As of June 2017, audits and certificates under AS/EN9100:2009, AS/EN9110:2015 and AS/EN9120:2010 are no longer available. From this point onwards, certification bodies are conducting audits according to AS/EN9100:2016 and AS/EN911/20:2017 only.
The transition process for certifications based on previous standard versions is laid out in the "Supplemental Rules".
AQMS certifications that have not completed transition to the 9100/9110/9120:2016 AQMS standard by September 15, 2018 are no longer valid. The certification will no longer be eligible for transition and an initial certification audit will be required.
The AS/EN9100:2016-series standard is divided into ten sections:
The revised standard is designed to extend its scope and to improve applicability in the service sector. For this reason the previously used term “product” has been replaced by “product and service”.
The AS/EN9100/9110/9120 standards previously supported the introduction of a process approach for the development, implementation and improvement of efficiency of a quality management system. The revised standard addresses this in more detail in Section 4.4 “Quality management system and its processes”. The input and output of each process must be defined, and measurement of performance indicators, assignment of responsibilities etc. need to be specified.
Risk and preventive action
The defined structure does not include specific requirements concerning “preventive measures.” This is because the function of “preventive instrument” is among the main purposes of an official management system (risk prevention). Prevention is dealt with in the various sections and sub-sections . Emphasis on a risk-based approach is embedded in several sections, from “Risk-based thinking” described in Section 1.3.3, “Leadership – General” (Section 5.1.1) and a dedicated sub-section in 8.1.1 “Operation risk management” to risk-based approaches of “Operational planning and control“ (Section 8.1) and “Management review” (Section 9.3).
“Documented information” covers terms previously in use such as “documents and records” with the aim of increasing stakeholders’ flexibility. This also applies to process documentation; companies are free to define the level of detail in which their processes are documented. The process instructions previously defined by the standard are no longer required.
Responsibility of Management
With the revised standard-series the “Responsibility of management” has been strengthened; the previous responsibilities of a quality management officer (QMO) now rests with the top management.
The scope of the “management review” was extended by the addition of “alignment with strategic orientation of organization”, consideration of “relevant interested parties” and “assessment of risks and opportunities” at strategic level.
The transition phase will be concluded in September 2018. We recommend a timely upgrade to the new standard as part of the audit cycle. As of June 2017, audits and certification under the previous standards of the AS/EN9100 series is no longer possible.