FAQ 9101:2016 / 9101F

Rev. 2 – 05 Mar 2018

Note 1: These FAQs correspond to 9101:2016 (9101F).

Note 2: The item number corresponds with the order of submittal of the questions. This will support traceability. The questions and answers are located in this
document in order of the clauses of the 9101 standard, in order to facilitate searching. New questions/adjustments since the previous issue are indicated in red.
Note 3: This is a ‘living’ document that will be updated regularly and published on the IAQG website.

# FAQ# Clause Question Answer

Rev.E
1 6 1.2 Can an organization that does not have ASD Yes, this is possible: see ‘IAQG ICOP and OASIS resolutions log’ under
business be certified to 9100? help/guidance on the OASIS website: www.iaqg.org/oasis, resolution #127.

2 9 3.3 Can you give an example of a major Example: Evidence of a missed heat-treat operation found during an audit of special
nonconformity that it is judged to be process control.
detrimental to the integrity of the product or Example: Dimensional nonconformance found in an inspection report that has not
service? been dispositioned by the appropriate authority.
3 10 3.3 Can you give an example of major Example: Evidence that the Test Verification/Validation procedure does not meet
nonconformity that could result in failure or customer requirements.
reduce the usability of the product or service? Example: Evidence of an unauthorized rework/repair without customer approval.
4 11 3.3 Can you give an example of major Example: Evidence that no internal audits had been performed during the last year
nonconformity that results in the total and no planning for the next year.
breakdown of a system to meet a 9100 Example: Evidence that there is no register of external providers to show their
requirement? approval status and their scope of approval.

5 86 3.3 What is meant by the term “probable” relating The auditor makes an assessment (based on objective evidence) as to whether the
to “any nonconformity that can result in the nonconformity would have been detected by the organization during subsequent
probable delivery of nonconforming product or activity, to prevent delivery of nonconforming product or service to the customer.
service”?
6 14 3.3 Is there a direct relationship between the major No. See 9101 clause 4.2.2.5.3 for evaluation of effectiveness.
3.4 and minor nonconformity definitions and the
effectiveness measurements defined in 9101?

Rev. 2 – 05 Mar 2018

FAQ 9101:2016 / 9101F

7 87 3.8 Is a performance metric required for both No, performance metrics for operational processes are defined by the organization in
quality and timeliness for every process relation to each identified operational process. Determination of Quality and OTD
covered in 9100-series clause 8? performance also needs to be measured by the organization to demonstrate
fulfillment of customer requirements, but this is not related to every process.
8 20 4.2.1 Is the verification of customer specific The auditor should establish with the organization if a customer has specified
performance targets the task of a CB audit, as performance targets and if "yes", review performance against those targets.
this is not a defined requirement in 9100-series
standards?
9 21 4.2.1 How shall an audit address ‘customer Audit planning should include evaluating actions taken to address ‘customer
concerns’? concerns’ such as customer complaints and OASIS feedback. These are inputs that
can influence the audit plan.
These can be audited at the (next) surveillance/recertification audit or by a special
audit (see 9101 clause 4.3.6)

10 23 4.2.1 Why customer specific QMS requirements 9100-series clause 4.4.1 states ‘The organization’s quality management system shall
shall be audited? also address customer and applicable statutory and regulatory quality management
system requirements.
The aim is that the QMS requirements of customers are included in the audit, to
reduce the need for additional QMS audits by the customers.
11 24 4.2.1 Can you give examples of customer specific Requirements related to: the use of 9102, traceability, nonconformity management,
requirements? role of the MRB, use of customer approved external providers, retained documented
information, flow down to external providers, etc.
12 25 4.2.1 How has an auditor access to customer Pre-audit information, contract files and/or purchase order notes all provide insight
specific requirements? into customer specific requirements. The audit team has the right of access to files
related to contracts.
13 27 4.2.1 Shall statutory/regulatory requirements be The applicable statutory and regulatory quality management system requirements
audited? shall be addressed (See 9100-series clause 4.4.1) during the audit. Results of
statutory and regulatory audits can be used to evaluate parts of the QMS such as
corrective action, internal audit and management review.

14 30 4.2.2.2 How do you conduct an opening meeting on a In most cases the team leader would expect the AEA at each site to conduct a site
site when the site is not visited by the audit specific opening meeting. Site specific personnel need to be informed of the
team leader but by an AEA only? important issues covered by clause 4.2.2.2. Audit team still need to ascertain
important specific information about the site. e.g. Health & Safety issues etc.

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FAQ 9101:2016 / 9101F

15 32 4.2.2.5 What is the level of detail for processes to be The process (e.g. Design, Manufacturing, Purchasing) is determined by the
recorded on the PEAR form? organization and recorded on the PEAR.
All processes are assessed at an appropriate level, and audit trails and audit
evidence are summarized in sufficient detail within Section 3 of the PEAR to provide
adequate visibility of the process audited.
16 33 4.2.2.5 Why is objective evidence for conforming To provide objective evidence of the audit findings and to meet the requirements of
situations recorded in addition to ISO17021-1 9.4.5 that requires conformity and nonconformity to be identified,
nonconforming situations? classified and recorded.
17 34 4.2.2.5 When would the recurrence of a nonconformity When the same or similar nonconformity is identified at the same site/location during
during a consecutive audit lead to a major one audit and the following audit to indicate that the corrective action process is not
nonconformity? effective.
18 36 4.2.2.5 Do I have to raise a major NCR against clause A major NCR would be raised against 9100-series standards 4.4.1.c and /or 4.4.1.g if
4.4.1.c and/or 4.4.1.g when the effectiveness the nonconformity was related to the effective operation and control of the QMS
level of the process is rated a “1”? processes and met the definition for a major nonconformity (9101 clause 3.3). NCRs
are the result of nonconformities identified during the audit in relation to process
realization and/or process results (see 9101 standard clause 4.2.2.5.1 and 4.2.2.5.2).
NCRs are not the result of the process effectiveness level.
19 37 4.2.2.5 If a regulatory audit (or customer audit or Yes, the CB auditor shall write NCRs if the corrective action has not taken place as
other) has taken place and NCRs have been scheduled.
written, should the same NCR be written by
the certification body auditor if the corrective
action has not yet taken place?
20 42 4.2.4 Do I have to be onsite to verify and close the Not always needed, dependent upon the documented information provided by the
NCR? organization. See also ISO 17021-1 9.4.10.
21 46 4.2.4 b Why do nonconformities have to be corrected Correction, corrective action(s) and corrective action plans have to be agreed
within 30 days from the end of the on-site between the CB and the organization within a maximum of 30 days after the end of
audit, while systemic issues typically take the on-site audit. It is recognized that implementation of the defined action(s) can in
longer than 30 days? some cases take longer.
22 48 4.2.4 b If agreement is not reached within 30 days Agreement within 30 days is a "requirement", but the CB may allow the organization
from the issuance of the nonconformity some extra time in exceptional circumstances, providing the agreement is being
although the organization is adequately actively managed.
reacting, can the CB allow the organization
some extra time?

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FAQ 9101:2016 / 9101F

23 47 4.2.4 Why the “Evaluation and closing of the Because the organization would need sufficient time to undertake a review of the
corrective action plan and associated identified nonconformity including correction, root cause analysis and corrective
corrective actions relating to a nonconformity action. Furthermore the audit plan would not accommodate additional time to
shall not be performed during the audit in undertake a review of the organizations response and objective evidence.
which the nonconformity was issued”?
24 89 4.2.4 Does the auditor need to create a new (or There is no requirement to create a new (or updated) audit report following an on-site
updated) audit report (Form 5) following an on- NCR verification visit. Section 3 of the NCR (Form 4) is used to document verification
site NCR verification follow up visit? of the corrective action and effectiveness of actions taken to prevent recurrence.
25 13 4.3 Clause 4.3 states "the CB shall require the If access is not permissible, it will be up to the auditor to determine similarity by
4.3.1 organization to provide information if any interviewing personnel and assessing maintained and retained documented
activities, programs, specifications and/or information that is available to draw this conclusion. If the auditor cannot make such a
conclusion then coordinate with the CB not to include the program or processes in
areas are not accessible because of restrictive
the scope of certification.
or confidential nature” and in 4.3.1 “the scope Note: Audit planning may include access permission or security clearances arranged
of certification shall not include processes that prior to Stage 2 or any onsite audit. Proprietary Information Agreement (PIA’s) may
were not audited to sufficient depth to verify also be included between the CB and the organization.
the organization's conformity, including the
determination of effectiveness. However they
may be included if the processes can be
proven to be similar to processes that were
assessed and the same QMS documented
information and controls are invoked.”
Therefore how can I determine effectiveness
and that they are truly using the same
documented information, etc. if I do not have
access to the information?
26 53 4.3.1.1 a What is the purpose to record revenue for The information is used as an input to Audit Planning (see 4.2.1 p) in order to
aviation, space and defense industry business determine the amount of audit time proportional to the level of business each
as a proportion of the organization’s total customer represents.
revenue?

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FAQ 9101:2016 / 9101F

27 55 4.3.2 Is there a limit to the number of Stage 1 audits There is no limit to the number of Stage 1 audits, however one Stage 1 audit should
that could be conducted? be sufficient. If during the (scheduled) audit days for the stage 1 audit, time is not
sufficient, additional days should be added.
The CB shall consider the need to repeat all, or part of the Stage 1 audit if any
significant changes occur that would impact the management system (see ISO17021-
1 9.3.1.2.4).
In the event the time period between Stage 1 and Stage 2 exceeds 6 months, an
additional Stage 1 audit shall be conducted (9101 4.3.3).
28 58 4.3.2.3 e Why do ‘export limitations/controls [e.g., In order to provide an understanding to the CB regarding product or service
International Traffic in Arms Regulations information, processes and documentation that may impact the audit and subsequent
(ITAR), Export Administration Regulation reporting.
(EAR)]’ have to be reviewed by the audit
team?

29 59 4.3.2.3 a Can an organization claim Design as “Not No, the justification shall not be accepted by the CB for organizations that perform
Applicable” within their certification scope if design activity needed to fulfill aviation, space and defense customer contracts.
they undertake design activity that in turn is
passed to their customer who has overall
design responsibility for the product?
30 60 4.3.2.3 f What is the difference between ‘direct ship’ It depends on the Airworthiness Authorities (FAA/EASA). See ARP/EN/SJAC 9107
and ‘direct delivery’? and 9114 and the IAQG dictionary, available via the IAQG website.
31 63 4.3.3 Why the Stage 1 and Stage 2 audit cannot be Because it cannot be foreseen before the Stage 1 audit that the organization is ready
performed on the same day or consecutive for the Stage 2 audit. So, the Stage 2 audit can only be scheduled after the Stage 1,
days? in order to ensure that there is sufficient time for the organization to take appropriate
action to eliminate possible areas of concern.
32 90 4.3.4 Can you clarify what is meant by “repeat The audit team leader may recommend suspension of the certification if the audit
nonconformities” and how that may lead to result identifies a trend of repeat nonconformity to indicate that previous corrective
suspension of the certification? action defined and implemented by the organization is deemed to be ineffective.

33 68 4.3.5 If it is justified to conduct a full or partial Stage If a Stage 1 audit is determined to be necessary during recertification, additional audit
NOTE 1 audit during recertification due to the days shall be added to the required audit duration defined in Table 2 (see 9104/1
appointment of a new audit team are these 8.2.2 h).
days included in the 9104/1 tables?

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FAQ 9101:2016 / 9101F

34 74 Form 1 What is the reason for the detailed information Information is needed to support audit planning including calculation of the audit
on “Aviation, Space and Defense” and “other” duration, coverage of shift patterns and to determine the amount of audit time
business as well as the separate call out of the proportional to the level of business each customer represents.
workforce?

Rev. 2 – 05 Mar 2018