SIST EN 9111:2008
(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 Wartungsfirmen (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
Relations
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
EN 9111:2005 (E) 2 Contents Page Foreword.3 1 Purpose.4 2 Quality System Assessment Report content.4 Annex A (normative)
Maintenance Organizations Quality System Questionnaire.12 Annex B (normative)
Systems audit scoring.47 Bibliography.50
EN 9111:2005 (E) 3 Foreword This European Standard (EN 9111:2005) 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 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.
EN 9111:2005 (E) 4 1 Purpose The purpose of this standard is to define the content and the presentation of the Assessment Report of the EN 9110 (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
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 .
EN 9111:2005 (E) 5
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:
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 9110 elements assessed [
] Partial facility assessed [
] Re-assessment [
] Partial 9110 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 __________
EN 9111:2005 (E) 6
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:
EN 9111:2005 (E) 7
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
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)
EN 9111:2005 (E) 8
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
EN 9111:2005 (E) 9
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:
EN 9111:2005 (E) 10
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:
EN 9111:2005 (E) 11
List of Recommendations/Observations/Comments Assessing company logo Organization: Audit report number: Site: Issued date:
Item Number Section Description
Lead Assessor Name: Signature:
EN 9111:2005 (E) 12 Annex A (normative)
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 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 16 is considered as a key requirement. 16 Does the output from the management review include any decisions and actions related to : 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? M
EN 9111:2005 (E) 13 In the second example below only part of question 03, i.e. d) is considered Key Requirement. 03 In planning product realization, does the organization determine the following, as appropriate: a) Quality objectives and requirements for the product? b) the need to establish processes, documents, and provide resources specific to the product? c) required verification, validation, monitoring, inspection and test activities specific to the product and the criteria for product acceptance? d) records needed to provide evidence that the realization processes and resulting product meet requirements (see 4.2.4)? e) the identification of resources to support operation and maintenance of the product?
P
Guidance notes: Under Key requirements column 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 51 part a). 51 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
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 9110 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 9110 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 9110 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 the Quality System Questionnaire the 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. ¾ 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 ¾ 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 = 10), or
EN 9111:2005 (E) 14 ¾ 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 = 25), or ¾ 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 = 40), or ¾ If, no CAR in a section, e.g. 4.1 General Requirements then score in “NO CAR” column (result = 50) ¾ When a single finding occurred on several questions affecting the same section of the scoring table( e.g. 4.2 & 4.3 or 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, where audit review comprises whole Quality System Questionnaire
or, 880, where audit review comprises Quality System Questionnaire less Design and Development. In this case, the final score = 880100TOTAL× 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: Score = score possible maximum of Sum100TOTAL× The higher the score the greater the level of compliance acknowledged by the audit activity.
EN 9111:2005 (E) 15 Summary
Section headings Page numbers 4 Quality management system
16 4.1 General requirements 16 4.2 Documentation requirements 17 4.3 Configuration management 19 5 Management responsibility 20 5.1 Management commitment 20 5.2 Customer focus 20 5.3 Quality policy 20 5.4 Planning 20 5.5 Responsibility, authority and communication 21 5.6 Management review 21 6 Resource management 23 6.1 Provision of resources 23 6.2 Human resources 23 6.3 Infrastructure 24 6.4 Work environment 24 7 Product realization 25 7.1 Planning of product realization 25 7.2 Customer-related processes 25 7.3 Design and development 27 7.4 Purchasing 31 7.5 Production and service provision 34 7.6 Control of monitoring and measuring devices 39 8 Measurement, analysis and improvement 40 8.1 General 40 8.2 Monitoring and measurement 40 8.3 Control of nonconforming product 44 8.4 Analysis of data 45 8.5 Improvement 46
EN 9111:2005 (E) QUALITY SYSTEM QUESTIONNAIRE ASSESSMENT QUESTIONS KEY Requirements S CAR Number Ma or mi N/A N/E
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 4 Quality management system 4.1 General requirements 01 Has the organization established, documented, implemented and maintained a quality management system and provided for the continuous improvement of its effectiveness in accordance with the requirements of this Standard?
02 Has the organization obtained and maintained
required quality management system approvals and or any other approvals certificates, ratings, licenses ant permits required by the responsible Authority (1)? M
03 Does the organization: a) identify the processes needed for the quality management system and their application throughout the organization (2)? b) determine the sequence and interaction of these processes (2)? 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?
04 Are these processes managed by the organization in accordance with the requirements of this Standard?
05 Where an organization chooses to outsource any process that affects product conformity with requirements, does the organization ensure control over such processes? P
06 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) Copies of valid approvals and associated ratings 2) Main processes formally identified in maintenance activities (capability management, documentation, training, release to service…)
Objective evidence assessed / Observations / Comments / N/A explanation
EN 9111:2005 (E) QUALITY SYSTEM QUESTIONNAIRE ASSESSMENT QUESTIONS KEY Requirements S CAR Number Ma or mi N/A N/E
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 4.2 Documentation requirements 4.2.1 General 07 Does the quality management system documentation include:
a) documented statements of a quality policy and quality objectives (1)? 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 Authorities, as well as the standards to which the organization intends to work?
08 Does the organization ensure that personnel have access to quality management system documentation and are aware of relevant procedures (2)?
09 Do Customer and/or regulatory Authority representatives have access to quality management system documentation (3)?
Guidance Note 1) Yearly objectives (current and previous year) 2) Formalized issue (information notice to the personnel or meeting report) 3) Customer and/or regulatory Authority audit report
Objective evidence assessed / Observations / Comments/ N/A explanation
EN 9111:2005 (E) QUALITY SYSTEM QUESTIONNAIRE ASSESSMENT QUESTIONS KEY Requirements S CAR Number Ma or mi N/A N/E
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 18 4.2.2 Quality manual 10 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. (See 1.2)? 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?
Notes 1,2,3 applicable to section 4.2.1 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. Note 3 : The documentation can be in any form or type of medium. 4.2.3 Control of documents 11 Are the documents required by the quality management system controlled? M
12 Are records controlled according to the requirements given in 4.2.4?
13 Has a documented procedure been established to define the controls needed to (4): 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?
14 Does the organization coordinate document changes with customers and/or regulatory authorities in accordance with contract or regulatory requirements (5)? P
Guidance Note 1) Quality manual reference and/or maintenance exposition manual and issues for the different documentation (refer to note 2 for auditing) 2) Check the procedure list and documented procedure for maintenance activities 3) International standard used as referential 4) Examined procedures and applications for - Customer documents (STC, Engineering Order, maintenance program…) - Authorities ( AD’s
regulation …) - Manufacturer/OEM ( CMM, AMM, TO, SB, SL…) - Maintenance organization ( issued procedures, work package…) 5) Check latest or applicable version used by supplier for maintenance data (AD’s,SB,CMM,AMM, …) DON’T ALWAYS USE LATEST VERSION
Objective evidence assessed / Observations / Comments/ N/A explanation
EN 9111:2005 (E) QUALITY SYSTEM QUESTIONNAIRE ASSESSMENT QUESTIONS KEY Requirements S CAR Number Ma or mi N/A N/E
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 19 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 (1)?
17 Has a documented procedure been established to define the controls needed for the identification, storage, protection, retrieval, retention time and disposition of records (2)?
18 Does the documented procedure define the method for controlling records that are created by and/or retained by suppliers (3)?
19 Are records available for review by customers and regulatory authorities in accordance with contract or regulatory requirements?
4.3 Configuration management 20 Has the organization established, documented and maintained a configuration management process appropriate to the product? P
Guidance Note 1) List records reviewed and check the back-up procedures when records are stored in electronic form
2) List of examined procedures 3) Examined examples related to the maintenance activities
Objective evidence assessed / Observations / Comments/ N/A explanation
EN 9111:2005 (E) QUALITY SYSTEM QUESTIONNAIRE ASSESSMENT QUESTIONS KEY Requirements S CAR Number Ma or mi N/A N/E
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 20 5 Management responsibility 5.1 Management commitment 01 Has Top management provided evidence of its commitment to the development and implemen-tation of the quality management system and continually improving its effectiveness by (1): a) communicating to the organization the importance of meeting customer as well as statutory and regulatory requirements? b) establishing the quality policy? c) ensuring that quality objectives are established? d) conducting management reviews? and e) ensuring t
...
Questions, Comments and Discussion
Ask us and Technical Secretary will try to provide an answer. You can facilitate discussion about the standard in here.