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Transition ISO/TS 16949:2009 To IATF-16949:2016: CQA - Paul de Geyter - September 2016

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Transition ISO/TS 16949:2009 to IATF-

16949:2016

CQA – Paul De Geyter – September 2016


IATF-16949:2016 general facts

- In 2015 IATF has establish a workgroup consisting of IATF Member


Organizations to develop a design specification for the revision of ISO/TS
16949 to align with the new ISO 9001:2015 standard

- The new standard will be named IATF 16949

2 Tuesday, August 18, 2020


IATF-16949:2016 general facts

- IATF-16949:2016 general facts

- The revised Standard IATF-16949:2016 cancels and replaces ISO/TS-16949:2009.


- •IATF-16949:2016 will fully respect the structure and requirements of ISO 9001:2015.
- •All “TS-3” (the current version as of 2009) certificates will expire September 14th, 2018.
- •All certified companies intending to keep their IATF related certification have to be
audited and it is recommended to be certified acc. to “IATF-16949” (the new standard) by
September, 14th 2018. If the certification process can not be completed up to the above
named date, organizations have to face a period without IATF certification.

- •IATF-16949 Requirements manual is expected to be published in October 2016.


- •With an IATF-16949 Transition audit a new audit and certification cycle starts.

- 160826-TNCERT Customer Information on IATF-16949 - Changes and Transition


Process - Rev.02

3 Tuesday, August 18, 2020


IATF-16949:2016 general facts

• The IATF-16949 “Rules for Certification” are not finished yet, but are
announced to be published mid of November 2016.
• The IATF-16949 3rd party auditor qualification process (training and
exams for both, IATF-16949 requirements and rules) is expected to
start in December 2016.

For more detailed information refer to


“IATF Transition Strategy ISO/TS 16949 to IATF-16949”,
published on
http://www.iatfglobaloversight.org/

4 Tuesday, August 18, 2020


IATF-16949-Development and Transition Timing Overview

2015 2016 2017 2018 2019


Sept. Sept.
ISO
ISO 9001:201 ISO 9001:2015 Transition
5 period
release

Jan.

ISO/TS-16949 3rd ISO/TS-16949 3rd edition


edition (maintain) (maintain during systematic review and withdrawal)

IAT Oct. 3rd 2016


F
New IATF-16949 New IATF-16949
(development and release) Transition period

…only 16 to 18 month !

5 Tuesday, August 18, 2020


IATF-16949:2016 general facts
Transition Efforts
• IATF requires that a transition audit have to be conducted with Recertification
audit man days (acc. to the current TS-3 audit time table) without any additional
time as announce previously.
• Clients may upgrade from valid ISO 9001:2015 with a man day reduction of 30%,
if upgrade is conducted by the same CB.
IATF database adjustments
• IATF database will be modified to suit the structure of IATF-16949. IATF
database will be used in parallel for both “TS-3” and IATF-16949 because of
overlapping activities for existing “TS-3” and new IATF-16949 certification
cases.
Transition Requirements on Auditors / Auditteams
• IATF-16949 transition audit allows a maximum of 7 onsite audit days by
one auditor.
• One or more auditors from current “TS-3” audit cycle are allowed to participate in
the transition audit to hand over the client to a new lead auditor resp. audit team.

.
IATF-16949:2016 general facts

Preparing for IATF-16949 Transition


• IATF-16949 transition requires an offsite documentation review (e.g.
QMM, processes, procedures…) performed by CB.
• If client doesn´t provide required information for Readiness Review / audit
preparation (e.g. internal and external performance data), the audit plan shall
include an onsite review of a minimum of 0,50 audit days prior to the one hour
on-site meeting for current performance review on OEM requirements.

Remote locations (RL):


• If the RL has not been audited acc. to IATF-16949 before the related
manufacturing site(s), the client has to ensure and provide a complete gap
analysis incl. an action plan to fulfill the IATF-16949 requirements. This
information must be available at the audit of the manufacturing site(s). If this
information is not available on site, the audit of the site shall be considered
“failed”.

- Rev.
IATF-16949:2016 general facts

Time line information and pre-requisites


• Clients can switch from “TS-3” to IATF-16949 only with respect to the
current “TS-3” audit relevant date (“ARD”, which is the last audit day of
either the initial or last re-certification day of the existing “TS-3” audit
cycle) within the current surveillance resp. re-audit cycle time frame,
as long as they achieve IATF-16949 certification by September 14th
2018.

• A transition audit to IATF-16949 is not permitted to be conducted in


conjunction with a transfer audit from one CB to another CB and / or
at any kind of special audit.

• Clients planning to transfer from one CB to another CB have first to go


for a “TS-3” transfer audit before they can go for IATF-16949
transition.

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IATF-16949:2016 general facts

Time line information and pre-requisites


• If the timing on IATF-16949 Transition Audits are not met, clients have
to start over with an IATF-16949 Initial Audit under the following
conditions:
• If the transition audit has not been conducted acc. to the related ARD from
the “TS-3” cycle then an IATF-16949 initial audit without Stage-1-
Readiness Review can be conducted within 18 month after the last “TS-3”
audit
• If a “TS-3” certificate was withdrawn, it is possible to have an IATF-16949
Initial audit (without Stage-1-Readiness Review) within 12 month after the
“TS-3” certificate has been withdrawn (for clarification refer to “TS-3” SI 12
on Rules 5.4h)
• in both cases, CB have to be unchanged and no waivers from IATF
are needed for this approaches

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IATF-16949:2016
Expectations regarding Transition Process

• When IATF-16949 will be issued and become valid with publishing


date October, 3rd 2016 organization have to
• review the changes and its impact to their QMS
• implement the changed requirements / adjust and update their QMS
accordingly
• conduct internal audits and management review based on IATF-
16949
(Note: this is still open item for decision by IATF)
• apply for transition audit
• conduct IATF-16949 transition audit
• close NCM (if needed).
• Only the review, implementation of changes as well as internal auditing
and management review will take weeks to month's after IATF-16949
is published / becomes valid.
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IATF-16949:2016
Expectations regarding Transition Process

• TNCERT will be able to conduct IATF-16949 audits and


certification after IATF-16949 auditors are trained and approved by
IATF resp. VDA-QMC as Oversight Office.
• All organizations seeking initial certification can be audited to the
existing ISO/TS 16949:2009 (“TS-3”) until September, 30th 2017
however the ISO/TS-16949:2009 certificate will only be valid
until September, 14th 2018.
• Starting on October, 1st 2017, organizations can only be audited
and newly certified to IATF-16949 standard.
• For organizations go for transition from “TS-3” to IATF-16949 it is
recommended to achieve IATF-16949 Certificate on September,
14th 2018 latest.

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IATF-16949:2016
Expectations regarding Transition Process

• The certification process (incl. NC-Management, decision on and


issuance of certificates) is allowed to take a maximum of 120 days
after “LAD” (Last Audit Date, which is the last audit day of either the
initial or last re-certification day of the existing “TS-3” audit cycle).
This means:
• that there might be a certificate-free time if IATF-16949 certificate
is not issued by September, 14th 2018.
• clients are recommended to check with there automotive
customers on acceptance if they expect a certificate free period. If
denied by customer, the transition certification process (incl. NCM,
certification decision and certificate issuance) shall be finished by
September, 14th 2018.

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IATF-16949:2016
Expectations regarding Transition Process

• Peak time for Transition audits is expected between 03/2017


and 07/2018 (refer to next slide). Please check with TNCERT /
your TNCERT auditor about your transition planning / approach.

• TNCERT expects that there might be a additional short term peak from
June to August 2017 initiated by those clients with “ARD” from October
to December to have an early “TS-3”- Surveillance resp. re-audit
based on “ARD” - 3 month. These clients may face some risk of having
a (too) late IATF-16949 transition acc. to the time requirements in
2018.

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TNCERT expectations regarding IATF-16949
Transition (Outlook to 2017/2018)
expected
Number
of Audits
E
x
p
e
c
t
e total
d IATF-16949
Audits IATF-16949
Transition Surv.-Audits
p Audits
e TS-3 IA /
a RA /
k Surv.-Audits

t
i
m IATF -16949
Initial-Audits
e

f
time
o
r

T Note: graph
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r
160826-TNCERT Customer Information on IATF-16949 - not to
016 a
Changes and Transition Process - Rev.02
scale
n
IATF- 16949 Transition:
TNCERT recommendations for clients

• For clients with surveillance audits with “ARD” in Nov. or December


2017 it is recommended to doe transition audit (“TRA”) in 2017 acc. to
the time window allowed by the rules based on their ARD. If they go to
“ARD” - 3 month in 2017 there is no time for Transition Audit (and
NCM, Certificate decision and issue etc.) after June 2018 or they have
to face a period without valid certificate.
• Clients with Recertification “ARD” in October 2017 could go for “TS-3”
Re-Audit in 2017 with “ARD” - 3 month to be able to have Transition
audit latest in July 2018 and have shorter (but maybe sufficient) time
for NCM etc), or they have to face a period without certificate.
• Alternatively in both above cases organizations can cancel their “TS-
3” contracts (with risk to breach of customer contracts) and go for
Initial Audit (incl. Stage-1 and Stage-2 audit) on IATF-16949 to receive
new certificated by September, 14th 2018.

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IATF-16949:2016 vs. ISO/TS-16949:2009

First IATF ideas on


main changes related to
IATF-16949 requirements
as presented by IATF at Stakeholder conference
Rome, April 2016

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Main Changes related to IATF-16949:2016

The following list is only impression / comments from TN


CERT based on information gathered within IATF
Stakeholder Conference, April, 12th to 13th 2016 in Rome
and
• are not documenting finally IATF defined /
approved requirements
• are potentially subject to change in the final version

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Main Changes related to IATF-16949:2016

Section 4
• 4.3.2 Customer-specific requirements
Customer-specific requirements shall be evaluated and included in the scope of
the organization’s quality management system.
• 4.4.1.1 Conformance of products and processes
The organization has the responsibility to ensure conformance of all products
and processes, including service parts and those that are outsourced, to all
customer, statutory, and regulatory requirements
• 4.4.1.1.1 Product safety
The organization shall have a documented process for the management of
product-safety related products and manufacturing-processes which shall
include a number of safety related activities (as lot traceability, specific training
of personnel, lessons learned, special approvals of FMEA and control plans,
…)

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-Section 5
• 5.1.1.1 Corporate responsibility
-The organization shall define and implement an employee code of conduct
policy and ethics escalation policy (“whistle-blower policy”) with the purpose
to ensure business integrity in the social and environmental performance of
the supply chain.

• 5.1.1.2 Process efficiency


- Top management shall review the product realization processes and the
support processes to ensure their effectiveness and efficiency. The results
of the top management process review activities shall be included in the
management review

• 5.1.1.3 Process owners


- Top management shall ensure that process owners are identified,
understand their roles, and are competent to perform them.

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Section 6
• 6.1.2.1 Risk Analysis
The organization shall include in its continual risk analysis, at a minimum,
potential and actual recalls, field returns and repairs, complaints, scrap, and
any rework.
• 6.1.2.2 Contingency plans
Numerous requirements from a) to g) including e.g.: prepare contingency
plans to ensure continuity of supply in the event of any of the following: key
equipment failures (also see Section 8.5.6.1), interruption from supplier
operations, natural disasters, utility interruptions, labour shortages, or
infrastructure. disruptions; periodically test the contingency plan for
effectiveness, including simulations, as appropriate; annual review of these
plans;…

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Section 6
• 6.2.2.1 Quality objectives and planning to achieve them -
supplement Top management shall ensure quality objectives that are
needed to address customer-specific requirements are defined, established,
and maintained for
relevant functions, processes, and levels throughout the organization

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Section 7
• 7.1.5.2 Measurement traceability
Records of the maintenance activities for all software used for product and
process control shall be retained
• 7.2.1 Training
Identification of training needs shall include awareness
• 7.3.1 Awareness - supplemental
The organization shall assure, that all employees are aware of their impact
on quality etc.,…..The organization shall evaluate the extent to which
personnel is aware of this impact …..
• 7.5.1.1 Quality management system documentation
The organizations QMS shall include a Quality Manual

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Section 8
• 8.2.1.2 Customer Communication - training
The organization shall ensure that personnel responsible for completing
customer communications – including but not limited to capacity reports,
corrective action reports, logistics information, and customer portals –
complete the associated customer-specific training for such communication
requirements

• 8.3.2.1 Multidisciplinary approach


Clarification of when the multi-disciplinary approach is to be used and who is
to be involved

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Section 8
• 8.3.2.2 Planning for design and development – training
The organization shall have a defined process for determining the training
needs of personnel in contact with the customer during the quotation phase,
project development phase, and production phase. When appropriate,
personnel shall be trained in advanced product quality planning (or equivalent)
and related customer specific requirements (CSRs). Records of such training
shall be available. Training shall include, but not be limited to, the following:
FMEA, manufacturing process control, and control plans.

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Section 8
• 8.3.6.1 Design and development changes - supplemental
The organization shall ensure that for products with embedded software the
actual configuration of software and hardware is documented and
communicated to the customer.
• 8.4.1.2 Supplier selection process
The organization shall have a defined supplier selection process. The
selection process shall:
a) be based on an evaluation of the supplier’s quality management
system,
b) include an assessment of the selected supplier’s risk to product conformity and
uninterrupted supply of the organization’s product to their customers, and
c) include multidisciplinary decision making.
The supplier selection process shall include 13 defined standard criteria

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Section 8
• 8.4.2.3.1 Products with embedded software
The organization shall require their suppliers of automotive products, with
embedded software, to implement and maintain a system for software quality
assurance for their products. A widely accepted protocol, such as
Automotive SPICE, or its equivalent, shall be utilized. The organization shall
require that an Automotive SPICE Supplier Self Report, or its equivalent, is
submitted as evidence of the supplier’s system capabilities.
• 8.4.2.4.1 Second-party audits
The organization shall ensure that supplier monitoring includes a second-party
audit process. The organization shall demonstrate the competence of the
auditors undertaking the second- party audits. When supplier monitoring
requires periodic second-party surveillance audits, the audits shall be
conducted at least annually. Records of the second-party audit reports shall
be retained.

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-Section 8
• 8.4.2.5.1 Supplier quality management system development
- The organization should require compliance to Minimum Automotive
Quality Management System Requirements for Sub-Tier Suppliers
(MAQMSR) as a further step beyond compliance with, or certification to,
ISO 9001.

• 8.4.2.5.2 Supplier performance development


- Consistent with the goal of this Automotive QMS Standard, the
organization shall implement actions necessary to resolve outstanding
performance issues and pursue opportunities for continual improvement.

• 8.4.3.1 Information for external providers – supplemental


-The organization shall pass down all applicable statutory and regulatory
requirements and special product and process characteristics to their
suppliers and require the suppliers to cascade all applicable requirements
down the supply chain to the point of manufacture

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Section 8
• 8.5.1.1. Control plan
Family control plans are acceptable for bulk material and similar parts using a
common manufacturing process The organization shall review and update
control plans for any of the following: …….; on a periodic basis not to exceed
one year, in a cross-functional team approach, in conjunction with the PFMEA
update.
• 8.5.1.5 Total productive maintenance
f) documented maintenance objectives including but not limited to
OEE (Overall Equipment Effectiveness), MTBF (Mean Time Between
Failure), and MTTR (Mean Time To Repair), which shall form an input into
management to e) periodic overhaul, where the equipment is periodically
stripped down, inspected, and overhauled at fixed intervals and any parts
found below standard are repaired or replaced

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Section 8
• 8.5.1.7 Production scheduling
Top management shall assign a designated person and a back-up person
to manage all customer inputs concerning production scheduling, including
electronic data interchange (EDI). Training records shall be retained and
made available upon request.
• 8.5.6.1 Change control
Changes, including those made at suppliers, may require a production trial run
for verification of changes

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Section 8
• 8.5.6.1.1 Control of bypassed processes
The organization shall identify and document the manufacturing processes
and error-proofing devices that can be bypassed. Based on FMEA severity,
bypass procedures shall be developed and approved internally and, if
required, approved by the customer(s). Prior to shipment of product that was
manufactured using bypass, if required, the organization shall obtain approval
from the customer(s). The organization shall maintain and periodically review
a list of approved bypass devices.

Annex 3.1.4 Bypass (definition)


Situation where one or more manufacturing operations or error proofing
devices are not utilized and alternative process(es) or controls have been
implemented to ensure conformance to specifications

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Section 8
• 8.6.1 Release of products and services — supplemental
The organization shall ensure that the planned arrangements to verify that the
product and service requirements have been met encompass the control plan
and are written documented? as specified in the control plan -> Strengthening
the process controls to align with the control plan

• 8.7.1.6 Non-conforming product disposition


The organization shall have a process for disposition of non-conforming
product not subject to rework. For product not meeting safety and regulatory
requirements, the organization shall ensure that the product to be scrapped is
rendered unusable prior to disposal.
…plus many more in detail….

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Section 9
• 9.1.1.1. Monitoring and measurement of manufacturing processes
The organization shall perform process studies on all new manufacturing
(including assembly or sequencing) processes…… These documents shall
include objectives for manufacturing, effectiveness, efficiency, process
capability, reliability, maintainability, and availability, as well as
acceptance criteria.
• 9.1.1.3 Knowledge of basic statistical concepts
…. shall be understood and used by employees involved in the collection and
analysis of data. The organization shall train and evaluate personnel whose
responsibilities include statistical data management and the identification of
statistical tools. This includes, but is not limited to, the appropriate use of
statistical analysis,….
• 9.1.2.1 Customer satisfaction - supplemental
The monitoring shall include the review of customer performance data
provided through online customer portals and customer scorecards.

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Section 9
• 9.2.2.1 Internal audit programme
The organization shall have a documented internal audit process. The process
shall include the development of an annual audit programme covering all
internal quality management system audits, manufacturing process audits,
and product audits. The organization shall determine the number of audits and
audit days for each audit type to accomplish an assessment of the entire
quality management system annually.

• 9.2.2.3 Manufacturing process audit


Manufacturing processes shall be audited on all shifts where they occur,
including the appropriate sampling of the shift handover. The manufacturing
process audit shall include an assessment of the effective implementation of
the FMEA, control plan, and associated documents.

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Section 9
• 9.2.2.5 Internal auditor qualification
The organization shall have a process to ensure internal auditors can
demonstrate competence to audit the requirements of this Automotive QMS
Standard, manufacturing processes, and products. The organization shall
maintain a list of qualified internal auditors. The organization shall ensure that
training is provided, regardless of subject matter, by a trainer who can
demonstrate competence as stated below. Internal auditors should be
qualified as defined in ISO 19011, Guidelines for Quality Management
Systems application. In addition, internal auditors shall be competent in the
following:
a) understanding and applying the automotive process approach for auditing;
b) core tools including FMEA, MSA, SPC, and other reference manuals;
c) the relevant internal/external customer requirements;
d) knowing the consequences for the customer of any non-conforming product or process;
e) evaluating internal audit results;
f) understanding product and process controls.
Maintenance of internal auditor competence shall be demonstrated through:
minimum # of audits and continuous training.

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Section 9
• 9.3.2.1 Management review inputs –
supplemental Input to management review shall
include:
a) cost of poor quality (failure, appraisal, and
prevention);
b) measures of process effectiveness;
c) measures of process efficiency;
d) product conformance;
e) plant, facility, and equipment planning to ensure manufacturing feasibility (see
Section 7.1.3.1);
f) customer satisfaction (see Section 9.1.2);
g) predictive and preventive maintenance action plans;
h) warranty performance;
i) review of customer scorecards;
j) identification of potential field failures identified through analysis of FMEA;
k) actual field failures and their impact on safety or the environment.

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Section 10
• 10.2.3 Problem solving
The organization shall have a defined process for problem solving (see Annex
D) including:
a) containment, interim actions, and related activities necessary for control of
nonconforming outputs (see Section 8.7);
b) root cause analysis, methodology used, analysis, and results;
c) implementation of systemic corrective actions, including consideration of the
impact on similar processes and products;
d) verification of the effectiveness of implemented corrective actions;
e) review and update of appropriate process documents (e.g., PFMEA, control
plan).

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Section 10
• 10.2.4 Error-proofing
The organization shall have a process to determine the use of appropriate
error-proofing methodologies. Details of the method used and test frequencies
shall be documented in the PFMEA and control plan (see Annex C and D).
The process shall include the testing of error-proofing devices for failure or
simulated failure. Records shall be maintained.
Masters and challenge parts, when used, are identified and calibrated where
applicable. Error-proofing device failures shall have a reaction plan (approved
bypass process, see Section 8.5.6.1.1)

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Section 10
• 10.2.5 Warranty management systems
The organization shall implement a warranty management process using
existing industry standards (see Annex D), unless otherwise specified by
the customer. This process shall also define the procedure for warranty part
analysis, including an NTF (no trouble found) process.

• 10.2.6 Preventive action


The organization shall establish a process to lessen the impact of negative
effects of risk including the following:
f) utilizing lessons learned to prevent recurrence in similar
processes

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