SIST EN 9101:2015

2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.Série aérospatiale - Systèmes de management de la Qualité - Exigences d’Audits pour les Organisations de l'Aéronautique, l'Espace et la DéfenseQuality Management Systems - Audit Requirements for Aviation, Space, and Defence Organisations49.020Letala in vesoljska vozila na splošnoAircraft and space vehicles in general03.120.10Vodenje in zagotavljanje kakovostiQuality management and quality assuranceICS:Ta slovenski standard je istoveten z:FprEN 9101 revkSIST FprEN 9101:2015en,fr,de01-februar-2015kSIST FprEN 9101:2015SLOVENSKI
STANDARD



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EUROPEAN STANDARD NORME EUROPÉENNE EUROPÄISCHE NORM
FINAL DRAFT
FprEN 9101 rev
December 2014 ICS
Will supersede EN 9101:2011English Version
Quality Management Systems - Audit Requirements for Aviation, Space, and Defence Organisations
Série aérospatiale - Systèmes de management de la Qualité - Exigences d'Audits pour les Organisations de l'Aéronautique, l'Espace et la Défense
This draft European Standard is submitted to CEN members for formal vote. It has been drawn up by the Technical Committee ASD-STAN. If this draft becomes a European Standard, 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.
This draft European Standard was established by CEN 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-CENELEC Management Centre has the same status as the official versions.
CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United Kingdom.
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Warning : This document is not a European Standard. It is distributed for review and comments. It is subject to change without notice and shall not be referred to as a European Standard.
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B-1000 Brussels © 2014 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. FprEN 9101 rev:2014 EkSIST FprEN 9101:2015



FprEN 9101:2014 (E) 2 Contents Page Foreword . 4 RATIONALE . 5 FOREWORD . 5 Introduction . 6 0.1 General . 6 0.2 Auditing approach . 6 0.3 Audit records and reports . 6 REQUIREMENTS . 7 1 Scope . 7 1.1 General . 7 1.2 Application . 7 2 Normative references . 7 3 Terms and definitions . 8 4 Auditing and reporting . 9 4.1 General . 9 4.1.1 Audit process . 10 4.1.2 Audit approaches . 12 4.1.2.1 Customer focus . 12 4.1.2.2 Organisational leadership. 12 4.1.2.3 Quality management system performance and effectiveness. 12 4.1.2.4 Process management . 13 4.1.2.5 Special processes . 14 4.1.2.6 Continual improvement . 14 4.1.3 Reporting . 14 4.2 Common audit activities . 15 4.2.1 Audit planning . 16 4.2.2 Conducting on-site audits . 17 4.2.2.1 General . 17 4.2.2.2 Conducting the opening meeting . 17 4.2.2.3 Site tour . 18 4.2.2.4 Audit conduct . 18 4.2.2.5 Identifying and recording of audit findings . 18 4.2.2.5.1 Process results . 19 4.2.2.5.2 Process realisation . 19 4.2.2.5.3 Process effectiveness . 19 4.2.2.6 Preparing audit conclusions . 19 4.2.2.7 Conducting the closing meeting . 20 4.2.3 Audit report . 20 4.2.4 Nonconformity management . 21 4.3 Audit phase specific requirements . 22 4.3.1 Pre-audit activities . 22 4.3.1.1 Application . 22 4.3.1.2 Application Review . 22 4.3.1.2.1 Requirements for the Certification Body . 22 4.3.1.2.2 Requirements for the audit team leader . 23 4.3.2 Stage 1 Audit . 23 4.3.2.1 General . 23 4.3.2.2 Collection of information . 23 4.3.2.3 Review of the organisation . 24 kSIST FprEN 9101:2015



FprEN 9101:2014 (E) 3 4.3.2.4 Stage 1 conclusions . 25 4.3.3 Stage 2 audit . 26 4.3.4 Surveillance audit . 26 4.3.5 Recertification audit . 27 4.3.6 Special audit . 27 5 Notes . 27
Appendices Appendix A (informative)
ACRONYM LOG . 28 Appendix B (normative)
FORMS . 29
Figures and Tables Figure 1 — OVERVIEW OF AUDIT PROCESS FLOW . 11 Table 1 — CERTIFICATION STRUCTURE REPORTING MATRIX . 15 Table 2 — RELATIONSHIP BETWEEN COMMON ACTIVITIES AND AUDIT PHASES . 16 Table 3 — PROCESS EVALUATION MATRIX. 20
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FprEN 9101:2014 (E) 4 Foreword This document (FprEN 9101:2014) 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 document is currently submitted to the Formal Vote. This document will supersede EN 9101:2011. kSIST FprEN 9101:2015



FprEN 9101:2014 (E) 5 RATIONALE This standard has been revised to incorporate the requirements for accredited Certification Bodies (CBs) introduced by International Organisation for Standardisation (ISO) / International Electrotechnical Commission (IEC) 17021:2011, 9104/1:2012, and inputs received from industry stakeholders associated to process-based auditing methods and the evaluation of process effectiveness.
FOREWORD To assure customer satisfaction, aviation, space, and defence organisations must produce and continually improve safe reliable products that meet or exceed customer and applicable statutory/regulatory requirements. The globalisation of the industry and the resulting diversity of regional and national requirements and expectations have complicated this objective. Organisations have the challenge of purchasing products from suppliers, at all levels of the supply chain, throughout the world. Suppliers have the challenge of delivering products to multiple customers having varying quality requirements and expectations. Industry established the International Aerospace Quality Group (IAQG), with representatives from companies in the Americas, Asia/Pacific, and Europe, to implement initiatives that make significant improvements in quality and reductions in cost throughout the value stream. This document has been prepared by the IAQG and standardises the requirements for conducting and reporting of Quality Management System (QMS) audits. It can be used by aviation, space, and defence organisations at all levels throughout the global supply chain. It provides requirements for an audit and reporting process, based on: • the process and continual improvement approach defined in 9100-series standards; • the specific aviation, space, and defence additions in 9100-series standards; • the use of common audit tools; and • the uniform, transparent, and standardised reporting of audit results. In this standard, the word “shall” indicates a requirement and the word “should” a recommendation to meet the intent of the standard. Words “typical”, “example”, or “e.g.” indicate suggestions given for guidance. Information marked “NOTE” is for guidance in understanding or clarifying the associated requirement.
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FprEN 9101:2014 (E) 6 Introduction General Auditing is a basic tool to assess effective implementation of and conformity to QMS requirements. In addition to the determination of conformity, this standard focuses on the evaluation of effectiveness (see ISO 9000 subclause 3.2.14) of the QMS and its associated processes. An organisation is not only required to be in conformity with QMS requirements, but to be effective in meeting customer expectations and delivering products that meet those expectations. Additionally, this standard takes into account the new requirements presented in the 2009 revisions of the 9100-series standards [e.g., critical items, special requirements, On-time Delivery (OTD) performance, risk management, project management]. Auditing approach This standard supports the engagement and evaluation of an organisation’s QMS process approach, as required by the 9100-series standards. When evaluating an organisation’s QMS, there are basic questions that should be asked of every process, for example: a) Is the process identified and appropriately defined? b) Are responsibilities assigned? c) Are the processes adequately implemented and maintained? d) Is the process effective in achieving the desired results? The collective answers to these and other associated questions will contribute to the evaluation results. In addition, product quality (as delivered), customer satisfaction, and QMS effectiveness can be considered as interrelated. This relationship should be reflected in the audit process and associated results. Audit records and reports This standard defines the audit records and reports to be generated, during the audit process. They are critical in providing the organisation and its’ customers with objective evidence on the conformity and effectiveness of the QMS (including process effectiveness), and reporting the audit results in a standard format/structure.
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FprEN 9101:2014 (E) 7 1. Scope 1.1 General This standard defines requirements for the preparation and execution of the audit process. In addition, it defines the content and composition for the audit reporting of conformity and process effectiveness to the 9100-series standards, the organisation’s QMS documentation, and customer and statutory/regulatory requirements. The requirements in this standard are additions or represent changes to the requirements and guidelines in the standards for conformity assessment, auditing, and certification as published by ISO/IEC (i.e., ISO/IEC 17000, ISO/IEC 17021). When there is conflict with these standards, the requirements of the 9101 standard shall take precedence. NOTE 1 In this standard, the term “9100-series standards” comprises the following Aerospace Quality Management System (AQMS) standards: 9100, 9110, and 9120; developed by the IAQG and published by various national standards bodies. NOTE 2 In addition to this standard, the IAQG publishes deployment support material on the IAQG website (see http://www.sae.org/iaqg/) that can be used by audit teams, when executing the audit process. 1.2 Application This standard shall be used for audits of 9100-series standards by CBs for certification of organisations, under the auspices of the aviation, space, and defence industry certification scheme [also known as Industry Controlled Other Party (ICOP) scheme]. The ICOP scheme requirements are defined in the 9104-series standards (i.e., 9104/1, 9104/2, 9104/3). NOTE Relevant parts of this standard can be used by an organisation in support of internal audits (1st party) and external audits at suppliers (2nd party). 2. Normative references The following documents, in whole or in part, are normatively referenced in this document and are indispensable for its application. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.
EN 9100*, Quality Management Systems — Requirements for Aviation, Space and Defence Organisations EN 9102*, Aerospace series — Quality systems — First article inspection EN 9104-001*, Aerospace series — Quality management systems — Part 001: Requirements for Aviation, Space, and Defence Quality Management System Certification Programs EN 9104-002*, Aerospace series — Quality management systems — Part 002: Requirements for Oversight of Aerospace Quality Management System Certification/Registrations Programs EN 9104-003*, Aerospace series — Quality management systems — Part 003: Requirements for Aerospace Quality Management System (AQMS) — Auditor Training and Qualification EN 9110*, Quality Management Systems — Requirements for Aviation Maintenance Organisations
* As developed under the auspice of the IAQG and published by various standards bodies [e.g., SAE International, European Committee for Standardisation (CEN), Japanese Standards Association/Society of Japanese Aerospace Companies (JSA/SJAC), Brazilian Association for Technical Norms (ABNT)]. kSIST FprEN 9101:2015



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EN 9115*, Quality Management Systems — Requirements for Aviation, Space and Defence Organisations — Deliverable Software (Supplement to EN 9100) EN 9120*, Quality Management Systems — Requirements for Aviation Space and Defence Distributors EN 9131*, Aerospace series — Quality Management Systems — Nonconformance Data Definition and Documentation IAF MD 2:2007, IAF Mandatory Document for the Transfer of Accredited Certification of Management Systems IAF MD 3:2008, IAF Mandatory Document for Advanced Surveillance and Recertification Procedures IAF MD 4:2008, IAF Mandatory Document for the Use of Computer Assisted Auditing Techniques (“CAAT”) for Accredited Certification of Management Systems IAQG Procedure 119, Forms Management ISO 9000:2005, Quality management systems — Fundamentals and vocabulary ISO/IEC 17000:2004, Conformity assessment — Vocabulary and general principles ISO/IEC 17021:2011, Conformity assessment — Requirements for bodies providing audit and certification of management systems 3. Terms and definitions For the purpose of this standard, the terms and definitions provided in ISO 9000, ISO/IEC 17000, 9100-series standards, 9104/1 standard, and the following apply. Furthermore, an acronym log for this standard is presented in Appendix A. 3.1 containment action to control and mitigate the impact of a nonconformity and protect the customer's operation (stop the problem from getting worse); includes correction, immediate corrective action, immediate communication, and verification that the nonconforming situation does not further degrade 3.2 Key Performance Indicator (KPI) measures associated with goals or targets showing how well an organisation is achieving its’ objectives or critical success factors for a particular project. KPIs are used to objectively define a quantifiable and measurable indication of the organisation’s progress towards achieving its goals. 3.3 major nonconformity a non-fulfilment of a requirement which is likely to result in the failure of the QMS or reduce its ability to assure controlled processes or compliant products/services; it can be one or more of the following situations: • a nonconformity where the effect is judged to be detrimental to the integrity of the product or service; • the absence of or total breakdown of a system to meet a 9100-series standard requirement, an organisation procedure, or customer QMS requirement; • any nonconformity that would result in the probable shipment of nonconforming product; and • a condition that could result in the failure or reduce the usability of the product or service and its intended purpose. kSIST FprEN 9101:2015



FprEN 9101:2014 (E) 9 3.4 Minor nonconformity a non-fulfilment of a requirement which is not likely to result in the failure of the QMS or reduce its ability to assure controlled processes or compliant products/services; it can be a single system failure or lapse in conformance with one of the following conditions: • a 9100-series standard requirement; • a customer QMS requirement; or • a procedure associated to the organisation’s QMS. Note 1 to entry: A number of minor nonconformities against one requirement (e.g., similar nonconformities associated to different sites or different departments/functions/processes within a single site) can represent a total breakdown of the system and thus be considered a major nonconformity. 3.5 Nonconformity Report (NCR) a document stating results and providing objective evidence of nonconformity against audit criteria, including the following information: containment, correction, root cause, corrective action implementation, and closure 3.6 Online Aerospace Supplier Information System (OASIS) Web-based IAQG database containing information on participating IAQG member companies, National Aerospace Industry Associations (NAIA), National Accreditation Bodies (NAB), accredited CBs, authenticated Aerospace Experience Auditors (AEAs), Aerospace Auditors (AAs) certified suppliers, certificates, and audit results. 3.7 planned activities the means, methods, and internal requirements by which the organisation intends to achieve planned results of a given process to meet customer requirements. Planned activities include conformity to process requirements and procedures. 3.8 planned results the intended performance of a process, as defined and measured by the organisation. Planned results include product conformity and OTD to meet customer requirements, and may include other elements related to the process, as defined by the organisation. 3.9 Process Effectiveness Assessment Report (PEAR) a document stating process evaluation results; providing evidence of conformity to requirements and process effectiveness 4. Auditing and reporting The audit and reporting process established to assess conformity, including the determination of QMS effectiveness to the 9100-series standards, shall meet the requirements of ISO/IEC 17021, as stated in each relevant clause of this standard. Additional audit requirements for the aviation, space, and defence industry are invoked by this standard. For combined and integrated audits, the requirements of 9104/1 subclause 8.2.3 apply. 4.1 General The audit process and associated activities (see subclause 4.1.1) shall be followed when auditing and certifying organisations to AQMS standards in the aviation, space, and defence industry. kSIST FprEN 9101:2015



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The audit process requirements consist of three main parts: a) the phases of the audit process (see subclause 4.1.1); b) the common activities (see subclause 4.2) that shall be used to support the audit phases; and c) the specific requirements for each audit phase (see subclause 4.3). 4.1.1 Audit process The audit process consists of the following phases (see Figure 1): a) Pre-audit activities (see subclause 4.3.1); b) Stage 1 audit (see subclause 4.3.2); c) Stage 2 audit (see subclause 4.3.3); d) Surveillance audit (see subclause 4.3.4); and e) Recertification audit (see subclause 4.3.5).
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Figure 1 — Overview of audit process flow (see ISO/IEC 17021 – Figure E.1) kSIST FprEN 9101:2015



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Pre-audit activities and Stage 1 / Stage 2 audits are applicable for initial certification. A Stage 1 audit can also be utilised for recertification audits and during CB transfer. NOTE 1 Although ‘Special Audit’ is not listed as a part of the audit program, it can be applicable after initial certification, when directed by special request. The requirements for special audits are addressed in subclause 4.3.6. NOTE 2 The requirements for certification are defined by the 9104/1 standard. 4.1.2 Audit approaches The following approaches (see subclauses 4.1.2.1 thru 4.1.2.6) shall be used, as appropriate, to conduct each on-site audit. 4.1.2.1 Customer focus The audit team shall determine that customer satisfaction is being evaluated and appropriate actions are taken by the organisation based on available performance information (e.g., nonconformity data, corrective action requests, results of satisfaction surveys, complaints regarding product quality, OTD, service provision, responsiveness to customer and internal requests) provided by the organisation’s customers (e.g., scorecards, report cards). 4.1.2.2 Organisational leadership There shall be an interview(s) with top management to evaluate the: a) establishment and continued relevance of the organisation’s quality policy and objectives; b) establishment of performance measures aligned to quality objectives; c) QMS development, implementation, and continual improvement; d) top management commitment; e) QMS performance and effectiveness; f) performance to customer expectations (e.g., supplier rating, scorecard, audit results); and
g) actions taken to address issues that are not meeting customer performance expectations. 4.1.2.3 Quality management system performance and effectiveness The audit of QMS performance and effectiveness shall include a review of the following: a) the processing of customer complaints, customer feedback data (e.g., periodic performance reports received from customers), and other relevant customer data (e.g., results of customer surveys); b) results and actions from internal and external audits of the QMS, including their associated records; c) stakeholder feedback (e.g., feedback from regulatory authorities or other interested parties); d) the processing of process/product nonconformities, including review of associated corrective actions and evaluation on the effectiveness of actions taken; e) the processing of preventive actions, including evaluation on the effectiveness of actions taken; kSIST FprEN 9101:2015



FprEN 9101:2014 (E) 13 f) management review conduct, including associated records (e.g., process inputs/outputs, actions taken); g) internal performance monitoring, measurement, reporting, and reviews against stakeholder and internal performance objectives and targets, including continual improvement activities and associated records; h) the organisation’s current performance against targets, including customer specific targets and associated records of applicable actions taken where targets are not being met; and i) the status and effectiveness of the organisation’s process performance improvement activities and their outcomes related to product quality. 4.1.2.4 Process management The audit team shall conduct QMS audits using a method that focuses on process performance and effectiveness; this ensures that priority is given to the following: a) reviewing the organisation’s processes, their sequence and interactions, the identification of functions and assignment of responsibilities, and performance against requirements and defined measures, with focus on processes that directly impact the customer; b) review
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