Services • Quality Management System

ISO 9001:2000 ISO 9000 stands for International Organization of Standardization, created in 1947. It is a worldwide federation of “Member Bodies” (i.e., National bodies – Government Institution or Organization incorporated by Public Law) with it's headquarter at Geneva, Switzerland. India is represented by BIS (Bureau of Indian Standards). ISO is important because of its systemic orientation. We think this is crucial. Many people in this field wrongly emphasize motivational and attitudinal factors. The assumption is that quality can only be created if workers are motivated and have the right attitude. This is fine, but it doesn't go far enough. Unless you institutionalize the right attitude by supporting it with the right policies, procedures, records, technologies, resources, and structures, you will never achieve the standards of quality that other organizations seem to be able to achieve. Unless you establish a quality attitude by creating a quality system, you will never achieve a world-class standard of quality. Simply put, if you want to have a quality attitude you must have a quality system. This is what ISO recognizes, and this is why ISO 9000 is important. ISO / TS 16949:2002 The ISO/TS 16949:2002 standard is the consensus of international quality requirements, which consists of policies and procedures that ensures worldwide consistence with the suppliers of parts, materials, or finishing services. How do automotive manufacturers assure that the numerous parts that they receive from suppliers are of the highest quality? How do automobile manufactures assure that suppliers provide products that manufacturers can be responsible for and are worthy of the manufacturers name? Automotive manufacturers assure quality by requiring registration to automotive quality standards that provide quality assurance. ISO/TS 16949:2002 is the latest automotive quality standard which was developed to be a new universally accepted quality standard for automobile suppliers. The ISO/TS 16949:2002 standard was developed to be an automotive standard for the customers’ of automotive manufacturers and it is aligned with the ISO-9001: 2002 standard. The purpose of ISO/TS 16949:2002 was to create standardization in the quality management standards for automobile suppliers throughout the world. ISO/TS 16949:2002 is a process approach quality standard, which places requirements that assure consistent quality, throughout organizations that supply automobile manufacturers. By requiring ISO/TS 16949:2002 certifications, automobile manufacturers can be assured that all of their suppliers are adhering to a consistent set of quality standards that are strict and intertwined throughout the supplier’s organization. ISO 13485:2003 ISO 13485:2003, based on the ISO 9001:2000 process model, suggests that the application and management of a system of processes is an effective way to ensure good quality management. All requirements of this International Standard are specific to organizations providing medical devices, regardless of the type or size of the organization. The standard strongly infers that clients should consider using ISO 9000:2000 to ensure understanding of the Process Model, definitions and other items of concern, too. The benefits of an ISO 13485:2003 compliant quality management system to the thousands of companies worldwide include: Recognition by regulators around the world of ISO 13485:2003 as a good basis for addressing medical device design and manufacturing regulatory requirements Controlled consistency of manufactured products Managed productivity and efficiency, controlling costs Competitive advantage and increased marketing and sales opportunities. Improved customer perception of the organization’s image, culture and performance. Improved communications, morale and job satisfaction – staff understand what is expected of them and each other. TL 9000 The TL-9000 is a quality management system standard (QMS) defined specifically by and for the telecommunications industry. It standardizes the quality system requirements for the design, development, delivery, installation, and maintenance of telecommunication products and services. It also defines the performance metrics required to measure the progress and results of its implementation. The TL-9000, which was based on the ISO-9000 Standard, was conceptualized in 1996 at the Quality Excellence for Suppliers of Telecommunications (QuEST) Leadership Forum, was drafted starting in 1998, and was introduced to the industry in 1999. The goal of this entire initiative was to create a consistent set of quality system requirements that would apply to more than 10,000 telecommunications suppliers worldwide. TL 9000 defines the telecommunications quality management system requirements for the design, development, production, delivery, installation, and maintenance of products and services. It also provides a measurement system that, when implemented, allows a company to track performance and improve results. TL 9000 supports three distinct certifications: TL 9000-HW for hardware, TL 9000-SW for software, and TL 9000-SV for services. TL 9000 registrations can cover hardware, software, services, or any combination thereof. Registration may also include an entire company, an organizational unit, a facility, or even a specific product line as mutually agreed by the supplier and the registrar. AS 9100 AS9100 defines additional areas within an aerospace quality management system that must be addressed when implementing an ISO 9001:2000-based quality system. Typically, these requirements are included within robust aerospace quality systems. The industry experts who wrote the standard and the representatives who approved it all agree that these additions are essential to ensure product, process and service safety and quality. All quality systems must be designed to meet the specific needs of the users. And although AS9100 identifies areas to address within the aerospace industry, system designers are encouraged to first establish a robust quality system that's both effective and efficient. This system should be a holistic entity with practices spanning multiple functions and processes within the business. The AS9100 standard provides guidance for managing variation when a "key characteristic" is identified. Keys are features of a material, process or part in which the variation has a significant influence on product fit, performance, service life or manufacturability. AS9100 requires that an organization establish and document a configuration management process. Planning product realization is essential for effective and efficient processes. The standard emphasizes planning for in-process verification when a product can't be verified at a later point. Tooling design must also be considered when process control methodology is used to ensure that process data will be captured. The AS9100 standard includes extensive supplementation in design-and-development functions. This isn't surprising given the complexity of aerospace products and customers' expectations for reliable performance during a protracted period of time.

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