새로운 프로그램을 위한 혁신적이며, 협업이 가능한 동기화된 프로그램 관리
항공 우주 및 방위
새로운 프로그램을 위한 혁신적이며, 협업이 가능한 동기화된 프로그램 관리산업 자세히 보기
자동차 및 운송
Integration of mechanical, software and electronic systems technologies for vehicle systems산업 자세히 보기
소비재 및 소매업
통합된 포뮬레이션, 패키징 및 제조 프로세스의 효율적인 관리를 통한 제품 혁신산업 자세히 보기
전자 기기 및 반도체
신제품 개발 시 데이터를 활용하여 품질과 수익성을 개선하고 시장 출시 기간을 단축하며 비용 절감산업 자세히 보기
에너지 및 공공 시설
Supply chain collaboration in design, construction, maintenance and retirement of mission-critical assets산업 자세히 보기
Construction, mining, and agricultural heavy equipment manufacturers striving for superior performanceExplore Industry
산업용 기계 및 중장비
Integration of manufacturing process planning with design and engineering for today’s machine complexity산업 자세히 보기
Insurance & Financial
Visibility, compliance and accountability for insurance and financial industriesExplore Industry
조선 및 해양
미래형 선박(future fleet) 개발 비용의 지속적인 절감을 위한 조선분야의 혁신산업 자세히 보기
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
의료 기기 및 제약
시장 요구사항의 충족과 비용 절감을 위해 디지털화를 통한 "개인 맞춤형 제품 혁신"산업 살펴보기
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