What's new with AS9110:2016?

Within the sections of the AS9110:2016 standard, new requirements above and beyond those specified in the previous revision AS9110B address:

Risk Based Thinking - The concept of risk has always been implicit in ISO 9001 but AS9110C makes it more explicit and builds it into the whole management system.  It ensures that risk is considered from the beginning and throughout and makes “prevention” part of strategic and operational planning.
 
Clause 6.1 - is related to risks in the quality management system such as new customers, new market, company partnerships, business localizations etc. Unlike clause 6.1, operational risk in 8.1.1 is applicable to the risks within the operational processes needed for the provision of products and services such as contract review and signature, new technologies introduction, external providers selection etc.
 
Concept of Change - Provides a framework which evolves to enable organizations to adapt to their changing environments or circumstances. The benefits of a robust process to control change is that business continuity is maintained and potential consequences of change are appropriately considered.
 
Organizational Knowledge - Knowledge specific to the organization is gained by experience and conveyed through lessons, identification of experts and the implementation of succession planning. AS9110:2016 can help you safeguard the organization from loss of knowledge, (e.g., through staff turnover; failure to capture and share information) and encourages your organization to acquire (e.g., learning from experience, benchmarking) and share knowledge (e.g. mentoring of newcomers).
 
Product Safety - including requirements to address product safety considerations throughout the product lifecycle.
 
Counterfeit Parts Prevention - Provides requirements to mitigate the effects of the growing threat of counterfeit / fraudulent product while recognizing the emerging counterfeit/fraudulent statutory/regulatory requirements on AQMS processes.
 
Suspect or Unapproved Parts - Similar to the definition and handling of counterfeit parts, suspect or unapproved parts are those where there is objective and credible evidence indicating that the part was likely not produced or maintained in accordance with approved or acceptable data. AS9110:2016 addresses this issue through internal activities such as nonconformance control, reporting, training, procurement, sources selection and control & inspection.
 
Awareness - AS9110:2016 now requires employees to be aware of their contribution to product or service conformity, to product safety and the importance of ethical behaviour.
 
Human Factors - Requires the consideration of human factors in the root cause analysis for nonconformities. To do that you must understand the interactions between people, machines and each other and their impact on human performance. Human factors could include physical fitness, physiological characteristics, personality, stress and fatigue to name just a few.