ISO 14971 risk management plays a big role in ensuring that medical devices are safe for patients. When you work with this standard, you are getting into a process that carefully evaluates risks and helps design safer devices. I have seen how thoroughly following ISO 14971 can provide peace of mind and build trust between…
AS9100 Risk Based Thinking is a key part of quality management in the aerospace industry. It helps companies spot and handle problems before they happen. This approach is built into the AS9100 Rev D standard, which guides how aerospace firms run their quality systems. Risk based thinking helps aerospace companies make better choices, avoid mistakes,…
Risk management in the laboratory is crucial for keeping workers safe and ensuring accurate test results. Labs handle dangerous materials and perform complex procedures daily. Without proper safeguards, accidents can happen that put people and data at risk. Good risk management in the laboratory helps labs prevent problems before they start and respond quickly if…
Risk management in ISO 13485 is a key part of making safe medical devices. ISO 13485 sets rules for quality control in the medical device industry. It tells companies how to find and deal with risks when making products. The 2016 update to ISO 13485 puts more focus on risk. Companies need to think about…
I have had a number of requests from my readers concerning examples of risk and opportunities. Many of you have requested a template. In this post I will provide an audit passing ISO 17025 Risks and Opportunities Template that you can use to document your risks and opportunities. In addition, the video below will discuss…
So, what is risk based thinking in ISO 9001? Risk-based thinking is a core concept integrated into ISO 9001, an international standard that sets out the criteria for a quality management system (QMS). It represents a shift from reacting to problems to a proactive mindset that seeks to anticipate and manage potential risks before they…
ISO 17025 Risk management is an essential component of maintaining accreditation for laboratories under ISO/IEC 17025. This international standard specifies the general requirements for the competence to carry out tests and calibrations, including sampling. It breaches the conceptual gap between maintaining high standards and providing a framework through which laboratories can demonstrate consistent operation and…
