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.?
At RH
ANDERSEN we are ready now to meet the challenge of
optimizing, implementing or maintaining your AS9100 Quality
Management System.
Call today for your free quality
consultation:
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