Quality Management at AGS-TECH Inc
All plants manufacturing parts and products for AGS-TECH Inc are certified to one or several of the following QUALITY MANAGEMENT SYSTEM (QMS) standards:
- ISO 9001
- TS 16949
- QS 9000
- AS 9100
- ISO 13485
- ISO 14000
Besides the above listed quality management systems, we assure our customers highest quality products and services by manufacturing according to well recognized international standards and certifications such as:
- UL, CE, EMC, FCC and CSA Certification Marks, FDA Listing, DIN / MIL / ASME / NEMA / SAE / JIS /BSI / EIA / IEC / ASTM / IEEE Standards, IP, Telcordia, ANSI, NIST
The specific standards that apply to a certain product depend on the nature of the product, its application field, usage and customer’s request.
We see quality as an area that needs continuous improvement and therefore we never restrict ourselves with these standards only. We continuously strive to increase our quality levels at all plants and all areas, departments and product lines by focusing on:
- Six Sigma
- Total Quality Management (TQM)
- Statistical Process Control (SPC)
- Life Cycle Engineering / Sustainable Manufacturing
- Robustness in Design, Manufacturing Processes and Machinery
- Agile Manufacturing
- Value Added Manufacturing
- Computer Integrated Manufacturing
- Concurrent Engineering
- Lean Manufacturing
- Flexible Manufacturing
For those who are interested in expanding their understanding on quality, let us briefly discuss these.
THE ISO 9001 STANDARD: Model for quality assurance in design/development, production, installation, and servicing. The ISO 9001 quality standard is used worldwide and is one of the most common. For initial certification as well as for timely renewals, our plants are visited and audited by accredited independent third-party teams to certify that the quality management standard’s 20 key elements are in place and functioning correctly. The ISO 9001 quality standard is not a product certification, rather a quality process certification. Our plants are periodically audited to maintain this quality standard accreditation. Registration symbolizes our commitment to conform to consistent practices, as specified by our quality system (quality in design, development, production, installation and servicing), including proper documentation of such practices. Our plants are also assured of such good quality practices by demanding our suppliers to be registered too.
THE ISO/TS 16949 STANDARD: This is an ISO technical specification aimed at the development of a quality management system that provides for continual improvement, emphasizing defect prevention and the reduction of variation and waste in the supply chain. It is based on the ISO 9001 quality standard. TS16949 quality standard applies to the design/development, production and, when relevant, installation and servicing of automotive-related products. The requirements are intended to be applied throughout the supply chain. Many of AGS-TECH Inc. plants maintain this quality standard instead of or in addition to the ISO 9001.
THE QS 9000 STANDARD: Developed by the automotive giants, this quality standard has extras in addition to the ISO 9000 quality standard. All of the ISO 9000 quality standard’s clauses serve as the foundation of the QS 9000 quality standard. AGS-TECH Inc. plants serving especially the automotive industry are certified to QS 9000 quality standard.
THE AS 9100 STANDARD: This is a widely adopted and standardized quality management system for the aerospace industry. AS9100 replaces the earlier AS9000 and fully incorporates the entirety of the current version of ISO 9000, while adding requirements relating to quality and safety. The aerospace industry is a high risk sector, and regulatory control is needed to assure that the safety and quality of services offered in the sector are world class. Plants manufacturing our aerospace components are certified to the AS 9100 quality standard.
THE ISO 13485:2003 STANDARD: This standard specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and regulatory requirements applicable to medical devices and related services. The main objective of ISO 13485:2003 quality standard is to facilitate harmonized medical device regulatory requirements for quality management systems. Therefore, it includes some particular requirements for medical devices and excludes some of the requirements of ISO 9001 quality system that are not appropriate as regulatory requirements. If regulatory requirements permit exclusions of design and development controls, this can be used as a justification for their exclusion from the quality management system. AGS-TECH Inc’s medical products such as endoscopes, fiberscopes, implants are manufactured at plants that are certified to this quality management system standard.
THE ISO 14000 STANDARD: This family of standards pertains to the international Environmental Management Systems. It concerns the way an organization’s activities affect the environment throughout the life of its products. These activities can range from production to disposal of the product after its useful life, and include effects on the environment including pollution, waste generation & disposal, noise, depletion of natural resources and energy. The ISO 14000 standard is related more to the environment rather than quality, but still it is one that many of AGS-TECH Inc.’s global production facilities are certified to. Indirectly though, this standard definitely can increase quality at a facility.
WHAT ARE THE UL, CE, EMC, FCC and CSA CERTIFICATION LISTING MARKS ? WHO NEEDS THEM ?
THE UL MARK: If a product carries the UL Mark, Underwriters Laboratories found that samples of this product met UL's safety requirements. These requirements are primarily based on UL's own published Standards for Safety. This type of Mark is seen on most appliances and computer equipment, furnaces and heaters, fuses, electrical panel boards, smoke and carbon monoxide detectors, fire extinguishers, flotation devices such as life jackets, and many other products throughout the World and especially in the USA. AGS-TECH Inc. relevant products for the US market are affixed with UL mark. In addition to manufacturing their products, as a service we can guide our customers throughout the UL qualification and marking process.Product testing can be verified through UL directories online at http://www.ul.com
THE CE MARK: The European Commission allows manufacturers to circulate industrial products with CE mark freely within the internal market of the EU. AGS-TECH Inc. relevant products for the EU market are affixed with CE mark. In addition to manufacturing their products, as a service we can guide our customers throughout the CE qualification and marking process.The CE mark certifies that the products have met EU health, safety and environmental requirements that ensure consumer and workplace safety. All manufacturers in the EU as well as outside the EU must affix the CE mark to those products covered by the ''New Approach'' directives in order to market their products within the EU territory. When a product receives the CE mark, it can be marketed throughout the EU without undergoing further product modification.
Most products covered by New Approach Directives can be self-certified by the manufacturer and do not require the intervention of an EU-authorized independent testing/certifying company. To self-certify, the manufacturer must assess the conformity of the products to the applicable directives and standards. While the use of EU harmonized standards is voluntary in theory, in practice the use of European standards is the best way to meet the requirements of the CE mark directives, because the standards offer specific guidelines and tests to meet safety requirements, while the directives, general in nature, do not. The manufacturer may affix the CE mark to their product after preparing a declaration of conformity, the certificate which shows the product conforms to the applicable requirements. The declaration must include the manufacturer's name and address, the product, the CE mark directives that apply to the product, e.g. the machine directive 93/37/EC or the low voltage directive 73/23/EEC, the European standards used, e.g. EN 50081-2:1993 for the EMC directive or EN 60950:1991 for the low voltage requirement for information technology. The declaration must show the signature of a company official for purposes of the company assuming liability for the safety of its product in the European market. This European standards organization has set up the Electromagnetic Compatibility Directive. According to CE, The Directive basically states that products must not emit unwanted electromagnetic pollution (interference). Because there is a certain amount of electromagnetic pollution in the environment, the Directive also states that products must be immune to a reasonable amount of interference. The Directive itself gives no guidelines on the required level of emissions or immunity that is left to the standards that are used to demonstrate compliance with the Directive.
The EMC-directive (89/336/EEC) Electromagnetic Compatibility
Like all other directives, this is a new-approach directive, which means that only the main requirements (essential requirements) are required. The EMC-directive mentions two ways of showing compliance to the main requirements:
•Manufacturers declaration (route acc. art. 10.1)
•Type testing using the TCF (route acc. to art. 10.2)
The LVD-directive (73/26/EEC) Safety
Like all CE-related directives, this is a new-approach directive, which means that only the main requirements (essential requirements) are required. The LVD-directive describes how to show compliance to the main requirements.
THE FCC MARK: The Federal Communications Commission (FCC) is an independent United States government agency. The FCC was established by the Communications Act of 1934 and is charged with regulating interstate and international communications by radio, television, wire, satellite and cable. The FCC's jurisdiction covers the 50 states, the District of Columbia, and U.S. possessions. All devices that operate at a clock rate of 9 kHz are required to be tested to the appropriate FCC Code. AGS-TECH Inc. relevant products for the US market are affixed with FCC mark. In addition to manufacturing their electronic products, as a service we can guide our customers throughout the FCC qualification and marking process.
THE CSA MARK: The Canadian Standards Association (CSA) is a nonprofit association serving business, industry, government and consumers in Canada and the global marketplace. Among many other activities, CSA develops standards that enhance public safety. As a nationally recognized testing laboratory, CSA is familiar with U.S. requirements. According to OSHA regulations, the CSA-US Mark qualifies as an alternative to the UL Mark.
WHAT IS FDA LISTING ? WHICH PRODUCTS NEED FDA LISTING ? A medical device is FDA-listed if the firm that manufactures or distributes the medical device has successfully completed an online listing for the device through the FDA Unified Registration and Listing System. Medical devices that do not require FDA review before the devices are marketed are considered ''510(k) exempt.'' These medical devices are mostly low-risk, Class I devices and some Class II devices that have been determined not to require a 510(k) to provide a reasonable assurance of safety and effectiveness. Most establishments that are required to register with the FDA are also required to list the devices that are made at their facilities and the activities that are performed on those devices. If a device requires premarket approval or notification before being marketed in the U.S., then the owner/operator should also provide the FDA premarket submission number (510(k), PMA, PDP, HDE). AGS-TECH Inc. does market and sell some products such as implants that are FDA listed. In addition to manufacturing their medical products, as a service we can guide our customers throughout the FDA listing process. More information as well as most current FDA listings can be found on http://www.fda.gov
WHAT ARE THE POPULAR STANDARDS AGS-TECH Inc. MANUFACTURING PLANTS COMPLY WITH ? Different customers demand from AGS-TECH Inc. compliance to different norms. Sometimes it is a matter of choice but many times the request depends on customer’s geographic location, or industry they serve, or product’s application…etc. Here are some of the most common ones:
DIN STANDARDS: DIN, the German Institute for Standardization develops norms for rationalization, quality assurance, environmental protection, safety and communication in industry, technology, science, government, and the public domain. DIN norms provide companies a basis for quality, safety and minimum functionality expectations and enable you to minimize risk, improve marketability, promote interoperability.
MIL STANDARDS: This is a United States defense or military norm, ''MIL-STD'', ''MIL-SPEC'', and is used to help achieve standardization objectives by the U.S. Department of Defense. Standardization is beneficial in achieving interoperability, ensuring products meet certain requirements, commonality, reliability, total cost of ownership, compatibility with logistics systems, and other defense-related objectives. It is important to note that defense norms are also used by other non-defense government organizations, technical organizations, and industry.
ASME STANDARDS: American Society of Mechanical Engineers (ASME) is an engineering society, a standards organization, a research and development organization, a lobbying organization, a provider of training and education, and a nonprofit organization. Founded as an engineering society focused on mechanical engineering in North America, ASME is multidisciplinary and global. ASME is one of the oldest standards-developing organizations in the US. It produces approximately 600 codes and standards covering many technical areas, such as fasteners, plumbing fixtures, elevators, pipelines, and power plant systems and components. Many ASME standards are referred to by government agencies as tools to meet their regulatory objectives. ASME norms are therefore voluntary, unless they have been incorporated into a legally binding business contract or incorporated into regulations enforced by an authority having jurisdiction, such as a federal, state, or local government agency. ASME are used in more than 100 countries and have been translated into many languages.
NEMA STANDARDS: The National Electrical Manufacturers Association (NEMA) is the association of electrical equipment and medical imaging manufacturers in the US. Its member companies manufacture products used in the generation, transmission, distribution, control, and end use of electricity. These products are used in utility, industrial, commercial, institutional, and residential applications. NEMA’s Medical Imaging & Technology Alliance division represents manufacturers of cutting-edge medical diagnostic imaging equipment including MRI, CT, X-ray, and ultrasound products. In addition to lobbying activities, NEMA publishes more than 600 standards, application guides, white and technical papers.
SAE STANDARDS: SAE International, initially established as the Society of Automotive Engineers, is a U.S.-based, globally active professional association and standards organization for engineering professionals in various industries. Principal emphasis is placed on transport industries including automotive, aerospace, and commercial vehicles. SAE International coordinates the development of technical standards based on best practices. Task forces are brought together from engineering professionals of relevant fields. SAE International provides a forum for companies, government agencies, research institutions…etc. to devise technical standards and recommended practices for the design, construction, and characteristics of motor vehicle components. SAE documents do not carry any legal force, but are in some cases referenced by the U.S. National Highway Traffic Safety Administration (NHTSA) and Transport Canada in those agencies' vehicle regulations for the United States and Canada. However, outside North America, SAE documents are generally not a primary source of technical provisions in vehicle regulations. SAE publishes more than 1,600 technical standards and recommended practices for passenger cars and other road travelling vehicles and over 6,400 technical documents for the aerospace industry.
JIS STANDARDS: Japanese Industrial Standards (JIS) specify the norms used for industrial activities in Japan. The standardization process is coordinated by the Japanese Industrial Standards Committee and published through the Japanese Standards Association. The Industrial Standardization Law was revised in 2004 and the ''JIS mark'' (product certification) was changed. Starting October 1, 2005, the new JIS mark has been applied upon re-certification. The use of the old mark was allowed during the three-year transition period until September 30, 2008; and every manufacturer obtaining new or renewing their certification under the authority's approval has been able to use the new JIS mark. Therefore all JIS-certified Japanese products have had the new JIS mark since October 1, 2008.
BSI STANDARDS: British Standards are produced by BSI Group which is incorporated and formally designated as the National Standards Body (NSB) for the UK. The BSI Group produces British norms under the authority of the Charter, which lays down as one of the BSI's objectives to set up norms of quality for goods and services, and prepare and promote the general adoption of British Standards and schedules in connection therewith and from time to time to revise, alter and amend such standards and schedules as experience and circumstances require. The BSI Group currently has over 27,000 active standards. Products are commonly specified as meeting a particular British Standard, and generally this can be done without any certification or independent testing. The standard simply provides a shorthand way of claiming that certain specifications are met, while encouraging manufacturers to adhere to a common method for such a specification. The Kitemark can be used to indicate certification by BSI, but only where a Kitemark scheme has been set up around a particular standard. Products and services which BSI certifies as having met the requirements of specific standards within designated schemes are awarded the Kitemark. It is mainly applicable to safety and quality management. There is a common misunderstanding that Kitemarks are necessary to prove compliance with any BS standard, but in general it is neither desirable nor possible that every standard be 'policed' in this way. Because of the move on harmonization of standards in Europe, some British Standards have been gradually superseded or replaced by the relevant European norms (EN).
EIA STANDARDS: The Electronic Industries Alliance was a standards and trade organization composed as an alliance of trade associations for electronics manufacturers in the United States, which developed standards to ensure the equipment of different manufacturers was compatible and interchangeable. The EIA ceased operations on February 11, 2011, but the former sectors continue to serve the constituencies of EIA. EIA designated ECA to continue to develop standards for interconnect, passive and electro-mechanical electronic components under the ANSI-designation of EIA standards. All other electronic components norms are managed by their respective sectors. ECA is expected to merge with the National Electronic Distributors Association (NEDA) to form the Electronic Components Industry Association (ECIA). However, the EIA standards brand will continue for interconnect, passive and electro-mechanical (IP&E) electronic components within ECIA. The EIA divided its activities into the following sectors:
•ECA – Electronic Components, Assemblies, Equipment & Supplies Association
•JEDEC – JEDEC Solid State Technology Association (formerly the Joint Electron Devices Engineering Councils)
•GEIA – Now part of TechAmerica, it is the Government Electronics and Information Technology Association
•TIA – Telecommunications Industry Association
•CEA – Consumer Electronics Association
IEC STANDARDS: The International Electrotechnical Commission (IEC) is a World organization that prepares and publishes International Standards for all electrical, electronic and related technologies. More than 10 000 experts from industry, commerce, governments, test and research labs, academia and consumer groups participate in IEC’s Standardization work. The IEC is one of three global sister organizations (they are IEC, ISO, ITU) that develop International Standards for the World. Whenever needed, the IEC cooperates with ISO (International Organization for Standardization) and ITU (International Telecommunication Union) to ensure that International Standards fit together well and complement each other. Joint committees ensure that International Standards combine all relevant knowledge of experts working in related areas. Many devices around the World that contain electronics, and use or produce electricity, rely on IEC International Standards and Conformity Assessment Systems to perform, fit and work safely together.
ASTM STANDARDS: ASTM International, (formerly known as the American Society for Testing and Materials), is an international organization that develops and publishes voluntary consensus technical standards for a wide range of materials, products, systems, and services. Over 12,000 ASTM voluntary consensus standards operate globally. ASTM was established earlier than the other standards organizations. ASTM International has no role in requiring nor enforcing compliance with its standards. They may however be considered mandatory when referenced by a contract, corporation, or government entity. In the United States, ASTM standards have been widely adopted by incorporation or by reference, in many federal, state, and municipal government regulations. Other governments also have referenced ASTM in their work. Corporations doing international business frequently reference an ASTM standard. As an example, all toys sold in the United States must meet the safety requirements of ASTM F963.
IEEE STANDARDS: The Institute of Electrical and Electronics Engineers Standards Association (IEEE-SA) is an organization within IEEE that develops global standards for a wide range of industries: power and energy, biomedical and health care, information technology, telecommunication and home automation, transportation, nanotechnology, information security, and others. The IEEE-SA has developed them for over a century. Experts from all over the world contribute to the development of IEEE standards. IEEE-SA is a community and not a government body.
ANSI ACCREDITATION: The American National Standards Institute is a private non-profit organization that oversees the development of voluntary consensus standards for products, services, processes, systems, and personnel in the United States. The organization also coordinates U.S. standards with international standards in an effort that American products can be used worldwide. ANSI accredits standards that are developed by representatives of other standards organizations, government agencies, consumer groups, companies, …etc. These standards ensure that the characteristics and performance of products are consistent, that people use the same definitions and terms, and that products are tested the same way. ANSI also accredits organizations that carry out product or personnel certification in accordance with requirements defined in international standards. The ANSI itself does not develop standards, but oversees the development and use of standards by accrediting the procedures of standards developing organizations. ANSI accreditation signifies that the procedures used by standards developing organizations meet the Institute's requirements for openness, balance, consensus, and due process. ANSI also designates specific standards as American National Standards (ANS), when the Institute determines that the standards were developed in an environment that is equitable, accessible and responsive to the requirements of various stakeholders. Voluntary consensus standards quicken the market acceptance of products while making clear how to improve the safety of those products for the protection of consumers. There are approximately 9,500 American National Standards that carry the ANSI designation. In addition to facilitating the formation of these in the United States, ANSI promotes the use of U.S. standards internationally, advocates U.S. policy and technical positions in international and regional organizations, and encourages the adoption of international and national standards where appropriate.
NIST REFERENCE: The National Institute of Standards and Technology (NIST), is a measurement standards laboratory, which is a non-regulatory agency of the United States Department of Commerce. The institute's official mission is to promote U.S. innovation and industrial competitiveness by advancing measurement science, standards, and technology in ways that enhance economic security and improve our quality of life. As part of its mission, NIST supplies industry, academia, government, and other users with over 1,300 Standard Reference Materials. These artifacts are certified as having specific characteristics or component content, used as calibration standards for measuring equipment and procedures, quality control benchmarks for industrial processes, and experimental control samples. NIST publishes the Handbook 44 that provides the specifications, tolerances, and other technical requirements for weighing and measuring devices.
WHAT ARE THE OTHER TOOLS AND METHODS AGS-TECH Inc. PLANTS DEPLOY TO PROVIDE HIGHEST QUALITY ?
SIX SIGMA: This is a set of statistical tools based on well known total quality management principles, to continually measure the quality of products and services in selected projects. This total quality management philosophy includes considerations such as ensuring customer satisfaction, delivering defect-free products, and understanding process capabilities. The six sigma quality management approach consists of a clear focus on defining the problem, measuring relevant quantities, analyzing, improving, and controlling processes and activities. Six Sigma quality management at many organizations simply means a measure of quality that aims for near perfection. Six Sigma is a disciplined, data-driven approach and methodology for eliminating defects and driving toward six standard deviations between the mean and the nearest specification limit in any process ranging from manufacturing to transactional and from product to service. To achieve Six Sigma quality level, a process must not produce more than 3.4 defects per million opportunities. A Six Sigma defect is defined as anything outside of customer specifications. The fundamental objective of the Six Sigma quality methodology is the implementation of a measurement-based strategy that focuses on process improvement and variation reduction.
TOTAL QUALITY MANAGEMENT (TQM): This is a comprehensive and structured approach to organizational management that aims for the improvement of quality in products and services through ongoing refinements in response to continuous feedback. In a total quality management effort, all members of an organization participate in improving processes, products, services, and the culture in which they work. Total Quality Management requirements may be defined separately for a particular organization or may be defined through established standards, such as the International Organization for Standardization's ISO 9000 series. Total Quality Management can be applied to any type of organization, including production plants, schools, highway maintenance, hotel management, government institutes…etc.
STATISTICAL PROCESS CONTROL (SPC): This is a powerful statistical technique used in quality control for on-line monitoring of part production and rapid identification of of the sources of quality problems. The goal of SPC is to prevent defects from occurring rather than to detect defects in production. SPC enables us to produce a million parts with only a few defective ones that fail quality inspection.
LIFE CYCLE ENGINEERING / SUSTAINABLE MANUFACTURING: Life cycle engineering is concerned with environmental factors as they relate to design, optimization and technical considerations regarding each component of a product or process life cycle. It is not so much a quality concept. The goal of life cycle engineering is to consider the reuse and recycling of products from their earliest stage of design process. A related term, sustainable manufacturing emphasizes the need to conserving natural resources such as materials and energy through maintenance and reuse. As such, neither is this a quality related concept, but an environmental.
ROBUSTNESS IN DESIGN, MANUFACTURING PROCESSES AND MACHINERY: Robustness is a design, a process, or a system that continues to function within acceptable parameters despite variations in its environment. Such variations are considered noise, they are difficult or impossible to control, such as variations in ambient temperature and humidity, vibrations on shop floor…etc. Robustness is related to quality, the more robust a design, process or system, the higher will be the quality of products and service.
AGILE MANUFACTURING: This is a term indicating the use of the principles of lean production on a broader scale. It is ensuring flexibility (agility) in the manufacturing enterprise so that it can quickly respond to changes in product variety, demand and customer needs. It can be considered as a quality concept since it aims for customer satisfaction. Agility is achieved with machines and equipment that has built-in flexibility and reconfigurable modular structure. Other contributors to agility are advanced computer hardware & software, reduced changeover time, implementation of advanced communications systems.
VALUE ADDED MANUFACTURING: Even though this is not directly related to quality management, it does have indirect effects on quality. We strive to add additional value in our production processes and services. Instead of having your products produced at many locations and suppliers, it is much more economical and better from a quality point of view to have them produced by one or only a few good suppliers. Receiving and then shipping your parts to another plant for nickel plating or anodizing will only result in increasing the chances of quality problems and add to cost. Therefore we strive to perform all the additional processes for your products, so you get a better value for your money and of course better quality due to lower risk of mistakes or damages during packaging, shipping….etc. from plant to plant. AGS-TECH Inc. offers all the quality parts, components, assemblies and finished products you need from a single source. To minimize quality risks we also do the final packaging and labeling of your products if you want it.
COMPUTER INTEGRATED MANUFACTURING: You can find out more on this key concept for better quality on our dedicated page by clicking here.
CONCURRENT ENGINEERING: This is a systematic approach integrating the design and manufacture of products with the view toward optimizing all elements involved in the life cycle of the products. The main goals of concurrent engineering are to minimize product design and engineering changes, and the time and costs involved in taking the product from design concept to production and introduction of the product into the marketplace. Concurrent engineering does however need top management’s support, have multifunctional and interacting work teams, need to utilize state-of-the-art technologies. Even though this approach is not directly related to quality management, it does indirectly contribute to the quality in a workplace.
LEAN MANUFACTURING: You can find out more on this key concept for better quality on our dedicated page by clicking here.
FLEXIBLE MANUFACTURING: You can find out more on this key concept for better quality on our dedicated page by clicking here.