EN 9111:2005
(Main)Aerospace series - Quality management systems - Assessment applicable to maintenance organizations (based on ISO 9001:2000)
Aerospace series - Quality management systems - Assessment applicable to maintenance organizations (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 9110 (based on ISO 9001:2000).
Luft- und Raumfahrt - Qualitätsmanagementsysteme - Audit für Instandhaltungsbetriebe (basiert auf ISO 9001:2000)
Série aérospatiale - Systèmes de management de la qualité - Évaluation applicable aux organismes d'entretien (basé sur ISO 9001:2000)
Aeronavtika - Sistemi vodenja kakovosti - Ocenjevanje, ki se uporablja v vzdrževalnih organizacijah (na podlagi ISO 9001:2000)
General Information
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Standards Content (Sample)
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.Aerospace series - Quality management systems - Assessment applicable to maintenance organizations (based on ISO 9001:2000)Aeronavtika - Sistemi vodenja kakovosti - Ocenjevanje, ki se uporablja v vzdrževalnih organizacijah (na podlagi ISO 9001:2000)Série aérospatiale - Systèmes de management de la qualité - Évaluation applicable aux organismes d'entretien (basé sur ISO 9001:2000)Luft- und Raumfahrt - Qualitätsmanagementsysteme - Audit für Wartungsfirmen (basiert auf ISO 9001:2000)49.020Letala in vesoljska vozila na splošnoAircraft and space vehicles in general03.120.10Vodenje in zagotavljanje kakovostiQuality management and quality assuranceICS:SIST EN 9111:2008en,fr,deTa slovenski standard je istoveten z:EN 9111:200501-junij-2008SIST EN 9111:2008SLOVENSKI
STANDARD
EUROPEAN STANDARDNORME EUROPÉENNEEUROPÄISCHE NORMEN 9111December 2005ICS 03.120.10; 49.020 English VersionAerospace series - Quality management systems - Assessmentapplicable to maintenance organizations (based on ISO9001:2000)Série aérospatiale - Systèmes de management de laqualité - Évaluation applicable aux organismes d'entretien(basé sur ISO 9001:2000)Luft- und Raumfahrt - Qualitätsmanagementsystems -Audit für Wartungsfirmen (basiert auf ISO 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 EuropeanStandard the status of a national standard without any alteration. Up-to-date lists and bibliographical references concerning such nationalstandards 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 translationunder the responsibility of a CEN member into its own language and notified to the Central Secretariat has the same status as the officialversions.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 STANDARDIZATIONCOMITÉ EUROPÉEN DE NORMALISATIONEUROPÄISCHES KOMITEE FÜR NORMUNGManagement Centre: rue de Stassart, 36
B-1050 Brussels© 2005 CENAll rights of exploitation in any form and by any means reservedworldwide for CEN national Members.Ref. No. EN 9111:2005: E
Maintenance Organizations Quality System Questionnaire.12 Annex B (normative)
Systems audit scoring.47 Bibliography.50
MAINTENANCE ORGANIZATIONS – Quality System Questionnaire associated to the International Quality Management System Standard EN 9110 (based on ISO 9001:2000) • Annex
Documents regarding the company: - Organization charts, - Copies of agreements and certifications .
ASSESSMENT REPORT Standards 9110/9111 Assessing company logo GENERAL ASSESSMENT INFORMATION 1
Maintenance Organization & Work Address Company Name: Tel Number:
Fax Number: Subsidiary of: e-mail: Organization Identification: CAGE code: Assessed Site Address: Assessment Representative & Title:
Quality Manager Representative & Title:
Main activities:
Product Types or Codes:
ISO Registration [
] ISO Registered Registrar Name: [
] ISO Standard / Revision Expiration Date (If applicable): [
] Aerospace Standard / Revision
Assessment Team Lead Assessor Name: Other Assessor Team Members: [
] Certified Auditor – Type & No.
[
] Qualified Auditor
Assessment Dates: 5
Assessment Scope [
] Total facility assessed [
] Initial assessment [
] All 9110 elements assessed [
] Partial facility assessed [
] Re-assessment [
] Partial 9110 elements assessed [
] Other: Elements not assessed: [
] Activity
assessed:
Assessment Disposition 7
Scoring [
] Conforming Scoring result: [
] Conforming with minor (mi) corrective action
[
] Nonconforming with Major (MA) corrective action
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 __________
ASSESSMENT REPORT Assessing company logo ASSESSMENT CONCLUSIONS (To be completed in English) General comments about the organization and the quality system of the assessed organization: Strong points: Improvement Opportunities:
ASSESSMENT REPORT Assessing company logo GENERAL ORGANIZATION INFORMATION 1
Legal and Financial Aspects ˆ Date of Formation: ˆ Legal Status: ˆ Capital: ˆ Other Data:
Third Prior Financial Year (
) Second Prior Financial Year (
) First Prior Financial Year (
) Current Financial Year (
) Sales
Earnings
Earnings used for Re-Investment
Workforce
Turnover breakdown and main Customers Activities Main Customers Sales Percentage Aircraft, Space and Defence Industry
Other Activity (be specific)
Clearances or Approvals granted by Authorities Name of the Authority Types and References End of Validity (date)
ASSESSMENT REPORT Assessing company logo ASSESSMENT RESULT SUMMARY Organization: Result Elements* (EN 9110 – 9111) S Ma mi N/AObservation / Corrective Action Request Number(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:
Rep’s name: Signature: Results Assessing Company:
Lead Assessor Name: 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
ASSESSMENT SCORING (Member logo) Organization: Result Major CAR or minor CAR on Key requirement Minor CAR on non Key requirement NO CAR RESULT
SCORING CHART Standards 9110/9111 Multiple findings Single finding Multiple findings Single finding
4 Quality management system (Max. 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 (Max. 150)
5.1 Management commitment 5.2 Customer focus 5.3 Quality policy 0 5 15 20 30
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 (Max. 100)
6.1 Provision of resources 6.2 Human resources 0 10 25 40 50
6.3 Infrastructure 6.4 Work environment 0 10 25 40 50
7 Product realization (Max.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 D& D Planning 0 5 15 20 30
7.3.2-3-4 Inputs, outputs & review 0 5 15 20 30
7.3.5-6 D&D 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 provision0 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 (Max. 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
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:
CORRECTIVE ACTION REQUEST (C.A.R.) Assessing company logo Organization: Identification C.A.R. No.: Site: Date issued: Reference Standard: Referenced Standard Element concerned: Criticality MA / mi Non-Conformance Description
Assessor Name: Assessor Signature: Assessed Organization to complete the Corrective Action Request with root cause analysis, corrective action and planned completion date of corrective action, and return to the assessing Company by due date. Due date: Action No.: Root Cause: Action No.: Corrective Action: Planned completion date of Corrective 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:
Yes
ˆ
No
ˆ Assessor Name: Assessor Signature:
List of Recommendations/Observations/Comments Assessing company logo Organization: Audit report number: Site: Issued date:
Item Number Section Description
Lead Assessor Name: Signature:
Maintenance Organizations Quality System Questionnaire associated to the International Quality Management System Standard EN 9110 (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 9110 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 EN 9110 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, 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
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