TRA Certification Tutorial, ISO 9000, ISO 14000, TL 9000

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TRA Certification - ISO 9000, TL 9000 and ISO 14001
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		*F.A.Q (Frequently Asked Questions)* Why is quality important? What is a quality management system? Why register? What is ISO 9001? What about ISO 14001? What about TL 9000? What are the benefits of registration or system" compliance"? How do we achieve registration? How do we achieve a document of "compliance"?
		*Why is quality important?* The competitive pressures facing business today can be intense. In times past, quality acted as a distinguishing characteristic between a company and its competitors. In today’s world, however, quality has become mandatory. It is an assumed characteristic. The distinguishing features then become verifiable quality, continuous improvement, innovation, superior customer service, etc. That’s why an accredited quality management system becomes mandatory in today’s environment.
		*What is a quality management system?* A system which is measurable and verifiable mechanism that can be used by a company to demonstrate quality. By defining and adhering to a system a company demonstrates that it has a repeatable and a reliable processes in place.
		*Why register?* While many companies have long established their own quality system; the way the world measures quality today has changed. Now as ISO 9001 continues to grow those companies who do not embrace standards of quality will find themselves at a stand still while their competitors move ahead. To stay competitive on a national or global scale it is necessary to be ISO registered or in "compliance to the ISO standards.
		*What is ISO 9001?* ISO 9001 is a set of international standard and guidance documents for quality management and quality assurance. The standard represents an international consensus on good management practices with the aim of ensuring that the organization can, time and time again, deliver the product or services that meet the client’s quality requirements. These good practices have been distilled into standardized set of requirements for a quality management system, regardless of what your organization does, its size, or whether it’s in the private, or public sector. The standard helps businesses define and document their own quality procedures for production and/or services. It can be used in any type of business and accepted around the world as proof that a business can provide assured quality. The quality system requirements defined by ISO 9001 are general in nature, allowing companies to develop their own procedures, policies, and work instructions. Each company defines, in detail, what standards and procedures are needed. ISO 9000 quality system standards were primarily intended for manufacturing, but have been adapted for services and other specialized businesses. The ISO 9000 series of standards and guidance consists of one document, ISO 9001, which details the requirements, and two guidance documents, ISO 9000 and ISO 9001. The standard ISO 9001:2000 is based on the “process approach.” The “process approach” is to examine each of the processes defined by the organization, and the interaction of the inputs and outputs of each process.
		*What about ISO 14001?* ISO 14001 is a series of international, voluntary environmental management standards. These standards were developed by ISO Technical Committee 207. The standards address environmental management systems, auditing and related investigations, labeling, life-cycle assessment, and other environment aspects. The ISO series of standards effectively address the needs of organizations worldwide by providing a common framework for managing their environmental issues. They promise to effect a broadly based improvement in environmental management, which in turn can facilitate trade and improve environmental performance worldwide. The standard requirements specified in ISO 14001 are supported by a series of guidelines documented in the ISO 14001 series. ISO 14001 is expected to become a prerequisite for doing business worldwide. Officials from the U.S. Environmental Protection Agency (EPA) and Occupational Safety and Health Administration (OSHA) have indicated that certification may lead to a reduction in the amount of inspections required. ISO (http://www.iso.ch) has published a brochure to help organizations choose the combination of ISO 14000 environmental management standards that best meet their needs. The first ISO 14000 standards were published in 1996. The family has now grown to include more than 20 documents.
		What about TL 9000? The TL 9000 standard defines quality requirements for those involved in the telecommunications industry. The requirements were developed by the QuEST forum (The Quality Excellence for Suppliers of Telecommunications Leadership); QuEST is comprised of leaders in the telecommunications field. Find out more about QuEST forum at www.questforum.org. The QuEST forum used ISO 9000 as a baseline and the requirements of existing industry standards and practices in developing the TL 9000 requirements. The sector-specific requirements for hardware, software, and services are an essential requirement for part of TL 9000. TL 9000 applies to all suppliers of telecommunications hardware, software, and services. Therefore, TL 9000 Quality system requirements allows for registration to the hardware, software, and services or any combination of the three categories: • TL 9000-H (hardware quality system requirements and metrics) • TL 9000-S (software quality system requirements and metrics) • TL 9000-V (services quality system requirements and metrics)
		ISO 13485 Partnering with NQA-USA to ensure the success of your medical device quality management system. ISO 13485:2003 contains requirements essential for organizations operating at any tier in the medical device and pharmaceutical supply chain. While ISO 13485 is a standard unto itself, it is largely based on ISO 9001 and follows that format for the convenience of its users. The primary objective of the standard is to facilitate harmonized medical device regulatory requirements and as a result, it includes some particular requirements for manufacture, installation and servicing, such as added requirements on record control, sterilization and risk management. Organizations can register to ISO 13485 as a standalone or in conjunction with an ISO 9001 or other registration. An ISO 13485 certification from NQA, USA demonstrates your organization's commitment to providing products and related services that consistently meet customer and regulatory requirements applicable to the medical industry. Benefits • Creates a competitive advantage. • Ensures a consistent and effective approach to business management. • Reduces risk factors via the use of risk management techniques. • Engages top management involvement. • Provides a robust framework for assuring product consistency. Requirements • Basic Quality System requirements with several enhancements. • Risk Management approach to product development and product realization. • Validation of processes. • Consideration of statutory and regulatory requirements. • Tracking and record keeping assuring positive product trace ability and recall.
		*What are the benefits of registration and/or "compliance"?* ISO 9001 and related registrations and/or "compliance" allow businesses to be recognized around the world for consistent quality. Achieving ISO 9001, for example, may result in increased sales, reduced cost, greater customer loyalty, etc. Reduced costs often come as a result of a reduction in mistakes and an improvement in product or service quality. Companies attaining ISO 9001 and related Registration and/or "compliance" often experience the following benefits: • Enhanced competitive position and ability to sell to companies requiring ISO 9001, or related standards. • Increased positive image worldwide. • Better teamwork through all employees working toward the same standard of performance. • Reduced costs due to improved efficiency of material usage, labor, and overhead. • Product/process improvement through the management of change. • Reduction or elimination of audits by customers. • Early detection/correction of errors. • A documented system which can be used as a training tool for employees. The certificate can also serve as a business reference between the organization and potential clients, especially when the supplier and client are new to each other, or far removed geographically, as in an export context.
		*How do we achieve registration?* To comply, a business must have identified and documented its process for quality and key procedures. Records must be maintained that prove how the company is following its own policies and procedures as written. Then, the company must successfully complete a registration or compliance audit, performed by an accredited third-party (registrar) to ensure an unbiased assessment. TRA-CD is an independent Registrar, who will conduct an on-site audit (assessment). The audit verifies that all operations of a facility conform to the ISO 9001 (or related) standards. Upon successful completion of the audit, the company is awarded a certificate and registered by TRA-CD. In North America these services are provided through our partnership with NQA-USA. For a complete explanation of the registration process, see What We Do (and Don't Do). *How do we achieve "compliance"?* Once you have achieved "compliance" in your operation an experienced auditor assess your "System Compliance" to the ISO standard. A document will be provided by TRA-CD giving you evidence of your "Compliance" to the ISO 9001 standard. Continued "compliance" will be renewed annually.