SIST EN 9121:2008

Aerospace series - Quality management systems - Assessment applicable to stockist distributors (based on ISO 9001:2000)

The purpose of this document is to define the content and the presentation of the Assessment Report of the EN 9120 (based on ISO 9001:2000).

Luft- und Raumfahrt - Qualitätsmanagementsysteme - Audit für Händler und Lagerhalter (basiert auf ISO 9001:2000)

Série aérospatiale - Systèmes de management de la qualité - Évaluation applicable aux distributeurs stockistes (basé sur ISO 9001:2000)

Aeronavtika - Sistemi vodenja kakovosti - Ocenjevanje, ki se uporablja za distributerje skladiščnike (na podlagi ISO 9001:2000)

General Information

• Status: Withdrawn
• Publication Date: 23-Apr-2008
• Withdrawal Date: 06-Apr-2009
• ICS: 03.120.10 - Quality management and quality assurance
• ICS: 49.020 - Aircraft and space vehicles in general
• Technical Committee: I13 - Imaginarni 13
• Current Stage: 9900 - Withdrawal (Adopted Project)
• Start Date: 02-Apr-2009
• Due Date: 25-Apr-2009
• Completion Date: 07-Apr-2009
• Ref Project: EN 9121:2005 - Aerospace series - Quality management systems - Assessment applicable to stockist distributors (based on ISO 9001:2000)

Relations

• Replaced By: SIST EN 9121:2009 - Aerospace series - Quality management systems - Assessment applicable to stockist distributors (based on ISO 9001:2000)
• Effective Date: 08-Jun-2022
• Replaced By: SIST EN 9121:2009 - Aerospace series - Quality management systems - Assessment applicable to stockist distributors (based on ISO 9001:2000)
• Effective Date: 01-May-2009

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN 9121:2008
01-junij-2008
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GLVWULEXWHUMHVNODGLãþQLNHQDSRGODJL,62
Aerospace series - Quality management systems - Assessment applicable to stockist
distributors (based on ISO 9001:2000)
Luft- und Raumfahrt - Qualitätsmanagementsysteme - Audit für Händler und Lagerhalter
(basiert auf ISO 9001:2000)
Série aérospatiale - Systèmes de management de la qualité - Évaluation applicable aux
distributeurs stockistes (basé sur ISO 9001:2000)
Ta slovenski standard je istoveten z: EN 9121:2005
ICS:
03.120.10 Vodenje in zagotavljanje Quality management and
kakovosti quality assurance
49.020 Letala in vesoljska vozila na Aircraft and space vehicles in
splošno general
SIST EN 9121:2008 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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EUROPEAN STANDARD
EN 9121
NORME EUROPÉENNE
EUROPÄISCHE NORM
December 2005
ICS 03.120.10; 49.020

English Version
Aerospace series - Quality management systems - Assessment
applicable to stockist distributors (based on ISO 9001:2000)
Série aérospatiale - Systèmes de management de la Luft- und Raumfahrt - Qualitätsmanagementsystems -
qualité - Évaluation applicable aux distributeurs stockistes Audit für Händler und Lagerhalter (basiert auf ISO
(basé sur ISO 9001:2000) 9001:2000)
This European Standard was approved by CEN on 28 October 2005.
CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European
Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references concerning such national
standards may be obtained on application to the Central Secretariat or to any CEN member.
This European Standard exists in three official versions (English, French, German). A version in any other language made by translation
under the responsibility of a CEN member into its own language and notified to the Central Secretariat has the same status as the official
versions.
CEN members are the national standards bodies of Austria, Belgium, Cyprus, Czech Republic, Denmark, Estonia, Finland, France,
Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Slovakia,
Slovenia, Spain, Sweden, Switzerland and United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
Management Centre: rue de Stassart, 36  B-1050 Brussels
© 2005 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN 9121:2005: E
worldwide for CEN national Members.

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EN 9121:2005 (E)
Contents Page
Foreword .3
1 Purpose.4
2 Quality System Assessment Report content.4
Annex A (normative) Stockist Distributors Quality System Questionnaire.12
Annex B (normative) Systems audit scoring .37
Bibliography.40

2

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EN 9121:2005 (E)
Foreword
This European Standard (EN 9121:2005) has been prepared by the European Association of Aerospace
Manufacturers - Standardization (AECMA-STAN).
After enquiries and votes carried out in accordance with the rules of this Association, this Standard has
received the approval of the National Associations and the Official Services of the member countries of
AECMA, prior to its presentation to CEN.
This European Standard shall be given the status of a national standard, either by publication of an identical
text or by endorsement, at the latest by June 2006, and conflicting national standards shall be withdrawn at
the latest by June 2006.
Attention is drawn to the possibility that some of the elements of this document may be the subject of patent
rights. CEN [and/or CENELEC] shall not be held responsible for identifying any or all such patent rights.
In December 1998, the Aerospace Industry has established the International Aerospace Quality Group (IAQG)
with the purpose of achieving significant improvements in quality and reductions in cost throughout the value
stream.
This organization, with representation from Aerospace companies in Americas, Asia and Europe and sponsored
by SAE, SJAC and AECMA has agreed to take responsibility for the technical contents of this standard.
This standard was reviewed by the Domain Technical Coordinator of AECMA-STAN's Quality Domain.
According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following
countries are bound to implement this European Standard: Austria, Belgium, Cyprus, Czech Republic,
Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania,
Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Slovakia, Slovenia, Spain, Sweden, Switzerland
and the United Kingdom.

3

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EN 9121:2005 (E)
1 Purpose
The purpose of this standard is to define the content and the presentation of the Assessment Report
of the EN 9120 (based on ISO 9001:2000).
2 Quality System Assessment Report content
The Assessment Report is made up of:
• Page 5 (required)
General Assessment Information
• Page 6 (required)
Assessment Conclusions
• Page 7 (optional)
General Organization Information
• Page 8 (required)
Assessment Result Summary
• Page 9 (required)
Quality System Scoring
• Page 10
Corrective Action Request (when required)
• Page 11
List of Recommendations/Observations/Comments
•
Annex
STOCKIST DISTRIBUTORS – Quality System Questionnaire associated to the International
Quality System Standard EN 9120 - Section 1 (based on ISO 9001:2000)
• Annex
Documents regarding the company:
- Organization charts,
- Copies of agreements and certifications .


4

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EN 9121:2005 (E)

Assessing company
ASSESSMENT REPORT Standards 9120/9121
logo
GENERAL ASSESSMENT INFORMATION
1 Distributor organization & Work Address
Company Name: Tel Number:
Fax Number:
Subsidiary of: e-mail:
Organization Identification: CAGE code:
Assessed Site(s) Address(es): Assessment Representative & Title:
Headquarter:
Warehouse(s): Quality Manager Representative & Title:

Main activities:
Product Types or Codes:
2 ISO Registration
[  ] ISO Registered Registrar Name:
[  ] ISO Standard / Revision Expiration Date (If applicable):
[  ] Aerospace Standard / Revision
3 Assessment Team
Lead Assessor Name: Other Assessor Team Members:
[  ] Certified Auditor – Type & No.

[  ] Qualified Auditor
4 Assessment Dates:
5 Assessment Scope
[  ] Total facility assessed [  ] Initial assessment [  ] All 9120 elements assessed
[  ] Partial facility assessed [  ] Re-assessment [  ] Partial 9120 elements assessed
[  ] Other: Elements not assessed:
[  ] Activity assessed:
6 Assessment Disposition 7 Scoring
[  ] Conforming Scoring result:
[  ] Conforming with minor (mi) corrective action
[  ] Nonconforming with Major (Ma) corrective action
8 Assessment Approval
Assessing Company Date Lead Assessor Name Signature


Distribution Agreement
This Assessment Report is the property of the assessed Organization and the assessing Company. Distribution to other
companies or individuals is authorized only after written agreement of the assessed Organization and of the assessing
Company.
To that end, a signature below by an Authorized Representative of the assessing company indicates that this report may
be copied by the organization for other customers.
If copied, the report must be disclosed in full including findings and any corrective actions.
Authorized Representative
Assessing Company Name _____________________________ Signature ___________________ Date __________
5

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EN 9121:2005 (E)

Assessing company
ASSESSMENT REPORT
logo
ASSESSMENT CONCLUSIONS
(To be completed in English)
General comments about the organization, distributed products and sources, traceability and
the quality system of the assessed organization:
Strong points:
Weak points- Improvement Opportunities:
6

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EN 9121:2005 (E)

Assessing company
ASSESSMENT REPORT
logo
GENERAL ORGANIZATION INFORMATION
1 Legal and Financial Aspects
� Date of Formation:
� Legal Status:
� Capital:
� Other Data:

Third Prior Second Prior First Prior Current
Financial Year Financial Year Financial Year Financial Year
(      ) (      ) (      ) (      )

Sales

Earnings

Earnings used for Re-
Investment

Workforce
2 Turnover breakdown and main Customers
Activities Main Customers Sales Percentage

Aircraft, Space and
Defence Industry

Other Activity
(be specific)
3 Clearances or Approvals granted by Authorities
Name of the Authority Types and References End of Validity
(date)
7

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EN 9121:2005 (E)

Assessing company
ASSESSMENT REPORT
logo
ASSESSMENT RESULT SUMMARY
Organization:
Result
Elements* Observation / Corrective Action Request Number
(EN 9120-9121) (Ma/mi)
S Ma mi N/A
4 - Quality Management System
4.1 General requirements
4.2 Documentation requirements
5 - Management responsibility
5.1 Management commitment
5.2 Customer focus
5.3 Quality policy
5.4 Planning
5.5 Responsibility, authority and

communication

5.6 Management review
6 - Resource management
6.1 Provision of resources
6.2 Human resources
6.3 Infrastructure
6.4 Work environment
7 - Product realization
7.1 Planning of product realization   Non applicable
7.2 Customer-related processes
7.3 Design and development   Non applicable
7.4 Purchasing
7.5 Production and service provision   7.5.2 Non applicable
7.6 Control of monitoring and
measuring devices
8 - Measurement, analysis and improvement
8.1 General
8.2 Monitoring and measurement
8.3 Control of nonconforming

product
8.4 Analysis of data
8.5 Improvement
Assessed Organization: Assessing Company:


Rep’s name: Lead Assessor Name:
Results
Signature: Signature:
* For each element, cross results of assessment: “S” for Satisfactory, “Ma” for major corrective action, “mi” for
minor or “N/A” for non applicable
8

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EN 9121:2005 (E)

(Member logo)
ASSESSMENT SCORING
Organization: Result
Major CAR or Minor CAR on
minor CAR on non
SCORING CHART
Key requirement Key requirement NO CAR RESULT

Standards 9120/9121
Multiple Single Multiple Single
findings finding findings finding
4 Quality management system (Max. 80)
4.1 General requirements 0 5 20 30 40
4.2 Documentation requirements 0 5 20 30 40
Management responsibility (Max. 80)
5
5.1 Management commitment
5.2 Customer focus 0 5 10 15 20
5.3 Quality policy
5.4 Planning 0 5 10 15 20
5.5 Responsibility, authority and communication 0 5 15 15 20
5.6 Management review 0 5 10 15 20
6 Resource Management (Max. 80)
6.1 Provision of resources
0 5 10 20 30
6.2 Human resources
6.3 Infrastructure
0 10 25 40 50
6.4 Work environment
7 Product realization (Max. 480)
7.1 Planning of product realization Not required
7.2 Customer-related processes 0 10 20 40 60
7.3 Design and development Not required
7.4 Purchasing 0 5 30 40 100
7.5 Production and service provision
7.5.1 Control of production and service provision 0 5 30 60 80
7.5.2 Validation of processes for production and service provision Not required
7.5.3 Identification and traceability 0 5 40 50 100
7.5.4 Customer property 0 5 10 15 20
7.5.5 Preservation of product 0 5 20 40 100
7.6 Control of monitoring and measuring devices 0 5 10 15 20
8 Measurement, analysis and improvement (Max. 280)
8.1 General 0 5 10 15 20
8.2 Monitoring and measurement
8.2.1 Customer satisfaction 0 5 10 15 20
8.2.2 Internal audit 0 5 10 15 20
8.2.3 Monitoring and measurement of processes 0 5 20 25 30
8.2.4 Monitoring and measurement of product 0 5 15 15 20
8.2.5 Evidence of conformance – Certificate of conformity 0 5 N/A N/A/ 100
8.3 Control of nonconforming product 0 5 20 25 30
8.4 Analysis of Data 0 5 10 15 20
8.5 Improvement 0 5 10 15 20
  Total Points Possible
  Total Points Achieved
  Score (pt achieved/pts × 100)
The assessed Organization agrees on the Quality System scoring and Corrective Action

requests
Organization Representative: Signature: Date:

9

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EN 9121:2005 (E)

CORRECTIVE ACTION REQUEST Assessing company
logo
(C.A.R.)
Organization: Identification C.A.R. No.:
Site: Date issued:
Reference Standard: Referenced Standard Element concerned:
Criticality Non-Conformance Description
Ma / mi

Assessor Name: Assessor Signature:
Assessed Organization to complete the Corrective Action Request with root cause analysis, corrective
Due date:
action and planned completion date of corrective action, and return to the assessing Company by
due date.
Action Root Cause:
No.:
Planned completion date
Action Corrective Action:
of Corrective Action:
No.:
Organization Representative Name: Signature: Current date:
Verification of the implementation of the completed Corrective Action by the Assessed Organization
Organization Representative Name: Signature: Current date:
Verification of the implementation of the completed Corrective Action to be filled out by the Assessing Company
Verification date: Accepted: Assessor Name: Assessor Signature:
  Yes �        No �

10

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EN 9121:2005 (E)

Assessing company
List of Recommendations/Observations/Comments
logo
Organization: Audit report number:
Site: Issued date:

Item Number Section Description


Lead Assessor Name: Signature:

11

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EN 9121:2005 (E)
Annex A
(normative)

Stockist Distributors
Quality System Questionnaire
associated to the International Quality Management System Standard
EN 9120 (based on ISO 9001:2000)
1 Purpose
The purpose of this standard is to present the questionnaire to be used during the “on site” quality
system assessment of Organizations in order to ensure common practices for these assessments.
This questionnaire is relative to EN 9120 standard (based on ISO 9001:2000).
2 Use of the questionnaire
The use of this questionnaire is mandatory and will be a part of the Assessment Report.
The questionnaire is based on the AS / EN /JISQ 9120 standard, section 1, which is relative to:
− ISO 9001:2000 requirements
− Additional Aerospace specific requirements are shown in bold and italics.
The audit is undertaken by review against the requirements of the questionnaire and the findings are
recorded as appropriate by annotation of respective columns,
� Satisfactory (S)
� Not applicable (N/A) the reason shall be documented in the bottom of the page
� Not evaluated (N/E)
� Corrective Action Request (CAR) Major (Ma) or Minor (mi.) finding:
The CAR number shall be referenced in the column “CAR number”
The category Ma for Major CAR or mi for Minor CAR shall be included in this column also.
Additional information on questionnaire
Key Requirements: Some requirements are deemed to be very significant and are so identified by
the presence of ‘P’ or ‘M’ against the specific section or question within the questionnaire,
“P” direct link with product
“M” direct link with Management
The extent of Key Requirement applicability is determined by the location of the ‘M’ or ‘P’. In the
example below all of question 12 is considered as a key requirement.
12 Does the output from the management review include any decisions and actions related to (2): M
a) Improvement of the effectiveness of the quality management system and its processes?
b) Improvement of product related to customer requirements? and
c) Resource needs?
12

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EN 9121:2005 (E)
In the second example below only part of question 04, i.e. a) is considered Key Requirement.
04 Does the organization:
a) determine the necessary competence for personnel performing work affecting product
quality (2)?
P
b) provide training or take other actions to satisfy these needs?
c) evaluate the effectiveness of the actions taken?
d) ensure that its personnel are aware of the relevance and importance of their activities and
how they contribute to the achievement of the quality objectives?
e) maintain appropriate records of education, training, skills and experience (see 4.2.4) (3)?

Guidance notes: Certain questions will have a numeric reference that refers to additional guidance
notes which are detailed within the ‘Guidance notes’ section located after the questions on each page.
The guidance notes provide the Auditor with further insight on type of objective evidence and/or
review expectations etc. In the example below, note (1) refers the auditor to additional notes
pertaining to question 46 part a).
46) Does the analysis of data provide information relating to:
a) customer satisfaction (see 8.2.1) (1)?
b) conformity to product requirements (see 7.2.1)?
P
c) characteristics and trends of processes and products including opportunities for preventive
action? And
d) organizations?

Guidance Note
1) Give examples and check how the organization measures the effectiveness.
References: When a reference (e.g. 4.1) is added to a question, it is linked to the appropriate chapter
(e.g. 4.1) of EN 9120.
Objective evidence assessed / Observations / Comments / N/A explanation
Record the objective evidence reviewed during the assessment or reason for not applicable.
Nonconformities:
Major: The absence of, or total breakdown of a management element specified in the EN 9120
standard or any nonconformities where the effect is judged to be detrimental to the integrity of
the product or service.
Minor: A single system failure or lapse in conformance with a procedure relating to the EN 9120
standard.
NOTE A number of minor nonconformities against one requirement can represent a total breakdown
of the system and this can be considered as a major nonconformity.
3 Use of the Assessment Scoring chart
Following completion of each chapter of the Quality System Questionnaire the nomenclature
Assessment Scoring chart can now be completed.
The findings of each section and sub-section of the completed Quality System Questionnaire are
reviewed and the Assessment Scoring sheet completed as follows.
� If, multiple findings (i.e. greater than 1) with Major (Ma) Corrective Action Request (CAR) or
minor (mi) CAR on Key requirement in a section, e.g. 4.1 General Requirements then score in
Major CAR or minor CAR on Key Requirement (i.e. any questions with ‘M’ or ‘P’ indicator)
“Multiple findings” column (result = 0), or
� If, single finding with Major (Ma) CAR or minor (mi) CAR on key requirements in a section, e.g.
4.1 General Requirements then score in Major CAR or minor CAR on Key Requirement
“Single finding” column (result = 5), or
13

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EN 9121:2005 (E)
� If, multiple findings on non Key requirement (i.e. greater than 1) with Minor (mi) (CAR) in a
section, e.g. 4.1 General Requirements then score in Minor CAR on non Key requirement
“Multiple findings” column (result = 20), or
� If, single finding on non Key requirement with Minor (mi) CAR in a section, e.g. 4.1 General
Requirements then score in Minor CAR on non Key requirement “Single findings” column
(result = 30), or
� If, no CAR in a section, e.g. 4.1 General Requirements then score in “NO CAR” column
(result = 40),
� When a single finding occurred on several questions affecting the same section of the scoring
table (e.g. 5.1-5.2-5.3), then score as “multiple findings”.
Further notes on scoring
The above review criteria should be considered sequentially.
Maximum audit total can be 1 000
If a complete section line of the score sheet has not been assessed (N/A or N/E) the score will be
calculated as follow:
TOTAL ×100
Score =
Sum of maximum possible score
The higher the score the greater the level of compliance acknowledged by the audit activity.
14

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EN 9121:2005 (E)
Summary


Section headings Page numbers
16
4 Quality management system
4.1 General requirements 16
4.2 Documentation requirements 17
19
5 Management responsibility
19
5.1 Management commitment
5.2 Customer focus 19
5.3 Quality policy 19
5.4 Planning 19
5.5 Responsibility, authority and communication 20
5.6 Management review 21
22
6 Resource management
6.1 Provision of resources 22
6.2 Human resources 22
6.3 Infrastructure 22
6.4 Work environment 22
23
7 Product realization
7.1 Planning of product realization Not required 23
7.2 Customer-related processes 23
7.3 Design and development Not required 24
7.4 Purchasing 25
7.5 Production and service provision 26
29
7.6 Control of monitoring and measuring devices
30
8 Measurement, analysis and improvement
8.1 General 30
8.2 Monitoring and measurement 31
8.3 Control of nonconforming product 34
8.4 Analysis of data 35
8.5 Improvement 36

15

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EN 9121:2005 (E)
QUALITY SYSTEM QUESTIONNAIRE
KEY S CAR N/A N/E
ASSESSMENT QUESTIONS
Requirements Number
Ma or mi

4 Quality management system
4.1 General requirements
01 Has the organization established, documented, implemented and maintained a quality
management system and continually improved its effectiveness in accordance with the
requirements of this Standard?
02 Does the organization:
a) identify the processes needed for the quality management system and their application
throughout the organization (1)?
b) determine the sequence and interaction of these processes (1)?
c) determine criteria and methods needed to ensure that both the operation and control of
these processes are effective?
d) ensure the availability of resources and information necessary to support the operation and
monitoring of these processes?
e) monitor, measure and analyze these processes? and
f) implement actions necessary to achieve planned results and continual improvement of these
processes?
03 Are these processes managed by the organization in accordance with the requirements of this
Standard?
04 Where an organization chooses to outsource any process that affects product conformity with P
requirements, does the organization ensure control over such processes (2)?
05 Is the control of such outsource processes identified within the quality management system?

Note: Processes needed for the quality management system referred to above should include processes for management, provision,
product realization and measurement.

Guidance Note
1) Main process formally identified (list, flow diagram, etc.)
2) List external processes can be affect product conformity

Objective evidence assessed / Observations / Comments / N/A explanation
S: Satisfactory - CAR: Corrective action required – Ma: Major corrective action – mi: Minor corrective action
N/A: Not applicable - N/E: Not evaluated - P: Product - M: Management
16

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EN 9121:2005 (E)
QUALITY SYSTEM QUESTIONNAIRE
KEY S CAR N/A N/E
ASSESSMENT QUESTIONS
Requirements Number
Ma or mi

4.2 Documentation requirements
4.2.1 General
06 Does the quality management system documentation include:
a) documented statements of a quality policy and quality objectives?
b) a quality manual?
c) documented procedures required by this Standard?
d) documents needed by the organization to ensure the effective planning, operation and
control of its processes?
e) records required by this Standard (see 4.2.4)? and
f) quality system requirements imposed by the applicable Regulatory Authorities?
07 Does the organization ensure that personnel have access to quality management system
documentation and are aware of relevant procedures?
08 Do Customer and/or regulatory authority representatives have access to quality
management system documentation?
4.2.2 Quality manual
09 Has the organization established and maintained a quality manual that includes (1):
a) the scope of the quality management system, including details of, and justification for, any
exclusions?
b) the documented procedures established for the quality management system, or reference to
them, and (2)
when referencing the documented procedures, is the relationship between the
requirements of this Standard and the documented procedures clearly shown (3)?
c) a description of the interaction between the processes of the quality management system?

Note 1: Where the term “documented procedure” appears within this Standard, this means that the procedure is established, documented,
implemented and maintained.
Note 2: The extent of the quality management system documentation can differ from one organization to another due to
a) the size of organization and type of activities,
b) the complexity of processes and their interactions, and
c) the competence of personnel

Guidance Notes
1) Quality manual reference and issue
2) Check the procedure list
3) Reference of standard used as referential

Objective evidence assessed / Observations / Comments / N/A explanation
S: Satisfactory - CAR: Corrective action required – Ma: Major corrective action – mi: Minor corrective action
N/A: Not applicable - N/E: Not evaluated - P: Product - M: Management
17

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EN 9121:2005 (E)
QUALITY SYSTEM QUESTIONNAIRE
KEY S CAR N/A N/E
ASSESSMENT QUESTIONS
Requirements Number
Ma or mi

4.2 Documentation requirements (continued)
4.2.3 Control of documents
10 Are the documents required by the quality management system controlled? M
11 Are records controlled according to the requirements given in 4.2.4?
12 Has a documented procedure been established to define the controls needed to:
a) approve documents for adequacy prior to issue?
b) review and update as necessary and re-approve documents?
c) ensure that changes and the current revision status of documents are identified?
d) ensure that relevant versions of applicable documents are available at points of use?
e) ensure that documents remain legible and readily identifiable?
f) ensure that documents of external origin are identified and their distribution controlled? and
g) prevent the unintended use of obsolete documents, and to apply suitable identification to
them if they are retained for any purpose?
13 Does the organization maintain appropriate documentation to verify the status of the P
products, e.g.: manufacturer's data, standards, airworthiness data (1)?
14 Does the organization coordinate document changes with customers and/or regulatory
authorities in accordance with contract or regulatory requirements?
4.2.4 Control of records
15 Are records established and maintained to provide evidence of conformity to requirements and
of the effective operation of the quality management system?
16 Do records remain legible, readily identifiable and retrievable (2)?
17 Has a documented procedure been established to define the controls needed for the
identification, storage, protection, retrieval, retention time and disposition of records?
18 Are records included where applicable (3): P
a) manufacturer, distributor, repair station, test and inspection reports,
b) original certificates of conformity (manufacturer, sub-tier distributor), copies of
airworthiness certificates,
c) non-conformance, concession and corrective action records,
d) lot traceability records,
e) environmental or shelf life condition records.
19 Are records are stored in an electronic form, the integrity of the system and the back-up
procedures shall be appropriately validated.
Are these records without possibility of change by software traceable to the original
documentation.
20 Are records of product origin, conformity and shipment maintain for a minimum of seven M
years, or as required by contract (4)?
21 Are records available for review by customers and regulatory authorities in accordance
with contract or regulatory requirements?

Guidance Note
1) List updated manufacturer’s documentation, standard, and airworthiness data
2) List records reviewed
3) Examples reviewed
4) Period of records retention

Objective evidence assessed / Observations / Comments / N/A explanation
S: Satisfactory - CAR: Corrective action required
...