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9100 Design Specification 9 January 2006

Design Specification for the Revision of the IAQG 9100 Standard


IAQG Initiative REQ-001

Contents
1.0 2.0 3.0 4.0 5.0 6.0 7.0 8.0 Annex A Annex B Annex C Introduction User Needs Purpose of the Revision Scope of the Standard Revision Process Structure of the Standard Draft Preparation and Control Ballot and Publishing Process Change Evaluation Tools Milestone Chart Guidance on Drafting

This document has been prepared by the IAQG 9100 Team, part of the IAQG Requirements Strategy stream.

Design Specification for the Revision of the IAQG 9100 Standard

1.0 Introduction
International Organization for Standardization (ISO) Technical Committee (TC) 176 is amending ISO 9001, Quality management systems Requirements, in 2008 to enhance the clarity of ISO 9001:2000 and to enhance its compatibility with ISO 14001:2004, Environmental management systems Requirements with guidance for use. The structure of ISO 9001:2008 will not change from ISO 9001:2000 and no new requirements are expected to be introduced. Changes are expected to be restricted so that the impact of the amendment on the users is limited, and changes will only be introduced where there are clear benefits to users. The International Aerospace Quality Group (IAQG) 9100 standard, Quality management systems Aerospace Requirements, is based on ISO 9001 and is thus affected by the TC176 revision activity. As a result, the IAQG has resolved that a project be undertaken to revise the IAQG 9100 standard for release in 2008 concurrent with, or soon after, the release of ISO 9001:2008. The IAQG 9100 standard revision initiative (number REQ-001) completed the IAQG Gate 0 process and obtained formal IAQG Council approval on 5 October 2005 at the Montreal IAQG meeting. This design specification has been prepared by the IAQG 9100 Team to document the basic considerations that will be used to guide the IAQG 9100 standard revision process.

2.0 User Needs


The IAQG 9100 Team has identified the following stakeholder segments and will consider user needs from these segments: certification/registration bodies & training organizations, civil aviation authorities, defense / NATO, IAQG and IAQG sector member companies, space sector, and suppliers.

The IAQG 9100 team will use a comments template, and a web-based survey form, to receive stakeholder comments/requests. Each stakeholder-proposed change must include a justification for the change in order to be considered. To satisfy the needs of the broad IAQG 9100 standard user community, the revised standard shall be suitable for use by all sizes and types of organization in the aviation, space, and defense sectors.

3.0 Purpose of the Revision


The purpose of the revision is to: enhance clarity of requirements to resolve interpretation issues, consider / address stakeholder needs, and ensure that the standard is compatible for use by all stakeholder segments.

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Design Specification for the Revision of the IAQG 9100 Standard

4.0 Scope of the Standard


The scope and purpose of the standard will be revised from aerospace to include the defense sector; the new scope will be defined as aviation, space, and defense.

5.0 Revision Process


The IAQG 9100 Team will use a disciplined process for the consideration of proposed changes or additions to the standard. Changes/additions that will be considered are those that: 1. constitute quality management system requirements that are not contractual in nature or contain product specific requirements, and that 2. enhance clarity of requirements or address stakeholder needs, and that 3. are compatible for use by all stakeholder segments and by organizations of all types and sizes, and when 4. the benefit of the proposed change/addition outweighs the impact of implementation. A decision tree based on the above consideration factors, and a benefit versus impact matrix, are presented in Annex A. The IAQG 9100 Team will be confined to addressing proposed changes/additions that meet the above consideration factors, and to comments resulting from coordination/ballot of the revised standard. Stakeholder requests must be related to existing or proposed new aviation, space, and defense sector requirements. Stakeholder requests for changes to ISO 9001 requirements are outside the scope of the IAQG 9100 team and will not be considered. The 9100 standard will utilize terms and definitions as established in ISO 9000, Quality management systems - Fundamentals and vocabulary. Terms and definitions specific to the aviation, space, and defense sectors will be defined, when necessary, within the 9100 standard. Note: The IAQG 9100 Team will collaborate with the IAQG People Capability Strategy stream when establishing terms and definitions. Key milestones affecting the revision process are presented in Annex B.

6.0 Structure of the Standard


The IAQG 9100 standard will be based on ISO 9001 and will retain the ISO 9001 architecture and process approach. All ISO 9001 requirements will be included within the 9100 standard; additional aviation, space, and defense sector requirements will be shown in bold, italic text. The concept of requirements annexes or addendums to the 9100 standard has been discussed but no requirement for their use has yet been identified. The 9100 team shall keep in mind that adoption of an annex concept may have an effect on the 9100 assessment and registration/certification processes.

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Design Specification for the Revision of the IAQG 9100 Standard

7.0 Draft Preparation and Control


The draft IAQG 9100 standard will be prepared and controlled as described below. Additional guidance on drafting the revised standard is presented in Annex C; this additional guidance is based on the guidelines developed by ISO TC176. The 9100 draft will be prepared by the designated team Scribe. The Scribe is responsible for configuration control of the draft versions. The Scribe is responsible for keeping the 9100 draft current with ISO 9001 drafts (i.e., CD, DIS, FDIS, IS). If ISO 9001 drafts have requirements that have been moved or if the clause numbering is changed, the Scribe will re-position any corresponding 9100 requirements and have the team validate the placement. The 9100 draft style and format will follow ISO 9001 style and format until completion of the project at which time the document will be reformatted by the IAQG Sector Standardization Focal points to comply with sector standards bodies formats. The initiative Team Leader, the Scribe, and other team members as necessary will review the reformatted sector versions of the standard prior to publication (reference IAQG procedure 106, Interfaces, Tasks, Timeframes Between SML, Sector, and Initiative Teams).

8.0 Ballot and Publishing Process


The IAQG 9100 standard will be balloted, ballot comments dispositioned, and the final standard published in accordance with IAQG procedure 101, Initiative Management Process, and with IAQG procedure 106.

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Design Specification for the Revision of the IAQG 9100 Standard

Annex A Change Evaluation Tools A.1 Decision Tree for Evaluation of Proposed Changes

Stakeholder proposed 9100 changes/additions, with justification, submitted via comments template or IAQG Web survey

Assess the nature, benefits, and impact of the proposed change

Does the change constitute a QMS requirement that is not contractual in nature and contains no product specific requirements?

Disposition As: NO Not meeting IAQG 9100 Design Specification requirements

YES

Does change: enhance clarity to resolve interpretation issues OR address stakeholder needs?

NO

YES

Does the benefit to the users outweigh the impact/cost of implementation?

NO

YES IAQG 9100 Team further evaluates proposed change for incorporation

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Design Specification for the Revision of the IAQG 9100 Standard

Annex A (Cont.) A.2 Benefit vs. Impact Matrix

The matrix shown below provides the basic methodology that will be used when necessary to determine the benefit versus impact of proposed changes to the standard. Note that this is a guide and that not all proposed changes falling within the acceptable for further consideration area of the matrix will be automatically included in the standard. The tools contained in this annex are guidelines that are used as necessary to filter proposed changes. Those changes that pass the filtering tools are still subject to analysis and approval or disapproval by the IAQG 9100 Team.

Benefit High Impact Low Medium High 1 1 2 Medium 1 2 3 Low 2 3 3

1.

Acceptable for Further Consideration: The proposed change appears to have benefits that outweigh the impact of implementation and is acceptable for further consideration by the IAQG 9100 Team. Requires Detailed Analysis: The proposed change appears to have marginal benefits in comparison to the impact of implementation and requires a detailed analysis. Not Acceptable for Further Consideration: The impact of implementation of the proposed change outweighs the benefits and is not acceptable for further consideration.

2. 3.

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Annex B Milestone Chart

2005 2007 2008

2006

Sep Oct Nov Dec Jan Feb Mar Apr May Jun Jul Aug Sept Oct Nov Dec Jan Feb Mar Apr May Jun Jul Aug Sept Oct Nov Dec Jan Feb Mar Apr

IAQG & 9100 Team Meetings


4/3 4/7 IAQG San Diego 4/-4/-9100 Team - San Diego 10/-10-9100 Team - Seville 4/-4/-9100 Team - Melbourne 10/-10/-9100 Team - Americas 10/3 10/6 IAQG Seville 4/-4/-IAQG Melbourne 10/-10/-IAQG Americas 4/-4/-IAQG Europe 4/-4/-9100 Team - Europe

10/3 10/7 IAQG Montreal

11/8 11/10 9100 Team - Paris

Stakeholder Input
8/15 Stakeholder Input 3/1 Supplier Input Data Mining Input Consolidation 5/1 8/15 10/1

1/1

Analysis/Draft/Ballot/Release
10/1 4/15 Prepare 9100 Draft ISO 9001 CD Analysis ISO 9001 DIS Analysis 4/15 1st SML Ballot IAQG Gate 1 8/1

Design Specification for the Revision of the IAQG 9100 Standard

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Committee Draft 1Q 2006 Draft International Standard 4Q 2006

10/6 IAQG Gate 0 Approval

8/1 10/15 Disposition Comments IAQG Gate 2a 10/15 1/1 2nd SML Ballot

ISO 9001 FDIS Analysis 1/1 4/15 2nd Disposition Comments IAQG Gate 2b 9100 Release for Publication IAQG Gate 3

ISO 9001:2008 Estimated Timeline


Final Draft International Standard 4Q 2007 ISO 9001:2008 Publication

Note: Exact dates for release of 9001 drafts not known forecast is by expected quarter.

Design Specification for the Revision of the IAQG 9100 Standard

Annex C Guidance on Drafting C.1 General

In order to maintain and further improve clarity, terminology and presentation style, and to increase user friendliness of the standard, the drafting group shall ensure that: the original intent of the standard is maintained, the standard is free from cultural bias, the standard is written in a style that can be understood by all stakeholders, not just quality functional specialists, the standard is written in a clear style that can be easily translated into other languages, consideration is given to the auditability of all requirements (this should focus on the need to eliminate or reduce ambiguity rather than produce prescriptive requirements for documents or records that are of minimal value to those implementing the standard), requirements are clearly separated from any explanatory guidance information, the use of cross-referencing within the standard enhances user friendliness, the standard is written to be unambiguous to give a common understanding that avoids multiple interpretations, consistent use of terminology is maintained avoiding the excessive use of quality terms and jargon, terms that cannot be quantified (significant) are avoided, and sentences are kept short to reduce excessive wordiness; however, requirement statements shall not be so short as to be ambiguous.

C.2

Translation issues

Text where translation difficulties may occur should be identified by consultation with the various language speakers within the drafting group and where appropriate from language experts outside the drafting group. This may include technical writers, non-quality personnel and IAQG members from non-English speaking countries to review the text of the draft standard for clarity and translatability.

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