VOL. 20 September ISSUE YEAR 2019
in Vol. 20 - September Issue - Year 2019
ISO 9001 to AS EN 9100 Transition
Most organisations within the supply chains for engineering and manufacturing industries maintain a quality assurance accreditation. The most ubiquitous is the ISO 9000 family of quality assurance standards, with ISO 9001 being applicable to manufacturing and service providers.
ISO 9001 is an excellent general standard, but the aerospace and defence sectors have additional demands and so expect accreditation to the AS 9100 family of quality standards.
AS 9100 Aviation, Space and Defense
AS 9110 maintenance
AS 9120 distributors
AS 9115 deliverable software
These use ISO 9001 as the baseline standard but have additional requirements due to the very critical safety aspects in these industry sectors.
In order to transition from ISO 9001 to AS 9100 an organisation must establish a project plan which includes:
Procure and review current copies of AS 9100 standard and the supporting AS 9101 forms. The IAQG (International Quality Group) and SAEmobilus websites are suitable sources.
Contract the services of suitably AS 9100 experienced consultants and/or send quality management staff to AS 9100 training.
Undertake a gap analysis of the current system to the AS 9100 requirements.
Implement the changes needed to meet the AS 9100 requirements, including education and training for all staff in the new procedures.
Self-audit the system using the AS 9101 forms.
Implement corrective actions from the self-audit.
Schedule the initial audit with the accreditation body.
AS9100 has over 100 additional requirements to ISO 9001. An organization can decide that a requirement is not applicable, but only if this decision will not result in failure to achieve:
conformity of products and services
enhancement of customer satisfaction
Any non-applicability should be documented with the supporting justification. This can be recorded in the quality manual, which, unlike ISO 9001, is still a requirement of AS 9100. Both standards use the same ten-clause structure and it is recommended that the quality manual also has this same ten-clause structure. This makes compiling, reviewing and auditing the quality system more easily aligned to the requirements in the standard.
AS 9100 also defines additional terminology for Counterfeit Parts and Product Safety, these being critical issues in aerospace and defense industries. There is specific consideration to control of foreign objects and to product obsolescence.
AS 9100 also maintains the requirement for a management representative, whilst still requiring evidence of quality leadership from top management.
Training and demonstration of competence requirements are similar to those in ISO 9001. But AS 9100 also states that consideration should be given for the periodic review of the necessary competence. The general aviation industry expectation is that some form of requalification and demonstration of competence is undertaken within a twelve-month period. This accords with Nadcap requirements, which suppliers in the aerospace industry often need to achieve, depending on the processes being undertaken.
Also in training and competence, AS 9100 requires that individuals be aware of relevant quality documentation, also their contribution to product safety and ethical behaviour.
AS 9100 has explicit requirements in identifying and approving quality documents. Also, ensuring that access to obsolete documents is controlled. Electronic documentation is identified as having particular requirements.
Stronger project planning and management is expected, including detailed risk assessment at a more detailed level than ISO 9001.
The control of externally provided products and services (outsourcing) is strongly featured in AS 9100. Work activity can be outsourced but responsibility for verifying the conformity of the product remains with the original organisation. So there are a number of explicit requirements to meet if a company sends-out work to another organisation.
Gaining accreditation to AS 9100 is a considerable step-up in the control and management of quality assurance for an ISO 9001 accredited company. However, a smooth transition is achievable providing that it is well-planned and adequately resourced.
For questions contact firstname.lastname@example.org
by Paul Huyton,
MFN Course Director World Wide
more information at www.mfn.li/trainers