To answer these questions, we must first and foremost understand that not all risk is equal.
ISO 9001 2015 VS ISO 13485 2016 MATRIX ISO
Why the ISO 9001:2015 change, and are there more stringent risk requirements in the AS9100 standard as well? However, in the new ISO 9001:2015 and in AS9100D, the concept of risk is much more prevalent, including a complete section devoted to the subject in the informational clauses and the annex. While AS&D has always had a major focus on examining risks that may occur in jeopardizing satisfactory outcomes of processes, the word “risk” is barely mentioned in ISO 9001:2008. Risk is not a new concept for the standards, but it has a more pronounced role, content, and influence in an organization’s actions and approach to processes and the quality management system. The AS9100D revision embraces most of those concepts, expands many of them a bit further, and adds some new requirements pertaining to counterfeit parts and product safety for aviation, space, and defense (AS&D) organizations.One area that has gotten a lot of attention in both standards and is significantly amplified is the concept of risk. While there are not a lot of new concepts in ISO 9001:2015, there are new ways of looking at some of the requirements.
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In addition, the International Aerospace Quality Group (IAQG) updated AS9100 – Quality Management Systems – Requirements for Aviation, Space, and Defense Organizations – to align with ISO 9001:2015. ISO 9001:2015 has been out for almost a year, and many organizations have already updated their quality management systems to the revised standard or are in the process of alignment and adjustments.