Perhaps the most widely known of the ISO family of standards, ISO 9000 provides direction in regards to general manufacturing and service organizations’ quality management and quality assurance systems. The Technical Committee (TC) responsible for ISO 9000 is TC 176. Many companies consider the standard to be the ultimate guide to excellence in product, service and management quality. In fact, there are approximately 350,000 companies throughout the world that are certified to the standard.
The ISO 9001 quality management standard was originally published in 1987 and has continued to evolve since then. While process management has always been a core focus of the standard a greater emphasis has recently been placed on risk management and outputs than initially appeared in its first publication. With the recognition that quality demands are becoming increasingly more complex and challenging, ISO 9001 serves as a common means of communicating fundamental quality management system requirements to organizations of all sizes, types and industries. As is the case with organizations pursuing certification to any evolving standard, companies that seek adherence to ISO 9001 should continually evaluate their existing quality management systems for potential improvements and efficiencies.
The primary intent of ISO 13485 is to create a unified global structure for medical device quality management in the international market. As such, compliance with the ISO 13485 guidelines requires that medical device manufacturers establish quality systems and procedures that are adequately documented, controlled and maintained. To stay competitive in a flourishing global medical device market, more and more manufacturers are abandoning inefficient paper-based quality management systems in favor of more robust and effective automated systems. In doing so, they are better able to meet customer needs and industry expectations.
A family of international standards dedicated to environmental management, ISO 14000 provides a basic structure for the development of environmental management systems and the audit methodology behind such programs. ISO 14001, the cornerstone of the series of standards, offers criteria for the certification of environmental management systems. However, it serves as more of a general structure rather than a specified set of performance requirements. The intended befits of ISO 14000 include reduced waste, lowered costs, energy savings and enhanced corporate image.
Medical device manufacturers must establish risk management processes that allow them to identify hazards, and evaluate and plan for risks, and to develop, implement and track the effectiveness of risk control measures. The internationally recognized standard for medical device companies’ risk management practices if ISO 14971. This risk-focused standard is particularly useful in helping medical device companies effectively manage vital documentation throughout a device’s lifecycle.
With an aim toward promoting the harmonization of medical practices around the world, ISO 15189 outlines the requirements for quality and competence that are specific to medical laboratories. The standard is intended to protect the health and safety of both patients and healthcare providers. It supports the efficient exchange of information and protection of data, and also enhances the general quality of care. Laboratory clients, regulatory authorities, and accreditation organizations rely on ISO 15189 to ensure competence. The version of the standard updated in 2012 contains technical and quality management system requirements.
First issued by ISO and the International Electrotechnical Commission (IEC) in 1999, ISO 17025 is the most important standard worldwide for calibration and testing laboratories. Accreditation to the ISO 17025 standard enables laboratories to demonstrate technical competence and allows them to prove that they are able to produce precise and accurate test and/or calibration data. Laboratories affected by ISO 17025 include first-, second- and third-party laboratories and laboratories where testing and/or calibration plays a part in inspection and product certification. The standard covers testing and calibration that is carried out utilizing standard and non-standard methods as well as methods developed in the laboratory.
Based on existing German, French, Italian and United States standards, ISO/TS 16949 is a technical specification that globally aligns automotive quality system requirements under a single standard. It identifies quality system requirements for the design, development, installation, production and servicing of automotive products. Developed by the International Automotive Task Force (IATF), the technical specification encourages improvement in supply chain and certification processes. TS 16949 certification is a mandatory prerequisite to doing business for the majority of automobile manufacturers throughout the world. The specification is pertinent to all types of companies that supply automotive-related products, whether they are small manufacturers or multinational companies with multiple sites located across the globe.