Iso Redifined

IRCLASS/ISO9001 : 2015/IQA/2015/R0
AWARENESS TRAINING PROGRAM
On
IATF 16949 2016
Development Process of ISO standard
Final
Draft
Proposal Committee Int.
Stage Draft (CD) Std
Working Draft
Draft International
(WD) Std Publication
of ISO
standard
ISO9001 Editions
1987 1994 Preventive 2000 Process 2008 Process 2015 Risk

Procedure Action Approach Approach Management
ISO/TS 16949 Editions
2009 3rd 2016 – 4’th

Edition – Edition –
1999 – 1st 2002 2nd Alignment IATF 16949
QS 9000
Edition Edition with ISO based on
9001: Risk
Management
2008
ISO9001:2015 Transition Plan
IATF 16949 Transition Plan
Introduction
1. Scope
2. Normative references
3. Terms and definitions
4. Context of the organization
5. Leadership
6. Planning
7. Support
8. Operation
9. Performance evaluation
10. Improvement
PDCA
establish the objectives of the

system and its processes, and the
resources needed to deliver results
in accordance with customers’
requirements and the organization’s
policies, and identify and address
risks and opportunities;
take actions to improve implement what was

performance, as necessary. planned;
monitor and (where applicable)

measure processes and the
resulting products and services
against policies, objectives,
requirements and planned
activities, and report the results;
PDCA
11
IATF 16949 – Main clauses
4 Context of 9 10
5 8
the 6 Planning 7 Support Performance Improvem
Leadership Operation
organization evaluation ent
8.1 Operational
5.1 7.1 Resources planning and 9.1
4.1
Leadership control Monitoring,
Understan
and 6.1 measurement,
ding the
commitment Actions to analysis and
organizati
address 8.2 evaluation
on and its 7.2 Competence
context risks and Requirements 10.1
opportunit for products General
ies and services
5.2 Policy 7.3 Awareness

4.2 8.2 9.2 Internal
Understan Requirements audit
ding the for products
needs and and services
7.4
expectatio Communication
ns of 8.3 Design and
interested 6.2 Quality development of
parties 5.3 objectives products and 9.3
Organizatio and 7.5 Documented services Management
nal roles, planning information review
responsibilit to achieve 10.2
4.3 ies and them 8.4 Control of Nonconfo
Determini authorities externally provided rmity and
processes, products
ng the and services
corrective
scope of action
the quality
manageme 8.5 Production
nt system and service
6.3 provision
Planning
of changes
4.4 Quality 8.6 Release of
manageme products and
nt system services 10.3
and its Continual
processes improve
ment
8.7 Control of
nonconforming
IRCLASS/ISO9001 : 2015/IQA/2015/R0 outputs
IATF 16949 2016
“shall” indicates a requirement;

“should” indicates a recommendation;
“may” indicates a permission;
“can” indicates a possibility or a capability.
“NOTE” is for guidance in understanding or

clarifying the associated requirement.
Risk
effect of uncertainty.
An effect is a deviation from the expected — positive or

negative.
Uncertainty is the state, even partial, of deficiency of

information related to, understanding or knowledge of, an
event, its consequence, or likelihood.
Risk is often characterized by reference to potential events and

consequences or a combination of these.
Risk is often expressed in terms of a combination of the

consequences of an event (including changes in circumstances)
and the associated likelihood of occurrence.
Opportunities
Situation Favourable to achieve an objective.
A positive deviation arising from Risk Can Provide opportunities.
Risk Based Thinking
...was implicit in the ISO/TS 16949 2009
Preventive action to prevent occurrence of the potential
nonconformities.
Taking action to prevent recurrence of the nonconformities.
Determine Risk
Plan & Implement Actions to
reduce negative effect
Improve the Effectiveness of QMS
Improve product
Improve Process
Determine Opportunities
Plan & Implement Actions to encash
opportunities
Improve the Effectiveness of QMS
Improve product
Improve Process
Normative Terms &
Scope
Reference Definitions
IATF 16949 2016 requirements are generic.
By implementing the requirements Organization can demonstrate
•Consistent Products & Services
•Meeting Legal Requirements
•Enhance Customer satisfaction
Context of the organization
Clause 4 - Key terms/Requirements
• Organization and its context
• Internal issues
• External issues
• Interested parties
• SCOPE of the QMS, CSR Shall be part of
QMS.
• Documented Product safety management
process – definition of escalation process
and flow of information ,including Top
management.
Leadership
• Leadership
• Accountability
• Promoting risk based thinking
• Engaging
• Business processes
• Corporate responsibility – define and implement
– Anti bribery policy,
– Employee code of conduct and
– Ethics escalation policy.
• Customer focus (risk to customer)
• Establish, Implement, maintain and communicate the
Quality Policy
• Ensure that responsibilities and authorities are
communicated and understood within the organization
Planning
• Determine risks and opportunities
• Actions to address risks and opportunities
• Risk analysis
• Evaluate the effectiveness of the actions
• Contingency plan – notification process, test
the contingency plan for effectiveness,
contingency plan reviews minimum
annually,
• Establishment of annual quality objectives –
time frame
• Planning of Changes (MOC)
Support
• Assessments of manufacturing feasibility and
evaluation of capacity planning shall be inputs
to MRM
• Monitoring and measuring resources
• Organization knowledge
• Internal auditor competency
• Second party auditor competency
• Quality manual
• Record retention policy..PO, PPAP, Design
Record, Tooling
• Engineering Specifications review should be
completed within 10 working days
Operation
• Review consequences of unintended changes, taking
action to mitigate any adverse effects
• Confidentiality
• Organization can meet claims for products and
services offered
• Determining requirement for products – Recycling,
environmental impact, disposal of material….
• Design planning – organization shall consider level of
control expected for D & D process by customer and
relevant interested party
• Development of products with embedded software
• Product design input – assessment of risk with the
input requirements and the organizations ability to
mitigate/manage risks , including from the feasibility
analysis
Operation
• Product design input – Targets for health
and safety
• Organization shall take into consideration
effectiveness of the controls applied by
external provider
• Selection of supplier shall include – an
assessment of the selected suppliers risk to
product conformity and an uninterrupted
supply of products to the customers
• Evaluation of suppliers QMS
• Financial stability
• Business continuity
Operation
• Legal requirement – Country of receipt,
country of shipment and country of
destination
• Supplier QMS – Certificate from
Accreditated certifying body
• Second party audits – to cover supplier
risk assessment
• Family control plans are acceptable for
similar parts
• Verification after shutdown
Operation
• Total Productive maintenance – Periodic
Overhaul – MTTR/MTBF/OEE
• Property belonging to Customers and External
providers
• Post delivery activities – nature, use and
intended lifetime of its products and services.
• Control Of changes
• Temporary change of process control.
• Control of nonconforming outputs.
• Control of suspect/rework/repaired product
• Non conforming product disposition.
Performance evaluation
• Prioritization
• All QMS processes shall be audited
over each three year calendar period
• MRM at least annually
Improvement
• Organization shall determine and
select opportunities for
improvement.
• Challenge parts
• No trouble found
Core Tools
• FMEA
• MSA
• PPAP
• SPC
• APQP
• Knowledge of core tools is a must for
internal auditors.
Customer specific
requirements
• All internal auditors must be aware
of CSRs
• CSR must be audited at specific
functions during internal audits
Legal Requirements
• All internal auditors must be aware
of the legal requirements.
• Legal requirements must be audited
at appropriate functions in internal
audits
WAY FORWARD>>>>>>>>>
Develop an implementation plan and

timetable
Provide appropriate training for all

parties
Update existing quality management
system Documentation
One Round Of IQA and MRM
Involve IRQS...

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IRCLASS/ISO9001 : 2015/IQA/2015/R0

AWARENESS TRAINING PROGRAM

IATF 16949 2016

1987 1994 Preventive 2000 Process 2008 Process 2015 Risk

2009 3rd 2016 – 4’th

establish the objectives of the

take actions to improve implement what was

monitor and (where applicable)

5.2 Policy 7.3 Awareness

“shall” indicates a requirement;

“NOTE” is for guidance in understanding or

An effect is a deviation from the expected — positive or

Uncertainty is the state, even partial, of deficiency of

Risk is often characterized by reference to potential events and

Risk is often expressed in terms of a combination of the

Situation Favourable to achieve an objective.

A positive deviation arising from Risk Can Provide opportunities.

IATF 16949 2016 requirements are generic.

By implementing the requirements Organization can demonstrate

•Consistent Products & Services

•Meeting Legal Requirements

•Enhance Customer satisfaction

Develop an implementation plan and

Provide appropriate training for all

One Round Of IQA and MRM

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