SIST EN 9121:2009
(Main)Aerospace series - Quality management systems - Assessment applicable to stockist distributors (based on ISO 9001:2000)
Aerospace series - Quality management systems - Assessment applicable to stockist distributors (based on ISO 9001:2000)
The scope of this document is to define the content and the presentation of the Assessment Report of the section 1 of EN 9100 standard (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
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
SIST EN 9121:2009
01-maj-2009
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SIST EN 9121:2008
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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 9121:2009
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 9121:2009 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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SIST EN 9121:2009
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SIST EN 9121:2009
EUROPEAN STANDARD
EN 9121
NORME EUROPÉENNE
EUROPÄISCHE NORM
March 2009
ICS 03.120.10; 49.020 Supersedes EN 9121:2005
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 - Qualitätsmanagementsysteme -
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 11 July 2008.
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 CEN Management Centre 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 CEN Management Centre has the same status as the
official versions.
CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland,
France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal,
Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
Management Centre: Avenue Marnix 17, B-1000 Brussels
© 2009 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN 9121:2009: E
worldwide for CEN national Members.
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SIST EN 9121:2009
EN 9121:2009 (E)
Contents Page
Foreword .3
1 Scope .4
2 QUALITY SYSTEM ASSESSMENT REPORT CONTENT .4
Annex A (normative) QUALITY MANAGEMENT SYSTEM QUESTIONNAIRE . 12
1 PURPOSE . 12
2 USE OF THE QUESTIONNAIRE . 12
3 USE OF THE ASESSMENT SCORING CHART . 13
Annex B (normative) QUALITY MANAGEMENT SYSTEM AUDIT SCORING . 36
2
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SIST EN 9121:2009
EN 9121:2009 (E)
Foreword
This document (EN 9121:2009) has been prepared by the Aerospace and Defence Industries Association of
Europe - Standardization (ASD-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 ASD,
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 September 2009, and conflicting national standards shall be
withdrawn at the latest by September 2009.
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.
This document supersedes EN 9121:2005.
This standard was reviewed by the Domain Technical Coordinator of ASD-STAN’s Quality Domain.
After inquiries and votes carried out in accordance with the rules of ASD-STAN defined in ASD-STAN's General
Process Manual, this standard has received approval for Publication.
To assure customer satisfaction, aerospace industry organizations must produce, and continually improve,
safe, reliable products that meet or exceed customer and regulatory authority requirements. The globalization
of the aerospace industry, and the resulting diversity of regional/national requirements and expectations, has
complicated this objective. End product organizations face the challenge of assuring the quality of, and
integrating, product purchased from suppliers throughout the world and at all levels within the supply chain.
Aerospace suppliers and processors face the challenge of delivering product to multiple customers having
varying quality expectations and requirements.
The aerospace industry has established the International Aerospace Quality Group (IAQG) for the purpose of
achieving significant improvements in quality and safety, and reductions in cost, throughout the value stream.
This organization includes representatives from aerospace companies in the Americas, Asia/Pacific, and
Europe. This international standard has been prepared by the IAQG.
According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following
countries are bound to implement this European Standard: Austria, Belgium, Bulgaria, Cyprus, Czech
Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia,
Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain,
Sweden, Switzerland and the United Kingdom.
3
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SIST EN 9121:2009
EN 9121:2009 (E)
1 Scope
The scope of this document is to define the content and the presentation of the Assessment Report of
the section 1 of EN 9100 standard (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)
Specific Organization Information
• Page 8 (required)
QMS Assessment Result Summary
• Page 9 (required)
QMS Assessment Scoring
• Page 10
Corrective Action Request (when required)
• Page 11
Observations / Comments
• Annex
Quality Management System Questionnaire relative to EN 9120 (based on ISO 9001:2000)
• Annex
Quality Management Systems Audit Scoring
4
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SIST EN 9121:2009
EN 9121:2009 (E)
Audit Report No.:
Assessing company
ASSESSMENT REPORT
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) Addresse(s): Assessment Representative & Title:
Headquarter:
Quality Manager Representative & Title:
Warehouse(s):
Main activities:
Product Types or Codes:
2 QMS Registration
[ ] ISO Standard / Revision: [ ] Aerospace Standard / Revision:
Expiration Date (if applicable): Expiration Date (if applicable):
Registrar Name: Registrar Name:
3 Assessment Team
Lead Assessor Name: Other Assessment Team Members:
[ ] Certified Auditor – Type & No.
[ ] Qualified Auditor
4 Assessment Dates:
5 Assessment Scope
[ ] Total facility assessed [ ] Initial assessment [ ] All EN 9120 clauses assessed
[ ] Partial facility assessed [ ] Re-assessment [ ] Partial EN 9120 clauses assessed
[ ] Other: Clauses 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 ____________
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SIST EN 9121:2009
EN 9121:2009 (E)
Audit Report No.:
Assessing company
ASSESSMENT REPORT
logo
ASSESSMENT CONCLUSIONS
General comments about the organization, distributed products and sources, traceability and
the quality system of the assessed organization:
Strong points:
Weak points- Improvement Opportunities:
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SIST EN 9121:2009
EN 9121:2009 (E)
Audit Report No.:
Assessing company
ASSESSMENT REPORT
logo
SPECIFIC ORGANIZATION INFORMATION
1 Legal and Financial Aspects
ˆ Date of Formation:
ˆ Legal Status:
ˆ Capital:
ˆ 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)
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SIST EN 9121:2009
EN 9121:2009 (E)
Audit Report No.:
Assessing company
ASSESSMENT REPORT
logo
QMS ASSESSMENT RESULT SUMMARY
Organization:
Observation / Corrective Action Request
Result
Clauses* Number
S Ma mi N/A N/E
(Ma/mi)
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:
Results
Rep’s name: Lead Assessor Name:
Signature: Date: Signature:
* For each clause, cross results of assessment: “S” for Satisfactory, “Ma” for major corrective action, “mi” for minor
or “N/A” for non applicable and “N/E” for not evaluated.
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SIST EN 9121:2009
EN 9121:2009 (E)
Audit Report No.:
Assessing company
QMS ASSESSMENT SCORING
logo
Organization: Result
Major CAR or minor Minor CAR on non
CAR on Key
SCORING CHART
Key requirement
NO CAR RESULT
requirement
(Col. A) (Col. B) (Col. C) (Col. D)
Multiple Single Multiple Single
findings finding findings finding
4 Quality management system
80
4.1 General requirements 0 5 20 30 40
4.2 Documentation requirements 0 5 20 30 40
5 Management responsibility
80
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
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
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
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
The assessed Organization agrees on the Quality Management
System scoring and Corrective Action requests
Total Points Achieved
Organization Representative: Signature: Date:
Score
(pts achieved/pts possible)
× 100
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SIST EN 9121:2009
EN 9121:2009 (E)
Audit Report No.:
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,
Due date:
corrective action, and planned completion date of corrective action, and return to the Assessing
Company by due date.
Action Root Cause:
No.:
Planned completion
Action Corrective Action:
date of Corrective
No.:
Action:
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 ˆ No ˆ
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SIST EN 9121:2009
EN 9121:2009 (E)
Audit Report No.:
Assessing company
OBSERVATIONS / COMMENTS
logo
Organization: Audit Report number:
Site: Issued date:
Item Number Section Description
Lead Assessor Name: Signature:
Date:
S: Satisfactory – CAR: Corrective action request – Ma: Major corrective action – mi: Minor corrective action
N/A: Not applicable – N/E: Not evaluated – P: Product – M: Management
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SIST EN 9121:2009
EN 9121:2009 (E)
Annex A
(normative)
QUALITY MANAGEMENT SYSTEM
QUESTIONNAIRE
Associated to the International Quality System Standard EN 9120
(based on ISO 9001:2000)
1 PURPOSE
The purpose of this Annex is to present the questionnaire to be used during the “on-site” quality
management system assessment of Organizations in order to ensure common practices for these
assessments.
2 USE OF THE QUESTIONNAIRE
The use of this questionnaire is mandatory and will be a part of the Assessment Report.
The audit is undertaken by review of the organization’s QMS against the requirements of the
EN 9100 standard, using the questionnaire as a guide. Findings are recorded as appropriate by the
following annotations in the respective columns of the questionnaire:
¾ Satisfactory (S)
¾ Not applicable (N/A) the reason shall be documented in the bottom of the page
¾ Not evaluated (N/E)
¾ 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:
¾ “P” – direct link with Product
¾ “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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SIST EN 9121:2009
EN 9121:2009 (E)
In the second example below only part of question 04, i.e. a) is considered Key Requirement.
04 Does the organization:
P
a) determine the necessary competence for personnel performing work affecting product
quality (2)?
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)?
c) characteristics and trends of processes and products including opportunities for preventive
action? And
d) organizations?
Guidance Notes
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
clause (e.g., 4.1) of the EN 9120 standard.
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 ASESSMENT SCORING CHART
Refer to Annex B for instructions and guidance on how to score the EN 9100 audit.
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SIST EN 9121:2009
EN 9121:2009 (E)
Summary
Section headings Page numbers
4 QUALITY MANAGEMENT SYSTEM 15
4.1 General requirements 15
4.2 Documentation requirements 16
5 MANAGEMENT RESPONSIBILITY 18
5.1 Management commitment 18
5.2 Customer focus 18
5.3 Quality policy 18
5.4 Planning 18
5.5 Responsibility, authority and communication 19
5.6 Management review 20
6 RESOURCE MANAGEMENT 21
6.1 Provision of resources 21
6.2 Human resources 21
6.3 Infrastructure 21
6.4 Work environment 21
7 PRODUCT REALIZATION 22
7.1 Planning of product realization Not required 22
7.2 Customer-related processes 22
7.3 Design and development Not required 23
7.4 Purchasing 23
7.5 Production and service provision 25
7.6 Control of monitoring and measuring devices 28
8 MEASUREMENT, ANALYSIS AND IMPROVEMENT 29
8.1 General 29
8.2 Monitoring and measurement 30
8.3 Control of nonconforming product 33
8.4 Analysis of data 34
8.5 Improvement 35
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SIST EN 9121:2009
EN 9121:2009 (E)
QUALITY MANAGEMENT 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 improve its effectiveness in accordance with the
requirements of this International 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
International 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 Notes
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 request – Ma: Major corrective action – mi: Minor corrective action
N/A: Not applicable – N/E: Not evaluated – P: Product – M: Management
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SIST EN 9121:2009
EN 9121:2009 (E)
QUALITY MANAGEMENT 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 International Standard?
d) documents needed by the organization to ensure the effective planning, operation and
control of its processes?
e) records required by this International 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 International 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 International 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 request – Ma: Major corrective action – mi: Minor corrective action
N/A: Not applicable – N/E: Not evaluated – P: Product – M: Management
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SIST EN 9121:2009
EN 9121:2009 (E)
QUALITY MANAGEMENT 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) nonconformance, 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 Notes
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 request – Ma: Major corrective action – mi: Minor corrective action
N/A: Not applicable – N/E: Not evaluated – P: Product – M: Management
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