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.

Quality inspector using table during ISO 9001 inspection

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 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.

ISO 9001 QMS benefits

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

Additional benefits:

  • Improved operations

  • Reduced waste

  • Enhanced company reputation

  • New business opportunities