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ISO QMSCAPA™
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audits and recording CAPA results.
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This standard AS9100 includes ISO 9001:2008 quality management
system requirements and specifies additional requirements for a
quality management system for the aerospace industry. The additional
aerospace requirements emphasize that the quality management system
requirements specified in this standard AS9100 are complementary
(not alternative) to contractual and applicable law and regulatory
requirements.
AS9100 Revision C Summary of Changes
Clause 1.1 (Scope) ADDITION
Scope extended beyond Aviation & Space to now include Defense
Clause 3 (New Definitions) ADDITION
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
Clause 4.2.2 (Quality Manual Relationships)
DELETION
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
Clauses 5.2 (Customer Focus/Satisfaction) ADDITION
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
Clause 7.1.1 (Project Management) ADDITION
New requirement for planning and managing product realization in a
structured and controlled way to meet requirements at acceptable
risk, within resource and schedule constraints.
Clause 7.1.2 (Risk Management) ADDITION
New requirement to implement a risk management process applicable to
the product and organization covering: responsibility, criteria,
mitigation & acceptance
Clause 7.1.3 (Configuration Management) Moved from 4.3
Structured in line with ISO 10007 requirements
Clause 7.1.4 (Work Transfer) Moved from 7.5
The organization must have a process to plan and control the
transfer activities
Expanded to cover permanent transfer
Clause 7.4.1 (Recognition of Supplier Quality Data)
REVISION
Objective and reliable data from external sources may be used during
supplier selection and evaluation
Clause 7.4.3 (Validation of Test Reports) DELETION
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.
Clause 7.5.1.1 (Process Verification) Moved from 8.2.4.2
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).
Clause 8.2.2 (Detailed Tools and Techniques)
DELETION
Redundant to ISO 9001 text, too prescriptive.
Clause 8.2.4 (Sampling Inspection) REVISION
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).
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