ISO 9001:2008; TS 16949; ISO 13485; ISO 14001 (EMS); ISO 22000; Registrar Services,EEOC/Title 7 Training,AS9100 Rev. C;  IECQ QC 080000; ISO 26000;  ISO/IEC 17025;  A2LA ,OHSAS 18001; HACCP; Healthcare; Social Services,International Consulting; Medical Device,Quality Management Systems; QMS Quality Consulting and TrainingCT NY NJ MA Connecticut New York New Jersey Mass SAE AS9100  Rev. C  Changes Explained
 
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The International Aerospace Quality Group (IAQG) released AS9100 Rev C in January of  2009, and with it the Standard broadened it's scope to include defense. The addition of many new requirements may pose a challenge for many registered to AS9100 Rev B. Organizations are urged to study and embrace the changes and include these in the scope of their audits. Below are what are considered to be the significant differences in this new revision:

Addition to Clause 1.1 (Scope)

Scope extended beyond Aviation & Space to Defense

Addition to Clause 3 (New Definitions)

  • Risk - an undesirable situation or circumstance that has both a likelihood of occurring and a potentially negative consequence. (Key to applying Risk Management)
  • Special requirements - Those requirements which have high risks to being achieved thus, requiring their inclusion in the risk management process. Factors include:
    • Product or Process Complexity
    • Past Experience
    • Product or Process Maturity
  • Critical Items - Those items having significant effect on the product realization and use of the product; including safety, performance, form, fit, function, producibility, service life, etc., that require specific actions to ensure they are adequately managed. Examples include:
    • Safety Critical Items
    • Fracture Critical Items
    • Mission Critical Items
    • Key Characteristics

Removed from Clause 4.2.2 (Quality Manual Relationships)

  • Delete requirement to create a document showing the relationship between AS9100 requirements and the organizations documented procedures.
  • NOTE: Auditors need to identify appropriate documented procedures as an inherent part of the audit.

Addition to Clauses 5.2 (Customer Focus/Satisfaction)

  • Management responsibility for measuring ‘product conformity’ and ‘on-time delivery’ and for taking appropriate remedial actions
  • Requirement to evaluate customer satisfaction using specific QMS information, then develop plans that address deficiencies

Addition to Clause 7.1.1 (Project Management)

  • New requirements for planning and managing product realization in a structured and controlled way to meet requirements at acceptable risk, within resource and schedule constraints.

Addition to Clause 7.1.2 (Risk Management)

  • A new requirement to implement a risk management process applicable to the product and organization covering: responsibility, criteria, mitigation & acceptance

Moved from 4.3, Configuration Management is now part of 7.1.3

  • Structured in line with ISO 10007 requirements

Moved from 7.5, Wrok Transfer is now part of Clause 7.1.4

  • The organization must have a process to plan and control the transfer activities
  • Expanded to cover permanent transfer

A revision to Clause 7.4.1 (Recognition of Supplier Quality Data)

  • Objective and reliable data from external sources may be used during supplier selection and evaluation

Removed from Clause 7.4.3 (Validation of Test Reports)

  • Where the organization utilizes test reports to verify purchased product, the data in those
    reports shall be acceptable per applicable specifications. The organization shall periodically validate test reports for raw material.

Moved from 8.2.4.2, Process Validation is now part of Clause 7.5.1.1

  • Requirement to validate the production processes, documentation and tooling are capable of producing parts and assemblies that meet requirements. This process shall be repeated when changes occur that invalidate the original results (e.g. engineering or manufacturing
    processes changes).

Removed from Clause 8.2.2 (Detailed Tools and Techniques)

  • Redundant and too prescriptive text already in ISO 9001.

A revision to Clause 8.2.4 (Sampling Inspection)

  • When the organization uses sampling inspection as a means of product acceptance, the sampling plan shall be justified on the basis of recognized statistical principles and appropriate for use (i.e., matching the sampling plan to the criticality of the product and to the process capability).

 

Need more information on Revision C details, or for help implementing changes, training staff, etc.?

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