NR.

IRIS ISO Clause

IRIS Question
In case of transfer or outsourcing of activity
within the execution of a contract does a
transfer procedure including feasibility study,
risk analysis, planning, communication to
customer and FAIs to the appropriate level
exist?

6 KO

14

15

17

4.1

POOR
(1 point)

DEFINED
(2 points)

QUALIFIED
(3 points)

OPTIMIZED
points)

(4

Transfer procedure
including feasibility
study, risk analysis,
planning,
communication to
customer and FAIs
to the appropriate
level exists.

Does the QM system documentation include

a) documented statements of a quality policy
and quality objectives? b) a quality manual?
c) documented and applied procedures as
required by ISO 9001 : 2000? -Control of
documents -Control of records and data
-Internal audit -Control of nonconforming
product -Corrective action -Preventive
action

Mandatory
Documentation:
-Policy and
objectives
-Manual
-Control of
documents
-Control of records
and data
Procedure for
Internal Audit
-Control of
nonconforming
-Corrective action
-Preventive
action

Has a documented procedure been

Procedure for
established to define the controls needed to control of documents
a) approve documents for adequacy prior to
issue? b) review and update as necessary
and re-approve documents? c) ensure that
changes and the current revision status of
documents are identified? d) ensure that
relevant versions of applicable documents
are available at points of use? e) ensure that
documents remain legible and readily
identifiable? f) ensure that documents of
external origin are identified and their
distribution controlled? g) prevent the
unintended use of obsolete documents, and
to apply suitable identification to them if they
are retained for any purpose?

Procedure for
control of
documents. Matrix
"creator, review,
approval, control"
etc. ISO standard for
relevant documents.

Plus: Matrix
"creator, review,
approval, control"
etc. ISO standard for
all documents
including IRIS
standard.

Plus: Efficiency and

continuously
improvement
including ISO and
IRIS standard.

How does the organization ensure customer Process defined.

specification / requirements traceability
throughout the whole supply chain for design,
manufacturing, and field support activities?

Process for all

contracts.

Plus: Effective
process
implemented
through the main
supply chains to
capture customer
requirements.

Plus: Effective
process
implemented
through all the
supply chains to
capture customer
requirements.

4.2.1

4.2.3

4.2.3

4.2.4

How are records established and maintained

to provide evidence of conformity to
requirements and of the effective operation
Procedure for
of the QM system?
control of records

Procedure for
control of records.
Matrix identification,
creator , control ISO Plus: Analysis of
standard for all
actions for relevant
relevant records.
records.

Plus: Efficiency and

continuously
improvement
including ISO
standard.

NR. IRIS ISO Clause

Does the organization implement a Project

Management or New Product Development
process addressing the applicable areas of
PM, describing roles and responsibilities,
integrating the whole functions of the
organization in a multidisciplinary team?
Definition of the scope of a project: from
7.4 tender phase until end of warranty period.

92 KO

111 KO

POOR
(1 point)

DEFINED
(2 points)

A) quality objectives
and requirements for
the product are set
B) the need to
establish processes,
documents, and
provide resources
specific to the
The organization
product C) required
determines and
verification,
plans the following
validation,
appropriate, in
monitoring,
planning product
inspection and test
realization A) quality activities specific tot
objectives and
the product ant the
requirements for the criteria of product
product are set B) acceptance D)
the need to establish records needed to
processes,
provide evidence
How does the organization plan and develop documents, and
that the realization
the processes needed for product
provide resources
processes and
realization? Definition of planning: steps,
specific to the
resulting product
7.1 schedule and methods to achieve a result.
product.
meet requirements.

67

101 KO

IRIS Question

Organization has
defined criteria for
project / nonprojects business
including appropriate
procedures. New
Product
Development has to
be run as project.
Projects have
defined roles and
responsibilities for
the actors;
integrating the whole
functions of the
organization in a
multidisciplinary
team.

7.4.5

The organization
has a structured,
appropriate project
related quality
system in place with
manuals,
procedures and
quality plans to
Does the organization ensure that a process manage project
is in place to manage project deliverables?
deliverables.

7.4.9.1

Verification,
validation and
approval activities
are defined, to
ensure compliance
with customer
requirements
BEFORE
IMPLEMENTATION.
Are verification, validation AND APPROVAL Process
activities defined, to ensure compliance with implemented and
customer requirements BEFORE
records are
IMPLEMENTATION?
available.

QUALIFIED
(3 points)

Plus: the
organization
investigates
possibilities how to
improve planning
and product
realization

OPTIMIZED
points)

(4

Plus: The
organization is
monitoring process
performance and
has improvement
program in place.

NR. IRIS ISO Clause

126 KO

141 KO

145 KO

146

170

183

186

190 KO

IRIS Question

POOR
(1 point)

DEFINED
(2 points)

QUALIFIED
(3 points)

7.5.2

Does the organization ensure new

technologies/new products validation before
introduction in a customer project?

Specification
-Risk assessment
-Validation and
verification plan
-Test procedure and
test report
-FAI

7.5.6

Does the organization ensure that reports,

calculation, test results, etc., demonstrate
that the product definition meets the
specification requirements for all relevant
operational conditions?

Operational
requirement/product
data sheet

7.5.8

Documented
procedure defining
inspection,
verification, and
documentation of a
representative item
from the first serial
Does the organization's system provide a
production run of a
documented procedure defining inspection, new part, of
verification, and documentation of a
following any
representative item fro the first serial
subsequent change
production run of a new part, or following any that invalidates the
subsequent change that invalidates the
previous first article
previous first article inspection result?
inspection result

7.5.8

FAI are performed to

assess the outputs
of some production
processes FAI are
performed when
FAI are performed to changes in
How is AI performed subsequently to the
assess the outputs production
Plus: FAI are
verification of the production process? Is this of some production processes are
extended to critical
FAI procedure also applied to suppliers?
processes
implemented
suppliers

Formal procedures
defining
responsibilities and
systems for initial
sample approval
(FAI)

OPTIMIZED
points)

(4

Plus: An effective
FAI Process
covering internal and
suppliers production
processes and
relevant changes is
systematically
deployed

Plus: With evidence

of early and
continuous sub
contractor
involvement in
supplier product
process
development.

Plus: The procedure

also requires
evidence of process
capability on all
critical
characteristics.

7.7.4

Does the organization establish and

implement the inspection or other activities
necessary for ensuring that purchased
product meets specified purchase
requirements?

7.8.2.2

process owners
have explicitly
How does the organization control the
-process established appropriate authority
production process changes and are persons and maintained
to
authorized to approve changes to production
-process owner accept/reject/approv
processes identified?
defined
e changes

Plus: There is a
routine defined to
check, if changes
might have impacts
to requirements prior
to acceptance

Plus: Systematic
multifunctional
analysis of changes
on any impact prior
to acceptance.

7.8.2.3

Dedicated
resources, complete
list of all equipment,
tools and programs
Are production equipment, tools and
exists; maintenance
programs maintained and inspected
plan and first level
periodically according to documented
maintenance is in
procedures? Are storage requirements,
place. By this also
including periodic preservation/condition
the equipment in
checks established for production equipment storage is covered
or tooling storage
appropriately.

Plus: Maintenance
based on the record
of measurements
(tolerances).

Plus: Ad-hoc
preventative
maintenance on
deteriorating
tolerances.

7.8.3

-Identification of
special processes
established
-Guidelines for all
special processes
existing
-Skills checked and
Are special processes managed according to qualification records
the contractual requirements?
held.

Initial sampling
process done
occasionally

Plus: Additional
maintenance
contract with an
accredited party.

NR. IRIS ISO Clause

192

7.8.4

IRIS Question

Does the organization, where appropriate,

identify the product by suitable means
throughout product realization?

POOR
(1 point)

DEFINED
(2 points)

QUALIFIED
(3 points)

Serialization (serial
numbering) is
applied for the most
Serialization (serial important parts of
Serialization (serial numbering) is
the unit/system and
numbering) will only applied for the most there is a possibility
be put in place upon important parts of
to use customer
customer request
the unit/system.
serial numbering

212

Is the measuring equipment, where

necessary to ensure valid results; a)
calibrated or verified at specified intervals, or
prior to use, against measurement standards
traceable to international or national
7.11 measurement standards?

Instructions
implemented for
some
equipment/devices.

213

Is the basis used for calibration or verification

recorded, where no such standards exist? B)
adjusted or re-adjusted as necessary? C)
identified to enable the calibration status to
be determined? D) safeguarded from
adjustments that would invalidate the
measurement result? E) protected from
damage and deterioration during handling,
maintenance and storage? F) recalled to a
7.11 defined method when requiring calibration?

Instructions
implemented for
some
equipment/devices.

217

How does the organization maintain a

register of these monitoring and measuring
devices, and define the process employed
for their calibration including details of
equipment type, unique identification,
location, frequency of checks, check method
7.11 and acceptance criteria?

Process defined for

all equipment and
software to monitor,
to measure, to test Process
Process
the product
implemented for
implemented for all
conformity.
main product groups product groups

Plus: Serialization
(serial numbering) is
applied for all line
replaceable items of
the unit/system.

Instructions
implemented for all
equipment/devices

Instructions
implemented for all
equipment/devices

Standard
requirements are
exceeded

Efficiency of
continuous
improvement
(reduction of nonvalue-adding effort)

Standard
requirements are
exceeded

Efficiency of
continuous
improvement
(reduction of nonvalue-adding effort)

In the event of process non conformity, does

the organization: a) identify, record the non
conformity and take appropriate action to
correct the non conforming process? B)
evaluate whether the process non conformity
has resulted in product non conformity? C)
identify and control the non conforming
8.4 product?

Process to control
non conformity
processes (records,
process-FMEA, root
cause analysis, NC
reports.

8.6.2

How does the organization take action to

eliminate the cause of nonconformities in
order to prevent recurrence?

Process defined and

described including
authorities and
responsibilities for
non conformities
handling

Plus: Process
applied
systematically for all
processes and all
Plus: Results are
types of non
shared with
conformities
customers

8.6.2

Does the procedure documented covers the

requirements for: a) reviewing non
conformances (including customer
complaints)? B) determining the causes of
the non conformity? C) Evaluating the need
for action to ensure that non conformances
do not recur? D) determining and
implementing action needed? E) records of
the results of action taken? F) reviewing
corrective action taken? G) effectiveness and
closing of corrective action?

A documented
procedure is
established that
covers the aspects
somehow

A documented
procedure is
established that
covers all aspects in
detail

245 KO

251

(4

Field service
processes provide
actions to be taken
where problems are
identified after
Do field service processes provide: a)
delivery, including
actions to be taken where problems are
investigation,
identified after delivery, including
reporting activities,
investigation, reporting activates, and actions and actions on
7.9 on service information
service information.

201 KO

249

OPTIMIZED
points)

Efficiency of
continuous
improvement.

Plus: Joint work on

non conformities
with customer /
suppliers

Plus: Procedure is
regularly reviewed in
a multi functional
Plus: Updated as
assessment
needed.