Quality
in brief.

A workshop manufactures parts to customer drawings. How long is its EN 9100 recertification audit?

2012 method. Use the table band for 26 to 45 employees. The column for recertification without design gives a minimum of 3.5 on-site days. Preparation and reporting are counted separately.

2022 method. Start at 4 days. If the certification body applies a 20% reduction for the absence of design, this becomes 3.2 days. Assume medium risk and no other adjustments. Rounding to the nearest half day gives 3 audit days.

The 2012 edition (§ 8.2.2) requires additional time for preparation and reporting without specifying a fixed 20%. Under the 2022 edition (§ 8.5.1.6.6), the 20% is applied after rounding the audit duration.

In the 2022 calculation, the two 20% adjustments serve different purposes. The first reduces the 4-day baseline because there is no design. The second adds time for analysis, preparation and reporting to the rounded audit duration of 3 days.

The first site machines the parts and houses management. The second finishes, tests and ships them. Both have 40 employees and work to customer drawings.

2012 method. Assume the certification body treats the two sites as a campus. Combine all 80 employees. The baseline for recertification without design is 4.5 days. Adding the minimum 10% to audit the transfer of work between sites gives 4.95 days. Rounding up gives 5 audit days to allocate across the sites.

2022 method. Calculate each site separately, starting at 4 days. With a 20% reduction for the absence of design, medium risk and no other adjustments, each site comes to 3.2 days. Round each to 3 days, then add them together for 6 audit days.

The 2012 edition (§ 8.2.2) requires additional time for preparation and reporting without specifying a fixed 20%. Under the 2022 edition (§ 8.5.1.6.6), the 20% is applied after rounding the audit duration.

Under the 2022 method, the 20% reduction for the absence of design is applied to each site’s baseline. The 20% for analysis, preparation and reporting is applied to the combined 6 days, after rounding each site’s duration. Under the 2012 method, the 10% campus increase adds time to audit the links between the sites.

A company designs and manufactures aerospace equipment at three sites. Each has its own engineering office and manages its orders from drawing through final testing. Site A coordinates the shared quality management system. In this example, the parts stay at the site that makes them.

2012 method. Assume the certification body recognizes a category 1 multiple site structure. The three sites perform substantially the same activities using the same procedures. Audit all three at recertification. Use the recertification-with-design column for the headcount at each site.

2022 method. Start with each site individually. To illustrate the difference, assume the certification body assesses overall risk as high, for example because of recurring delays and customer-reported conformity issues. Add 10% to each baseline and round each result to the nearest half day. All sites perform design and the example assumes no other adjustments.

Why does site C still take 2 days? The 10% increase applies there too, but 2.2 is closer to 2 than to 2.5. Add the three durations after rounding them individually.

The comparison is 9 audit days in 2012, assuming the table minimums are sufficient, and 10 in 2022 under the high-risk scenario. At medium risk, the 2022 method would also give 9 days under the same assumptions.

How much time is needed to prepare and document the audit?

Add the time for audit preparation and reporting to the audit days. The 2022 edition sets a fixed 20%. The 2012 edition requires additional time for these activities without specifying a fixed percentage in § 8.2.2.

The 10% and 20% are applied at different stages. In this 2022 example, the 10% high-risk increase is applied to each site’s audit duration before rounding. The 20% is applied to the combined rounded durations for preliminary analysis, planning and reporting (§ 8.5.1.6.6).

At incoming inspection, an operator notices that the marking on a component looks different from usual. The certificate is present and production needs the part. How should the concern be handled?

What does AS9100D already require? The company must manage product safety and prevent the use of counterfeit or suspect parts. The notes describe possible activities such as training, verifying traceability and handling suspect components.

What has IAQG previewed? In the revision summary, several elements now in the notes become explicit requirements to be applied according to context. Hazard identification, product safety risk assessment, training and controls against counterfeiting are given greater prominence.

Can the person receiving the component recognize the anomaly, prevent its use and involve someone who can assess it? Can the company reconstruct the decision afterwards?

The carrier is about to leave. An operator discovers that a check was missed. Reporting it could hold up the shipment, and the supervisor is already under pressure.

What does AS9100D already require? The standard assigns responsibilities to top management and requires people to be aware of their contribution to conformity and product safety, and of the importance of ethical behaviour.

What has IAQG previewed? The proposed revision makes top management’s role in building a quality culture and promoting an ethical work environment more explicit. Examples include ways to report and review concerns and protect people who raise them from punitive action.

The response to that operator shows what the quality culture is like. Does the supervisor listen, arrange for the product to be checked and address the causes of the missed check?

Do people in your organization feel free to report a problem even when delivery is urgent?

Engineering saves a drawing in the folder used by production. Several people can edit it. An accidental change alters a dimension and the shop starts machining from that file.

What does AS9100D already require? Documented information must be available and protected. Processes for protecting electronic data must address issues such as loss, unauthorized changes and unintended alteration.

What has IAQG previewed? The summary introduces a specific information security requirement to protect the quality management system and strengthens the provisions for managing electronic data.

For an SME, the drawing is a practical starting point. Who can read it? Who can edit it? How can staff identify the authorized version and recover a correct file?

These questions connect information security to the quality of the part that leaves the workshop.

A pressure gauge returns from the laboratory. Someone on the shop floor says it has been calibrated and should now read correctly. What was actually done?

Calibration (taratura)

Calibration establishes the relationship between the instrument indications and the values provided by measurement standards, taking account of their uncertainties. This information is then used to obtain a measurement result from the instrument reading. Calibration characterizes the instrument’s behaviour.

Adjustment (regolazione)

Adjustment changes the measuring system so that it provides the prescribed indications, for example by adjusting zero or gain. Calibration is a prerequisite for adjustment, and the system generally needs to be calibrated again after adjustment.

A practical example

At a reference pressure of 10 bar, the gauge reads 10.2 bar. Calibration characterizes that relationship and the associated uncertainty. Changing the gauge indication is an adjustment. A subsequent calibration characterizes its behaviour after the intervention.

A note on Italian terminology

The national note to item 2.39 of UNI CEI 70099:2008 advises against the term calibrazione for calibration. The recommended Italian terms for calibration and adjustment are taratura and regolazione, respectively.

When an instrument returns from the lab, can you distinguish the calibration results from any adjustments made?

How does IAQG describe OASIS?

Online Aerospace Supplier Information System® (OASIS) is an online resource containing a list of suppliers certified/registered under the IAQG rules to comply with the aerospace quality management system requirements (9100 series). OASIS also contains all bodies involved (i.e. National Accreditation Bodies, Certification Bodies and Authenticated Aerospace Experienced Auditors). This is your reliable source for aerospace supplier certification and registration data if you are working in the aerospace industry and involved in aerospace supplier selection and surveillance.

IAQG source · OASIS

Imagine you need to qualify a new aerospace supplier. In OASIS you can check whether its EN 9100 certificate is valid and see its scope. Tier 2 comes into play when you want to read the latest audit report.

What can you see?

• Tier 1 · Public data. Certification information such as the standard, scope and certificate status.
• Tier 2 · Restricted data. Audit reports and results, nonconformities, corrective actions and OASIS Insights reports when available. Access must be authorized for the supplier concerned.

How do you request Tier 2 access?

1. Sign in to OASIS and find the organization under Search & Track → Supplier.
2. Open the supplier record and select Request Access.
3. The supplier’s OASIS administrator handles the request. Registration lets you submit a request. Authorization is managed separately for each supplier.

Under the certification rules, suppliers grant aerospace, space and defence customers and authorities access on request unless there is a justified reason, such as confidentiality, competition or a conflict of interest. Aerospace certification requirements · PRI.

OASIS guide to requesting Tier 2 access.

What does OASIS Insights add?

Introduced on 1 April 2025, it generates reports after initial, surveillance and recertification audit results are published. It provides anonymized comparisons and points to IAQG resources for improvement. IAQG source · OASIS Insights.

Who is the organization compared with? IAQG describes comparison groups based on the same standard, audit type and number of on-site audit days. The score is a snapshot that depends partly on the available data. In practice, I use it to identify areas worth exploring and interpret it in context. OASIS Insights documentation.

Partners with Tier 2 access can also see the supplier’s Insights reports. IAQG update on Tier 2 access.

After an audit, do you simply file the report, or use the findings to choose an improvement and check whether it works?

Example minutes · EN 9100, § 9.3.2 e)

During the review, top management examined the full action plan in the Risks and Opportunities Analysis [document number, revision and date]. For every completed action, management reviewed the evidence and the assessment of effectiveness. For actions still in progress or awaiting verification, it confirmed the due dates. The referenced document records the outcome of each assessment.

For the risk of slower operations after introducing the new quality management system software, top management judged the role-specific coaching effective. Checks showed that the staff involved could carry out their assigned tasks independently and that recording times had returned to the agreed limits. The coaching action was therefore closed as effective in the Risks and Opportunities Analysis.

Top management then reassessed the risk. The residual level was lower and considered acceptable. Monitoring will continue because new users, software updates or workflow changes could alter the level of risk.

As a review output, top management instructed the organization to revise the internal software management procedure. It now requires a practical check that new users and users affected by significant changes can work independently. Subsequent checks are routine controls under the procedure. The original action remains closed as effective.

A small business hires a consultant to prepare for EN 9100 certification. The consultant writes the quality manual and procedures, helps put them into practice and conducts the internal audit before the certification body visits.

The business keeps its employee skills matrix up to date. It records the skills needed for each role and who has been assessed as suitable. For the external auditor, the only record is the name in the audit programme. The business assigned the work without defining minimum requirements for the role or recording an assessment of suitability.

Two checks before assigning the audit

Competence (§ 7.2). The business defines what its internal auditor must be able to do. For example, the auditor must be able to conduct a process-based audit and apply the EN 9100 requirements relevant to the activities being audited. The business assesses evidence such as training, documented experience or a witnessed audit and records its decision and the scope of the assignment. An ISO 9001 auditor course can demonstrate training in audit techniques. Evidence relevant to aerospace is needed to verify the ability to apply aerospace requirements. The business makes the decision for external auditors as well.

Objectivity and impartiality (§ 9.2.2 c). When the consultant audits processes they helped design, they are assessing their own choices. For example, they set the supplier qualification criteria and now have to judge whether those criteria are adequate and effective. This creates a self-review risk. A small business can assign those processes to another competent auditor who did not help design them.

How can you make the decisions verifiable? A simple record can be enough. For competence, record the role requirements, the evidence reviewed, the decision and who made it. In the audit programme, identify who audits each process and how impartiality was protected. Both decisions remain the responsibility of the business.

The supplier name, Aerovexil QN47, is fictional. The case is based on an anonymized finding.

Applicable requirement

UNI EN 9100, § 8.4.1.1 d)

The organization shall define the necessary actions to take when dealing with external providers that do not meet requirements.

Nonconformity statement

The organization does not define the necessary actions to take when dealing with external providers that do not meet requirements.

Objective evidence

Deliveries from Aerovexil QN47 were up to 120 days late in 2026. The most recent evaluation available for this supplier was dated December 2025. The organization provided no evidence that it had defined actions to address the delivery delays identified during the audit.

How to write the finding

1. Always cite the applicable requirement. Give the standard and exact clause, including the letter or subclause where applicable. This example uses UNI EN 9100 § 8.4.1.1 d).
2. Keep the statement close to the requirement. Use the wording of the standard and negate the part the evidence shows was not met. Here shall define becomes does not define. The supplier’s delays reveal the circumstances in which the organization should have defined actions.
3. Give objective evidence in a separate block. Avoid vague wording such as “not always”, “sometimes”, “occasionally” and “now and then”. Say what you checked, which records you examined and what the sample showed. Where available, give the period, document references and the number of affected cases out of the total sampled.

How are internal audit nonconformities classified?

UNI EN 9100 § 9.2 leaves the classification of internal audit nonconformities to the organization. If it classifies them as major or minor, it applies the criteria it has defined in its own audit rules. Nonconformities and corrective actions are handled under the applicable requirements of § 10.2.

The definition of containment

Action to control and mitigate the impact of a nonconformity and protect the customer's operation (stop the problem from getting worse); includes correction, immediate corrective action, immediate communication, and verification that the nonconforming situation does not further degrade.

UNI EN 9101:2018 (AS9101F), § 3.1 · Containment

What consequence do we need to prevent immediately?

Return to the fictional supplier in Case 11. Suppose an order is still open and a further delay could interrupt a customer operation. The company promptly checks which orders are at risk, agrees with the supplier to prioritize the critical delivery, informs the customer and checks that the new date is met.

Here, containment protects continuity of the customer’s operations. Cause analysis asks a separate question. Why had the company failed to define how to respond when the supplier missed agreed dates?

A potential safety impact makes containment particularly urgent in aerospace. Case 13 shows what to do when some units have already been delivered.

Hypothetical case. A supplier assembles flight control actuators. The audit finds that two actuators were delivered before final verification of fastener torque. If a fastener loosened in service, flight control operation could be compromised.

Applicable requirement

UNI EN 9100, § 8.6 · Release of products and services. Release to the customer is subject to satisfactory completion of the planned arrangements, unless approved by the relevant authority and, where applicable, by the customer.

Nonconformity statement

The release of products and services to the customer proceeded even though the planned arrangements had not been satisfactorily completed.

Objective evidence

Of the four actuator release records reviewed, records RR-FCA-026-017 and RR-FCA-026-018 showed that the units were released and shipped before the final torque verification required by the Flight Control Actuator Inspection Plan, IP-FCA-026, Rev. B, operation 70. The organization confirmed that the verification had not been performed and that no approval had been granted for early release.

What does the supplier do immediately?

1. Stop releases and determine the scope. Suspend shipments of potentially affected units, segregate those still under the supplier’s control, and use traceability records to identify serial numbers, including units in transit and those already delivered.
2. Notify the customer promptly. Communicate the serial numbers and potential risk, ask the customer to hold any units not yet installed, and check whether any are already installed or in service. For those units, the customer involves the relevant functions to decide what measures apply.
3. Verify that containment has reached every affected unit. Reconcile the serial numbers with the customer’s feedback and check that each suspect unit has been located and accounted for.

Why is containment urgent? A suspect unit could be installed or remain in use without assessment. Technical verification against the applicable instructions determines whether the units conform. Corrective action addresses the cause that allowed release before the check.

At the Critical Design Review (CDR), the production manager raises a concern. Once the bracket is in place in the bay, there may be too little room to reach one of the fasteners with a torque wrench. The wrench fits in the 3D model, but the team wants to check whether there is also enough room to operate it and apply the specified torque.

The project lead authorizes the manufacture of a prototype for the test. Release of the drawing for series production remains conditional on the test result. In the minutes, the team records which revision to use for the prototype, who will run the test, the due date and the result needed to close the action.

The audit question
“Can you show me what you authorized at the end of the review and under what conditions?”

The prototype arrives in the workshop. The designer checks that the hole positions and overall dimensions specified on the drawing meet the customer’s interface requirements. This is design verification. The question is whether the design outputs meet the input requirements.

An operator then tries to install the bracket in a representative mock-up of the bay, with adjacent components already in place. The wrench reaches the fastener, but there is too little room to apply the specified torque. The test reveals a problem with the intended use, which is what validation is meant to assess.

Verification can also involve testing. To tell which activity a piece of evidence supports, I look at the question it needs to answer and the criterion against which it will be assessed.

The audit question
“What evidence shows that the interfaces meet the input requirements? What evidence shows that the operator can complete the installation under the intended conditions?”

To make room for the wrench, the designer changes the bracket profile and updates the drawing from revision A to revision B. The installation test is repeated on revision B and succeeds. The team still needs to decide how to treat the vibration test report, which recorded a pass for revision A.

The team reviews the actual change and assesses whether the new profile could affect the bracket’s stiffness or vibration response. It documents which evidence from revision A remains applicable and which checks or tests are needed for revision B. The reports identify the configuration actually tested so that the person authorizing release can trace the decision back to the supporting evidence.

The audit question
“Can you show me how you decided which revision A results could support the release of revision B?”

The team compares the two units’ records with the workflow. In both cases, torque verification was still open when the work order was forwarded to the release stage at shift handover. The handover screen showed the overall work order status. Individual outstanding operations were visible on a separate screen.

The team reproduces the sequence with a test order. The person authorizing release sees the order marked as ready, but the screen does not show that verification is still open. Reviewing the system acceptance tests, the team finds that release had been tested with a completed order. There was no test of an order forwarded with a mandatory verification still open.

The investigation distinguishes how the check was skipped, why the release process missed it and which gap in workflow testing allowed the problem to go undetected. The records, the reproduced sequence and the acceptance test results support these conclusions.

The audit question
“What evidence led you to conclude that this was the cause?”

For the two actuators, the supplier coordinates the technical verification with the customer in accordance with the applicable instructions and records the result for each serial number. This establishes the status of the units already delivered.

The corrective action changes the workflow. The handover screen highlights outstanding operations. The system prevents routine release while mandatory torque verification is open or has a failing result. The team adds these scenarios to the acceptance tests for future updates and identifies other products that use the same release workflow.

The audit question
“What changed in the process after the affected units were dealt with? How did you check whether the same problem could occur elsewhere?”

Before putting the new workflow into service, the team tests three orders. Routine release is blocked when verification is open or has a failing result. With a passing result, the order can proceed if the other release conditions are also met. The team records the test results.

Once the workflow is live, the team samples real orders across shifts, including orders transferred at handover. It compares verification completion timestamps with release authorization timestamps and checks how any blocked release attempts were handled. The criterion is that each sampled routine release took place only after verification had passed. The team records the period, sample and results in the corrective action report.

The audit question
“What test shows that the release block was implemented? What records show that it continues to work in day-to-day operations?”

When revision B is released, revision A brackets are still in stock and some units are already in production. After assessing work in progress and units already delivered, the company decides that, in this case, B applies from electronic unit serial number 051 onward. Earlier work orders retain the configuration specified for them in the approved change.

The change record states where the new revision takes effect and how to handle the remaining revision A stock. The bill of material and assembly instructions applicable to the work order for serial number 051 specify B. Approval establishes which change is authorized. Effectivity establishes which units are to incorporate it.

The audit question
“Where did you define the first serial number to use B? How did you handle stock and work orders already open?”

The auditor samples unit serial number 051. The bill of material released for its work order calls for B. The assembly record identifies the batch of the bracket actually installed. The auditor traces that batch to the acceptance record, which identifies both the bracket part number and revision B.

The bill of material describes the intended configuration for that unit. The link between serial number, assembly record and bracket batch establishes the as-built configuration. In this example the two match, and the auditor can demonstrate it by following the records.

The audit question
“Can you show me what was installed on this serial number?”

The customer requests a spare for serial number 042, which was delivered with revision A. A revision B bracket is available in stock. The team checks the unit’s history and asks the customer to confirm its current configuration, because work performed after delivery may have changed it.

The authorized technical function reviews the change data and assesses whether the spare is compatible with the unit’s interfaces and installation conditions. If B can be used, the decision identifies the configuration it applies to, which instructions to use and how to record the change after installation. Stock availability answers the logistics question. The technical decision establishes which bracket may be installed.

The audit question
“What record links the proposed spare to the unit’s current configuration and installation conditions?”

The revision B bracket used for design testing was machined with a temporary fixture. For production, the workshop will use a dedicated fixture, a released CNC program and a routing that defines the machining and inspection sequence. The prototype tests provide evidence for the design. Production process verification addresses the combination of documentation, equipment and operations planned for production.

The company selects a representative part from the first batch made using the production routing. It records the work order, the revision B drawing and the routing used so it can show which process produced the part selected for verification.

The audit question
“What shows that this part represents the process you will use to make the next ones?”

The auditor selects a hole position tolerance on the revision B drawing. In the First Article Inspection Report (FAIR), the auditor finds the characteristic identifier and the reference to the measurement report. That report gives the measured value, the datums used and the identity of the part measured.

The auditor traces the part to the production order and checks that the applicable drawing and routing were used. This links the design requirement to the result for the part actually manufactured. The same approach applies to the other applicable characteristics and their supporting evidence.

The audit question
“Starting from this characteristic on the drawing, can you show me the result and identify the part it relates to?”

After the first batch, the workshop replaces the fixture. The drawing stays at revision B, but the support points and clamp positions change. This could affect hole position and flatness after the part is unclamped.

The team compares the two setups, identifies every potentially affected characteristic and explains which previous results still apply. It performs the necessary checks on a part made with the new fixture. If 9102 applies and the assessment supports a partial FAI, the report identifies the reason for repeating the inspection, the baseline FAIR and the scope of the repeated checks.

The audit question
“What changed in the process? What evidence supports your decision about which checks to repeat and which previous results are still valid?”

A small aerospace company has scheduled its purchasing process audit for November. In March it introduces a new system that generates supplier purchase orders. The previous audit had found that some orders omitted customer requirements that should have been passed on to suppliers. The new system changes how those requirements are added to orders.

The company brings the audit forward to May, after the first orders have been issued through the new system. The scope covers order issue and its link to receiving inspection. The criteria are EN 9100 clause 8.4.3, the purchasing procedure and the applicable requirements for the sampled jobs. The auditor traces selected orders from the customer requirements, checks what was communicated to the supplier and verifies whether receiving inspectors have the information they need.

The programme could record the reason as follows:

The entry shows how the available information led to the audit decision. It explains why the date changed, what the auditor needs to check and what evidence will support the conclusion.

I graduated with a degree in mechanical engineering from Sapienza University of Rome in 2002. For over twenty years, I have worked in the aeronautical sector, spanning design, maintenance, and quality. In this notebook, I describe how regulatory requirements translate into the decisions made by those working in workshops, laboratories, and technical offices.

Auditing and training

Since 2016 I have conducted supplier audits and audits on behalf of certification bodies. I am an IAQG-approved audit team leader for EN 9100, EN 9110 and EN 9120. I am also an EMAR-145 auditor. I have conducted more than 300 audits in civil and defence companies, totalling over 800 audit days. I am qualified by RINA Academy as an instructor for aerospace courses, including EN 9100, EN 9110, EN 9120 and foreign object damage (FOD) prevention.

From the workshop to the laboratory

In aerospace I have worked in compliance monitoring, quality and safety. I led an EASA Part-21J design organization and oversaw the EN 9110 quality management system and internal audits.

In the calibration laboratory I worked with instruments used in maintenance, from calibration planning and measurement traceability to the assessment of out-of-tolerance results.

Production, maintenance and distribution

I learned about production firsthand by visiting workshops and advising small and medium-sized enterprises. Since 2019 I have supported Boeing’s maintenance quality activities at Pratica di Mare. I also provide consultancy on EN 9120 for the aerospace distribution sector.