Introduction to Certifications Around the World
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Introduction to Certifications Around the World (I) What is ISO9000? ISO carries out its technical activities through its 2,856 technical bodies. Of these, there are 185 technical committees (abbreviated as TC), 611 sub-technical committees (abbreviated as SC), 2,022 working groups (WG), and 38 task forces. The outcomes (products) of the technical activities of ISO’s 2,856 technical bodies are “international standards”. ISO has now established over 10,300 international standards, which mainly cover the technical specifications for various products in different industries (including service products and knowledge-based products). International standards established by ISO come with a standard name as well as a number; the format of this number is: ISO+standard number++colon+year of publication (the content in square brackets is optional). For example, ISO8402:1987 and ISO9000-1:1994 are the numbers corresponding to specific standards. ““ISO9000” does not refer to a single standard, but is a general term for a family of standards. According to the definition in ISO9000-1:1994, the ’ISO9000 family’ consists of all international standards developed by ISO/TC176. ” What is TC176? TC176 is the 176th technical committee under ISO; it was established in 1980. Its full name is \"Technical Committee on Quality Assurance,\" and in 1987 it was renamed \"Technical Committee on Quality Management and Quality Assurance.\" TC176 is specifically responsible for establishing standards for quality management and quality assurance techniques. The ISO9000 family has evolved as follows: The first version (i.e., the 1987 version) of the ISO9000 family standards consisted of only 6 standards, which were then referred to as the “ISO9000 series standards”. Starting in 1990, TC176 issued several more standards for quality management and quality assurance. In 1994, the first revisions to the aforementioned ISO9000 series of standards were made; by then, there were a total of 16 standards in the ISO9000 family (briefly). After 1994, the series of ISO9000 standards continued to expand. Before the revision in 2000, there were a total of 22 standards and 2 technical reports (TRs), which are commonly referred to as the second edition of the ISO9000 standards: ISO8402:1994 “Quality management and quality assurance – Vocabulary”; ISO9000-1:1994 “Quality management and quality assurance – Part 1: Guidelines for selection and use”; ISO9000-2:1993 “Quality management and quality assurance – Part 2: General guidelines for the implementation of ISO9001/2/3”; ISO9000-3:1993 “Quality management and quality assurance – Part 3: Guidelines for the use of ISO9001 in software development, supply, and maintenance”; ISO9000-4:1993 “Quality management and quality assurance – Part 4: Guidelines for reliability management”; ISO9001:1994 “Quality systems – Quality assurance models for design, development, production, installation, and service”; ISO9002:1994 “Quality systems – Quality assurance models for production, installation, and service”; ISO9003:1994 “Quality systems – Quality assurance models for final inspection and testing”; ISO9004-1:1994 “Quality management and quality system elements – Part 1: Guidelines”; ISO9004-2:1991 “Quality management and quality system elements – Part 2: Guidelines for services”; ISO9004-3:1993 “Quality management and quality system elements – Part 3: Guidelines for documented information”; ISO9004-4:1993 “Quality management and quality system elements – Part 4: Guidelines for quality improvement”; ISO10005:1995 “Quality management – Guidelines for quality planning”; ISO10006:1997 “Quality management – Guidelines for quality in project management”; ISO10007:1995 “Quality management – Guidelines for technical state management”; ISO10011-1:1990 “Guidelines for quality system auditing – Auditing”; ISO10011-2:1991 “Guidelines for quality system auditing – Criteria for evaluating quality system auditors”; ISO10011-3:1991 “Guidelines for quality system auditing – Management of audit activities”; ISO10012-1:1992 “Quality requirements for measuring equipment – Part 1: Systems for the verification of measuring equipment”; ISO10012-2:1997 “Quality requirements for measuring equipment – Part 2: Guidelines for controlling measurement processes”; ISO10013:1995 “Guidelines for preparing quality manuals”; ISO/TR10014:1998 “Guidelines for quality economics management”; ISO10015:1999 “Quality management – Guidelines for training”; ISO/TR10017:1999 “Guidelines for statistical techniques”. The revisions to the ISO9000 standards in 2000 resulted in the establishment of the following four core standards: ISO9000 “Quality management systems – Fundamentals and vocabulary” ; ISO9001 «Quality Management Systems – Requirements» ; ISO9004 “Quality Management Systems – Guidelines for Performance Improvement” ; ISO19011 «Guidelines for auditing quality and environmental management systems». 2. Core standards, Other standards, Technical report brochures * ISO9000, ISO10012, ISO10005 – “Quality Management Principles and Guidelines for Their Application” * ISO9001, ISO10006 – “Guidelines for Selection and Use” * ISO9004, ISO10007 – “Implementation Guidelines for Small Enterprises” * ISO19011, ISO10013, ISO10014, ISO10015, ISO10017. The role of ISO9000 certification – The ISO9000 family of standards are all international standards developed by the ISO/TC176 technical committee. They represent the first series of management standards issued by ISO (the International Organization for Standardization), namely quality management standards. These standards were created on the basis of summarizing the experience in quality management from various countries around the world, especially those with highly developed industries. At its core, the ISO9000 family focuses on customers, aiming to continuously meet their needs. Obtaining a quality system certification can enable an organization to improve its quality management level. A fundamental requirement for obtaining such certification is to establish a quality system in accordance with the ISO9000 standards. Establishing a quality system is the essential path for an organization to achieve the goals of high quality and low costs; it enables the organization to have mechanisms for reducing, eliminating, and especially preventing quality defects, thereby standardizing and regulating its quality management processes. During the certification application process, the certification consulting agency will guide the organization in establishing a new quality system to meet the requirements of the ISO9000 series standards. It enhances an organization’s reputation and competitiveness. Obtaining quality certification can bring a good reputation to an organization, earn recognition from industry regulatory bodies, gain customers’ trust, and also provide the right to bid on projects. Expand sales and achieve greater profits. Obtaining the ISO9000 quality certification mark is proof of the reliability of product quality. Products with certification marks have a clear competitive edge in the market and enjoy greater trust from customers. Experience has shown that, under market economy conditions, obtaining ISO9000 quality system certification is an effective means for organizations to succeed in competition and increase their profits. It is conducive to expanding into international markets. Implementing a quality certification system is a common practice in countries around the world today, especially in those with highly developed industries. Many purchasers involved in international trade are willing or require the purchase of certified products. Some buyers request that manufacturers provide proof of quality system certification in accordance with the ISO9000 standard when placing orders. In short, obtaining quality certification for an organization is necessary in order to bring its products into international markets and increase exports. Exemption from supervision and inspection by other authorities: Obtaining certification for a quality management system indicates that the organization’s quality management system is sound and operates in accordance with the ISO9000 standards; as a result, when undergoing inspections conducted by ** or industry regulations, inspection of the quality management system can be waived. The relationship between ISO9000 and ISO14000 – The quality management system certification standard ISO9000 and the environmental management system standard ISO14000 have many common requirements for organizations (companies, enterprises), and the two standards can be used together. Many enterprises and companies around the world have obtained certification under the ISO9000 series of standards, and they can apply the experience gained from obtaining ISO9000 certification to environmental management certification. The new version of the ISO9000 family of standards reflects more strongly the principle of using both sets of standards together, thereby establishing a closer connection between the ISO9000 family and the ISO14000 series of standards. The elements of the two standards are the same or similar. (See table below) ISO14000 ISO9000 Environmental policy Quality policy Organizational structure and responsibilities Responsibilities and authorities Environmental training for staff Quality training for staff Exchange of environmental information Exchange of quality information Control of environmental documents Control of quality documents Emergency preparedness and response (Some requirements are the same as those for fire safety) Non-conformities, corrective and preventive actions Non-conformities, corrective and preventive actions Environmental records Quality records Internal audits Internal audits Management reviews Management reviews Once again, the main difference between the two standards lies in their target audiences: the ISO9000 standard is a commitment to customers, while the ISO14000 standard is directed at the environment, society, and various stakeholders (including shareholders, lenders, insurance companies, etc.) ; The ISO9000 standard lacks an effective external supervision mechanism, whereas when implementing the ISO14000 standard, one is subject to the supervision of **, law enforcement authorities, the general public, and various interested parties. Finally, within this system, the two sets of standards differ significantly in terms of certain aspects and the overall approach adopted, including the identification of environmental factors, the assessment and control of significant environmental factors; the identification of applicable environmental laws and regulations, as well as the evaluation of compliance with these laws and regulations and the monitoring of any updates to them; and the formulation and implementation of environmental objectives and indicators. All these efforts are aimed at preventing pollution, saving energy and reducing consumption, improving the efficiency of resource and energy use, and ultimately achieving continuous improvement in environmental practices. This post was last edited by QXZ-1966 on 2009-3-17 09:30.]Range of products subject to certification in Russia: Electronic equipment · Household appliances · Cables, wires, switches and automatic switching devices for instruments, complete sets of equipment and connection devices · Lighting products · Protection devices for adjustment · Low-voltage control devices · Low-power transformers · Welding equipment · Personal computers and laptops · Chemical supply sources · Small and medium-sized engines · Measuring tools · Electronic instruments and equipment · Video game consoles · Information technology equipment and office equipment · Equipment and tools for film photography · Radio communication, radio broadcasting, and television equipment · Communication and fax equipment · Low-voltage complete sets of equipment, high-voltage equipment · Electric heating equipment · Medical technical equipment · Industrial and commercial catering equipment · Washing and dry cleaning equipment · Tools with insulated handles · Agricultural and gardening machinery.
Chemical, petrochemical products, and petroleum processing products · Inorganic chemical products · Polymer materials · Daily chemical products · Mineral fertilizers · Rubber products and asbestos products · Petroleum products (light and heavy grades) · Lubricants.
Products from the timber industry and packaging materials · Plywood and boards · Furniture · Paper and cardboard packaging (wooden packaging, metal packaging, polymer packaging, paper packaging, glass packaging, bottle caps, metal lids, stoppers, cork) · School notebooks, wallpaper, and pulp products.
Textiles and light industry products · Yarns, fabrics, non-woven linen, knitted products (cotton, linen, wool, silk, coarse textiles) · Insulating varnished cloth · Knitted and sewn products · Artificial leather · Daily necessities and hygiene products · Rugs and floor coverings · Shoes and leather goods · Toys.
Basic contents of EU directives (ROHS and WEEE): On February 13, 2003, the European Parliament and the European Commission published in their Official Journal the Directive on Waste Electrical and Electronic Equipment (hereinafter referred to as the “WEEE Directive”) and the Directive on the Restriction of the Use of Certain Hazardous Substances in Electrical and Electronic Equipment (hereinafter referred to as the “RoHS Directive”).
Table 1: List of products covered by ROHS and WEEE regulations
| Serial Number | Product Category | Product Name |
| --- | --- | --- |
| 1 | Large household appliances | Large refrigeration appliances, refrigerators, freezers, other large appliances used for food cooling, preservation, and storage, washing machines, dryers, dishwashers, rice cookers, electric stoves, electric heating plates, microwaves, other large appliances used for food cooking and processing, electric heaters, space heaters, other large appliances used for heating rooms, beds, and seats, electric fans, air conditioning appliances, other devices for blowing air, ventilation, and air conditioning |
| 2 | Small household appliances | Vacuum cleaners, carpet cleaners, other cleaning appliances, appliances for sewing, weaving, and other textile processing, irons and other appliances for ironing, flattening, and caring for clothes, toasters, electric pans, grinders, coffee makers, devices for opening or sealing containers or packages, electric razors, hair dryers, toothbrushes, shavers, massage devices, and other devices for body care, electric clocks, electronic watches, and other devices for measuring, displaying, or recording time, electronic scales |
| 3 | Information and communication equipment | Central data processors, personal computers, printers, copying devices, electromechanical typewriters, desktop and pocket calculators, other products and devices for collecting, storing, processing, displaying, or transmitting information electronically | ; User terminal and system ; Fax machine ; telegraph ; Phone ; Paid phone call ; cordless phone ; Mobile phone ; Response system ; Products or devices that transmit sound, images, or other information via electrical signals 4 Consumer products: radios, televisions, video recorders ; Recorder ; High-fidelity recorder ; Attack and defense machine ; Musical instruments ; Other products or devices for recording or reproducing sound or images 5 Lighting equipment Fluorescent lamps (excluding household lighting equipment) ; Straight fluorescent lamp ; Compact fluorescent lamp ; High-brightness discharge lamps, including pressure sodium lamps and metal halide lamps ; Low-pressure sodium lamp ; Other lighting devices used for transmitting or controlling light (excluding filament bulbs) 6 Electrical and electronic tools Electric drills ; chainsaw ; sewing machine ; Equipment for turning, milling, sanding, grinding, sawing, cutting, shearing, drilling, punching, folding, bending, or similar processing of wood, metal, or other materials ; Tools used for driving rivets, nails, or screws, or for removing them ; Tools for welding or similar purposes ; Equipment for spraying, propagating, dispersing, or otherwise processing liquids or gases ; Tools used for mowing grass or other gardening tasks (7) Toys, leisure, and sports equipment Electric trains or racing cars ; Handheld video game console ; Video game console ; A measuring device used for cycling, diving, running, rowing, and other activities ; Motion devices with electronic or electrical components ; Vending machines (8) Medical devices (excluding implanted or infected products) Radiation therapy equipment ; Equipment for the heart ; Perspective device ; Pulmonary ventilator ; Nuclear medical equipment ; Diagnostic laboratory equipment in glass containers ; Analyzer ; Refrigerator ; Reproductive testing equipment ; Other devices used for detecting, preventing, monitoring, treating, and alleviating diseases and injuries 9 Monitoring and control instruments Smoke detectors ; Thermoregulator ; Thermostat ; Measuring, weighing, or regulating instruments for household or laboratory use ; Other monitoring instruments used in industrial installations (such as on control panels) 10 Vending machines Vending machines for hot drinks ; Vending machines for bottled or canned hot or cold beverages ; Automatic vending machine for solid products ; Automatic currency vending machine ; Instructions for all devices that automatically dispense various types of products: Items numbered (7) and (8) are enclosed in parentheses, indicating that these items are not currently subject to the RoHS directive ; Table 2: Six categories of hazardous substances restricted under the RoHS directive Sequence Number Substances restricted by the directive Examples of uses for these substances Exemptions specified by the directive 1 Mercury Thermostats, sensors, switches and relays, light bulbs Compact and standard straight fluorescent lamps, as well as special-purpose straight fluorescent lamps, with a mercury content not exceeding specified levels (5, 8, or 10 mg) 2 Lead Solder, glass, PVC stabilizers CRTs, electronic components, and fluorescent tube glass Lead in alloy steels