ISO 9001

ISO 9001 is the international standard that sets out requirements for quality management systems (QMS).

What is ISO 9001?

Manufacturers must observe and apply several 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 9001so manufacturers complying with IATF 16949 must also achieve IS0 9001 compliance. Many OEMs consider ISO 9001 certification 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 applies the standard 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 on customer input and 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 it applies to. As part of these good management practices, ISO 9001:2015 requires a company’s top management to demonstrate leadership in implementing an ISO 9001 QMS, including proactively integrating of the QMS into their daily activities.

Related products: Opcenter Quality | Teamcenter Quality and Compliance Management

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Understand the benefits

The ISO 9001 standard is designed to help companies reduce risks and increase customer satisfaction by increasing the consistency of their product quality.

Improved operations

Ensure consistent quality across products or services by establishing and enforcing good management practices.

Reduced waste

Emphasize effective risk management and implement quality procedures, thereby minimizing errors and inefficiencies in manufacturing processes.

Enhanced company reputation

Demonstrate a commitment to quality management, which increases customer satisfaction and trust in the consistency of products or services.

ISO 9001 compliance and risk management

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 assess the risks according to frequency and severity and 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 planning quality procedures to reduce and manage risks; 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.

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