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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.
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.
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.
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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
Does the change constitute a QMS requirement that is not contractual in nature and contains no product specific requirements?
YES
Does change: enhance clarity to resolve interpretation issues OR address stakeholder needs?
NO
YES
NO
YES IAQG 9100 Team further evaluates proposed change for incorporation
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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.
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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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
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
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Committee Draft 1Q 2006 Draft International Standard 4Q 2006
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
Note: Exact dates for release of 9001 drafts not known forecast is by expected quarter.
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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