Innovación y gestión de programas colaborativa y sincronizada para nuevos programas
Sector aeroespacial y defensa
Innovación y gestión de programas colaborativa y sincronizada para nuevos programasConocer el sector
Automotive & Transportation
Integration of mechanical, software and electronic systems technologies for vehicle systemsConocer el sector
Productos de consumo y comercio minorista
Innovación de productos mediante una gestión eficaz de las formulaciones integradas, el embalaje y los procesos de fabricaciónConoce el sector
Componentes electrónicos y semiconductores
El nuevo proceso de desarrollo de productos aprovecha los datos para mejorar la calidad y la rentabilidad y reducir el tiempo y los costes de comercialización.Conocer el sector
Energía y Utilidades
Supply chain collaboration in design, construction, maintenance and retirement of mission-critical assetsConocer el sector
Construction, mining, and agricultural heavy equipment manufacturers striving for superior performanceExplore Industry
Maquinaria industrial y maquinaria pesada
Integration of manufacturing process planning with design and engineering for today’s machine complexityDescubra el sector
Insurance & Financial
Visibility, compliance and accountability for insurance and financial industriesExplore Industry
Innovación en la construcción naval para reducir de manera sostenible los costes de desarrollo de la flota futura.Conocer el sector
Media & Telecommunications
Siemens PLM Software, a leader in media and telecommunications software, delivers digital solutions for cutting-edge technology supporting complex products in a rapidly changing market.Explore Industry
Dispositivos médicos y productos farmacéuticos
Innovación de los productos personalizados mediante la digitalización para satisfacer las exigencias del mercado y reducir los costes.Conocer el sector
Faster time to market, fewer errors for Software DevelopmentExplore Industry
Small & Medium Business
Remove barriers and grow while maintaining your bottom line. We’re democratizing the most robust digital twins for your small and medium businesses.Explore Industry
Siemens Digital Industries Software What is ISO 9001?
ISO 9001 is the international standard that sets out requirements for quality management systems (QMS). Manufacturers must observe and apply a number of standards, methods, and systems on a day-to-day basis, and ISO 9001 is central among them. In fact, standards like IATF 16949 refer to ISO 9001 in such a way that manufacturers complying with IATF 16949 must also achieve IS0 9001 compliance. ISO 9001 certification is considered by many OEMs to be an essential element of vendor or supplier approval.
Because of its most recent update, the standard is specifically referred to as ISO 9001:2015. This revision replaces ISO 9001:2008 and makes the standard applicable to a broader range of industries. One of the most consequential changes to the standard in the 2015 version is that the ISO 9001 quality management system model is based not just on customer input but also on input from regulatory bodies, internal departments, the surrounding community, and other interested parties.
Manufacturers use ISO 9001 software to demonstrate ISO 9001 compliance. This requires an audit, documented in a report, verifying that the manufacturer has implemented and maintains a QMS that fulfills the ISO 9001 standard.
Instead of specifying requirements for the product or process itself, ISO 9001 establishes good management practices that result in consistent quality for any product or service to which it is applied. As part of these good management practices, ISO 9001:2015 requires a company’s top management to demonstrate leadership in the implementation of an ISO 9001 QMS, including proactive integration of the QMS into their daily activities.
The ISO 9001:2015 update emphasizes risk-based thinking. The standard defines risk as the effect uncertainty has on an expected result. Uncertainty means that variation in manufacturing processes occurs because of the high number of variables – equipment settings, ambient conditions, employees, raw material characteristics, incoming goods characteristics, and much more.
Two aspects of each risk must be assessed: the probability of the risk occurring, and the impact that risk has on quality. Some low-risk events may create substantial impacts and some high-risk events create little impact. ISO 9001 requires manufacturers to investigate both vectors. Under ISO 9001, manufacturers not only assess the risk according to frequency and severity but also implement preventive actions to control them.
Once ISO 9001 certification is achieved, manufacturers maintain their ISO 9001 QMS by implementing tasks that may be organized under the Deming “Plan, Do, Check, Act” model. The certification process involves the planning of quality procedures to reduce and manage risks; of course, manufacturers must implement these procedures to benefit from them.
Areas of implementation that contribute to good risk management include training, supplier monitoring and assessment, and customer satisfaction activities like concern and complaint management. Effective ISO 9001 software addresses all these areas.
The ISO 9001 standard is designed to help companies reduce risks and increase customer satisfaction by increasing the consistency of their product quality.
Enhanced company reputation
New business opportunities