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May we apply for AS9100 registration to attract aerospace business?
May we apply for AS9100 registration to attract aerospace business?
So the real question is; Is it even possible to establish the required documentation, i.e., engineering, purchasing, ITAR etc without having AS 9100 contracts?You can, however, you may be in a "Catch 22" situation. You have to demonstrate you have a QMS which complies with AS9100 first. You cannot be granted AS9100 if you haven't yet implemented the requirements and have data to support the implementation.
If you're not already certified to a standard, you could achieve ISO 9001 certification, then upgrade to AS9100.
Yes. To elaborate: In my consulting practice, I "sometimes" come across unregistered [to any QMS Standard] operations which could pass a registration audit on the first pass, but that "sometimes" is about 1%!So the real question is; Is it even possible to establish the required documentation, i.e., engineering, purchasing, ITAR etc without having AS 9100 contracts?
In theory, yes, it is possible, but you must realize that if the CB and their auditors are worth their salt, the stage 1 audit for your AS9100 certification will be really "testy" (see below for the laundry list to be covered during that part of the audit.So the real question is; Is it even possible to establish the required documentation, i.e., engineering, purchasing, ITAR etc without having AS 9100 contracts?
During the Stage 1 audit the audit team shall collect sufficient information that allows the CB to:
• confirm the audit program;
• review the need for additional technical experts and/or auditors to compose a competent audit team;
• determine any additional audit activities, as needed, for the fulfilment of the requirements for initial certification; and
• schedule the Stage 2 audit activities.
The audit team leader shall require the organization to provide the necessary information and documentation for review, including the following:
• quality manual;
• description of processes showing their sequence and interactions, including the identification of any outsourced processes;
NOTE 1: The processes can be depicted in various ways [e.g., process maps, turtle diagrams, SIPOC method (breakdown of supplier, inputs, process steps/tasks, outputs, customer), octopus].
• performance measures and trends for the previous 12 months;
• evidence that the requirements of the applicable 9100-series standards are addressed by the organization’s documented procedures established for the quality management system (e.g., by referencing them in the quality manual or by using a cross reference);
• interactions with support functions on-site or at remote locations/sites;
• evidence of internal audits of processes/procedures, including internal and external quality management system requirements;
• the latest management review results;
• list of all major (e.g., top five) aviation, space, and/or defense and any other customers requiring 9100-series standard compliance, including an indication of how much business each customer represents and their customer specific quality management system requirements, if applicable; and
• evidence of customer satisfaction and complaint summaries, including verification of customer reports, scorecards, and special status or equivalent.
NOTE 2: Examples of customer specific quality management system requirements are: product process verification, including First Article Inspection (FAI) requirements (e.g., 9102); quality records to be created and maintained by the organization; coordination of document changes; defined special requirements/critical items/key characteristics; approval of design changes by the customer; flow down of requirements to sub-tiers; customer notification of production process changes; traceability; handling of nonconformities; and applicability of other IAQG quality management system standards in contracts (e.g., 9115, 9131).
4.3.2.3 Review of the Organization
During the Stage 1 audit, the subjects listed in clause 4.3.2.2 plus the following items shall be addressed, as applicable:
• number of employees (i.e., full time, part time, contract, temporary) dedicated to aviation, space, and defense;
• number of shifts and shift patterns specific to production and/or maintenance;
• evaluation of multiple site eligibility for determination of audit time and sampling;
• identification of high risk associated with processes and products;
• risk management and associated tools [e.g., Failure Mode and Effect Analysis (FMEA)];
• identification of special processes performed or subcontracted;
• regulatory requirements and authority approvals/recognitions;
• additional requirements on configuration management;
• project/program management;
• continual improvement activities;
• OTD and quality performance measures;
• identification of special requirements/critical items, including key characteristics;
• production process verification [i.e., production readiness, production planning verification, FAI requirements (e.g., 9102)], as invoked in contracts;
• prevention programs [e.g., Foreign Object Debris/Damage (FOD)];
• special work environments [e.g., Electrostatic Discharge Sensitive (ESDS), clean room];
• customer presence at organization [e.g., resident representatives, regular meetings, reason(s) for presence];
• customer satisfaction and complaints status, including customer reports and scorecards;
• any customer specific organization approval statuses, e.g., limited approval, probation, suspension, withdrawal;
• customer restricted areas or proprietary information/confidentiality;
• exclusions from 9100-series standards (exclusions must be limited to clause 7) and supporting justification;
• export limitations/controls [e.g., International Traffic in Arms Regulations (ITAR), Export Administration Regulation (EAR)];
• customer delegated verifications and Materials Review Board (MRB) authority; and
• customer authorized direct ship/direct delivery.
NOTE: The audit team can begin recording objective evidence related to the quality manual, quality management system process documentation, and the applicable process and procedural conformity results to the requirements of the applicable 9100-series standards.