Press Release (ePRNews.com) - SOFIA, Bulgaria - Jul 25, 2017 - Going to New Places
ISO 9001:2015 was released in September 2015 ISO – Building on the earlier version of the standard ISO 9001:2015 is moving into new territory – that of risk ! – With more focus on management responsibilities.
Note 1– If we combine the function of EASA Quality & Safety it does not directly read across, however if we consider only EASA Quality then the management focus is on Root Cause and driven by ICAO SMS the management focus is related to Risk within a given business area.
Note 2 – Note there is a 3 year transition period before compliance to the new standard is required for those that maintain certification to ISO 9001:2008.
Where is the difference in EASA / ISO focus?
ISO 9001:2015 focuses on a process approach including both proactive and strategic planning considerations.
EASA Quality Assurance – Focuses predominantly on Compliance – with the new Job Title of the Quality Manager being the Compliance Manager “CM”.
A major change to the ISO-9001-2015 revision is the incorporation of risk based thinking within the management structure of the organization.
Note – Not to be confused with a standalone risk management procedure, rather the introduction of a risk awareness and identification process throughout the system as a whole together with processes that allow foresight and planning for possible risk factors. In addition to ensure the identification of exposures that may have a negative impact on process and performance and to identify and take advantage of possible opportunity.
ISO 9001-2015 – Operation without a Quality Manual!
It is no longer a fundamental requirement to provide a Quality Manual – Organization may still choose to use and maintain a manual. (However it is no longer required by the standard.)
Who’s in charge?
ISO – 9001: 2015 has removed the requirement for a single point of contact regarding the QMS replacing it with a new section on leadership to better emphasis a greater involvement from the leadership team. Compare with EASA where we have specific roles and responsibilities and a clear understanding of who is managing each business objective, whilst still ultimately identifying the responsibility of the nominated persons.
EASA off course requires a nominated manager for Quality & Safety, which may be a combined role but clearly identifies roles and responsibilities.
The Quality Manager – “Compliance Manager “(CM) is uniquely positioned to ensure by clearly identifying exposures that the organisation meets all regulatory requirements both internally and externally. The Safety Manager on the other hand is essentially a service provider with the obligation of sharing with the business area owners the status of organisational exposure.
In respect of ISO Compliance It remains to be seen how it will be possible to effectively manage a standard without documenting through a controlled “manual” To note however this option is not available in the EASA “world” where all process & procedures must be clearly documented.
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