Quality 101: Quality Standards Defined
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With so many numbers and letters, it is difficult to keep all of the quality standards straight, particularly for those new to the industry. Quality has compiled a brief summary of some of the more widely used industry standards.
• ISO 9001: 2000 specifies requirements for a quality management system where an organization needs to demonstrate its ability to consistently provide product that meets customer and applicable regulatory requirements, and aims to enhance customer satisfaction through the effective application of the system, including processes for continual improvement of the system and the assurance of conformity to customer and applicable regulatory requirements. All requirements of this international standard are generic and are intended to be applicable to all organizations, regardless of type, size and product provided.
Where any requirements of this international standard cannot be applied because of the nature of an organization and its product, this can be considered for exclusion. Where exclusions are made, claims of conformity to this international standard are not acceptable unless these exclusions are limited to specific requirements (as found in clause 7 of the standard) and such exclusions do not affect the organization's ability, or responsibility, to provide product that meets customer and applicable regulatory requirements.
• ISO 13485: 2003 specifies requirements for a quality management system for the medical device industry. Organizations need to demonstrate the ability to provide medical devices and related services that consistently meet customer requirements and regulatory requirements applicable to medical devices and related services.
Its primary objective is to facilitate harmonized medical device regulatory requirements for quality management systems. As a result, it includes some particular requirements for medical devices and excludes some of the requirements of ISO 9001 that are not appropriate as regulatory requirements. Because of these exclusions, organizations whose quality management systems conform to this international standard cannot claim conformity to ISO 9001 unless their quality management systems conform to all the requirements of ISO 9001.
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. These regulations can provide alternative arrangements that are to be addressed in the quality management system. It is the responsibility of the organization to ensure that claims of conformity with ISO 13485: 2003 reflect exclusion of design and development controls.
The processes required by ISO 13485: 2003 that are applicable to the medical devices but that are not performed by the organization, are the responsibility of the organization and are accounted for in the organization's quality management system.
• ISO/TS 16949: 2002, in conjunction with ISO 9001: 2000, defines the quality management system requirements for the design and development, production and, when relevant, installation and service of automotive-related products. ISO/TS 16949: 2002 can be applied throughout the automotive supply chain. This technical specification is applicable to sites of the organization where customer-specified parts, for production or service, are manufactured. Supporting functions, whether on-site or remote, such as design centers, corporate headquarters and distribution centers, form part of the site audit as they support the site, but cannot obtain stand-alone certification to this technical specification.
• ISO 14001: 1996 gives requirements for an environmental management system, to enable an organization to develop a policy and objectives that take into account legislative requirements and information about significant environmental impacts.
The ISO 14000 standards are designed to provide an internationally recognized framework for environmental management, measurement, evaluation and auditing. They do not prescribe environmental performance targets, but provide organizations with the tools to assess and control the impact of their activities, products or services on the environment. They address the following subjects: environmental management systems, environmental auditing, environmental labels and declarations, environmental performance evaluation and life-cycle assessment.
• ISO/IEC 17025 provides a framework for the special needs of organizations that want to control their laboratory processes and are seeking to achieve an independent, external accreditation. Based on ISO 9001, but written for the particular needs of laboratory management, ISO/IEC 17025 addresses the proficiency of the organization to perform the testing and calibration activities.
• AS9100 was developed using the ISO 9001, AS9000 and EN9000-1, and builds upon their requirements to produce a globally harmonized standard that meets the requirements of aerospace companies worldwide. The first standard available for use across the global aerospace community, AS9100 adds the additional requirements necessary to address both civil and military aviation and aerospace needs.