What's new with AS9120:2016?

Within the sections of the AS9120:2016 standard, new requirements above and beyond those specified in the previous revision AS9120A address:

Risk Based Thinking - The concept of risk has always been implicit in ISO 9001 but AS9120:2016 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.
 
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.  AS9120:2016 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.
 
Awareness - AS9120:2016 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 onconformities. 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.
 
Obsolescence - In the planning process, you must consider the consequences of product obsolescence.

Project Management - Requires that you must plan and manage product and service provision in a structured and controlled manner including scheduled events performed in a planned sequence.
 
Design and Development of Products and Services - AS9120:2016 now includes a requirement that an organization is to establish, implement, and maintain a design and development process that is appropriate to ensure the subsequent provision of products and services. An organization can determine that this (and any other requirement) is not applicable if its decision will not result in failure to achieve conformity of products and services (see AS9120 4.3 and annex A A.5).