Beruflich Dokumente
Kultur Dokumente
IATF : 16949
Brief History
ISO 9000:
ISO 9001:2000 ISO 9001:2008 ISO 9001:2015
1994
2
Transition Timing
Expiration of all TS
Release of IATF
16949:2009
16949: 2016
certificates
01-Oct-2016
14-Sep-2018
Suspension of Audit In
Release of ISO 9001:
accordance to TS
2015
16949:2009
23-Sep-2015
1-Oct-2017
ISO
9001
IATF IATF
16949 Implementation
CSR
6
Key changes in approach
A new common format has been developed for use in all management system
standards: “high-level structure”.
8
Process Approach
PDCA Representation
Performanc
Customer Planning Leadership e Results of the
requirements (6) (5) evaluation QMS
(9)
Check
Act Products and
Improveme services
Needs and nt
expectation (10)
of relevant
interested
parties (4)
10
Key Changes in IATF
• Consideration of support functions on-site or remote (now included in standard)
• Periodicity / frequency (re)defined.
Contingency plan review – at a minimum annually
Establishing quality objectives – annual, at a minimum
audit all quality management system processes and all manufacturing processes over
each three-year calendar period
Management review shall be conducted at least annually
Record retention of …. for the length of time that the product is active for production
and service requirements, plus one calendar year
Review of Engineering Specifications should be completed within 10 working days
• prioritization of MSA studies should focus on critical or special product or process
characteristics
• Corporate Responsibility
• Step-by-step development of supplier quality management system
• Auditors competency
• OEE , MTBR, MTBF
11
Section 1- Scope
• Needs to demonstrate its ability to consistently provide product or service that meets
customer and applicable statutory and regulatory requirements, and
• Aims to enhance customer satisfaction through the effective application of the system,
including processes for improvement of the system and the assurance of conformity to
customer and applicable statutory and regulatory requirements.
Changes:
– Exclusion now get addressed at clause 4.3
– Used Improvement in place of continual improvement
– Used products and services in place of product
IATF
This defines the quality management system requirement for
• Design and development, assembly, installation and services for automotive related
products, including products with embedded software
• Applicable to the site of organisation where manufacturing of customer specified production
part, service part accessories parts occur
• To be applied throughout the automotive supply chain
Changes:
– Inclusion of embedded software
– Supporting function (design center, corporate, distribution center ) moved to clause 4.3.1
(determining the scope of quality management system supplemental)
– Section 1.2 - Application removed, exclusion included in clause 4.3.1
13
15
16
Section 4 – Context of organization
4.1 : Context
Entire clause 4 requires the organisation to consider itself and its context, determination of scope,
issues and requirement,
This is taken as an input to the development f QMS
Context analysis also helps in identifying opportunity. Opportunities thus identified to be included in
business plan
Determine external and internal context that are relevant to its purpose and its strategic
direction and that affect its ability to achieve the intended result(s) of its quality management
system
Monitor and review the information about these issues and consider these as an input to
development of QMS
External context – market, competitive, legal & Regulatory, technological, Social, local etc..
21
Supporting functions , on-site or remote (design function, corporate head quarters and distribution
centers) are now in scope
22
4.4 : Quality management system
Organisation shall establish, implement, maintain and continually improve a quality management
system, including the processes needed and their interactions, in accordance with the
requirements of this International Standard.
Organisation shall retain documented information to have confidence that the processes are being
carried out as planned
Training on ISO 9001 QMS Concepts, Audit Concepts @
24
TPIPL
4.4.1.1 : Conformance of Products & Processes
Organisation shall ensure conformance of all product and processes including service IATF
parts & outsourced part for customer, statutory and regulatory requirements
26
Section 5 – Leadership
28
5.1 : Leadership & commitment
This clause identifies specific aspects of the QMS where top management
are expected to play an important role to demonstrate both leadership and
commitment where they :
Top management shall demonstrate leadership and commitment with respect to customer focus
by ensuring that:
o customer requirements and applicable statutory and regulatory requirements are
determined and met;
o the risks and opportunities that can affect conformity of products and services and the
ability to enhance customer satisfaction are determined and addressed;
o the focus on enhancing customer satisfaction is maintained.
o Personnel responsible for conformity of product to have authority to stop shipment / production
to correct quality problem.
o Effected product must be contained
o Immediately inform to person with responsibility of corrective action
o Person responsible for product conformance to be available in all shifts
Section 6 – Planning
6.1.1
When planning for the quality management system, the organization shall consider the issues
referred to in 4.1 and the requirements referred to in 4.2 and determine the risks and
opportunities that need to be addressed to:
o give assurance that the QMS can achieve its intended result(s)
o prevent, or reduce, undesired effects;
o achieve continual improvement.
6.1.2
The organization shall plan:
actions to address these risks and opportunities;
how to:
1) integrate and implement the actions into its QMS processes (see 4.4);
2) evaluate the effectiveness of these actions.
Actions taken to address risks and opportunities shall be proportionate to the potential impact on
the conformity of products and services.
o This now requires identification, analysis and action on risk and opportunity
o An organisation can address risk by avoiding, mitigating, sharing, taking as opportunity etc.
o This sets platform for a risk based thinking and a proactive approach
o Implements a PDCA approach
Determine and take action to prevent potential non conformities , preventive act ion to be
appropriate to the severity. Action to include :
Determine potential non conformities and their causes
Evaluate the need for action to prevent occurrence
Determine and implement action
Review the effectiveness
Lesion learned record
Training on ISO 9001 QMS Concepts, Audit Concepts @
40
TPIPL
6.1.2.3 Contingency Plan
IATF
o Identify internal and external risk to all manufacturing processes and infrastructure including
externally provided product and services, labour interruption, utility services, natural
disasters etc..
o Define contingency plan and impact on customer
o Notification process to customer
o Periodically test the contingency plan and its effectiveness (simulate as appropriate)
o Review with multidisciplinary team and update revision number for any change
Risk Management
Smart Objective
Specific
Measurable
Achievable
Results orientated
Time bound
6.2.2: When planning how to achieve its quality objectives, the organization shall determine:
o what will be done;
o what resources will be required;
o who will be responsible;
Strictly defining the
o when it will be completed; structure to drive
quality objective
o how the results will be evaluated.
45
46
6.3 – Planning of changes
The organisation shall determine the need to change the QMS and while changing the
organization shall consider:
o the purpose of the change and any of its potential consequences;
o the integrity of the quality management system;
o the availability of resources;
o the allocation or reallocation of responsibilities and authorities.
Section 7 - Support
7.1 Resource
7.2 Competence
7.3 Awareness
7.4 Communication
7.1.1 General
The organization shall determine and provide the resources needed for the establishment,
implementation, maintenance and continual improvement of the quality management system.
The organization shall consider:
a) the capabilities of, and constraints on, existing internal resources;
b) what needs to be obtained from external providers.
7.1 - Resources
7.1.2 People
To ensure that the organization can consistently meet customer and applicable statutory and
regulatory requirements, the organization shall provide the persons necessary for the effective
operation of the quality management system, including the processes needed.
7.1.3 Infrastructure
The organization shall determine, provide and maintain the infrastructure for the operation of its
processes to achieve conformity of products and services.
Infrastructure can include:
a) buildings and associated utilities;
b) equipment including hardware and software;
c) transportation;
d) information and communication technology.
No major changes
7.1 - Resources
7.1.3.1 Plant Facility and Resource Planning
IATF
o Use multidisciplinary approach for risk identification and risk mitigation methods for
developing and improving plant, facility and equipment plan.
o While designing layout optimise material flow, material handling ad value added use of
floor space including control of non conforming product
o Facilitate synchronous material flow as applicable
o Develop method for evaluate manufacturing feasibility for new product or new operations
including capacity planning
o Monitor process effectiveness, including periodic re-evaluation and changes and approval
of changes
o Apply lean manufacturing principles
52
7.1 - Resources
7.1.4 Environment for operation of its processes
The organization shall determine, provide and maintain the environment necessary for the
operation of its processes and to achieve conformity of products and services.
NOTE: Environment for the operation of processes can include physical, social, psychological,
environmental and other factors (such as temperature, humidity, ergonomics and cleanliness).
53
7.1 - Resources
The organization shall retain appropriate documented information as evidence of fitness for
purpose of monitoring and measurement resources.
7.1.5.1.1
Prioritisation of MSA can be done
7.1 - Resources
7.2 - Competence
a) determine the necessary competence of person(s) doing work under its control
that affects its quality performance;
b) persons are competent on the basis of appropriate education, training, or
experience;
c) where applicable, take actions to acquire the necessary competence, and evaluate
the effectiveness of the actions taken;
d) retain appropriate documented information as evidence of competence.
NOTE Applicable actions can include, for example, the provision of training to, the
mentoring of, or the re- assignment of currently employed persons; or the hiring or
contracting of competent persons.
7.2 - Competence
61
7.3 - Awareness
Persons doing work under the organization’s control shall be aware of:
a) the quality policy;
b) relevant quality objectives;
c) their contribution to the effectiveness of the QMS, including the benefits of
improved quality performance;
d) the implications of not conforming with the quality management system
requirements.
62
7.4 - Communication
The organization shall determine the internal and external communications relevant
to the QMS including:
a) on what it will communicate;
b) when to communicate;
c) with whom to communicate;
d) how to communicate..
Replaces internal communication section 5.5.3 of older version and includes external
communication also
63
7.5.1 General
The organization’s quality management system shall include
a) documented information required by this International Standard;
b) documented information determined by the organization as being necessary for
the effectiveness of the QMS
NOTE: The extent of documented information for a QMS can differ from one
organization to another due to:
a) the size of organization and its type of activities, processes, products and services;
b) the complexity of processes and their interactions;
c) the competence of persons.
o Replaces the requirement from older version of 4.2.1 and 4.2.2 quality manual
o Does not mention the requirement of quality manual
o Flexibility in choosing appropriate documentation
o The term documented information covers both documents and records
65
68
Clause 8 – Operation
The organization shall plan, implement and control the processes, must consider
clause 4.4 and 6.1
a) determining requirements for the product and services;
b) establishing criteria for the processes and for the acceptance of products and
services;
c) determining the resources needed to achieve conformity to product and service
requirements;
d) implementing control of the processes in accordance with the criteria;
e) retaining documented information
The organization shall control planned changes and review the consequences of
unintended changes, taking action to mitigate any adverse effects, as necessary.
71
Include all applicable government, safety, and environmental regulations related to acquisition,
storage, handling, recycling, elimination, or disposal of material
73
8.3.1 General
the organization shall establish, implement and maintain a design and development process and
development of processes for production and services provision
For service organisation , process for service delivery
77
78
8.3 Design and development of products and services
Inputs shall be adequate for design and development purposes, complete, and unambiguous.
Conflicts among inputs shall be resolved.
79
80
8.3 Design and development of products and services
81
• 8.3.4.1 Monitoring
– Measurement at specified stage of design and development of product or process shall be defined,
analysed, and reported in MRM, where possible include risk, cost, lead time, critical path etc.
• 8.3.4.2 Design and development validation
– Consider customer requirements, statutory and regulatory norms, including planning timing in alignment
with customer-timing
• 8.3.4.3 Prototype programme
– When required by customer, where possible use production tooling, process, supplier
• 8.3.4.4 Product approval process
– Earlier 7.3.6.3 including - obtain documented product approval prior to shipment, if required by the
customer
– NOTE Product approval should be subsequent to the verification of the manufacturing process.
82
8.3 Design and development of products and
services
8.3.5 Design and development outputs
Design and development output should :
a) meet the input requirements for design and development
b) Be adequate for the subsequent processes
c) Include monitoring and measuring requirements, and acceptance criteria
d) are fit for intended purpose for safe and proper use
83
86
8.4 Control of externally provided products and services
89
90
8.5 Production and service provision
91
93
94
8.5 Production and service provision
95
8.5.4 Preservation
Should preserve process output by means of identification, handling, packaging, storage,
transmission or transportation, and protection.
97
99
The organization shall implement the planned arrangements at appropriate stages to verify that
product and service requirements have been met
The release of products and services to the customer shall not proceed until the planned
arrangements for verification of conformity have been satisfactorily completed, unless otherwise
approved by a relevant authority and, as applicable, by the customer.
Documented information shall provide traceability to the person(s) authorizing release of products
and services for delivery to the customer.
100
8.6 Release of products and services
8.6.1 Release of products and services – supplemental
Ensure that the planned arrangements to verify that the product and service requirements have
been met encompass the control plan
Ensure that the planned arrangements for initial release of products and services encompass
product or service approval.
Ensure that product or service approval is accomplished after changes following initial release.
8.6.2 Layout inspection and functional testing
For layout inspection and functional verification for each product as specified in control plan.
Result to be available to customer
8.6.3 Appearance items
Organisation to provide – resources including lighting, master for grain, colour, texture, gloss etc.
Ensure competency of person
8.6.4 Verification and acceptance of conformity of externally provided products and services
Shall have a process to receipt and evaluation, inspection testing, second / third party assessment,
part evaluation etc.
101
102
8.7 Control of nonconforming process outputs, products
and services
a) correction;
b) segregation, containment, return or suspension of provision of products and services;
c) informing the customer;
d) obtaining authorization for: use “as-is’;
e) release, continuation or re-provision of the products and services;
f) acceptance under concession.
g) Where nonconforming process outputs, products and services are corrected, conformity to the
requirements shall be verified.
h) The organization shall retain documented information of actions taken
103
106
9.1 Monitoring, measurement, analysis and evaluation
9.1.1 General
The organization shall determine:
a) what needs to be monitored and measured;
b) the methods for monitoring, measurement, analysis and evaluation, as applicable, to ensure
valid results;
c) when the monitoring and measuring shall be performed;
d) when the results from monitoring and measurement shall be analysed and evaluated
e) retain appropriate documented information
f) evaluate the quality performance and the effectiveness of QMS
108
9.1 Monitoring, measurement, analysis and evaluation
109
9.1.3.1 Prioritization
Trends in quality and operational performance to be compared with progress toward objectives
And, lead to action to support prioritization of actions for improving customer satisfaction.
110
9.2 Internal audit
9.2.1 The organization shall conduct internal audits at planned intervals to check if QMS conforms
to :
a) the organization’s own requirements for its quality management system
b) the requirements of this International Standard
c) is effectively implemented and maintained
111
112
9.2 Internal audit
• 9.2.2.1 Internal audit programme
– Have a documented internal audit process covering quality management system audits,
manufacturing process audits, and product audits.
– The audit programme to be prioritized based upon risk, internal and external performance
trends, and criticality of the process(es).
– The frequency of audits to be reviewed and, where appropriate, adjusted based on occurrence
of process changes, internal and external nonconformities, and/or customer complaints.
– The effectiveness of the audit programme to be reviewed as a part of management review.
• 9.2.2.2 Quality management system audit
– Audit all quality management system processes over each three-year calendar period,
according to an annual programme, using the process approach
– Sample customer-specific quality management system requirements for effective
implementation.
113
114
9.3 Management review
9.3.1 shall review the organization's quality management system, at planned intervals, to ensure its
continuing suitability, adequacy, and effectiveness
Important consideration:
a) status of actions from previous management reviews
b) changes in external and internal issues
c) nonconformities and corrective actions;
d) monitoring and measurement results;
e) audit results;
f) customer satisfaction;
g) issues concerning external providers and other relevant interested parties;
h) adequacy of resources required for maintaining an effective QMS
i) process performance and conformity
j) effectiveness of actions taken to address risks and opportunities
k) new potential opportunities for continual improvement
115
116
9.3 Management review
117
Clause 10 - Improvement
10.1 General
121
• 10.2.4 Error-proofing
– Have a documented process to determine the use of appropriate error-proofing methodologies.
– Document the methods in the process risk analysis (such as PFMEA)
– Test frequencies to be documented in the control plan.
– Include the testing of error-proofing devices for failure or simulated failure.
– Maintain records
– Challenge parts, when used, to be identified, controlled, verified, and calibrated where feasible.
– Error-proofing device failures to have a reaction plan.
• 10.2.5 Warranty management systems
– As applicable, implement a warranty management process.
– Include in the process a method for warranty part analysis, including NTF (no trouble found)
• 10.2.6 Customer complaint and field failure test analysis
– The organization shall perform analysis on customer complaints and field failures, including any
returned parts
123
124