ISO 9001 is an international standard that outlines the requirements for a quality management system (QMS). It provides a framework for organizations to establish and maintain a system that ensures they consistently deliver high-quality products or services that meet customer and regulatory requirements. ISO 9001 has been revised several times since its initial publication in 1987, with the latest version being ISO 9001:2015. In this blog, we'll look at the key differences between ISO 9001:2015 and ISO 9001:2008.
Risk-based thinking: ISO 9001:2015 introduced a new requirement for organizations to adopt a risk-based approach to their QMS. This involves identifying potential risks and opportunities that may impact the QMS and taking actions to address them. ISO 9001:2008 did not have this requirement.
Context of the organization: ISO 9001:2015 emphasizes the importance of understanding the organization's context, including its internal and external factors, and how they may impact the QMS. This requirement was not present in ISO 9001:2008.
Leadership: ISO 9001:2015 places a greater emphasis on leadership and requires top management to take a more active role in the QMS. This includes ensuring that the QMS is aligned with the organization's strategic direction and promoting a culture of quality. ISO 9001:2008 did not have this requirement.
Documentation: ISO 9001:2015 places less emphasis on documentation than ISO 9001:2008. While ISO 9001:2008 required documented procedures and a quality manual, ISO 9001:2015 only requires documented information that is necessary for the effective operation of the QMS.
Continuous improvement: While both ISO 9001:2015 and ISO 9001:2008 emphasize the importance of continuous improvement, ISO 9001:2015 places a greater emphasis on this requirement. It requires organizations to continually monitor and evaluate their QMS and make improvements as necessary.
Overall, ISO 9001:2015 represents a shift towards a more holistic and proactive approach to quality management. It places a greater emphasis on risk-based thinking, leadership, and continuous improvement, while also reducing the emphasis on documentation. Organizations that are certified to ISO 9001:2008 will need to transition to the new standard by the end of the transition period to maintain their certification.
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