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    • Abstract: (PEAR), which may be found in AS9101D, and. evaluated for effectiveness during the audit. ... AS9101D. Rules for Upgrade– Stage 1. Rules for Upgrade Stage 1. f. d. d f ...

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ISO 9001:2008 AS9100 Rev C
9001:2008, Rev.
and AS9101 Rev. D
Interpretations to Effectiveness
Peter P. Kucan
Director of Registrar Operations
Aerospace Experienced Auditor
www.priregistrar.org
Introduction
• The goal of this presentation is to review
the currently known rules for upgrade per
the new audit support document, AS9101
Revision D and to highlight the major
changes to the ISO 9001:2008, AS9100
Revision C standards.
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Rules for Upgrade
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Rules for Upgrade
• All audits after July 1, 2011 shall be to Revision C
di f J l 1 h ll b R ii
• All certs to Revision B shall be withdrawn after
July 1
J l 1, 2012
• Company must tell registrar in which audit they
wish to be upgraded and formerly declare
conformance to the 2009 version of the AQMS
standard to the registrar prior to having the
transition audits.
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Rules for Upgrade
• The number of audit days for an upgrade will be
calculated via the requirements stated in SR-001
and AS9104
d AS9104.
• All processes in Section 7 shall be documented on
aPProcess Effectiveness Assessment Report
Eff ti A tR t
(PEAR), which may be found in AS9101D, and
evaluated for effectiveness during the audit.
• No company can restart their three year contract
cycle via an upgrade during a surveillance audit.
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AS9101 D
Rules for Upgrade– Stage 1
Upgrade
• Th audit t
The dit team l d shall require the organization to
leader h ll i th i ti t
provide the necessary information and documentation for
review, including the following:
• quality manual;
• description of processes showing their sequence and
interactions, including the identification of any outsourced
i i i l di h id ifi i f d
processes;
• NOTE 1: The processes can be depicted in various ways
[e.g., process maps, turtle diagrams, SIPOC method
(breakdown of supplier, inputs, process steps/tasks,
outputs, customer), octop s]
o tp ts c stomer) octopus].
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AS9101D
Rules for Upgrade– Stage 1
Upgrade
• performance measures and trends f the
f d d for h
previous 12 months (This is a MUST. We cannot
transition the client without these being in place!);
• evidence that the requirements of the applicable
9100 series
9100-series standards are addressed by the
organization’s documented procedures
established for the quality management system
q y g y
(e.g., by referencing them in the quality manual
or by using a cross reference);
• interactions with support functions on-site or at
remote locations/sites; 7 www.priregistrar.org
AS9101D
Rules for Upgrade– Stage 1
Upgrade
• evidence of internal audits of processes/procedures,
p p ,
including internal and external quality management
system requirements;
• th l t t management review results;
the latest t i lt
• list of all major (e.g., top five) aviation, space, and/or
de e se a d a y ot e custo e s equ
defense and any other customers requiring 9 00 se es
g 9100-series
standard compliance, including an indication of how much
business each customer represents and their customer
specific quality management system requirements, if
requirements
applicable; and
• evidence of customer satisfaction and complaint p
summaries, including verification of customer reports,
scorecards, and special status or equivalent. www.priregistrar.org
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AS9101D
Rules for Upgrade– Stage 1
Upgrade
• NOTE 2: E
2 Examples of customer specific quality
l f t ifi lit
management system requirements are: product process
verification, including First Article Inspection (FAI)
requirements (e.g., 9102); quality records to be created
and maintained by the organization; coordination of
document changes; defined special requirements/critical
items/key characteristics; approval of design changes by
the customer; flow down of requirements to sub-tiers;
customer notification of production process changes;
t tifi ti f d ti h
traceability; handling of nonconformities; and
applicability of other IAQG quality management system
standards in contracts
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ISO 9001:2008
and AS9100C
What requirements
are new or changed?
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ISO 9001:2008
• 4.2 A documented procedure shall be
established to define the controls needed
f) to ensure that documents of external origin
determined by the organization to be
d t i d b th i ti t b
necessary for the planning and operation of
the
th quality management system are identified
lit t t id tifi d
and their distribution controlled
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4.2 Doc Requirements
• The organization shall ensure that personnel
have access t and are aware of, relevant
h to, d f l t
quality management system documentation
and changes.
d h
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5.2 Customer Focus
• Top management shall ensure that product
p g p
conformity and on-time delivery
p f
performance are measured and that
appropriate action is taken if planned
results are not, or will not be, achieved.
, ,
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5.5.2 Management Rep
• Top management shall appoint a member
of the organization's management who,
f g z g ,
irrespective of other responsibilities, shall
have responsibility and authority that
p y y
includes…the organizational freedom and
unrestricted access to top management to
p g
resolve quality management issues.
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7.1.1 Project Management
• As appropriate to the organization and
the product the organization shall plan
product,
and manage product realization in a
structured and controlled manner to
meet requirements at acceptable risk,
within resource and schedule
constraints.
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7.1.2 Risk Management
• The organization shall establish, implement and
maintain a process f managing risk to the
p for g g
achievement of applicable requirements, that
includes as appropriate to the organization and
the product
h d
a) assignment of responsibilities for risk
management, t
b) definition of risk criteria (e.g., likelihood,
consequences,
consequences risk acceptance)
acceptance),…..
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7.1.2 Risk Management
c) id tifi ti
) identification, assessment and communication
t d i ti
of risks throughout product realization,
d) identification, implementation and management
of actions to mitigate risks that exceed the defined
risk acceptance criteria, and
e) acceptance of risks remaining after
implementation of mitigating actions.
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7.1.3 Configuration Mgt.
• The organization shall establish, implement and
maintain a configuration management process
that includes, as appropriate to the product
a) configuration management planning,
b) configuration identification,
c) change control,
d) configuration status accounting, and
e) configuration audit.
NOTE See ISO 10007 for guidance.
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7.1.4 Control of
Work Transfers
f
• The organization shall establish, implement
and maintain a process to plan and control
the temporary or permanent transfer of work
h f f k
(e.g., from one organization facility to
another, f
h from the organization to a supplier,
h i i li
from one supplier to another supplier) and to
verify the conformity of the work to
if h f i f h k
requirements.
( Was formerly in Control of Manufacturing)
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7.3.1 Design and
Development Planning
• Where appropriate, the organization shall
divide the design and development effort
g p ff
into distinct activities and, for each
activity, define the tasks, necessary
y, f , y
resources, responsibilities, design content,
input and output data and planning
p p p g
constraints.
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7.3.1 Design and
Development Planning
p g
Design and development planning
shall consider the ability to
h ll id h bili
p
produce, inspect, test and
, p ,
maintain the product.
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7.4.1 Purchasing Process
• The organization shall
A) maintain a register of its suppliers that includes
approval status (e g approved conditional
(e.g., approved, conditional,
disapproved) and the scope of the approval (e.g., product
type, process family),…
E) define the process, responsibilities and authority for
the approval status decision, changes of the approval
status and conditions for a controlled use of suppliers
depending on the supplier's approval status, and
F) determine and manage the risk when selecting and
using suppliers (see 7.1.2).
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7.4.1 Purchasing Process
• Purchasing information shall describe the
product to be purchased, including, where
appropriate
h) records retention requirements
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7.5.1.1 Production
Process Verification
f
• The organization shall use a representative item from the
first production run of a new part or assembly to verify
that the production processes, production documentation
processes
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 changes, manufacturing process
changes, tooling changes).
NOTE This activity is often referred to as first article
inspection.
(Was formerly in Inspection)
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8.2.1 Customer Satisfaction
• Information to be monitored and used for the
evaluation of customer satisfaction shall include,
f f
but is not limited to, product conformity, on-time
delivery performance, customer complaints and
corrective action requests. Organizations shall
i i O i i h ll
develop and implement plans for customer
satisfaction improvement that address deficiencies
identified by these evaluations, and assess the
effectiveness of the results.
ff f
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ISO 9001:2008
• 8.2.2 Internal Audits
Records of the audits and their results
shall be maintained
h ll b i i d
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8.2.3 Monitoring and
Measurement Processes
In the event of a process nonconformity, the
organization shall…
g z
c) determine if the process nonconformity is limited
to a specific case or whether it could have affected
other processes or products…
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ISO 9001:2008
• 8.2.4 Records shall indicate the
person(s) authorizing release of
product f d li
d t for delivery t th
to the
customer
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8.2.4 Monitoring and
Measurement of Product
f
• Measurement requirements for product
acceptance shall be documented and shall
include…
include
c) required records of the measurement
results (at a minimum, indication of
acceptance or rejection)…
p j
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8.2.4 Monitoring and
Measurement of Product
f
• 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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8.3 Control of
Nonconforming Product
• Where applicable, the organization shall deal with
nonconforming product by one or more of the following
ways:
d) by taking action appropriate to the effects, or potential
effects, of the nonconformity when nonconforming
product is detected after delivery or use has started;
The organization's nonconforming product control
process shall provide for timely reporting of delivered
nonconforming product;…
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8.3 Control of
Nonconforming Product
f g
• Where applicable, the organization shall deal with
pp , g z
nonconforming product by one or more of the following
ways:
e) b t ki actions necessary to contain the effect of the
) by taking ti t t i th ff t f th
nonconformity on other processes or products.
Dispositions of use-as-is or repair shall only be used after
approval by an authorized representative of the
organization responsible for design.
The organization shall not use dispositions of use as is or
use-as-is
repair, unless specifically authorized by the customer,
if the nonconformity results in a departure from the
f y p f
contract requirements.
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8.5.1 Continual Improvement
• The organization shall monitor the
implementation of improvement
i l i fi
activities and evaluate the
effectiveness of the results.
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8.5.2 Corrective Action
• A documented procedure shall be
established to define requirements f
f q for
i) determining if additional
nonconforming product exists based
on the causes of the nonconformities
and taking further action when
required.
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8.5.3 Preventive Action
• NOTE Examples of preventive action
opportunities include risk
management, error p f g f
g proofing, failure
mode and effect analysis (FMEA), and
information on product problems
reported by external sources.
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ISO 9001:2008
• Corrective and Preventive Action both
now require that the actions taken are
reviewed for
EFFECTIVENESS.
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Achieving Excellence Together
Thanks for your attention
and for choosing
PRI Registrar
as your partner iin
Continual Improvement
Improvement.
37 www.priregistrar.org


Use: 0.0485