radio and television receivers and similar consumer goods
  • 26.51 Manufacture of measuring, testing, and navigation instruments and devices
  • 26.52 Manufacture of watches and clockmaking materials
  • 26.60 Manufacture of irradiation, electromedical, and electrotherapeutic equipment
  • 26.70 Manufacture of optical and photographic instruments and equipment
  • 26.80 Manufacture of magnetic and optical media
  • 27.11 Manufacture of electric motors, generators, and transformers
  • 27.12 Manufacture of distribution and control equipment for electrical installations
  • 27.20 Manufacture of batteries and accumulators
  • 27.31 Manufacture of fiber optic cables
  • 27.32 Manufacture of other electrical and electronic wires and cables
  • 27.33 Manufacture of cable and wire accessories
  • 27.40 Manufacture of electric lamps and other lighting equipment
  • 27.51 Manufacture of household electrical appliances
  • 27.52 Manufacture of non-electrical household appliances
  • 27.90 Manufacture of other electrical equipment
  • 29.31 Manufacture of electrical and electronic equipment for motor vehicles
  • 33.13 Repair of electronic and optical equipment
  • 33.14 Repair of electrical equipment
  • 95.11 Repair of computers and peripheral equipment
  • 95.12 Repair of communication equipment

Information Technology

  • 58.21 Publishing of computer games
  • 58.29 Publishing of other software programs
  • 62.01 Computer programming activities
  • 62.02 IT consultancy activities
  • 62.03 Management and repair of IT equipment
  • 62.09 Other IT and information technology service activities
  • 63.11 Data processing, hosting, and related activities
  • 63.12 Web portals

Manufacturing (Not Classified Elsewhere)

  • 31.01 Manufacture of office and shop furniture
  • 31.02 Manufacture of kitchen furniture
  • 31.03 Manufacture of mattresses
  • 31.09 Manufacture of other furniture
  • 32.11 Coin minting
  • 32.12 Manufacture of jewelry, goldsmithing, and similar articles
  • 32.13 Manufacture of costume jewelry
  • 32.20 Manufacture of musical instruments
  • 32.30 Manufacture of sports goods
  • 32.40 Manufacture of games and toys
  • 32.50 Manufacture of medical and surgical instruments and materials
  • 32.99 Other manufacturing industries, n.e.c.
  • 33.19 Repair of other equipment
  • Other services
  • 81.21 General building cleaning
  • 81.22 Other cleaning activities for buildings and industrial equipment
  • 81.29 Other cleaning activities