EN 9101:2008
(Main)Aerospace series - Quality management systems - Assessment (based on ISO 9001:2000)
Aerospace series - Quality management systems - Assessment (based on ISO 9001:2000)
The purpose of this document is to define the content and the presentation of the Assessment Report for the EN 9100 standard.
Luft- und Raumfahrt - Qualitätsmanagementsysteme - Audit (basiert auf ISO 9001:2000)
Der Zweck dieses Dokumentes ist die Festlegung von Inhalt und Gestaltung des Auditberichts der Norm EN 9100.
Série aérospatiale - Systèmes de management de la qualité - Évaluation (basé sur ISO 9001:2000)
Aeronavtika - Sistemi vodenja kakovosti - Ocenjevanje (na podlagi ISO 9001:2000)
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
01-julij-2008
Aeronavtika - Sistemi vodenja kakovosti - Ocenjevanje (na podlagi ISO 9001:2000)
Aerospace series - Quality management systems - Assessment (based on ISO
9001:2000)
Luft- und Raumfahrt - Qualitätsmanagementsysteme - Audit (basiert auf ISO 9001:2000)
Série aérospatiale - Systèmes de management de la qualité - Évaluation (basé sur ISO
9001:2000)
Ta slovenski standard je istoveten z: EN 9101:2008
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
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
EUROPEAN STANDARD
EN 9101
NORME EUROPÉENNE
EUROPÄISCHE NORM
April 2008
ICS 03.120.10; 49.020
English Version
Aerospace series - Quality management systems - Assessment
(based on EN ISO 9001:2000)
Série aérospatiale - Systèmes de management de la Luft- und Raumfahrt - Qualitätsmanagementsysteme -
qualité - Évaluation (basé sur EN ISO 9001:2000) Audit (basiert auf EN ISO 9001:2000)
This European Standard was approved by CEN on 28 December 2007.
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: rue de Stassart, 36 B-1050 Brussels
© 2008 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN 9101:2008: E
worldwide for CEN national Members.
Contents Page
Foreword.3
1 PURPOSE .5
2 QUALITY MANAGEMENT SYSTEM ASSESSMENT REPORT CONTENT.5
Annex A (normative) QUALITY MANAGEMENT SYSTEM QUESTIONNAIRE.13
Annex B (normative) QUALITY MANAGEMENT SYSTEM AUDIT SCORING.45
Bibliography .48
Foreword
This document (EN 9101:2008) 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 October 2008, and conflicting national standards shall be withdrawn at
the latest by October 2008.
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.
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.
Page intentionally left blank
1 PURPOSE
The purpose of this document is to define the content and the presentation of the Assessment Report
for the EN 9100 standard.
2 QUALITY MANAGEMENT SYSTEM ASSESSMENT REPORT CONTENT
The Assessment Report is made up of:
• Page 6 (required)
General Assessment Information
• Page 7 (required)
Assessment Conclusions
• Page 8 (optional)
Specific Organization Information
• Page 9 (required)
QMS Assessment Result Summary
• Page 10 (required)
QMS Assessment Scoring
• Page 11 (required when nonconformities are identified during assessment)
Corrective Action Request
• Page 12 (required when observations/comments are identified during assessment)
Observations/Comments
• Annex A
Quality Management System Questionnaire
Audit Report No.:
Assessing company
ASSESSMENT REPORT
logo
GENERAL ASSESSMENT INFORMATION
1 Organization & Work Address
Company Name: Tel Number:
Fax Number:
Subsidiary of: E-mail:
Organization Identification: CAGE code:
Assessed Site Address: Assessment Representative & Title:
Management Representative & Title:
Product Types or Codes:
Main activities:
No. of employees at assessed site:
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 9100 clauses assessed
[ ] Partial facility assessed [ ] Re-assessment [ ] Partial EN 9100 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 ___________
Audit Report No.:
Assessing company
ASSESSMENT REPORT
logo
ASSESSMENT CONCLUSIONS
General comments about the organization and the quality management system of the assessed
organization:
Strong points:
Improvement Opportunities:
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
Defense Industry
Other Activity
(be specific)
3 Clearances or Approvals granted by Authorities
Name of the Authority Types and References End of Validity
(date)
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
4.3 Configuration management
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
7.2 Customer-related processes
7.3 Design and development
7.4 Purchasing
7.5 Production and service provision
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
Management Rep’s name: Lead Assessor Name:
Signature: Signature:
* For each clause, indicate with an “X” the results of assessment: “S” for Satisfactory, “Ma” for major corrective action, “mi” for
minor, “N/A” for not applicable, or N/E for not evaluated.
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 (100)
4.1 General requirements 0 10 25 40 50
4.2 & 4.3 Documentation requirements & Configuration management 0 10 25 40 50
5 Management responsibility (150)
5.1 Management commitment
5.2 Customer focus 0 5 15 20 30
5.3 Quality policy
5.4 Planning 0 10 20 30 40
5.5 Responsibility, authority and communication 0 5 15 20 30
5.6 Management review 0 10 25 40 50
6 Resource Management (100)
6.1 Provision of resources
0 10 25 40 50
6.2 Human resources
6.3 Infrastructure
0 10 25 40 50
6.4 Work environment
7 Product realization (450)
7.1 Planning of product realization 0 5 15 20 30
7.2 Customer-related processes 0 10 30 50 60
7.3 Design and development
7.3.1 Design and development planning 0 5 15 20 30
7.3.2-3-4 Inputs, outputs & review 0 5 15 20 30
7.3.5-6 Design and development verification & validation 0 5 15 20 30
7.3.7 Control of design and development changes 0 5 15 20 30
7.4 Purchasing 0 10 30 50 60
7.5 Production and service provision
7.5.1 Control of production and service provision 0 10 25 40 50
7.5.2 Validation of processes for production and service provision 0 10 20 30 40
7.5.3 Identification and traceability 0 10 20 30 40
7.5.4-5 Customer property & Preservation of product 0 5 15 20 30
7.6 Control of monitoring and measuring devices 0 5 10 15 20
8 Measurement, analysis and improvement (200)
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 15 20 30
8.2.3 Monitoring and measurement of processes 0 5 15 20 30
8.2.4 Monitoring and measurement of product 0 5 15 20 30
8.3 Control of nonconforming product 0 5 15 20 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
Name of Representative: Signature: Date:
Score
(pts achieved/pts possible)
× 100
Audit Report No.:
CORRECTIVE ACTION REQUEST
Assessing company
logo
(CAR)
Organization: Identification C.A.R. No.:
Site: Date issued:
Reference Standard: Referenced Standard Clause concerned:
Criticality Nonconformance Description
Ma / mi
Assessor Name: Assessor Signature:
Assessed Organization to complete the CAR with root cause analysis, corrective action, and
Due date:
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 c
...
Questions, Comments and Discussion
Ask us and Technical Secretary will try to provide an answer. You can facilitate discussion about the standard in here.