IRIS Standard

1
IRIS Standard

• Zusatzforderung
• zur
• DIN EN ISO 9001 2000

Juli 2006
2
IRIS - Zusatzforderungen

• 4.3 Knowledge management
• Best practice shall be documented and regularly
• updated.
• Note, this can include
• gt Design rules
• gt Return of experience after a project
• gt Methods / Manufacturing Engineering standards

Juli 2006
3
IRIS - Zusatzforderungen

• 4.4 Management of multi site projects
• In the case that a project involves multiple
  sites, an
• appropriate Business Management System (e.g.
  Project
• Quality Plan) shall be implemented for
  (operational
• interfaces, communication channels, work split,
  applicable
• Procedures).
• Cross site process efficiency shall regularly be
  assessed.

Juli 2006
4
IRIS - Zusatzforderungen

• 5.3 Quality policy
• The organisation shall establish and update at
  least
• annually a Business Plan, with covers at a
  minimum the
• following topics Railway Industry activities,
  company
• Misson and Vision, SWOT, Market and product
  strategy
• including obsolescence, Make or Buy strategy,
  company
• capacity,developement plans of new product /
  process,
• business obejectives

Juli 2006
5
IRIS - Zusatzforderungen

• 5.5.1 Responsability and Authority
• Roles and responsabilities for all processes
  having an
• impact on customer satisfaction (including RAMS
  and
• special processes) shall be described.
• Owernship of business processes shall be defined.

Juli 2006
6
IRIS - Zusatzforderungen

• 5.5.2 Management Representative
• All shifts shall be staffed with personnel in
  charge of, or
• hold delegated responsabilty for ensuring product
  quality

Juli 2006
7
IRIS - Zusatzforderungen

• 5.5.3 Internal Communication
• The organization shall establish a communication
  system
• from management to ist personal, as a minimum
• policy, mission and vision, company performance,
• customer related issues

Juli 2006
8
IRIS - Zusatzforderungen

• 5.5.4 Customer Relationship Management
• Top management shall appoint a member of
  management
• who, irrespective of other responsabilities,
  shall have
• responsability and authority that includes
• processes needed to customer satisfaction are
  established, implemented and maintained
• reporting to top management on the performance of
  these processes
• promotion of awareness of customer satisfaction
  throughout the organisation

Juli 2006
9
IRIS - Zusatzforderungen

• 5.6 Management Review
• Planned intervals shall not exceed 12 months.
• 5.6.2 Review Input
• Key issues from previous project reviews
• Analysis of actual and potential field-failures
• KPI for customer on time delivery performance
• KPI customer non conformities for the entire life
  cycle

Juli 2006
10
IRIS - Zusatzforderungen

• 6.2.2.1 Product design skills
• The organisation shall ensure that personnel with
  the
• responsability for product design have the
  necessary
• compentence.
• Applicable tools and techniques shall be
  identified

Juli 2006
11
IRIS - Zusatzforderungen

• 6.2.2.2 Training
• The organization shall establish and maintain
  documented procedures for identifying and
  planning training needs
• Output of Knowledgemanagement activities (see
  section 4.3) shall taken into consideration as an
  input to training planning
• Personal performing specific assigned tasks (e.g.
  special processes) shall be qualified. A system
  shall be in place to maintain and upgrade the
  qualifications of such personal.
• Appropriate rules shall apply for temporary
  workers and new comers.
• Critical activities affecting the product quality
  and safety shall be identified
• Personal whose work can affect quality and safety
  shall be informed about the consequences to the
  customer of nonconformity to quality and safety
  requirements

Juli 2006
12
IRIS - Zusatzforderungen

• 6.2.2.3 Employee motivation and empoverment
• The organization shall motivate employees to
  achieve
• business, quality and safety objectives.

Juli 2006
13
IRIS - Zusatzforderungen

• 6.2.2.4 Performance management planning
• An appraisal system shall be established to
  regularly set
• individual objectives linked with business
  objectives and
• review the individual performance

Juli 2006
14
IRIS - Zusatzforderungen

• 6.3.2 Contingency plan
• The organization shall prepare contingency
• plans for utility interruptions, labour
  shortage,
• key equipement failure an field returns.

Juli 2006
15
IRIS - Zusatzforderungen

• 7.2.2 Review of Requirements related to the
  Product
• Multidisciplinary approach shall be used.
• Project Management and Design / Development must
• be appropriatly represented in all requirements
  reviews.
• The organisation shall ensure that the
  requirements are identified, negotiated,
  evaluated, understood and committed.
• Deficiencies identified in the review shall be
  managed.
• Risks shall be identified monitored and
  mitigated.
• The Reviews shall cover critical product
  characteristics, customer regulatory
• requirements, scope, time, cost, quality,
  resources, communication, risk, changes

Juli 2006
16
IRIS - Zusatzforderungen

• 7.3 Tender Management
• Prior to commitment to start the quotation
  process the
• organisation shall
• use a multidisciplinary approach to investigate
  customer regulatory requirememts, confirm and
  document the feasibility of the proposed products
  in the tender review and approve the offer,
  including planning,resources.
• ensure that the requirements are identified,
  negotiated, evaluated, understood and committed

Juli 2006
17
IRIS - Zusatzforderungen

• 7.4 Project Management
• The organisation shall implement a Project
  management or
• New Product Developement Process addressing the
• applicable areas of Project management (see
  7.4.ff),
• describing the roles and responsabilities,
  integrating all
• functions of the organization into a
  multidisciplinary team.

Juli 2006
18
IRIS - Zusatzforderungen

• 7.4.1 Integration Management
• An integrated project plan shall be developed
  reflecting the
• specific rules to follow whilst executing a
  project (e.g. multi
• site project, consortium) throughout the entire
  product life
• cycle, including project plan change control.

Juli 2006
19
IRIS - Zusatzforderungen

• 7.4.2 Scope Management
• The organization shall ensure that the entire
  scope of work
• is identified, subdivided in work packages,
  controlled and
• verified.
• Scope change shall be controlled and consistency
• guaranteed troughout the project and reflected in
  the
• project plan.

Juli 2006
20
IRIS - Zusatzforderungen

• 7.4.3 Time Management
• The organization shall ensure timely completion
  of the
• project through the identification of
• Specific activities
• Interactivity dependencies of the work package
• Activity sequences, resource requirements and
  duration
• Critical path
• These activities shall be regularly reviewed,
  controlled and recorded
• In case of imminent deviation the organization
  shall identify and implement
• appropriate counter measures to avoid impact on
  the customer. A change of
• the delivery schedule must be authorized by the
  customer.
• Project plan shall be regularly reviewed and
  updated

Juli 2006
21
IRIS - Zusatzforderungen

• 7.4.4 Cost Management
• The organization shall ensure the project is
  completed
• within the budget approved at the tender stage.
• A process shall be in place to regularly follow
  the cost
• progress on each work package and on each item of
  the
• total cost breakdown, including also the
  identification of
• estimate to completion.

Juli 2006
22
IRIS - Zusatzforderungen

• 7.4.5 Quality Management
• The organization shall ensure a process is in
  place to
• manage project deliverables (e.g. customer
  deliverables,
• milestones, product characteristics, etc. )
• As a mimimum the following tasks shall be
  managed
• identification, clarification, fulfilment and
  control
• Validation and delivery on time
• Approval by the customer (where required)
• Open issues shall be controlled
• Documented project reviews shall take place at
  regular intervals
• troughout the entire project life.
• Phase Reviews shall take place at predefined
  project phases /
• milestones

Juli 2006
23
IRIS - Zusatzforderungen

• 7.4.6 Human Resources Management
• Requirements in section 6 of this standard shall
  be
• deployed at the project team level. It shall
  cover as a
• minimum
• Identification, documentation and assignment of
  project
• roles, responsabilities and reporting
  relationships
• Acquisition of appropriate resources assigned to
  and
• working until project completion
• Developement of individual and group competencies
  to
• enhance project performance

Juli 2006
24
IRIS - Zusatzforderungen

• 7.4.7 Communication Management
• The organization shall ensure that the project
  team
• determines and communicates needs of the
  stakeholders.
• This information, including performance
  information, shall
• be made available to project stakeholders in
  timely manner.

Juli 2006
25
IRIS - Zusatzforderungen

• 7.4.8 Risk and Opportunity Management
• The organization shall ensure a systematic
  process is in
• place to identify, analyse and when necessary
  decide
• upon the risk response.
• The risk response or opportunity enhancement
  shall be
• recorded and reported to all stakeholders as
  appropriate.
• The effectiveness of the response plan shall be
  assessed
• on regular basis
• Output of the risk assessment shall be regularly
  reviewed
• and updated troughout the project execution

Juli 2006
26
IRIS - Zusatzforderungen

• 7.4.9 Change Management
• 7.4.9.1 General
• The organization shall have a process to control
  and react to changes
• that impact product realization.
• The effects of any change, including those
  changes caused by any
• supplier, shall be assessed and verification,
  validation and approval
• activities shall be defined, to ensure compliance
  with customer
• requirements before implementation.
• For proprietary designs, impact on form, fit and
  function shall be
• reviewed with the customer so that all effects
  can be propery
• evaluated.

Juli 2006
27
IRIS - Zusatzforderungen

• 7.4.9.1 General
• When required by the customer, additional
  verification /
• identification requirements, such as those
  required for new product introduction, shall be
  met.
• 7.4.9.2 Obsolescence Management
• The organization shall establish a process to
  ensure, for
• the defined and agreed product life cycle, the
  availability of
• the supplied products and spare parts.

Juli 2006
28
IRIS - Zusatzforderungen

• 7.5.1 Design and Development Planning
• The organization shall determine task sequence,
• mandatory steps, significant stages and method of
• configuration control

Juli 2006
29
IRIS - Zusatzforderungen

• 7.5.2 Design and Development Inputs
• The organization shall ensure new technologies /
• new products are valid before introduction into a
  
• customer project.
• This new technology / new product development
• shall apply the design and development
• requirements described in section 7.5.2
• RAMS and LCC shall be taken into account

Juli 2006
30
IRIS - Zusatzforderungen

• 7.5.3 Design and Development Outputs
• The production process input (design output)
  shall include
• Specifications and drawings
• Information on materials
• Production process flow chart
• P FMEAs
• Control plan
• Work instructions
• Process and product acceptance criteria
• Data for quality, measurement, reliability,
  maintainability, etc.
• Results of error proofing activities
• Methods of rapid detection and feedback of
  product and process NCs

Juli 2006
31
IRIS - Zusatzforderungen

• 7.5.4 Design and Development Review
• At suitable stages, systematic reviews of design
  and
• developement shall be performed in accordance
  with the
• planned arrangements

Juli 2006
32
IRIS - Zusatzforderungen

• 7.5.6 Design and Development Validation
• Design and development validation shall be
  demonstrated
• for all identified operatinal conditions.
• Where tests are necessary for verification and
  validation, these tests
• shall be planned, controlled, reviewed and
  documented to ensure and
• prove the following
• test plans
• Test procedures
• correct configuration
• Requirements of test plan
• Acceptance criterias

Juli 2006
33
IRIS - Zusatzforderungen

• 7.5.8 First Article Inspection (FAI)
• The organization shall provide a documented
  procedure
• defining the inspection, verification, and
  documentation of a
• representative item from the first production run
  of a new
• part, or following any subsequent change that
  invalidates
• the previous first article inspection result.
• FAI shall be performed subsequently to the
  verification of
• the production process.
• This FAI procedure shall also be applied to
  suppliers

Juli 2006
34
IRIS - Zusatzforderungen

• 7.6 Configuration Management
• The organization shall establish, document and
• maintain a configuration management process
• appropriate to the product, this shall include
• Define a list of products including their parts,
  the
• configuration of which must be managed. This
  list shall be approved be the customer
• Adress configuration management within change
• management process
• Maintain traceability during production and
  operations

Juli 2006
35
IRIS - Zusatzforderungen

• 7.7 Purchasing
• 7.7.1 Purchasing Process
• The organization shall
• Maintain a register of approved suppliers with
  includes the scope of
• their approval.
• Ensure that all suppliers use customer approved
  special processes.
• Ensure that the function for supplier quality
  systems has the authority to
• reject the use of sources

Juli 2006
36
IRIS - Zusatzforderungen

• 7.7.1 Purchasing Process
• The organization shall
• Develop suppliers with the goal of improving
  supplier operational
• performance.
• suppliers shall be third party registered to ISO
  9001 2000 by an accredited third party
  certification body (otherwise specified by the
  customer)
• The organization shall implement a system to
  ensure the quality of all
• products purchased from suppliers.
• .

Juli 2006
37
IRIS - Zusatzforderungen

• 7.7.2 Purchasing Information
• The organization shall
• Ensure that the suppliers offer is selected only
  after thorough prior negotiation. The negotiation
  shall take into account
• level of compliance with the purchasing
  information
• the total cost requirements (incl. LCC)
• previous product quality, costs and delivery
  performance
• Purchasing information shall also include p.e.
  name of specifications, requirements for design
  and test, approval process, This informations
  (where applicable) shall be documented seperately
  in the contract / purchase order.

Juli 2006
38
IRIS - Zusatzforderungen

• 7.7.3 Supply chain management
• Supplier deliveries shall be scheduled in order
  to meet the purchasing requirements.
• Ordering shall be supported by an information
  system covering the whole supply chain.
• The organization shall communicate a forecast to
  ist suppliers.
• Suppliers shortages shall be identified and
  communicated to the organization. Actions shall
  be established to recover the delivery schedule.

Juli 2006
39
IRIS - Zusatzforderungen

• 7.7.4 Verification of purchased product
• Verification activities shall include
• Obtaining objective evidence of the quality of
  the product from the suppliers.
• Inspection and audit at the suppliers premises
• Review of the required documentation
• Inspection of products upon receipt
• Delegation of verification to the supplier

Juli 2006
40
IRIS - Zusatzforderungen
7.7.4 Verification of purchased product The
purchased product shall not be used or processed
until it has been verified as conforming to the
specified requirements. The organization shall
periodically verify test reports for raw
material. In case of delegation of verification
activities the requirements for delegation shall
be defined.
Juli 2006
41
IRIS - Zusatzforderungen
7.8 Production and service provision 7.8.1 Prod
uction scheduling Production (including test
equipement) shall be scheduled (short-, mid- and
long term) in order to meet the purchase
requirements. The organization shall use custome
forecast and orders to plan capacity and
resources. Bottlenecks in the production shall
be identified an improvement action plan
established.
Juli 2006
42
IRIS - Zusatzforderungen

• 7.8.1 Control of production and service provision
• Controlled conditions shall include
• Accountability for all products during
  manufacturing (e.g. parts, quantities, spilt
  orders, nonconforming product)
• Evidence that all manufacturing and inspection
  operations have been completed as planned

Juli 2006
43
IRIS - Zusatzforderungen

• 7.8.2.1 Production documentation
• Production operations shall be carried out in
  accordance with approved datas like
• drawings, parts lists, process flow charts,
• tooling lis and numerical control (NC) machine
  programs,

Juli 2006
44
IRIS - Zusatzforderungen

• 7.8.2.2 Control of production process change
• The organization shall
• Establish, document and maintain a process to
  control production process changes.
• Responsabilities to approve changes shall be
  identified.
• The organization shall identify and obtain
  acceptance of changes that require customer and /
  or regulatory authority approval.
• Changes affecting processes, production
  equipement, tools and programs shall be
  documented.

Juli 2006
45
IRIS - Zusatzforderungen

• 7.8.2.3 Maintenance of equipement and tools
• Production equipement, tools and programs shall
  be validated prior to use and maintainted an
  inspected periodically according to documented
  procedures.
• Storage requirements, including periodic
  preservation / condition checks, shall be
  established for production equipement or tooling
  storage.
• Validation prior to production use shall include
  also verification of first article.

Juli 2006
46
IRIS - Zusatzforderungen

• 7.8.2.3 Validation of processes for production
• and service provision
• Special processes shall be managed according to
  contractual and / or internal requirements.
• A process shall be established for the control of
  this special processes including qualification
  and approval of the process prior to use.

Juli 2006
47
IRIS - Zusatzforderungen

• 7.8.6 Preservation of product
• The organization shall ensure that the product
  documentation required by the contract / order
  is present at delivery and is protected against
  loss and deterioration.

Juli 2006
48
IRIS - Zusatzforderungen

• 7.9 Commissioning / customer service
• Where field service is a specified requirement,
• processes shall provide for
• Actions to be taken where problems are
  identified after delivery,
• including investigation, reporting activities
  and actions on service
• informations
• The control and updating of technical
  documentation
• The Approval, control and use of repair
  schemes
• The organization shall demonstrate the adequate
  customer support during commissioning and
  warranty until complete product validation and
  final customer acceptance
• Suitable resoucre shall be available
• Maintenenance contracts shall be managed

Juli 2006
49
IRIS - Zusatzforderungen

• 7.10 RAMS / LCC
• The organization shall have
• Documented procedure to cover all aspects of RAMS
• Process in place to manage LCC
• Resource shall be in place to address the RAMS
  and LCC requirements
• RAMS / LCC data collection and analysis shall be
  supported by return of experience from operation
  and after warranty period

Juli 2006
50
IRIS - Zusatzforderungen

• 7.11 Control of monitoring and measuring
• devices
• The organization shall
• Maintain a register of these monitoring and
  measuring devices and define the process employed
  for their calibration including details of
  equipement type, unique identification, location,
  frequency of checks, check method and acceptance
  criteria.
• Ensure ambient conditions are suitable for the
  carrying out of the calibration, inspection,
  measurement and testing.

Juli 2006
51
IRIS - Zusatzforderungen

• 8.2.2 Internal Audit
• The organization shall audit all processes of ist
  management system to verify compliance with all
  requirements.
• The auditprogramm shall cover all production
  shifts.

Juli 2006
52
IRIS - Zusatzforderungen

• 8.2.3 Monitoring and measurement of processes
• Each process identified as such in these
  requirements shall be supported be key
  performance indicator (KPI)

Juli 2006
53
IRIS - Zusatzforderungen

• 8.2.4 Monitoring and measurement of product
• Measurement requirements for product or service
  acceptance shall be documented and include
• criteria for acceptance and / or rejection
• where in the sequence measurement and testing
  operations are
• performed
• a record of the measurement results
• Type of measurement instruments
• Test records shall show actual test results data
  when required by specification or acceptance
  plan.

Juli 2006
54
IRIS - Zusatzforderungen

• 8.3.2 Customer waiver
• Whenever the product or production process differ
  from that which is currently approved, the
  organization shall obtain a customer concession
  or deviation permit prior to further processing.
• Records of the expiration date of such
  concessions shall be maintained.
• Material shipped under concession conditions
  shall be clearly and appropriate identified.
  These aplies also to purchased products.

Juli 2006
55
IRIS - Zusatzforderungen

• 8.4 Control of nonconforming processes
• A process shall be in place to
• identify, record the non conformity and take
  appropriate
• action to correct the non conforming process
• evaluate whether the process non conformity has
  
• resulted in product non conformity

Juli 2006
56
IRIS - Zusatzforderungen

• 8.6.3 Corrective Action
• The procedure shall define requirements to
  document the effectiveness and close out of
  corrective action.

Juli 2006