Management
ABNT NBR ISO 13485:2016 HEALTH PRODUCTS MANAGEMENT SYSTEM
Certification for the ABNT NBR ISO 13485:2016 health product management system is derived from the internationally accepted ISO 9001, adapted to process models for medical devices to ensure conformity in the entire product cycle (design, production, installation, maintenance, and sales).
ABNT NBR ISO 13485:2016 accredited scopes
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
• Non-active Medical Devices. non-deployable general purpose
• Devices for treating injuries
• Non-active implants
Medical Material Sterilization Methods
• Aldehydes (formaldehyde and Glutaraldehyde), Dry heat (ovens and ovens)
• Moist heat
• Radiation sterilization (gamma radiation, alpha radiation, electron beam)
• Ethylene Oxide (ETO)
• Aseptic Processing
Active Implantable Medical Devices
• General implantable active medical devices.
• Active implantable medical devices (Other devices)
Devices that incorporate/use specific substances/technologies
• Medical devices that incorporate medicinal substances
• Medical devices that use tissues of animal origin
• Medical devices incorporating human blood derivatives
• Medical devices that use micromechanics
• Medites devices that use nano materials
• Medical devices that use biological coatings
• Medical devices that incorporate or use specific substances/technologies/elements. other than specified above
ABNT NBR ISO 9001:2015 MANAGEMENT SYSTEM
The ABNT NBR ISO 9001:2015 certification aims to guarantee the company numerous benefits, providing, in addition to quality standards, the continuous search for customer satisfaction. Following a management system is a strategic decision that makes it possible to find and adjust inefficient organizational processes.
ABNT NBR ISO 9001:2015 Accredited scopes
Rubbers and Plastic Products
• 22.11 Manufacture of rubber tires and tubes; retreading and rebuilding of rubber tires
• 22.19 Manufacture of other rubber products
• 22.21 Manufacture of plastic plates, sheets, tubes, and profiles
• 22.22 Manufacture of plastic packing goods
• 22.23 Manufacture of builders’ ware of plastic
• 22.29 Manufacture of other plastic products
Basic metals and Fabricated Metal Products
• 24.10 Manufacture of basic iron and steel and of ferro-alloy
• 24.20 Manufacture of tubes, pipes, hollow profiles and related fittings, of steel
• 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 Precious metals production
• 24.42 Aluminum production
• 24.43 Lead, zinc, and tin production
• 24.44 Copper production
• 24.45 Other non-ferrous metal production, 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 and parts of structures
• 25.12 Manufacture of doors and windows of metal
• 25.21 Manufacture of central heating radiators and boilers
• 25.29 Manufacture of other tanks, reservoirs, and containers of metal
• 25.30 Manufacture of steam generators (except central heating hot water boilers)
• 25.50 Forging, pressing, stamping and roll-forming of metal; powder metallurgy
• 25.61 Treatment and coating of metals
• 25.62 Machining
• 25.71 Manufacture of cutlery
• 25.72 Manufacture of locks and hinges
• 25.73 Manufacture of tools
• 25.91 Manufacture of steel drums and similar containers
• 25.92 Manufacture of light metal packaging
• 25.93 Manufacture of wire products, chain, and springs
• 25.94 Manufacture of fasteners and screw machine products
• 25.99 Manufacture of other fabricated metal products n.e.c.
• 33.11 Repair of fabricated metal products
Machinery and Equipment
• 25.40 machinery and equipment
• 28.11 Manufacture of engines and turbines (except aircraft, vehicle, and cycle engines)
• 28.12 Manufacture of fluid power equipment
• 28.13 Manufacture of other pumps and compressors
• 28.14 Manufacture of other taps and valves
• 28.15 Manufacture of bearings, gears, gearing and driving elements
• 28.21 Manufacture of ovens, furnaces, and furnace 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 power-driven hand tools
• 28.25 Manufacture of non-domestic cooling and ventilation equipment
• 28.29 Manufacture of other general-purpose machinery, n.e.c.
• 28.30 Manufacture of agricultural and forestry machinery
• 28.41 Manufacture of metal forming machinery
• 28.49 Manufacture of other machine tools
• 28.91 Manufacture of machinery for metallurgy
• 28.92 Manufacture of machinery for mining, quarrying and construction
• 28.93 Manufacture of machinery for food, beverage, and tobacco processing
• 28.94 Manufacture of machinery for textile, apparel, and leather production
• 28.95 Manufacture of machinery for paper and paperboard production
• 28.96 Manufacture of plastics and rubber machinery
• 28.99 Manufacture of other special-purpose machinery, n.e.c.
• 30.40 Manufacture of military fighting vehicles
• 33.12 Repair of machinery
• 33.20 Installation of industrial machinery and equipment
Optical Electrical Equipment
• 26.11 Manufacture of electronic components
• 26.12 Manufacture of loaded electronic boards
• 26.20 Manufacture of computers and peripheral equipment
• 26.30 Manufacture of communication equipment
• 26.40 Manufacture of consumer electronics
• 26.51 Manufacture of instruments and appliances for measuring, testing and navigation
• 26.52 Manufacture of watches and clocks
• 26.60 Manufacture of irradiation, electromedical and electrotherapeutic equipment
• 26.70 Manufacture of optical instruments and photographic equipment
• 26.80 Manufacture of magnetic and optical media
• 27.11 Manufacture of electric motors, generators, and transformers
• 27.12 Manufacture of electricity distribution and control apparatus
• 27.20 Manufacture of batteries and accumulators
• 27.31 Manufacture of fiber optic cables
• 27.32 Manufacture of other electronic and electric wires and cables
• 27.33 Manufacture of wiring devices
• 27.40 Manufacture of electric lighting equipment
• 27.51 Manufacture of electric domestic appliances
• 27.52 Manufacture of non-electric domestic 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 Other software publishing
• 62.01 Computer programming activities
• 62.02 Computer consultancy activities
• 62.03 Computer facilities management activities
• 62.09 Other information technology and computer service activities
• 63.11 Data processing, hosting, and related activities
• 63.12 Web portals
Manufacture of Furniture
• 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 Striking of coins
• 32.12 Manufacture of jewelry and related articles
• 32.13 Manufacture of imitation jewelry and related articles
• 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 dental instruments and supplies
• 32.99 Other manufacturing, n.e.c.
• 33.19 Repair of other equipment
Other Services
• 81.21 General cleaning of buildings
• 81.22 Other building and industrial cleaning activities
• 81.29 Other cleaning activities