ASQ Presentation FCG November 2017

IATF 16949:2016
Application in Organizations
FCG All rights reserved

1
About FCG
 International consulting and training since 2000
 Working with major automotive organizations

worldwide, such as GE, Magna, Ternium and many others
 Specializing in QMS, EMS, H&SMS
 Integrated Management Systems, Risk Assessment,

Internal Audits, Problem Solving
FCG All rights reserved 2

We Will Cover
 What is New in IATF 16949 (former ISO/TS 16949)
 Integration with EMS
 Key Points in Customer Specific Requirements
 What Does it Mean for Your Organization

IATF 16949:2016 Based
on ISO 9001:2015
 ISO 9001:2015 is a global Quality Management System

standard which can be applied anywhere
 IATF 16949:2016 is a standard specific to Automotive

Industry which includes all the requirements of ISO
9001 + additional requirements unique to the
Automotive

4
Annex SL
 ISO 9001:2015 and ISO 14001:2015 are based on

Annex SL, which is a common structure for all new and
revised standards
 It means that various schemes can now be easily

integrated

Definitions
Site – location at which value-added manufacturing
processes occur
Support Function – non-production activity (conducted

on site or at a remote location) that supports one (or
more) manufacturing sites of the same organization

Remote Locations
 Both sites and remote locations have to be audited
 Remote locations are to be audited before the site, and

within 90 days window
 Transition audits must include all support functions,

both remote and on site
 CBs are required to include evidence of linkages

between supporting functions and site’s processes

Changes in Clauses /
Requirements
 There are total of 96 differing (13 new / 83 changed)
requirements in IATF 16949 compared to the previous
standard revision
 Becoming compliant will require significant amount of

work / updates

How to Use the Latest
Standards
 Level 1 – ISO 9001:2015
 Level 2 – IATF 16949:2016
 Level 3 – Customer Specific Requirements (Ford, GM,

FCA)

In the New Standard
Revisions
 Less focus on “documented procedures”
 More focus on risk management
 More focus on value added to the company

10
Main Areas of Change
ISO 9001/ ISO 14001
 4.1 Understanding the Organization and Its Context
 4.2 Understanding the Needs and Expectations of

Interested Parties
 5.1 Leadership and Commitment
 5.2 Quality / Environmental Policy
 6.1.1 Actions to Address Risks and Opportunities
11
IATF
 4.3.2 Customer Specific Requirements
 4.4.1.2 Product Safety
 5.1.1 Corporate Responsibility
 5.1.1.3 Process Owners
 6.1.2.3 Contingency Planning (more detailed)
 8.2.2.3 and 8.4.2.3.1 Embedded Software

IATF – Cont.
 8.4.3.1 Requirements Pass to External Providers (SC,
legal requirements etc.)
 8.5.1.5 TPM
 8.5.1.4 Post Shutdown Protocols
 8.6.6.1.1 Temporary Change of Process Controls
 8.6.5 Externally Provided Products – Legal requirements
in the Country Manufactured
 10.2.5 Warranty Management
KEY CHANGES IN
STANDARD
REQUIREMENTS
EXPLAINED

Clause 4
Context of the
Organization

15
4.1 Understanding the
Organization and Its
Context
Combination of internal and external issues that can have
an effect on organization’s approach to developing and
achieving its objectives

Context
 Context of the organization is also referred to as
“business environment”
 Internal and external issues can include positive and

negative factors
 This information must be monitored on an ongoing

basis and revised if any changes occur

Organization and Its Context
External issues may include legal, technological,
competitive, market, cultural, social and economic
environment

Context
 Internal sources guidance – corporate policies and
directives, customers, external providers, organizational
structure, technological capabilities
 External sources guidance – laws (including

international), standards, industry analysis, media
reports, community groups

Context
Context of the Organization is typically a top level

document and should be reviewed in detail and approved
by Senior Site Management

Needs and Expectations
of Interested Parties
 Part of the process for understanding the context of

the organization is to identify its interested parties
 It is very important to include all relevant interested

parties, which extend beyond just the customers

Interested Parties
Definition
Person or organization that can affect, be affected by, or
perceive themselves to be affected by a decision or
activity

22
Examples of Interested
Parties
 Company share holders
 Customers
 Consumers
 Employees
 External Providers
 Neighbors / Community
 Insurance Companies
 Legal Bodies

4.3 Determining the
Scope of the
Management System
 Based on the context of the organization, as well as
needs and expectations of relevant interested parties
 May include the entire organization, or certain sections
 May be one or more functions across a group of

organizations

4.3 Determining the
Scope of the
Management System
 The only permitted exclusion is 8.3 Product Design
(justification required)
 Scope is documented, and includes all products and

services

Scope IATF
Supplemental
 Any supporting functions (corporate, remote)
must be identified in the scope
 May include sales, design and development,

procurements, HR, warehousing etc.
 Applicable Customer Specific Requirements

must be included in the scope

26
4.4 Quality Management
System
Management System comprises of system processes:
 Inputs and outputs of these processes

 Their sequence and interaction
 Criteria and methods for effective operation
 Resources, responsibilities / authorities
 Risks and opportunities
 Evaluation and improvement

System
 Documented information is required to support

operation of system processes
 And to have confidence that the processes are carried

out as planned

IATF Additional Requirements
 4.4.1.1 All products and processes must meet all

applicable customer, statutory and regulatory
requirements
 Includes service parts and outsourced processes
 4.4.1.2 Documented processes for the management of

all product-safety related products and manufacturing
processes

29
4.4.1.2 Product Safety
 Defined responsibilities, escalation process and flow of

information up to Top Management
 Customer notification
 Training requirements
 Lessons learned

System
 Typical evidence for documented information is an
overall process map (including linkages with remote
processes), as well as individual process map for each
system process
 Examples of system processes are: Manufacturing,

Engineering, Logistics, HR, Purchasing, Maintenance etc.

Clause 5
Leadership

32
5.1 Leadership and
Commitment
 Top Management is now accountable for system
effectiveness
 Policy and objectives are established in line with the

context of the organization
 Integration is now a requirement
 Promote process approach and risk-based thinking
 Ensure that QMS achieves its intended result

5.1 Leadership and
Commitment
Accountability implies that Top Management is deeply
involved in system design and performance
Quality Department is no longer solely involved with the

QMS, it is distributed amongst the Process Owners

5.1.1.1 Corporate Responsibility

Corporate policies must include at a minimum:
 an anti-bribery policy
 an employee code of conduct
 ethics escalation policy
 Ford has additional requirements on 5.1.1.1

35
5.1.1.2 Process Effectiveness and Efficiency
 Product Realization and support processes must be

reviewed by Top Management to evaluate and improve
their effectiveness and efficiency
 Results become input to Management Review

36
5.1.1.3 Process Owners
 Process owners for managing processes and related

outputs must be identified by Top Management
 Process owners must be competent in their roles

37
5.1.2 Customer Focus
Top Management must demonstrate leadership and

commitment with respect to customer focus
 Understanding customer and legal requirements
 Performing analysis of risks and opportunities
 Focus on enhancing customer satisfaction

5.2.1 Developing the Q/E
Policy
 Policy must be appropriate to the purpose and
context of the organization
 Framework for setting objectives
 Commitment to satisfy applicable requirements
 Commitment to Continual Improvement of the system

5.2.2 Communicating the
Policy
 Available and maintained as documented
information
 Communicated, understood and applied within the
organization
 Available to relevant interested parties, as
appropriate

40
5.3 Organizational Roles,
Responsibilities and
Authorities
 Top Management must ensure that responsibilities and
authorities are assigned, communicated and understood
 This includes maintaining the integrity of the QMS when

changes are planned and implemented

Ford CSR
The organization shall notify Ford Motor Company

Supplier Technical Assistance in writing within 10 working
days of any changes to senior management responsible for
Product Quality or company ownership

Assign responsibilities for personnel involved in:
 selection of special characteristics

 setting quality objectives and related training
 corrective and preventive actions
 product design and development
 capacity analysis
 logistics information
 customer scorecards and portals

 Personnel with authority to stop

shipment and production to correct
quality problems
 Personnel with authority and responsibility

for corrective actions is immediately
notified to ensure shipment is contained
 Production operations across all shifts are

stuffed with personnel in charge

44
5.3 Organizational Roles,
Responsibilities and
Authorities
 Please note that there is no longer a requirement for
“Management Representative”
 Important to remember that not only “roles and

responsibilities”, but also “authorities” need to be
defined and communicated / understood

Clause 6
Planning

46
6.1 Actions to Address
Risks and Opportunities
 Consider context of the organization and needs
and expectations of interested parties
 Determine the risks and opportunities that need to

be addressed

6.1 Actions to Address
Risks and Opportunities
Options to address risks and opportunities are:
 avoiding risk
 taking risk in order to pursue an opportunity
 eliminating the risk source
 changing the likelihood
 sharing the risk
 retaining the risk by informed decision

48
6.1.2.1 Risk Analysis
At a minimum, risk analysis must include lessons learned

from the following sources:
 product recalls
 product audits
 field returns and repairs
 complaints
 scrap and rework

49
6.1.2.2 Preventive Action
 Implement actions to eliminate the causes of potential

nonconformities
 Appropriate to the severity of the potential issues
 Documented information is required

50
6.1.2.3 Contingency Plans for:
 key equipment failure

 interruption from externally provided
products, processes and services
 natural disasters
 fire
 utility interruptions
 labor shortages
 infrastructure disruptions

6.1.2.3 Contingency Plans
 notification process to the interested

parties
 periodic testing of the plans
 review annually as a minimum
 documented information / revisions /
persons authorizing the changes

The contingency plans must include provisions to validate

that product continues to meet customer specifications
after the re-start of production following an emergency,
when production was stopped and the regular shutdown
processes were not followed

6.2 Objectives and
Planning to Achieve Them
 Established at relevant functions, levels and processes
 Consistent with the policy
 Take into account applicable requirements
 Relevant to conformity of products, services and
customer satisfaction
 Measurable, monitored, communicated and updated
 Documented

6.2 Objectives and
Planning to Achieve Them
Much more prescriptive with the new standard revision
Required to determine:
 what will be done

 resources required
 responsible
 when completed
 how the results will be evaluated

6.2.2.1 Quality Objectives
 Top Management must ensure quality objectives

meeting customer requirements are defined,
established and maintained
 Established and reviewed at least annually

6.3 Planning of Changes
Changes needed by the organization are carried out in a
planned and systematic manner, considering:
 purpose of the changes and their potential

consequences
 integrity of the System
 availability of resources
 allocation and reallocation of responsibilities and
authorities

57
Clause 7
Support

58
7.1 Resources
7.1.1 General
 Determine and provide the resources needed for the

QMS, including establishment, implementation,
maintenance and continual improvement
 Consider capabilities of existing internal resources,

constraints on existing resources, what needs to be
obtained from external providers

7.1 Resources
7.1.2 People
 Provide the people necessary for the effective

implementation of the QMS and for the operation and
control of its processes and to achieve product or service
conformity
 New requirement – self explanatory??

7.1 Resources
7.1.3 Infrastructure
 Determine, provide and maintain the infrastructure for

the operation of processes to achieve conformity
 Infrastructure includes buildings, utilities, equipment

(hardware and software,) transportation, IT

7.1.3.1 Plant, Facility and Equipment Planning
 multi disciplinary approach

 plant layout design – optimize material flow
 methods to evaluate manufacturing feasibility for new
products and operations, including capacity planning

62
7.1.3.1 Plant, Facility and Equipment Planning – cont.
 process effectiveness to incorporate changes, Control

Plan maintenance and verification of job set ups
maintained
 feasibility / capacity reviews are input to management
review
 application of Lean Manufacturing principles

63
7.1 Resources
7.1.4 Environment for the Operation of Processes
 Determine, provide and maintain the environment

necessary for the operation of processes
 Environment includes physical, social and

psychological

7.1.4.1 Environment Supplemental
Premises must be maintained in a

state of order, cleanliness and repair
that is consistent with the product
and manufacturing process needs

65
7.1.6 Organizational
Knowledge
 Determine what knowledge is needed to operate
processes and achieve product conformity
 Knowledge is maintained and made available as
necessary
 Part of change management, consider how to obtain
additional knowledge

66
7.1.6 Organizational
Knowledge
 This is a new and very practical requirement
 Many times when people leave, decades of knowledge

they have accumulated are lost by the organizations
 The key, as part of risk assessment process, is to extract

and document this knowledge

7.2.2 On-the-job Training
 Provided to personnel with new or modified

responsibilities
 Applies to temporary personnel
 Level of details corresponds to level of education
of trained personnel
 Persons whose work can affect quality must be
informed regarding the consequences of nonconformity
to customer requirements

7.2.3 Internal Auditor Competency
 Documented processes to verify that internal

auditors are competent
 List of qualified internal auditors, including

manufacturing process and product auditors
 Competencies include automotive process

approach, CSR, IATF requirements, core tools
and how to plan, conduct, report and close out
audit findings
7.2.3 Internal Auditor Competency – Cont.
 Manufacturing process auditors must demonstrate

understanding of processes, including Control Plans and
FMEAs
 Product auditors must demonstrate understanding of

product requirements and test equipment
 Auditors’ training records maintained
 Define competency requirements – minimum number

of audits per year, knowledge of relevant requirements
based on internal and external changes
7.2.4 Second Party Auditor
Competency
 Second party auditors must

meet customer specific
requirements for auditor
qualification and demonstrate
all core competencies for
internal auditors

7.3 Awareness
People working under the organization’s control have to
be aware of:
 the quality policy

 relevant objectives
 their contribution to the effectiveness of the QMS,
including benefits of improved performance
 the implications of not conforming with the
System requirements

7.4 Communication
The requirement is more prescriptive in the new revision
Determine for both internal and external communication:
 what it will communicate

 when
 with whom
 how
 who

 7.5.1.1 Quality Management System Documentation
 Quality Manual which can be a series of documents
 Structure is dependent upon the size, culture and

complexity of the organization
 If series of documents is used, a list of documents that

make up the Quality Manual is required

7.5.1.1 Quality Management System Documentation –
cont.
 Quality Manual includes the scope of the QMS, including
justification of any exclusions
 Documented processes established for the QMS, or
reference to them
 Sequence and interaction of processes, including any
outsourced processes
 Document (i.e. matrix) indicating where within
the QMS customer specific requirements are
addressed

Documented Information
Documents and records in the previous revision are now

replaced with documented information
“maintain” = document
“retain” = record

7.5.3.2.1 Record Retention
 Document record retention policy that satisfies all

statutory, regulatory, organizational and customer
requirements
 PPAP approvals, tooling records, product and process design

records, PO, contracts and amendments must be maintained
for the length of time the product is active plus one calendar
year
 GM CSR require that certain records shall be maintained for

50+ years

 7.5.3.2.2 Engineering Specifications
 Documented process for review, distribution and

implementation of all customer engineering standards /
specifications and related revisions
 Records of when each change is implemented in

production, including updates to all relevant documents
 Review of each change must be completed within 10

days of receiving the change notification

Clause 8
Operation

79
8.1 Operational Planning
and Control
 This requirement is essentially aligned with the APQP
process
 Required to keep documented information to have
confidence that the processes have been carried out as
planned, and demonstrate conformity of products and
services to requirements
 Control planned changes and review consequences of
unplanned changes
 Ensure that outsourced processes are controlled

Outsourced Processes
An external organization that provides the outsourced

process is outside of the scope of the QMS, but the
outsourced function or process is within the scope

81
8.1.1 Operational Planning and Control – Supplemental
The following must be included:

 customer product requirements and technical
specifications
 logistics requirements
 manufacturing feasibility
 project planning
 acceptance criteria

8.1.2 Confidentiality
The confidentiality of customer-contracted products and

projects under development, including related product
information, must be ensured

8.2.1.1 Customer Communication – Supplemental
 All written and verbal communication must be

in the customer agreed language
 Must be able to communicate in a customer-specified

computer language and format

8.2.2.1 Determining the Requirements – Supplemental
 Includes recycling, environmental impact and
characteristics identified as a result of the
organization’s knowledge of the product and
manufacturing process
 All applicable government, safety and
environmental regulations related to acquisition,
storage, handling, recycling, elimination or
disposal of materials
 Integration!!!

85
Environmental
 Establish controls for transportation or delivery, use,

end-of-life treatment and final disposal of products and
services
 Ensure environmental controls are in place for external

providers of products and services

8.3. Design and
Development of Products
and Services
 Requirements for design and
development have been significantly
expanded
 If your site holds product design
responsibility, updates are required
 Product design is also part of life
cycle assessment for Environmental
System

8.3.1.1 Design and Development – Supplemental
 Design requirements apply also to manufacturing

process design
 The design and development process must be

documented

88
8.3.2.2 Product Design
Skills
Personnel with product design
responsibility must be competent
in achieving design requirements
and are skilled in product design
tools and techniques, as defined
by the organization

89
8.3.2.3 Development of
Products with Embedded
Software
 Software development assessment methodology must
be used to assess the process
 Documented information on the software

development capability self assessment
 Software development must be included within the

internal audit program scope

90
8.3.3 Design and
Development Inputs
 Functional and performance requirements
 Information from similar designs
 Statutory and regulatory requirements
 Codes of practice
 Potential consequences of product or service
failure
 Targets for conformity including preservation, reliability,
durability, serviceability, HSE, development timing and
cost (IATF Supplemental)

8.3.3.2 Manufacturing Process Design Inputs
Include:
 Product design output, including special characteristics
 Targets for productivity, process capability, timing and
cost
 Manufacturing technology alternatives
 Customer requirements
 Previous experience
 New materials
 Product handling and ergonomics
 DFM / DFA
 Appropriate error proofing methods

8.3.4.3 Prototype Program
 Prototype program and Control Plan

(as required by customer)
 If possible, use the same tooling,
suppliers, manufacturing processes as
production
 Monitor for timely completion and
conformance to requirements
 Outsourced processes controlled as
well

8.4 Control of Externally
Provided Processes,
Products and Services
Determine controls to be applied when:
 Products and Services are provided by external

providers for use in the organization’s own products
and services
 Products and services are shipped direct to the

customer by external provider on behalf of the
organization
 A process or part of a process is provided by an

external provider as a result of a decision taken by the
organization FCG All rights reserved 94
8.4.1.1 General Supplemental
 All products and services that affect customer
requirements must be included in the scope of
externally provided products, processes and services
 Examples – sub-assembly, sequencing, sorting, rework,

calibration

8.4.1.2 Supplier Selection Process

Documented process, including:
 risk assessment
 quality and delivery performance
 supplier QMS evaluation (as well as EMS)
 multidisciplinary decision making
 assessment of software capabilities, if applicable

8.4.1.2 Supplier Selection Process
Should be considered:
 volume of automotive business

 financial stability
 product complexity and technology
 resources and capabilities
 change management
 business continuity planning
 logistics and customer service

Managing Suppliers
8.4.2 Type and Extent of Control

Choose controls based on effect to the process, products
and/or services of the organization
8.4.2.1 Supplemental
Documented process for control of outsourced
processes and to escalate / reduce controls based on
supplier performance
Note – all customers have detailed additional

requirements on managing suppliers
Managing Suppliers
8.4.2.2 Statutory and Regulatory Requirements
 Documented process of ensuring statutory and

regulatory requirements are followed in country of
receipt, shipment and destination
 Follow special controls that are defined

8.4.2.3 Supplier QMS Development
Suppliers must be certified to ISO 9001 with the aim of

becoming certified to IATF 16949, unless otherwise
authorized by the customer

8.4.2.4.1 Second Party Audits
Documented process, which includes as a minimum:
 2nd party audit process must be included in the supplier

management approach
 criteria for determining the need, type, frequency and
scope of 2nd party audits documented
 records of 2nd party audits retained
 follow automotive process approach

101
8.5.1.2 Standardized Work
Includes operator safety and language needs of operators
8.5.1.3 Verification of Job Set-ups

Last-off comparison now required
8.5.1.4 Verification After Shutdown (new)

Verification of product conformance after planned or
unplanned shutdown

8.5.1.5 Total Productive Maintenance (new)
 OEE
 MTBF – mean time between failures
 MTBR – mean time to repair

8.5.1.6 Management of Production Tooling
 Applies to customer and organization’s tooling

 Ownership to be marked in a visible area
 Tool design modification information and engineering
changes
 System to track outsourced activities

8.5.1.7 Production Scheduling
Includes additional planning information, such as customer

orders, supplier on time delivery performance, capacity
etc.

8.5.3 Property Belonging
to Customers or
External Providers
 Proper care while property is under organizations
control
 Identification, verification, protection and safeguarding of
property
 Documented notification to the owner if there are any
issues with the property
 Property includes material, components, tools,
equipment, premises, intellectual property and data

8.7.1.4/5 Control of Reworked/Repaired Product
 Documented rework process, compliance to original

specifications
 Instructions for disassembly, rework, re-inspection, and

traceability
 Records of reworked product including quantity,

disposition date and traceability

Clause 9
Performance Evaluation

108
9.1 Monitoring,
Measurements, Analysis
and Evaluation
9.1.1 General
 Determine what needs to be monitored and measured,

ensure valid results when performed, and the results to
be analyzed
 Evaluate effectiveness of the QMS and retain records

9.1.2 Customer Satisfaction
 Monitor customer perception
 Determine methods for obtaining and reviewing this
information

9.1.3 Analysis and
Evaluation
 Conformity of products and services
 Customer satisfaction
 Performance and effectiveness of the QMS
 Effectiveness of planning
 Effectiveness of actions taken to address risks
and opportunities
 Performance of external providers
 Improvement of the QMS

9.1.3.1 Prioritization
Review quality and operational performance data against

objectives to support prioritization of action to improve

9.2.2.1 Internal Audit Program
 Documented processes for system, manufacturing

process and product audits
 Audit frequency adjusted based on process changes,

internal and external nonconformities and customer
complaints
 Review effectiveness in Management Review

9.2.2.2 Quality Management System Audit
Audit all QMS processes over a three year schedule,

using an annual program, with a process approach
including sampling of customer specific requirements

9.2.2.3 Manufacturing Process Audit
 Audit all manufacturing processes over a three year

schedule, using customer specified approach
 Include evidence of all shifts being audited, and the shifts

handover
 Evidence of PFMEA, Control Plan and associated

documents implementation
9.2.2.4 Product Audit
 Customer specified approach or develop internal approach

9.3 Management Review
9.3.1 General
Top Management shall review at planned intervals

continuing suitability, adequacy and effectiveness of the
system and alignment to strategic direction

9.3.1.1 Management Review – Supplemental
Once a year minimum and increased based on risk to

meeting customer requirements and external changes
impacting the QMS performance

9.3.2/3 Management
Review Inputs/Outputs
Inputs to Management Review are prescriptive in both
ISO 9001 and IATF
Should all be included in the agenda, for the ease of

providing objective evidence

9.3.2.1 Management Review Inputs – Supplemental
 cost of poor quality

 process effectiveness and efficiency
 product conformance
 manufacturing feasibility
 customer satisfaction
 maintenance objectives
 warranty performance
 customer scorecards
 potential field failures identified through risk analysis
 actual field failures and their impact on safety or the
environment
9.3.3.1 Management Review Outputs – Supplemental
 Document and implement an action plan when

customer performance targets are not met
 Ultimate responsibility is with the Top Management

Clause 10
Improvement

121
10.1 Improvement
 Select opportunities for improvement and implement

actions to meet customer requirements and improve
 Improve products and services, correct and prevent or

reduce risk

10.2 Nonconformity and
Corrective Action
 Respond to nonconformities
 Evaluate the need for action to eliminate causes
 Implement actions
 Review effectiveness of the action
 Update risks and opportunities
 Retain documented information

123
10.2.5 Warranty Management Systems
Warranty part analysis and NTF (No Trouble Found) –
see CQI-14
10.2.6 Customer Complaints and Field Failure Test

Analysis
Communicate results both to customer and internally

124
10.3.1 Continual
Improvement
 Documented process for continual improvement
including methodology, objectives, measurement,
effectiveness and records, manufacturing process
improvement plan
 Lean, Six Sigma suggested

125
TRANSITION PLANNING

Important to Know
 The cut off date for IATF 16949 certification, as well as

ISO 14001:2015 is September 14, 2018
 All previous revision certificates will be no longer valid

as of this date

Transition Audit
 Can be either part of a regular surveillance or
certificate renewal
 Timing is -3/+1 for surveillance audits and -3/+0 for

certificate renewal
 If timing is not met, you start a new certification

however stage 1 can be waived if audit takes place
within 18 months

Transition Audit
 As per IATF Rules, an off site quality management
system documentation review must be conducted
 If not provided, extra .5 day is added to the transition

audit time
 For remote locations, if not ready to be compliant with

IATF requirements, the site shall have a gap analysis and
detailed action plan

Transitioning to IATF
16949 and ISO 14001
Strategy
 Select a project champion and process owners
 Implementation strategy
 Gap analysis (including remote locations)
 Project plan with key dates
 Develop documentation
 Train and implement
 Internal audits
 Management review
 Transition audit
No part of this presentation may be stored in a retrieval
system, transmitted or reproduced in any way, without prior
agreement and written permission of the presenter

131

ASQ Presentation FCG November 2017

Transféré par

Informations du document

Description originale:

Copyright

Formats disponibles

Partager ce document

Partager ou intégrer le document

Options de partage

Avez-vous trouvé ce document utile ?

Ce contenu est-il inapproprié ?

Droits d'auteur :

Formats disponibles

ASQ Presentation FCG November 2017

Transféré par

Droits d'auteur :

Formats disponibles

IATF 16949:2016

FCG All rights reserved

 Working with major automotive organizations

 Specializing in QMS, EMS, H&SMS

 Integrated Management Systems, Risk Assessment,

FCG All rights reserved 2

 What is New in IATF 16949 (former ISO/TS 16949)

 Integration with EMS

 Key Points in Customer Specific Requirements

 What Does it Mean for Your Organization

FCG All rights reserved 3

 ISO 9001:2015 is a global Quality Management System

 IATF 16949:2016 is a standard specific to Automotive

FCG All rights reserved

 ISO 9001:2015 and ISO 14001:2015 are based on

 It means that various schemes can now be easily

FCG All rights reserved 5

Support Function – non-production activity (conducted

FCG All rights reserved 6

 Remote locations are to be audited before the site, and

 Transition audits must include all support functions,

 CBs are required to include evidence of linkages

FCG All rights reserved 7

 Becoming compliant will require significant amount of

FCG All rights reserved 8

 Level 2 – IATF 16949:2016

 Level 3 – Customer Specific Requirements (Ford, GM,

FCG All rights reserved 9

 More focus on risk management

 More focus on value added to the company

FCG All rights reserved

 4.2 Understanding the Needs and Expectations of

 5.1 Leadership and Commitment

 5.2 Quality / Environmental Policy

 6.1.1 Actions to Address Risks and Opportunities

 4.4.1.2 Product Safety

 5.1.1 Corporate Responsibility

 5.1.1.3 Process Owners

 6.1.2.3 Contingency Planning (more detailed)

 8.2.2.3 and 8.4.2.3.1 Embedded Software

FCG All rights reserved 12

FCG All rights reserved 14

FCG All rights reserved

FCG All rights reserved 16

 Internal and external issues can include positive and

 This information must be monitored on an ongoing

FCG All rights reserved 17

FCG All rights reserved 18

 External sources guidance – laws (including

FCG All rights reserved 19

Context of the Organization is typically a top level

FCG All rights reserved 20

 Part of the process for understanding the context of

 It is very important to include all relevant interested

FCG All rights reserved 21

FCG All rights reserved

FCG All rights reserved 23

 May include the entire organization, or certain sections

 May be one or more functions across a group of

FCG All rights reserved 24

 Scope is documented, and includes all products and

FCG All rights reserved 25

 May include sales, design and development,