Final Version International Aerospace Quality Group IAQG Document 104 27 June 2001 WG1/40/01 Requirements for Aerospace Supplier Quality System Certification / Registration schemes for use by the IAQG Sectors Foreword In December 1998, the Aerospace Industry has established the International Aerospace Quality Group (IAQG) with the purpose of achieving significant improvements in quality and reductions in cost throughout the value stream. The IAQG has developed specific requirements for quality systems that are to be implemented and maintained throughout the supply chain in the manufacture of products used in aviation and space applications. These requirements are published simultaneously as AS/EN/JIS 9100-series by SAE in the USA, AECMA in Europe and JIS Q in Japan. Other countries will follow with technical identical national standards. In this document these standards will be indicated as 9100. A further initiative of the IAQG was the development of a truly global scheme for the use of assessment results performed by certification bodies/registrars, based on the these 9100 series standards and taking into account the schemes already in use or under development in the various IAQG sectors. All these schemes are have two major elements in common: - use of a voluntary certification/registration scheme with specific aerospace elements and requirements, under the supervision and control of the aerospace industry - a harmonised approach to the certification bodies/registrars. and with the purpose to improve the quality level and control throughout the whole supply chain. This procedure provides requirements for sectorial/regional schemes for the controlled use of assessment results of certification bodies/registrars, based on three fundamentals: - the use of approved certification bodies/registrars - the use of qualified and approved auditors - the use of international aerospace standards for quality management systems in aerospace industry This procedure addresses the following issues: a) qualification and accreditation of certification bodies/registrars b) assessment of quality systems by accredited certification bodies/registrars c) the principles for determining the content and duration of assessments d) reporting and control of non-conformity e) the form of registration recommendations f) minimum standards of qualification and experience for aerospace auditors employed by certification bodies/registrars g) authentication of auditors by certification bodies/registrars, Accreditation Bodies and the IAQG sectors DRAFT 30 th May 19 4 2 March Jan. 2001... [1] Requirements Guidelines for Aerospace... [2] Certification/Regi... [3] Assessments and... [4] in Application use by the IAQG S s ectors to recognise... [5]... [6] S AC... [7] SJAC (Internatinal... [8]... [9] : Numeración y... [10]... [11] Sharing of supplier... [12] This procedure... [13]... [14] bined and, harmonised... [15] guidelines : Numeración y... [16] the assessment of approval / : Numeración y... [17]... [18] : Numeración y... [19]
CONTENTS 1.0 SCOPE 3 2.0 PURPOSE 3 2.1 References 3 3.0 DEFINITIONS 3 4.0 GENERAL 4 5.0 REQUIREMENTS FOR ACCREDITATION BODIES 5 6.0 REQUIREMENTS FOR CERTIFICATION BODIES / REGISTRARS 5 7.0 REQUIREMENTS FOR AUDITORS 6 7.1 Auditors 6 7.2 Aerospace Experience Auditors 7 7.3 Continuing Qualification and Education 8 8.0 REQUIREMENTS FOR ASSESSMENT AND REPORTING 8 8.1 Aerospace Assessment Teams 8 8.2 Duration of Assessment 9 8.3 Non-Conformity 9 8.4 Audit Team Conclusions and Reporting 9 8.5 Surveillance and Re-assessments 10 8.6 Registration 10 9.0 AUTHENTICATION AND OVERSIGHT OF ACCREDITATION BODIES; 10 CERTIFICATION BODIES / REGISTRARS; AND AUDITORS 10.0 RECORDS 11 11.0 FEE 11 12.0 PROCEDURE RESPONSIBILITY 11 Salto de página Section 1. Scope Section 2. References Section 3. Definitions Section 4. General Section 5. Requirements for Accreditation Bodies Section 6. Requirements for Certification Bodies/Registrars Section 7. Requirements for Auditors 7.1 Qualified Auditors 7.2 Aerospace Experience Auditors Section 8. Requirements for Assessments and Reporting <#>Aerospace Assessment Teams <#>Duration of Assessment <#>Nonconformance <#>Audit Team Conclusions and Reporting <#>Surveillance and Reassessments <#>Registration Section 9. Authentication and Oversight of Registrars and Auditors Section 10. Requirements for Shared Audits by OEMs Section 11. Records Section 12. Fees Section 13. Procedure Responsibility 1.0 SCOPE 34 2.0 PURPOSE 34 2.1 REFERENCES 34 3.0 DEFINITIONS 45 4.0 GENERAL 56 5.0 REQUIREMENTS FOR ACCREDITATION BODIES 56 6.0 REQUIREMENTS FOR CERTIFICATION... [23] 2
1.0 SCOPE CC/40/01 These requirements are applicable to IAQG sector schemes when making use of Accreditation Bodies, Certification Bodies/Registrars and their auditors, for the assessment and certification/registration of supplier quality systems in accordance with the requirements of this document. The quality management system standard shall be 9100 and shall be applied to the supplier s complete Quality System that covers aerospace products. Sectors may use these requirements for other standards. 2.0 PURPOSE The purpose of this procedure is to give requirements on the process for providing aerospace companies and their suppliers with assessment and certification/registration of their quality systems, by accredited certification bodies/registrars. It will also provide requirements for OEM s auditing suppliers to 9100. 2.1 References Assessments will be based on the latest versions of the following quality systems standards and guidelines as appropriate. AS/EN/JIS 9100 Aerospace Standard Quality System Aerospace Model for Quality Assurance in Design, Development, Production, Installation and Servicing AS/EN/JIS 9101 Aerospace Standard Quality System Assessment ISO 8402 Quality Vocabulary ISO 9001:1994 Quality Systems Model for Quality Assurance in Design, Development, Production, Installation and Servicing ISO 9002:1994 Quality Systems Model for Quality Assurance in Production, Installation and Servicing ISO 9003:1994 Quality Systems Model for Quality Assurance in Final Inspection and Test ISO 9001:2000 Quality management systems - Requirements ISO 9004:2000 Quality management systems guidelines for performance improvements ISO 9004-1 Quality Management and Quality System Elements Guidelines ISO 10011-1 Guidelines for Auditing Quality Systems Auditing ISO 10011-2 Guidelines for Auditing Quality Systems Qualification Criteria for Quality System Auditors ISO 10011-3 Guidelines for Auditing Quality Systems Management of Audit Programmes ISO/IEC GUIDE 62 General Requirements for Bodies Operating Assessments and Certification / Registration of Quality Systems 3.0 DEFINITIONS For the purpose of this document the following definitions are used: 3.1 IAQG International Aerospace Quality Group A body of prime aerospace Original Equipment Manufacturers (OEMs). This group is chartered to develop common requirements for use by the aerospace industry for quality improvement. 3.2 Aerospace For the purpose of this procedure Aerospace is defined as the business of design, manufacture, overhaul, distribution and support of aerospace vehicles and engines, accessories and component parts, all ancillary and allied businesses including aerospace vehicle operations. : Numeración y Salto de página scheme / or - <sp><sp>it is also applicable for the use between OEM s that wish to utilise the results of assessments performed by one OEM s and shared with another. guidelines outline organizations EFERENCES AS9000 Aerospace Standard Aerospace Basic Quality System Standard Quality Systems Model for Quality Assurance in Design, Development, Production, Installation and Servicing Guidelines for Quality Systems Model for Quality Assurance in Design, Development, Production, Installation and Servicing EN 45012 / GUIDE 62 AIR5493 Aerospace Information Report Requirements for Approval of an Aerospace Quality Management Systems Auditor Training Course EA-7/01 European Accreditation guidelines on the application of EN 45012... [24]... [25] An 3
3.3 Aerospace Product Aerospace Product shall mean an aircraft, rotorcraft, guided weapon, spacecraft, other product designed to travel through the air, inside or outside the ground effect, or to travel outside the influence of the earth s atmosphere or major components of these products such as engines or major sub-systems or parts, appliances, equipment and materials as contained in these. 3.4 Auditor* An Auditor shall refer to a person that has met the requirements set forth in paragraph 7.1 of this document. Auditors conducting audits for OEMs in support of recognised audits at suppliers may be referred to as Aerospace Auditors provided they meet the OEM s requirements which are to be the same as or similar to paragraph 7.1. 3.5 Aerospace Experience Auditor* An Aerospace Experience Auditor shall refer to an auditor that has met the requirements set forth in paragraph 7.2 of this document. Auditors conducting audits for OEMs in support of recognised audits at suppliers may also be referred to as Aerospace Experience Auditors provided they meet the OEM s requirements which are to be the same as or similar to paragraph 7.2. 3.6 Sector Management Structure (SMS) The Sector Management Structure as used in this procedure is defined as the organisation established in a sector that manages the application of the sector scheme based on this procedure. Further description is in Section 9.0 of this document. Each sector may use a different name for this organisation, e.g. Registrar Management Committee in the US, Certification Body Management Committee within AECMA-EASE, ASCS Management Board in the UK. 3.7 Accreditation body A body recognised by an IAQG sector that has the primary responsibility for the accreditation of certification bodies/registrars to issue certifications / registrations to Quality Management Systems standards. 3.8 Certification body/registrar(s) A party that audits and registers the quality management system of organizations with respect to published quality management system standards and any supplementary documentation required under the system. The two terms are interchangeable. 3.9 IAQG Sector or sector A sub-structure of the IAQG, consisting of the members in a specific area, such as Americas, Europe and Asia. *Note: sectors may use other names for 'Auditor', Aerospace Auditor' and 'Aerospace Experienced Auditor' as long as the requirements of this documents are applied. 4.0 GENERAL 4.1 The requirements stated herein shall be based on the latest versions of the documents found in Section 2. 4.2 Aerospace unique requirements are listed in 9100 as boldface items. These elements are in addition to ISO 9001 elements and should also be applied in the organization s quality system. 4.3 Data (in the form of checklists, approvals or other company specific information) generated by this procedure shall be handled as confidential between the parties generating, collecting, or using the data. Companies using this data shall keep its usage confidential for internal use only. Qualified Qualified n auditor recognized shared z shared y. a Outside North America they are commonly referred to as certification bodies, in North America as rgistrars. [An alternative is to use 'Other party' throughout this whole document!!] : Numeración y e Qualified a Salto de página Elements to which particular attention [is this true?] should be given during assessment of aerospace companies both internally and externally. 4
However, this data may be subject to audit or review at any time by government or regulatory bodies. 5.0 REQUIREMENTS FOR ACCREDITATION BODIES Based on the situation in a sector (single or multiple accreditation bodies), the responsibilities and role of the accreditation bodies may vary. 5.1 Single accreditation Body. In case of a single body the responsibilities of the Accreditation Body shall be to review and recommend approval of the certification bodies/registrars to the requirements of this document. The Accreditation Body shall approve the use of marks and logos for use on certificates of approval. The Accreditation Body shall work with the IAQG-sector to give assurance that certification bodies/registrars continue to perform in a manner consistent with the requirements contained herein and in the IAQG-sector scheme. Accreditation Bodies that are signatories to the IAF (International Accreditation Forum) MLA (multi-lateral agreement) may also use this document to approve certification bodies/registrars with IAQG-sector approval. Accreditation Bodies shall be in conformance to ISO/IEC Guide 61 and IAF Guidance on ISO/IEC 61 (latest version). 5.2 Multiple Accreditation Bodies: In case of multiple accreditation bodies in a sector, the IAQG-sector may choose to review the certification bodies/registrars direct, without intermediate role of Accreditation Bodies. In that situation Certification bodies/registrars seeking recognition under this procedure shall have ISO9000-series accreditation in the aerospace sector by National Accreditation Bodies acceptable for that IAQG-sector. 6.0 REQUIREMENTS FOR CERTIFICATION BODIES / REGISTRARS 6.1 Certification bodies/registrars seeking qualification under the sectorial procedures based on these requirements must first be accredited in accordance with ISO/IEC Guide 62 and IAF Guidance on ISO/ IEC Guide 62 for ISO 9001and / or ISO 9002 for at least a year prior to submitting an application. As such, the certification body / registrar shall have been successfully assessed for conformance to ISO/IEC guide 62 and ISO 10011, Parts 1, 2, and 3. 6.2 Accreditation requirements shall include, among other things, evidence that the certification body/registrar s management committee or advisory group have person(s) with aerospace background and knowledge. A certification body/registrar may or may not already be approved by the accreditation body for the scope category of aerospace represented by Scope Sector 21 (NACE DM 35.3) (formerly U.S. SIC Code 372 and 376) in accordance with accreditation body procedures and requirements. The certification body/registrar shall have qualified auditors and/or technical experts engaged in registration activities. Requirements for certification bodies/registrars to obtain 9100 qualification shall include as a minimum: a. The certification body/registrar itself must use an auditor-training program that complies with detailed requirements per IAQG sector and records thereof for quality system requirements. Minimum content of these training program is: 9100 (the standard) 9101 (the assessment report and checklist) or equivalent The scheme as used in the specific sector for Registration of Quality Systems to 9100 (in the US AIR5359, in Europe AECMA-EASE Procedure 2.12, the UK TS 157) Additional sectorial training requirements Civil Aviation Authority requirements (Such as FAA Title 14 CFR Part 21, JAR 21 or equivalent per the national CAA) and applicable advisory material. b. Certification bodies/registrars shall document their auditor-training program and it shall be reviewed and approved by the accreditation body during the accreditation process b For the purposes of this document the Accreditation Body shall be considered to be ANSI-RAB for the U.S.A. unless changed by the AAQG. Other AAQG s accordance with. Accreditation Bodies must prepare an Application for completion and submission to the Accreditation Body by a certification body/registrar desiring to become 9100 qualified. This Application must incorporate the main principles of the sector scheme to provide the Accreditation Body with confidence that the certification body/registrar has developed the necessary documented process to meet the sector requirements. All information required by the Application must be appropriate and acceptable prior to submission of the certification body/registrar to the SMS... for [26] b EN9100[should be???] a y... [27] Salto de página... [28] guidelines registration body have auditor training 5
c. The certification body/registrar must utilize qualified auditors as defined in Section 7 of this document. The certification body/registrar audit team must meet the requirements of Section 8 of this document. d. The certification body/registrar must have the specific procedures, tools and techniques in its systems for performing audits at aerospace organizations per accreditation body and IAQG minimum requirements (e.g. 9100 and -9101 checklist, briefing notes, etc.) and section 8 of this document. e. The basis for accreditation body approval of certification bodies/registrars to 9100 may include an initial witness audit of a certification body/registrar team per the accreditation body(ies) operating procedures. f. The certification body/registrar agrees to periodic surveillance audits by the accreditation body(ies) and by IAQG sectors. Accreditation bodies, or in case of 5.2 the IAQG-sector, shall conduct annual Surveillance audits of certification bodies/registrars holding 9100 accreditation. IAQG member companies shall perform oversight of certification bodies/registrars used by their suppliers and report results to the sector management structure (SMS) as established in each sector. g. The certification body/registrar must agree to the Right of Access by IAQG member companies, accreditation body(ies) and other regulatory or Government bodies for the purpose of establishing that the correct criteria and methods were used in issuing organization approvals to 9100. This also includes information or records pertaining to accreditation body approval of the certification body/registrar. h. No certificates or approvals to 9100 or any combination of 9100 with ISO 9001 or 9002 shall be issued unless all major and minor non conformities have been satisfactorily corrected with the root cause analysis and corrective action verified by the certification body/registrar. i. The certification body/registrar must leave copies of all information pertaining to the audit results (including checklists, findings, supporting documents, or other correspondence) with the organization for the purpose of the organization sharing this information with their customers. j. No certification body/registrar shall be allowed to certify an organization to 9100 with whom the certification body/registrar or a related body has provided consulting services related to registration within the past two years. In addition, any individual who has, in the past two years, provided consulting services to an organization, shall have no involvement with the 9100 certification/registration of that organization. Where there might appear to be a conflict of interest, either through consulting or the offering of training to a potential client this shall be disclosed to the accreditation body and the sector management structure (SMS) prior to performing the registration process to determine if there is a conflict of interest. NOTE: If a certification body/registrar performs training for an organization for which it will provide registration services, the training must be conducted and managed separately from the certification body/registrar s certification/registration program. In addition any training of auditors for 9100 shall be conducted in accordance with sectorial schemes. 7.0 REQUIREMENTS FOR AUDITORS 7.1 Auditors shall or : Numeración y Qualified Auditors of Quality Systems shall, as a minimum, continually meet the education, training, work experience and audit experience of ISO 10011-1 & -2 and continually have the following: 6
a. Auditing Experience: To have participated in at least 4 audits for a minimum of 20 days, that cover all the elements of the ISO 9001 standard or the 9100 standard within the last 3 years and has the ability to cover all the elements of ISO 9001 as determined by the certification body/registrar s Audit Program Manager or equivalent. b. The Auditor must be trained in 9100 requirements. This training can be performed by the certification body/registrar or may be obtained independently. For the certification body/registrar, the training program shall be reviewed and approved by the Accreditation Body as part of the approval process. The 9100 training program shall also be in accordance with sectorial training requirements c. Continuing Qualification and Education: Per the certification body/registrar s requirements for maintenance of qualification, that includes the elements of 7.2 below, as necessary to maintain current knowledge (ref. 7.3 below). 7.2 Aerospace Experience Auditors Auditors that are to be considered, as Aerospace Experience Auditors must have 4 years aerospace industry experience, meet the requirements of 7.1 above and the following: 7.2.1 Work Experience: 4 years in the aerospace industry directly involved in Engineering, Design, Manufacturing, Quality or Process Control for a major airframe manufacturer, prime supplier, auxiliary equipment supplier and/or appropriate official civil, military or space organisation, such as NAA, ESA/NASA, MoD (the 4 years shall have been within the prior ten calendar years). The work experience should have included direct involvement or knowledge of the elements as defined in 7.2.2 below; or 7.2.2 If less than 4 years aerospace industry experience in the last 10 (or more than 6 consecutive years since last industry work experience from date the of application) the completion of an initial in-depth Aerospace Industry Competency course developed by the certification body/registrar or an independent organisation that has approval of the sectorial management structure, is required. The course shall include the following topics as a minimum: Aerospace Industry Quality Perspective Civil Aviation Authority Roles/ Responsibilities/Regulations Overview MoD/DCMA Roles / Responsibilities 1 st Production Article Inspection Airworthiness and safety requirements Design, Development, Verification and Validation Aerospace material traceability requirements Aerospace material accountability systems Aerospace subcontractor approval and control requirements Key / critical characteristic classification Quality requirements flow downs FOD program requirements Use of Customer supplied products Positive Recall System Stamp control Nonconforming material, system requirements and operation Sampling inspection requirements and limitations and 7.2.3 In addition to 7.2.2 the auditor must have participated in at least two full aerospace industry audit(s) within the past 3 years and have been witnessed by a previously qualified Aerospace Experienced Auditor or the Accreditation Body, who themselves have not certification body/registrar s guidelines of 7.. 3 2.1.1 3 (see Appendix... [30] B... [31].1 managent (AS/EN9102) : Numeración y... [32] (AS9103) 2.2.1 T... [29] 7
become qualified via training as per para 7.2.2. The auditor candidate must receive a positive and documented recommendation for qualification on all audits. Note: In exceptional circumstances applications for Aerospace Experienced Auditors who have not worked in the Aerospace Industry will be considered providing candidates can demonstrate adequate and relevant Aerospace knowledge and experience as per para s 7.2.2 and 7.2.3 If an auditor holds a current auditor certification under an existing accredited aerospace auditor procedure acceptable to the SMS not based on above requirements (e.g. Approval to SBAC TS 157 before January 2001) the requirements for an auditor shall be satisfied with the addition of the required 9100 training; 7.2.4 The following table represents a summary of the requirements for Aerospace Industry Auditors:- (7.2.3.1)..1 2.2. earlier plan requirements( OEM Auditor & Auditor(7.1) Aerospace Experienced Auditor (includes 7.1 & 7.2) All Auditors and Aerospace Experienced Auditors (7.2.3) Auditors are to be approved for ISO 9001 auditing per ISO 10011-2, -3 and trained per ISO 10011-1 General knowledge of IAS 9100 Standards Auditor training in industry standards and current industry requirements (6.2.a) 4 years of Aerospace work experience in the last 10 years (7.2.1) OR Industry experience & training on Aerospace Industry and two witness audits (7.2.2) Continuation Education for Auditors within every 3 years (7.3) Note: References in parentheses ( ) in the above diagram refer to this document. 7.3 Continuing Qualification and Education To maintain qualification all auditors and aerospace auditors must participate in at least 4 aerospace audits in 3 years and participate in continuing education in accordance with sectorial training requirements that requires review of the changes to the aerospace industry standards, auditing methods and ISO requirements at a minimum of 15 hours total within 3 years. 8.0 REQUIREMENTS FOR ASSESSMENT AND REPORTING 8.1 Aerospace Assessment Teams 8.1.1 The Assessment Team Leader, must be a qualified lead auditor per ISO 10011-1 & -2, as identified in the certification body/registrar s accredited system. The team shall include an Aerospace Experience Auditor (7.2) and be supported by other Auditors according to 7.1 as required. ation A ( Experienced and Qualified) every Salto de página Qualified 8
The assessment team must include an Auditor (7.1) qualified for the supplier s commodity(ies) and the team leader shall ensure that all members of the team are aware of the requirements of this document as may affect the scope of their assessment activity. Additionally the Aerospace Experience Auditor(s) shall provide guidance to the assessment team throughout the assessment on the interpretation of aerospace requirements and, when requested, the significance of any issues identified. The commodity requirement may be met by a technical expert in-lieu of an auditor that is additional to the team membership. 8.1.2 Regulatory Agency or Customer representatives or OEM s may accompany the assessment team as observers of the assessment process at any time. When Customer or Government representatives are participating in the audit, the Team Leader shall have the option of including (or not) in the assessment report any findings brought forward by these representatives. 8.2 Duration of Assessment 8.2.1 A 9100 qualified certification body/registrar is responsible for ensuring the continued integrity and validity of the certificates it issues and for drawing up and implementing a procedure to enable it to carry out this responsibility. 8.2.2 Requirements are to be established for minimum auditor-person days, both initial assessment and surveillance, appropriate to the size of the organization being assessed. For aerospace organizations these requirements may be varied to take into account the complexity of the quality system and the number and variety of activities, but the guidance in Annex 2 of the IAF guidance to ISO/IEC Guide 62 is to be used as minimum. 8.2.3 It is anticipated that the requirements of 9100 shall add on-site assessment, depending on size and commodity of the organization involved: The duration of an assessment shall be as agreed between the organization being assessed and the certification body/registrar, using ISO/IEC Guide 62 and IAF guidance as a minimum. 8.3 Non-conformity The assessment team shall record all non-conformities identified during an assessment. The team leader shall assign a non-conformity to the aerospace categories of Major or Minor. These are defined as: Major: Minor: The absence of, or total breakdown of a management element specified in the 9100 standard or any non-conformities where the effect is judged to be detrimental to the integrity of the product or service. A single system failure or lapse in conformance with a procedure relating to the 9100 standard. Note A number of minor non-conformities against one requirement can represent a total breakdown of the system and this can be considered as a major non-conformity. 8.4 Audit Team Conclusions and Reporting The Assessment Team leader shall present the audit report to the supplier's organization using the items listed in 9101 audit report requirements as a minimum, stating its conclusions on conformance and effectiveness of the quality system to the 9100 requirements. The 9100 audits shall be documented on the 9101-checklist (paper or electronic version). For surveillance, the team leader shall advise whether recorded non-conformities jeopardize an existing certificate. In the event that certification/registration is denied or suspended, an appropriate course of action shall be agreed between the organization and the registration body. Where there is a failure to agree on a course of action, the appropriate appeals procedure of the certification body/registrar may be invoked. a of the auditor which <#>All auditor members of the team are required to meet the requirement of Section 7.1 of this document. : Numeración y r An Guidelines s time of an organization in accordance with the following table Certified entity:... [33] Salto de página Nonconformance nonconformance nonconformance nonconformance nonconformance (s) 9
The certification body/registrar shall submit the summary results of the assessments performed to 9100 to a dedicated organisation(s) in each sector and this organisation shall make this information globally accessible through electronic means to members in each sector. The information shall include as a minimum: Certification Body / Registrars name, contact person, phone fax and / or e mail address Supplier name and address and locations involved in the assessment Scope of the activities assessed Type of assessment performed Audit dates and Auditors involved Number of Major / Minor non-conformities (per element of the 9100-series standard) Audit summary Follow-up visits performed Certificates issued Industry members may contact the Supplier directly for more detailed information on assessment results. 8.5 Surveillance and Re-assessments Accredited certificates issued by certification bodies/registrars shall have surveillance audits and re-assessments conducted by the certification body/registrar in accordance with ISO / IEC Guide 62 guidelines and the requirements of IAF Guidance (current issue). The requirements of this procedure equally applies to all surveillance and re-assessment visits. 8.6 Registration Certificates issued by an 9100 qualified certification body/registrar shall refer to the national/sectorial aerospace standard, e.g. AS9100 in the US, EN9100 in Europe, JIS Q9100 in Japan and the appropriate ISO 9001/2 standard and the particular version(s) of both. 9.0 AUTHENTICATION AND OVERSIGHT OF ACCREDITATION BODIES; CERTIFICATION BODIES/REGISTRARS; AND AUDITORS 9.1 Accreditation bodies must be members of the IAF and signatories of the IAF MLA per section 5 above, to be participate in this process. The sector management structure (SMS) shall approve and determine which Accreditation Bodies may participate in selection of Certification bodies/registrars and auditors. 9.2 The 9100 qualification of certification bodies/registrars shall be by the accreditation body in accordance with this document. This shall require an annual review by the sector management structure (SMS) to evaluate certification bodies/registrars and the effectiveness of the process for approval of certification bodies/registrars. The review shall be in accordance with Accreditation Body(ies) procedures and Sector Management Structure (SMS) approval. globally through electronic means available of the IAQG the information items indicated in 9101 AQG. SJAC : Numeración y : Numeración y 9.3 Each auditor s aerospace credentials shall be initially endorsed by the SMS. 9.4 The certification body/registrar s Audit Management Program shall be approved via Accreditation Body (or SMS in case of 5.2) oversight. 9.5 Accreditation Bodies (or SMS in case of 5.2) shall conduct annual surveillance audits which may include one witness audit per year (minimum) of certification bodies/registrars holding 9100 accreditation, per Accreditation Body guidelines. IAQG sector member companies shall perform oversight of certification bodies/registrars used by their suppliers and report negative results to the SMS, as necessary. and 10
9.6 Any complaints from either audited organizations or OEM s regarding certification body/registrar performance shall be handled directly by complainant with the appropriate certification body/registrar. The certification body/registrar s internal appeals / complaint process is to be used before other actions are taken. If any supplier / OEM cannot resolve issues with the certification body/registrar then the matter shall be referred to the accreditation body. If the problem is related to certification body/registrar performance and can not be resolved to the satisfaction of the organization or the OEM(s) involved, the matter shall be referred to the SMS. The SMS could recommend loss of the certification body/registrar s or 9100 qualification, removal of an individual auditor s approval or removal of the Accrediting Body for failure to properly govern certification bodies/registrars. The decision of the SMS is final. 9.7 Certification bodies/registrars may lose their 9100 qualification from Accreditation Bodies using the Accreditation Body rules and surveillance methods and based on performance. The SMS shall be notified immediately by the Accreditation Bodies when accreditation is withdrawn from a certification body/registrar. 9.8 OEM s shall require suppliers to notify them when they lose registration or their certification body/registrar loses 9100 accreditation. Certification bodies/registrars shall also notify the dedicated organisation in each sector (see 8.4) when suppliers lose or lapse their or 9100 certificates to correct the database. 10 RECORDS 11 FEE Supporting evidence of the certification body / registrar s qualification to 9100 shall be maintained at the offices of the Accreditation Body(ies) (or SMS in case of 5.2). SMS shall have access to records regarding approval of certification bodies/registrars holding 9100 qualification. Each sector may establish a fee for recognition and approval of certification bodies/registrars and auditors. 12 PROCEDURE RESPONSIBILITY 12.1 Any issues related to the implementation or use of this document shall be referred to the IAQG Oversight function. Any issues regarding this document that are not resolved by the IAQG Oversight function shall be referred to the IAQG Council. The decision of the IAQG Council is final. 12.2 The IAQG oversight function will: a) Monitor that each Sector is implementing their Sector schemes as documented and agreed upon by the other Sectors. b) Provide a mechanism for a periodic review of the lessons learned by each of the Sectors and a review of any proposed changes to the Sector schemes. c) Ensure that the database(s) operates effectively and is accessible to the IAQG members. d) Provide a summary report to the full IAQG on the periodic reviews of each of the Sectors schemes. 12.3 Each IAQG Sector appoints 2 representatives (that are part of the sector management structure) to meet at least yearly with representatives from the other Sectors to accomplish the above listed objectives. Their meeting can be scheduled in connection with a regularly scheduled IAQG meeting. 12.4 The Sector Management Structure (SMS) has the responsibility for the management, review, approval, implementation and modification of the sectorial procedure. The SMS shall be the : Numeración y <sp> 10 REQUIREMENTS FOR SHARED AUDITS BY OEMS OEMs may use the requirements set forth in this document as a means to share audits within the industry provided the requirements and guidelines set forth in Sections 7 & 8 of this document are incorporated into the OEMs operating procedures. Also, the appropriate standards checklists are used and results reported in accordance with this document. Reporting of results to the dedicated organisation in each sector is not required, but all documentation shall be left with the organization and the organization can determine if it should be made available to its other customers.... [34] Appendix C of this document... [35] 1 Salto de página... [36] 2 Details of the... [37] 3 3 xxxx xxxx 3-3 11
governing body by which the requirements for and approval of certification bodies/registrars and auditors to 9100 is determined, within the requirements of this procedure. Major modification of these requirements needs IAQG approval. 12.5 The composition of each SMS is based on the local situation of each sector and can be comprised of members from Accreditation Bodies, Certification bodies/registrars and sector group such as AAQG, EAQG, AECMA-EASE, etc. Accreditation Bodies and Certification bodies/registrars can serve in an advisory capacity without formal voting rights. guidelines M the these guidelines 3 13.3. 12
Página 1: [1] u406436 30/05/2001 12:38:00 Página 1: [2] Eliminado u406436 30/05/2001 12:33:00 for Aerospace Supplier Quality System Página 1: [2] Eliminado u406436 30/05/2001 12:33:00 Página 1: [3] Eliminado Dale K Gordon 19/03/2001 14:39:00 Certification/Registration schemes Página 1: [4] Eliminado Dale K Gordon 19/03/2001 14:40:00 to Página 1: [5] Eliminado H.Luijt 23/02/2001 21:16:00 to recognise Other Party assessment results Página 1: [6] Eliminado Luijt 14/03/2001 17:46:00 The aerospace industry requires that all elements of the production and supply chain operate to levels of quality and performance that assure safe and reliable high quality products. Quality systems must be designed to assure that all aspects of the design, manufacture and support of aerospace products meet their intended functions. In parallel with the aerospace industry s development of quality systems, as a means of ensuring that products comply with exacting requirements, equal importance has been attached to the role of quality systems assessment. Página 1: [7] Eliminado H.Luijt 23/02/2001 21:19:00 S Página 1: [7] Eliminado H.Luijt 23/02/2001 21:19:00 AC Página 1: [8] Eliminado H.Luijt 23/02/2001 21:17:00 IAS Página 1: [8] Eliminado H.Luijt 23/02/2001 21:19:00 (Internatinal Aerospace Standards 9100-series). Página 1: [9] u406436 11/05/2001 10:22:00 Página 1: [10] Cambio Luijt 14/03/2001 18:03:00 Numeración y con formato Página 1: [11] u406436 11/05/2001 10:23:00 Página 1: [12] Eliminado H.Luijt 23/02/2001 21:19:00 Sharing of supplier quality system assessment results by aerospace industry is one of the prime areas for cost reduction. Página 1: [13] Eliminado Luijt 14/03/2001 17:45:00 This procedure was developed as a consequence of the implementation by the aerospace industry of these quality system requirements and with the purpose of making use of certification bodies/registrars for the certification of these systems. Recognising the highly professional and effective assessment of the supplier quality systems by the aerospace industry in the past with oversight by the regulatory agencies, further steps can be taken by using a voluntary certification scheme with specific aerospace elements and requirements, under the supervision and control of the aerospace industry. This can be realised in an effective and efficient manner by a common Página 1: [14] H.Luijt 23/02/2001 21:21:00
Página 1: [15] Eliminado Luijt 14/03/2001 17:45:00, harmonised approach to the certification bodies/registrars, instead of subcontracting these activities by each member company individually. Página 1: [16] Cambio H.Luijt 23/02/2001 21:11:00 Numeración y con formato Página 1: [17] Cambio Dale K Gordon 19/03/2001 15:25:00 Numeración y con formato Página 1: [18] Dale K Gordon 19/03/2001 15:22:00 Página 1: [19] Cambio H.Luijt 23/02/2001 21:11:00 Numeración y con formato Página 1: [20] Cambio H.Luijt 23/02/2001 21:11:00 Numeración y con formato Página 1: [21] Eliminado u406436 30/05/2001 12:36:00 g) sharing of audits between OEMs Página 1: [22] Eliminado Dale K Gordon 19/03/2001 15:14:00 using a 2 nd party shared method Página 2: [23] Eliminado u406436 30/05/2001 13:49:00 1.0 SCOPE 34 2.0 PURPOSE 34 2.1 REFERENCES 34 3.0 DEFINITIONS 45 4.0 GENERAL 56 5.0 REQUIREMENTS FOR ACCREDITATION BODIES 56 6.0 REQUIREMENTS FOR CERTIFICATION BODIES/REGISTRARS 67 7.0 REQUIREMENTS FOR AUDITORS 78 7.1 Auditors 78 7.2 Aerospace Experience Auditors 78 7.3 Continuation Education 910 8.0 REQUIREMENTS FOR ASSESSMENT AND REPORTING 1011 8.1 Aerospace Assessment Teams 1011 8.2 Duration of Assessment 1011 8.3 Non-conformity 1112 8.4 Audit Team Conclusions and Reporting 1112 8.5 Surveillance and Re-assessments 1112 8.6 Registration 1112 9.0 AUTHENTICATION AND OVERSIGHT OF ACCREDITATION BODIES; CERTIFICATION BODIES/REGISTRARS; AND AUDITORS 1213
10 REQUIREMENTS FOR SHARED AUDITS BY OEMS 1213 11 RECORDS 1314 12 FEE 1415 13 PROCEDURE RESPONSIBILITY 1415 Página 3: [24] Eliminado H.Luijt 23/02/2001 21:38:00 AIR5493 Aerospace Information Report Requirements for Approval of an Aerospace Quality Management Systems Auditor Training Course EA-7/01 European Accreditation guidelines on the application of EN 45012 AS and AIR standards and reports available from SAE, 400 Commonwealth Drive, Warrendale, PA 15096-0001, USA or www.sae.org. EN standards are available from AECMA, Gulledelle 62, B - xxxx Belgium, ISO standards are available through the National Standardization offices. Página 3: [25] Eliminado u406436 11/05/2001 12:14:00 Salto de página Página 5: [26] Eliminado Luijt 14/03/2001 16:53:00 9100 qualified. This Application must incorporate the main principles of the sector scheme to provide the Accreditation Body with confidence that the certification body/registrar has developed the necessary documented process to meet the sector requirements. All information required by the Application must be appropriate and acceptable prior to submission of the certification body/registrar to the SMS for consideration of approval Página 5: [27] Eliminado u406436 11/05/2001 12:15:00 Página 5: [28] Eliminado u406436 11/05/2001 12:15:00 Salto de página 6.0 REQUIREMENTS FOR CERTIFICATION BODIES/REGISTRARS Página 7: [29] Eliminado u406436 11/05/2001 12:17:00
Requirements for Aerospace Industry AUDITORS OEM Auditor & Auditor(7.1) Aerospace Experienced Auditor (includes 7.1 & 7.2) All Auditors and Aerospace Experienced Auditors (7.2.3) Auditors are to be approved for ISO 9001 auditing per ISO 10011-2, -3 and trained per ISO 10011-1 General knowledge of IAS 9100 Standards Auditor training in industry standards and current industry requirements (6.2.a) 4 years of Aerospace work experience in the last 10 years (7.2.1) OR Industry experience & training on Aerospace Industry and two witness audits (7.2.2) Continuation Education for Auditors within every 3 years (7.3) Note: References in parentheses ( ) in the above diagram refer to this document. Página 7: [30] Eliminado Luijt 14/03/2001 17:05:00 (see Appendix B for further definition) Página 7: [31] Eliminado u406436 11/05/2001 10:34:00 Página 7: [32] Cambio u406436 10/05/2001 16:36:00 Numeración y con formato Página 9: [33] Eliminado Luijt 14/03/2001 16:28:00 Certified entity: Initial Assessment IAS9100 Surveillance IAS9100 (only) Number of employees Total additional Auditor-days Annual (auditor days) 5-100 +1.0 +0.5 101-1000 +1.5 +0.5 to 1.0 over 1000 +2.0 to 3.0 +1.0 to 2.0 Página 11: [34] Eliminado u406436 30/05/2001 13:13:00 set forth in Sections 7 & 8 of this document are incorporated into the OEMs operating procedures. Also, the appropriate standards checklists are used and results reported in accordance with this document. Reporting of results to the dedicated organisation in each sector is not required, but all documentation shall be left with the organization and the organization can determine if it should be made available to its other customers. Reporting shall be in accordance with 8.4 Página 11: [35] Eliminado u406436 30/05/2001 13:13:00 of this document and be made available with the audit checklist. Auditor credentials shall be made available to requesting companies upon request. Página 11: [36] Eliminado u406436 11/05/2001 12:19:00 Salto de página Página 11: [37] Eliminado Luijt 14/03/2001 16:36:00
Details of the application process for AS9000 or AS9100 qualification and current fees are available on request from the xxxxxxxxxxxxxxxx.