AS9100 scope  

The scope will be changed from aerospace to aviation, space and defense to recognize that complex systems can include multiple sectors. The U.S. Department of Defense was interested in this change so it could contractually flow the AS9100 QMS into defense procurements. It is hoped this scope expansion into defense will result in additional recognition and synergies with NATO-allied quality assurance publications.

The application section was clarifi ed to help organizations know when to apply AS9100 instead of AS91 10—Quality Management Systems—Aerospace—Requirements for Maintenance Organizations ¹ or AS9120—Quality Management Systems—Aerospace— Requirements for Stockist Distributors. ²

QMS 

requirements imposed by customer, statutory and regulatory authorities

The requirement to include quality system requirements imposed by regulatory authorities when developing QMS documentation is currently required by clause 4.2.1.

This requirement was broadened to include customer and statutory authorities and was moved to the revision’s clause 4.1 dealing with general requirements. The

movement to clause 4.1 addresses customer and applicable statutory and regulatory QMS requirements within the entire organization’s QMS. In the past, this requirement could be interpreted to apply only to QMS documentation. 

Introduction of a new

term, “special requirements”

Special requirements are those identifi ed by the customer or determined by the organization that have high risks to being achieved, thus requiring their inclusion in the risk management process. Factors used in the determination of special requirements include product or process complexity, past experience and product or process maturity. Examples of special requirements include performance requirements imposed by the customer that are at the limit of state-of-the-art, or

requirements determined by the organization to be at the limit of their technical or process capabilities.

Introduction of a new term, “critical items,” including key characteristics

Critical items (for example, functions, parts, software, characteristics and processes) are those having signifi cant effect on product realization and use of the product. They

include safety, performance, form, fi t, function, producibility and service life, all of which require specifi c actions to ensure they are adequately managed. Examples of critical items include safety critical items, fracture critical items, mission critical items and key characteristics.

New clause 7.1.1, project management

This new AS9100 requirement provides additional emphasis on planning and managing product realization activities (product life-cycle) in a structured and controlled way to meet requirements at acceptable risk and within resource and schedule constraints. ISO 10006³ can be used as an information resource for organizations that might want insight on how to apply project management using ISO 9001’s principles and structure.

New clause 7.1.2, risk management

This new AS9100 requirement involves implementation of a risk management process throughout product realization (product life-cycle).

The stated requirement for risk management within the current version of AS9100 is to understand risk during review of requirements related to the product during contracting activities. Risk management, to some extent, has always been at least inferred by QMSs through planning and preventive action processes. The new risk management clause requires organizations to establish a process for managing risks to achieving customer, statutory and regulatory requirements.

The process should consider: assignment of responsibilities for risk management; criteria for risk acceptance; identifi cation, assessment and communication of risk; and identifi cation, implementation and management of actions to mitigate risk.