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News

31 March 2019:

Added the document set D 10 - Quality tools

  Promotion of the week Promotion of the week

For week 20 the set of documents D 35v15 ISO 9001 internal audit version 2015 is at 14 euros (instead of 28 euros) 

  Promotion of the month Promotion of the month

For May the course T 41v16 AS9100D internal audit version 2016 is with a 50% decrease (from 100 euros to 50 euros)

IATF 16949 v 2016 REQUIREMENTS

Requirements IATF 16949 v 2016

You want to familiarize yourself with the structure of the standard, identify and understand the requirements of IATF 16949 v 2016, then it's up to you to play!

Start

The "IATF 16949 v 2009 Requirements" quiz will help you understand the main requirements of the standard.

The questions (requirements) included in this quiz are 108 of the 511 in the standard, but don't worry. These 108 requirements are among the most important. So do not hesitate to learn in a fun way!

Do not think you can finish this quiz in less than an hour, or even two hours, unless of course you are a little genius!

News about ISO 9001 version 2015

The ISO 9001 v 2015 requirements

Some news about the IATF 16949 v 2016

The course T 15v15 ISO 9001 v 2015 readiness

The course T 35v15 ISO 9001 v 2015 internal audit

The package of courses T 65v15 training package ISO 9001 v 2015 readiness and internal audit

The course T 16v16 IATF 16949 v 2016 readiness and its free demo

The course T 36v16 IATF 16949 v 2016 internal audit and its free demo

The package of courses T 66v16 training package IATF v 2016 readiness and internal audit

Based on ISO 9001 v 2015 the 309 requirements (verb shall) of clauses 4 to 10 are as follows: 

ISO 9001 : 2015 requirements 
No
Clause
PDCA cycle
Requirement No
Quantity
4
Context Plan 1 ÷ 24 24
5
Leadership Plan, Do, Check, Act
25 ÷ 50
26
6
Planning Plan
51 ÷ 77
27
7
Support Do
78 ÷ 120
43
8
Operation Do
121 ÷ 248
128
9
Performance Check
249 ÷ 291
43
10
Improvement Act
291 ÷ 309
18
Total
309

 

Based on IATF 16949 v 2016 the 511 requirements (verb shall) of clauses 4 to 10 are as follows:

IATF 16949 v 2016 requirements 
No
Clause
PDCA cycle
Requirement No
Quantity
4
Context Plan 1 ÷ 19 19
5
Leadership PlanDoCheckAct
20 ÷ 30
11
6
Planning Plan
31 ÷ 50
20
7
Support Do
51 ÷ 133
83
8
Operation Do
134 ÷ 425
292
9
Performance Check
426 ÷ 479
54
10
Improvement Act
480 ÷ 511
26
Total
511

iso 9001

ISO 9001 2015 requirements

IATF requirements

IATF 16949 2016 requirements

 

pdca

The Deming PDCA cycle

Note 1. Any requirement normally begins with "The organization shall...". For simplicity's sake we present the requirements directly, starting with the verb

Note 2. All 309 ISO 9001 v 2015 requirements are on this page

Note 3. We use external provider instead of supplier (conformity with ISO 9001 v 2015)

Note 4. We use documented information to retain instead of record (conformity

IATF 16949 v 2016 - Requirements and comments

 No

 Clause, sub-clause

 Requirement

Comment, link

  4
Context of the organization
 
4.1
The organization and its context
 
 
 
See ISO 9001 v 2015 requirements  
  4.2
Needs and expectations of interested parties
 
 
  See ISO 9001 v 2015 requirements  
  4.3
Scope of the quality management system
 
 
 
See ISO 9001 v 2015 requirements  
  4.3.1
Scope of the quality management system
supplemental
1
4.3.1 
Include supporting functions, whether on-site or remote, in the scope for the quality management system (QMS) Such as design centers, corporate headquarters, distribution centers, laboratory
2
 4.3.1
Justify the exclusions and maintain as documented information Cf. sub-clause 7.5. The only permitted exclusion relates to the product design and development requirements, cf. sub-clause 8.3 of ISO 9001
3
 4.3.1
Never exclude manufacturing process design It is never authorized
  4.3.2
Customer-specific requirements
 
4
 4.3.2
Determine customer-specific requirements Evaluate these requirements and include them in the scope of the QMS, cf. sub-clause 4.3
  4.4
Quality management system and its processes
 
  4.4.1
 
 
 
 
See ISO 9001 v 2015 requirements  
  4.4.1.1
Conformance of products and processes
up
 5
 4.4.1.1
Ensure conformity to all applicable customer, statutory and regulatory requirements Of all products and manufacturing processes including service parts and those that are outsourced, cf. sub-clause 8.4.2.2
  4.4.1.2
Product safety
 
6
4.4.1.2
Define documented processes for the management of product-safety related products and manufacturing processes Cf. sub-clause 7.5
7
4.4.1.2 a
Identify statutory and regulatory product-safety requirements Cf. sub-clause 8.4.2.2
8
4.4.1.2 b
Notify customer of statutory and regulatory product-safety requirements Cf. sub-clause 8.4.2.2
9
4.4.1.2 c
Realize special approvals for design FMEA Cf. 8.3.2.1. Special approval is any safety-related approval
10
4.4.1.2 d
Identify product safety-related characteristics Cf. sub-clause 8.5.2.1 f
11
4.4.1.2 e
Identify and control safety-related characteristics of product At the point of manufacture of these characteristics
12
4.4.1.2 f
Realize special approval Of control plans and process FMEAs
13
4.4.1.2 g
Realize reaction plans during monitoring and measurement Cf. sub-clause 9.1.1.1 
14
4.4.1.2 h
Define responsibilities, escalation process and flow of information Including top management and customer notification
15
4.4.1.2 i
Identify training for product-safety related products and associated processes Cf. sub-clause 7.2
16
 4.4.1.2 j
Approve changes of product or process prior to implementation Evaluate potential effects on product safety from changes. Cf. 8.3.6
17
4.4.1.2 k
Prepare for the transfer of product safety requirements throughout the supply chain Including customer-designated sources, cf. sub-clause 8.4.1.3 
18
4.4.1.2 l
Prepare for product traceability by manufactured lot throughout the supply chain Cf. sub-clause 8.5.2.1
19
4.4.1.2 m 
Learn lessons from new product introduction Including during the manufacture of the prototypes, cf. Sub-clause 8.3.4.3
  4.4.2
 
up
 
  See ISO 9001 v 2015 requirements  
 
5
Leadership
PlanDo, CheckAct 
 
5.1 
Leadership and commitment
 
5.1.1 
General
 
 
 
See ISO 9001 v 2015 requirements  
 
5.1.1.1 
Corporate responsibility
 
20 
5.1.1.1 
Define and implement an anti-bribery policy, an employee code of conduct and an ethics escalation policy The corporate responsibility concerns everybody in the company and addresses expectations for improved integrity in social matters
 
5.1.1.2 
Process effectiveness and efficiency
 
21 
5.1.1.2 
Review the product realization and support processes On order to evaluate and improve their effectiveness and efficiency. Do not confuse effectiveness and efficiency:
  • effectiveness is the level of achievement of planned results
  • efficiency is the ration between results and resources
 22
5.1.1.2 
Include the results of the process review activities As input to the management review, cf. sub-clause 9.3.2.1 b and c 
 
5.1.1.3
Process owners
up
 23
5.1.1.3
Assign for each process an owner This is done exclusively by top management
24 5.1.1.3  Understand the role and ensure the necessary skills Each process owner assumes responsibility for its role, cf. sub-clause 7.2
 
5.1.2
Customer focus
 
 
  See ISO 9001 v 2015 requirements  
 
5.2
Policy
 
5.2.1
Establishing the quality policy
 
 
 
See ISO 9001 v 2015 requirements  
 
5.2.2
Communicating the quality policy
 
    See ISO 9001 v 2015 requirements  
 
5.3
Roles, responsibilities and authorities
 
 
 
See ISO 9001 v 2015 requirements  
 
5.3.1
Roles, responsibilities and authorities
supplemental
25
5.3.1
Assign personnel with the responsibility and authority to ensure that customer requirements are met This is done exclusively by top management
26
5.3.1
Document this mission Cf. sub-clause 7.5.3.1 
27
5.3.1 
Include in this mission concrete requirements Such as selection of special characteristics, determination of quality objectives, implementation of corrective and preventive actions, product design and development, analysis of scorecards
 
5.3.2
Responsibility and authority for product requirements and corrective actions
up
28
5.3.2 a
Stop shipment and production to correct quality problems This authority is given to the quality manager (or the one responsible for meeting product requirements) by top management. When to stop production immediately is impossible isolate the lot and block the shipment
29
5.3.2 b
Inform promtly personnel responsible for corrective action of products or processes that do not conform to requirements In order to avoid shipping nonconforming products. Any product even with a suspicion of nonconformity is immediately identified and isolated. See subclauses 8.7 and 10.2
 30  5.3.2 c Provide all shifts with a responsible person who ensures product conformity This could be the team leader or another person who has received a delegation
 
6
Planning
 
 6.1
Actions to address risks and opportunities
 
6.1.1 and 6.1.2
 
 
 
 
See ISO 9001 v 2015 requirements  
 
6.1.2.1
Risk analysis
 
31
 6.1.2.1 Include in risk analysis lessons learned that can contribute to improvement opportunities Specific risks associated with the automotive industry such as product recalls, product audits, field returns and repairs, complaints, scrap and rework. Cf. sub-clauses 8.79.210.2 and 10.3   
32
 6.1.2.1 Retain documented information on the results of risk analysis Cf. sub-clause 7.5.3.1 
 
6.1.2.2
Preventive action
 
33
 6.1.2.2 Determine an implement actions to eliminate the causes of potential nonconformities In order to prevent their occurrence. Preventive actions are appropriate to the severity of the potential issues
34
 6.1.2.2 Establish a process to lessen the impact of negative effects of risk Cf. sub-clauses 6.1.1 and 6.1.2  
35
 6.1.2.2 a Include the identification of potential nonconformities Including identification of their causes
36
 6.1.2.2 b Include the evaluation of the need for action In order to prevent their occurrence
37
 6.1.2.2 c Include the determination of action needed Including their implementation
38
 6.1.2.2 d Include the provision of documented information Relating to action taken, cf. sub-clause 7.5.3.1
39
 6.1.2.2 e Include the review of the effectiveness of the preventive action taken Identifying and reviewing similar processes towards prevention
40
6.1.2.2  f Include the use of lessons learned In order to prevent the recurrence of the same causes in similar processes, cf. sub-clause 7.1.6
 
6.1.2.3
Contingency plans
up
41
6.1.2.3 a Identify and evaluate internal and external risks to all manufacturing processes and infrastructure equipment In order to maintain production output and to ensure that customer requirements are met
42
6.1.2.3 b Define contingency plans According to risk and impact to the customer
43
6.1.2.3  c Prepare contingency plans for continuity of supply In the event of key equipment failure, interruption from externally provided products, processes and services, natural disasters, fires, utility interruptions, labor shortages or infrastructure disruptions
44
6.1.2.3 d Include in contingency plans a notification process In order to inform all interested parties of the extent and duration of the emergency
45
6.1.2.3 e Test periodically the contingency plans In order to evaluate their effectiveness. Simulations, risk analysis
46
6.1.2.3 f Review contingency plans at least once a year Include a multidisciplinary team and top management. Perform updates
47
6.1.2.3 g Retain documented information on emergency plans and revisions Including the persons who authorized the changes, cf. sub-clause 7.5.3.1
48
6.1.2.3  Validate the product after the re-start of production following an emergency In order to prove that the product continues to meet customer specifications
 
6.2
Quality objectives and planning to achieve them
 
 
 
See ISO 9001 v 2015 requirements  
 
 6.2.1 and 6.2.2
 
 
 
  See ISO 9001 v 2015 requirements  
 
 6.2.2.1
Quality objectives and planning to achieve them
supplemental
49
6.2.2.1  Ensure that quality objectives to meet customer requirements are defined, established and maintained It is the responsibility of top management to ensure that this is done for the functions and processes involved
50
 6.2.2.1 Take into account the results of the review regarding interested parties When quality objectives and associated performance indicators are set
 
 6.3
Planning of changes
up
 
  See ISO 9001 v 2015 requirements  
 
 7
Support
 
 7.1
Resources
 
 
7.1.1 
General
 
 
  See ISO 9001 v 2015 requirements  
 
7.1.2
People
 
 
  See ISO 9001 v 2015 requirements  
 
7.1.3 
 Infrastructure  
 
  See ISO 9001 v 2015 requirements  
 
7.1.3.1
Plant, facility and equipment planning
 
51
7.1.3.1  Use a multidisciplinary approach to the development and improvement of plant, facility and equipment plans Including risk identification and risk mitigation methods
52
7.1.3.1 a Optimize material flow, material handling, value-added use of floor space and control of nonconforming products Such as "prison" areas to segregate nonconformities
53
7.1.3.1 b Facilitate synchronous material flow As applicable
54
7.1.3.1  Develop and implement methods to evaluate manufacturing feasibility for new product Or new operations
55
7.1.3.1  Include in production feasibility assessments capacity planning Cf. sub-clause 8.1
56
7.1.3.1 Ensure that these methods are also applicable for evaluating proposed changes  Regarding existing operations
57
7.1.3.1 Maintain process effectiveness during changes made throughout manufacturing processes Including periodic re-evaluation of risk. Cf. sub-clauses 8.5.1.18.5.1.3 and 6.1.1
58
7.1.3.1 Include feasibility assessments and capacity planning in the inputs of the management review Cf. sub-clause 9.3.2.1 Use the Lean approach
 
7.1.4
Process environment up
 
  See ISO 9001 v 2015 requirements The requirements of the future ISO 45001 standard will be used for occupational safety aspects
 
7.1.4.1
Process environment
supplemental
59
7.1.4.1 Maintain production premises in a state of order and clean According to product and process needs
 
 7.1.5
Monitoring and measuring resources
 
 7.1.5.1
General
 
 
7.1.5.1 See ISO 9001 v 2015 requirements  
 
7.1.5.1.1
Measurement system analysis
 
60
7.1.5.1.1 Conduct statistical studies In order to analyze the variations in the results of each type of inspection, measurement and test equipment system included in the control plan. Cf. sub-clause 8.5.1.1 and annex A 
61
7.1.5.1.1 Use analytical methods and acceptance criteria conform to those in reference manuals See AIAG publication references in Appendix B: MSA (Measurement Systems Analysis) and SPC (Statistical Process Control). Focus on critical or special characteristics
62
7.1.5.1.1 Use other analytical methods and acceptance criteria If approved by the customer
63
7.1.5.1.1 Retain documented information of customer acceptance of alternative methods Along with results from alternative measurement systems analysis. Cf. sub-clause 9.1.1.1
 
 7.1.5.2
Measurement traceability
 
    See ISO 9001 v 2015 requirements Use a serial number or another identifier traceable to the device calibration documented information
 
 7.1.5.2.1
Calibration/verification documented information up
64
7.1.5.2.1 Use a documented process for managing documented information of calibration and verification Cf. sub-clause 7.5.3.1
65
7.1.5.2.1 Retain documented information related to calibration and verification of gauges and measuring and test equipment In order to provide evidence of conformity to internal, statutory, regulatory and customer requirements. Cf. sub-clause 7.5.3.1. Including employee-owned, customer-owned or on-site external provider-owned equipment
66
7.1.5.2.1 a Include in calibration and verification activities and documented information revisions following engineering changes to measurement systems Cf. sub-clause 8.5.6.1 
67
7.1.5.2.1 b Include in calibration and verification activities and documented information any out-of-specification readings Cf. sub-clause 7.5.3.1
68
7.1.5.2.1 c Include in calibration and verification activities and documented information an assessment of the risk of the intended use of the product When an out-of-specification condition occurs
69
7.1.5.2.1 d Include in calibration and verification activities and documented information the retention of documented information on the validity of previous results and the last and next calibration date When a measuring or test equipment is found to be out of calibration
70
7.1.5.2.1 e Include in calibration and verification activities and documented information notification to the customer if suspect product has been shipped Including suspect material, cf. sub-clause 8.7.1.6
71
7.1.5.2.1 f Include in calibration and verification activities and documented information statements of conformity to specification After calibration or verification
72
7.1.5.2.1 g Include in calibration and verification activities and documented information verification of the software version as specified  Software used for product and process control
73
7.1.5.2.1 h Include in calibration and verification activities documented information of the calibration and maintenance activities for all gauging Including employee-owned, customer-owned or on-site external provider-owned equipment
74
7.1.5.2.1 i Include in calibration and verification activities and documented information the verification of production-related software used for product and process control Including software installed on employee-owned, customer-owned or on-site external provider-owned equipment
 
 7.1.5.3
Laboratory requirements
 
 
7.1.5.3.1
Internal laboratory
up
75
7.1.5.3.1  Describe the scope of the internal laboratory Including its capability to perform the required inspection, test or calibration services
76
7.1.5.3.1  Include the laboratory scope description in the QMS documentation Cf. sub-clause 4.3.1
77
7.1.5.3.1 a Specify and implement requirements for adequacy of the technical procedures used Accreditation to ISO 17025 may be used to demonstrate conformity to this requirement
78
7.1.5.3.1 b Specify and implement requirements for competency of personnel Cf. sub-clause 7.2
79
7.1.5.3.1 c Specify and implement requirements for testing the product Accreditation to ISO 17025 may be used to demonstrate conformity to this requirement
80
7.1.5.3.1 d Specify and implement requirements for capability to perform these services correctly, traceable to the relevant process standard such as ASTM, EN When a standard does not exist define and implement a methodology to verify measurement system capability
81
7.1.5.3.1 e Specify and implement requirements for meeting customer requirements, if any Accreditation to ISO 17025 may be used to demonstrate conformity to this requirement
82
7.1.5.3.1 f Specify and implement requirements for review of laboratory activity documented information Cf. sub-clause 7.5.3.1
 
 7.1.5.3.2
External laboratory
 
83
7.1.5.3.2  Describe the scope of the external laboratory Including its capability to perform the required inspection, test or calibration services
84
7.1.5.3.2 Be accredited to ISO 17025 or equivalent And include within the scope of the accreditation the relevant  inspection, test or calibration services
 85 7.1.5.3.2  Include the mark of a national accreditation body For all calibration certificates or test reports
86
7.1.5.3.2  Provide evidence that the laboratory is accepted by the customer Documented information signed by the customer is sufficient
87
7.1.5.3.2  Perform calibration services by the equipment manufacturer When a qualified laboratory is not available
88
7.1.5.3.2  Ensure that internal laboratory requirements are met When a qualified laboratory is not available
89
7.1.5.3.2  Obtain government regulatory confirmation, if required When calibration services other than those provided by qualified laboratories are used
  7.1.6
Organizational knowledge
up
    See ISO 9001 v 2015 requirements  
   7.2
Competence 
 
    See ISO 9001 v 2015 requirements  
 
 7.2.1
Competence
supplemental
90
 7.2.1 Establish and maintain a documented process for identifying training needs Including awareness and competence related to product and process conformity. Cf. sub-clause 7.5.3.1
91
 7.2.1 Obtain a qualification for specific tasks Pay particular attention to the satisfaction of customer requirements
 
 7.2.2
Competence - On-the-job training
 
92
7.2.2  Provide on-the-job training on customer requirements for new or modified responsibilities When this may affect meeting quality, internal, statutory and regulatory requirements
93
7.2.2  Include contract or agency personnel for on-the-job training These persons need more training than others
94
7.2.2  Adapt the level of detail for on-the-job training with the level of education the personnel possess And also in relation to the complexity of daily tasks
 95 7.2.2  Inform personnel about the consequences of nonconformity to customer requirements Cf. sub-clause 8.7.1
 
 7.2.3
Internal auditor competence
96
7.2.3  Use a documented process to verify internal auditor competency Based on customer and ISO 19011 specific requirements
97
7.2.3 Maintain a list of qualified internal auditors Cf. sub-clause 7.5.3.1
98
7.2.3 a Demonstrate competency for an internal auditor on understanding of the automotive process approach Risk-based thinking is part of the process approach. Cf. sub-clause 6.1
99
7.2.3 b Demonstrate competency for an internal auditor on understanding of applicable customer-specific requirements Cf. sub-clause 4.3.2
100
 7.2.3 c Demonstrate competency for an internal auditor on understanding of applicable requirements to the scope of the audit Cf. sub-clause 9.2.2 
101
 7.2.3 d Demonstrate competency for an internal auditor on understanding of applicable core tool requirements Cf. annex B of l'IATF 16949
102
 7.2.3 e Demonstrate competency for an internal auditor on understanding how to plan, conduct, report and close out audit findings Cf. sub-clause 9.2 and ISO 19011 
103
 7.2.3 Demonstrate technical understanding of the relevant manufacturing process to be audited Including process risk analysis (process FMEA) and control plan
104
 7.2.3 Demonstrate competence in understanding product requirements Including using relevant measuring and test equipment in order to verify product conformity
105
7.2.3 Retain documented information on provided training and trainer competency In order to acquire the necessary skills
106
7.2.3 f Maintain and improve internal auditor competence by carrying out regular audits The number of audits per year per auditor is defined internally
107
7.2.3 g Maintain and improve internal auditor competence by maintaining knowledge of relevant requirements Including following internal and external changes (standards, core tools, customer-specific requirements)
 
7.2.4
Second-party auditor competency
up
108
7.2.4 Demonstrate the competence of the auditors undertaking the second-party audits Training, conducted audits with experienced auditors
109
7.2.4 Meet customer specific requirements Cf. sub-clause 4.3.2 
110
7.2.4 a Demonstrate that second-party auditors possess the competence and understanding of the automotive process approach Including risk-based thinking
111
7.2.4 b Demonstrate that second-party auditors possess the competence and understanding of applicable customer-specific requirements Cf. sub-clause 4.3.2
112
7.2.4 c Demonstrate that second-party auditors possess the competence and understanding of applicable requirements to the scope of the audit Cf. sub-clause 9.2.2 
113
7.2.4 d Demonstrate that second-party auditors possess the competence and understanding of applicable manufacturing process to be audited Including PFMEA (process FMEA) and control plan, cf. sub-clause 8.5.1.1 
114
7.2.4 e Demonstrate that second-party auditors possess the competence and understanding of applicable core tool requirements related to the scope of the audit Cf. annex B of IATF 16949
115
7.2.4 f Demonstrate that second-party auditors possess the competence and understanding of how to plan, conduct, prepare audit reports and clause out audit findings Cf. sub-clause 9.2 and ISO 19011 
   7.3 Awareness
 
    See ISO 9001 v 2015 requirements  
 
7.3.1
Awareness
supplemental
116
 7.3.1 Retain documented information on employees' awareness of their impact on product quality, customer requirements and the importance of their activities in achieving, maintaining and improving quality Including the risks involved for the customer with nonconforming product, cf. sub-clause 8.7.1
 
7.3.2
Employee motivation and empowerment
117
 7.3.2 Maintain a documented process to motivate employees Especially create an appropriate work environment (which motivates employees and promotes innovation). Cf. sub-clause 7.5.3.1
118
 7.3.2 Include in the process the promotion of quality and technological awareness throughout the whole organization Cf. sub-clause 10.3.1
   7.4
Communication 
 
    See ISO 9001 v 2015 requirements  
   7.5
Documented information
 
 
7.5.1
General
 
 
  See ISO 9001 v 2015 requirements  
   7.5.1.1
QMS documentation
 
119
7.5.1.1 Document the QMS including a quality manual The quality manual is adapted to the size, culture and complexity of the organization
120
 7.5.1.1 Retain a list of all documents When the quality manual comprises a series of documents
121
 7.5.1.1 a Include the scope of the QMS Including the justification for any exclusions, cf. sub-clause 4.3.1
122
 7.5.1.1 b Include documented processes or a reference to them Cf. sub-clause 4.4.1.1
123
 7.5.1.1 c Include processes, their sequence and their interactions Including outsourced processes, cf. sub-clause 8.4.2. A matrix of how the requirements of the IATF 16949 standard are addressed by the internal processes may be used
124
 7.5.1.1 d Include a document indicating where customer-specific requirements are addressed Cf. sub-clause 4.3.2
 7.5.2
Creating and upating
 
 
  See ISO 9001 v 2015 requirements  
   7.5.3
Control of documented information
 
 7.5.3.1 and 7.5.3.2
 
up
    See ISO 9001 v 2015 requirements

Summary of ISO 9001 v 2015 and IATF 16949 documented information.

Documented information to maintain (procedures, documented process):

  • scope (sub-clause 4.3)
  • product safety (sub-clause 4.4.1.2)
  • processes (sub-clause 4.4.2 a)
  • quality policy (sub-clause 5.2.2 a)
  • quality objectives (sub-clause 6.2.1)
  • manage calibration and verification (sub-clause 7.1.5.2.1)
  • competence of personnel (sub-clause 7.2.1)
  • internal auditor competency (sub-clause 7.2.3)
  • employee motivation (sub-clause 7.3.2)
  • engineering specifications (sub-clause 7.5.3.2.2)
  • operational control (sub-clause 8.1)
  • design and development (sub-clause 8.3.1.1)
  • external provider selection (sub-clause 8.4.1.2)
  • outsourced processes (sub-clause 8.4.2.1)
  • statutory and regulatory requirements (sub-clause 8.4.2.2)
  • external provider performance ( sub-clause 8.4.2.4)
  • job set-ups status (sub-clause 8.5.1.3)
  • TPM system (sub-clause 8.5.1.5)
  • identification and traceability (sub-clause 8.5.2.1)
  • feedback (sub-clause 8.5.5.1)
  • control of changes (sub-clause 8.5.6.1)
  • manage alternative methods (sub-clause 8.5.6.1.1)
  • reworked product (sub-clause 8.7.1.4)
  • repairs (sub-clause 8.7.1.5)
  • nonconforming product disposition (sub-clause 8.7.1.7)
  • internal audit (sub-clause 9.2.2.1)
  • problem solving (sub-clause 10.2.3)
  • error-proofing devices (sub-clause 10.2.4)
  • continual improvement (sub-clause 10.3.1)
Documented information to retain (records):
  • exclusion justification (sub-clause 4.3.1)
  • product safety (sub-clause 4.4.1.2)
  • processes (sub-clause 4.4.2 b)
  • meeting customer requirements (sub-clause 5.3.1)
  • results of risk analysis (sub-clause 6.1.2.1)
  • contingency plans (sub-clause 6.1.2.3)
  • adequacy of inspection resources (sub-clause 7.1.5.1)
  • alternative methods (sub-clause 7.1.5.1.1)
  • calibration (sub-clause 7.1.5.2)
  • calibrations and verifications (sub-clause 7.1.5.2.1)
  • internal laboratory scope (sub-clause 7.1.5.3.1)
  • competence of personnel (sub-clause 7.2)
  • list of qualified internal auditors (sub-clause 7.2.3)
  • training to achieve competency (sub-clause 7.2.3)
  • awareness of employee (sub-clause 7.3.1)
  • quality manual (sub-clause 7.5.1.1)
  • of external origin (sub-clause 7.5.3.2)
  • date of change in production (sub-clauses 7.5.3.2.29.1.1.1)
  • product and service conformity (sub-clause 8.1)
  • authorized concession (sub-clause 8.2.3.1.1)
  • special characteristics (sub-clause 8.2.3.1.2)
  • results of the review of product and services requirements (sub-clause 8.2.3.2)
  • design and development inputs (sub-clause 8.3.3)
  • design and development planned results, reviews, verifications and validations (sub-clause 8.3.4)
  • product approval (sub-clause 8.3.4.4)
  • design and development outputs (sub-clause 8.3.5)
  • design and development changes (sub-clause 8.3.6)
  • activities and evaluation actions of external providers (sub-clause 8.4.1)
  • software development self-assessment (sub-clause 8.4.2.3.1)
  • second-party audit report (sub-clause 8.4.2.4.1)
  • product and service characteristics or activities to be performed, results to be achieved (sub-clause 8.5.1)
  • control plan (sub-clause 8.5.1.1)
  • operator safety rules (sub-clause 8.5.1.2)
  • process and product approval (sub-clause 8.5.1.3)
  • traceability response time (sub-clause 8.5.2.1)
  • product and service traceability (sub-clause 8.5.2)
  • customer-own property status (sub-clause 8.5.3)
  • results of change review (sub-clause 8.5.6)
  • change verification and validation (sub-clause 8.5.6.1)
  • list of the process controls (sub-clause 8.5.6.1.1)
  • restart period (sub-clause 8.5.6.1.1)
  • release of products and services (sub-clause 8.6)
  • customer concession (sub-clause 8.7.1.1)
  • product rework (sub-clause 8.7.1.4)
  • product repair (sub-clause 8.7.1.5)
  • customer notification of nonconforming product shippment (sub-clause 8.7.1.6)
  • nonconforming product and service processing (sub-clause 8.7.2)
  • inspection results (sub-clause 9.1.1)
  • significant process events (sub-clause 9.1.1.1)
  • date of process change implementation (sub-clause 9.1.1.1)
  • audit program and audit results (sub-clause 9.2.2)
  • management review outputs (sub-clause 9.3.3)
  • action plan (sub-clause 9.3.3.1)
  • nonconformity, actions and results (sub-clause 10.2.2)
  • test with error-proofing devices (sub-clause 10.2.4)
  7.5.3.2.1
Documented information retention
up
125
 7.5.3.2.1 Define, document and implement a documented information retention policy Cf. sub-clause 7.5.3.1
126
 7.5.3.2.1 Satisfy statutory, regulatory, internal and customer requirements To control all documented information
127
 7.5.3.2.1 Retain documented information for the length of time that the product is active for production and service, plus one calendar year, unless otherwise specified Documented information relating to production part approvals, tools (including maintenance and ownership), product and process design, purchase orders, contracts and amendments
  7.5.3.2.2
Engineering specifications
 
128
 7.5.3.2.2 Use a documented process describing the review, distribution and implementation of all customer engineering standards and specifications Including related revisions and customer schedules. Cf. sub-clause 7.5.3.1
129
 7.5.3.2.2 Refer to change control requirements when a change of a standard or engineering specification results in a product design change Cf. sub-clause 8.3.6
130
 7.5.3.2.2 Refer to change control requirements when a change of a standard or engineering specification results in a product realization process change Cf. sub-clause 8.5.6.1
131
 7.5.3.2.2 Retain documented information of the date on which each change is implemented in production Cf. sub-clause 7.5.3.1 
132
 7.5.3.2.2 Include updated documents Retain the date of implementation
133
 7.5.3.2.2 Conduct the review within 10 working days Upon notification of engineering standards or specifications changes
   8
Operation
Do 
   8.1
Operational planning and control
 
    See ISO 9001 v 2015 requirements  
 
8.1.1
Operational planning and control
Supplément 
134 8.1.1 a Include in planning for product realization the technical specifications and customer product requirements Cf. 7.5.3.2.2
135 8.1.1 b Include in planning for product realization the logistics requirements In order to adapt planning to the way the company operates
136 8.1.1 c Include in planning for product realization the manufacturing feasibility Cf. sub-clause 8.2.3.1.3
137 8.1.1 d Include in planning for product realization the project planning Cf. sub-clause 8.3.2
138 8.1.1 e Include in planning for product realization the acceptance criteria Cf. sub-clause 8.6.6
139 8.1.1 Determine necessary resources needed to achieve conformity of products and services The activities required are verification, validation, monitoring, measurement, inspection, specific test and acceptance criteria
  8.1.2
Confidentiality
140 8.1.2  Ensure the confidentiality of customer-contracted products and projects under development And during implementation
 8.2
Requirements for products and services
 
   8.2.1
Customer communication
 
    See ISO 9001 v 2015 requirements  
 8.2.1.1
Customer communication
supplemental
141 8.2.1.1 Speak in the language agreed with the customer Concerning written or verbal communication, cf. sub-clause 7.4
142 8.2.1.1 Ensure the ability to communicate in a computer language and format specified by the customer Such as computer-aided design data and electronic data interchange
   8.2.2
Requirements for products and services
 
    See ISO 9001 v 2015 requirements  
 
8.2.2.1
Requirements for products and services
supplemental
143 8.2.2.1 Include recycling and environmental impact requirements Identify the characteristics of the product and processes
144  8.2.1.1 Include compliance obligations, applicable government and safety requirements Related to acquisition, storage, handling, recycling, elimination or disposal of material. Cf. sub-clause 8.2.2 a
   8.2.3 Review of the requirements for products and services
 
 
8.2.3.1
 
up
    See ISO 9001 v 2015 requirements  
 
 8.2.3.1.1
Review of the requirements for products and services
supplemental
145 8.2.3.1.1  Retain documented evidence (approval) of a customer-authorized concession Cf. sub-clauses 7.5.3.1 and 8.7.1
 
 8.2.3.1.2
Customer-designated special characteristics
 
146 8.2.3.1.2  Control the customer's special characteristics Identification, approval and control, cf. sub-clause 8.2.3.1
  8.2.3.1.3 Organization manufacturing feasibility
 
147 8.2.3.1.3  Utilize a multidisciplinary approach to conduct an analysis to determine if it is feasible to consistently produce product That meets all of the engineering and capacity customer requirements, cf. sub-clauses 7.1.3.1 and 8.1.1
148 8.2.3.1.3  Conduct a feasibility analysis for any new technology or for any changed process or product design Cf. sub-clause 8.3.6 
149 8.2.3.1.3 Validate the ability to make product at the required rate Through production runs or other method such as simulation
 
8.2.3.2
 
 
    See ISO 9001 v 2015 requirements  
 
8.2.4
Changes to requirements for products and services
 
    See ISO 9001 v 2015 requirements  
   8.3
Design and development of products and services
 
   8.3.1
General
up
    See ISO 9001 v 2015 requirements  
 
8.3.1.1
Design and development of products and services
supplemental
150 8.3.1.1  Focus on error prevention rather than detection Take into account the requirements of sub-clause 8.3.1 also for processes
151 8.3.1.1 Document the design and development process Cf. sub-clause 7.5.3.1
   8.3.2 Design and development planning  
    See ISO 9001 v 2015 requirements  
 
8.3.2.1
Design and development planning
supplemental
152 8.3.2.1 Include all affected interested parties in the design and development planning Including, as appropriate, the supply chain
153 8.3.2.1 a Include in the multidisciplinary approach the project management As APQP, cf. annex B 
154 8.3.2.1 b Include in the multidisciplinary approach the use of alternative product and manufacturing process design activities Concerning product and manufacturing processes, cf. annex B
155 8.3.2.1 c Include in the multidisciplinary approach the development and review of product design risk analysis and actions to reduce potential risks Such as product FMEA
156 8.3.2.1 d Include in the multidisciplinary approach the development and review of manufacturing process risk analysis Such as PFMEA, process flows, control plans
 
 8.3.2.2
Product design skills
 
157  8.3.2.2 Ensure that personnel are competent to achieve design requirements And control applicable product design tools and techniques
158  8.3.2.2 Identify applicable tools and techniques for product design Such as digitized mathematically based data
 
 8.3.2.3
Development of products with embedded software
 
159 8.3.2.3 Use a process for quality assurance for products with internally embedded software Concerning one or more embedded systems by product
160 8.3.2.3 Assess the software development process Cf. sub-clauses 8.3.3.1 h, 8.3.4.2, and 8.4.2.3.1
161 8.3.2.3 Retain documented information of a software development capability self-assessment Using prioritization based on risk and potential impact to the customer. Cf. sub-clause 7.5.3.1
162 8.3.2.3 Include software development within the internal audit program Cf. sub-clause 9.2.2.1 
   8.3.3
Design and development inputs
up
    See ISO 9001 v 2015 requirements  
 
 8.3.3.1
Product design input
 
163 8.3.3.1 Identify, document and review product design input requirements After each contract review. Cf. sub-clause 7.5.3.1
164 8.3.3.1 a Include in product design input requirements the product specifications and special characteristics Cf. sub-clause 8.3.3.3 
165 8.3.3.1 b Include in product design input requirements the boundary and interface requirements Limits not to exceed and links to other products and assemblies
166 8.3.3.1 c Include in product design input requirements the identification, traceability and packaging Cf. sub-clauses 8.5.2 and 8.5.4.1
167 8.3.3.1 d Include in product design input requirements the consideration of design alternatives Such as compromise curves
168 8.3.3.1 e Include in product design input requirements the assessment of risks Including the ability to mitigate the risks and the feasibility analysis, cf. sub-clauses 6.1 and 8.2.3.1.3
169 8.3.3.1 f Include in product design input requirements the objectives for product conformity Such as preservation, reliability, durability, serviceability, health, safety, environmental, development timing and cost
170 8.3.3.1 g Include in product design input requirements the applicable statutory and regulatory requirements Of the customer-identified country of destination, if provided
171 8.3.3.1 h Include in product design input requirements the embedded software requirements Such as requirements related to predictability, analyzability, verifiability and comprehensibility. Cf. sub-clause 8.3.2.3
172 8.3.3.1 Ensure a process to deploy appropriate information Such as gained from previous design projects, benchmarking, feedback, field data
 
 8.3.3.2
Manufacturing process design input
 
173 8.3.3.2 Identify, document and review manufacturing process design input requirements Cf. sub-clause 7.5.3.1
174 8.3.3.2 a Include in process design input the product design output data Including special characteristics
175 8.3.3.2 b Include in process design input the objectives for performance Such as productivity, process capability, timing and costs
176 8.3.3.2 c Include in process design input the manufacturing technologies alternatives Bench marking
177 8.3.3.2 d Include in process design input the customer requirements Cf. sub-clause 4.3.2
179 8.3.3.2 e Include in process design input the experiences acquired Such as previous design projects, benchmarking, feedback
180 8.3.3.2 f Include in process design input the new materials That will be used for new products
181 8.3.3.2 g Include in process design input the product handling and ergonomic requirements Cf. sub-clause 7.1.4
182 8.3.3.2 h Include in process design input design for manufacturing and design for assembly Cf. annex B
183 8.3.3.2  Include the use of appropriate error-proofing methods Cf. sub-clause 10.2.4
 
8.3.3.3
Special characteristics
up
184 8.3.3.3  Use a multidisciplinary approach to establish, document and implement a process to identify special characteristics Cf. sub-clause 7.5.3.1. Taking into account the special characteristics resulting from the risk analysis
185 8.3.3.3 a Include all special characteristics and identify them with special markings in all concerned documents Such as drawings, FMEAs, control plans, work instructions
186 8.3.3.3 b Control special characteristics of products and processes Development of control and monitoring strategies throughout the production chain
187 8.3.3.3 c Obtain customer-specified approvals When required
188 8.3.3.3 d Observe customer-specified definitions and symbols Or use equivalent symbols defined in a conversation table
189 8.3.3.3 d Submit the symbol conversion table to the customer for approval If required
   8.3.4
Design and development controls
 
    See ISO 9001 v 2015 requirements  
 
8.3.4.1
Monitoring
 
190 8.3.4.1 Define, analyze and report summary of measurements as an input to management review, at specified stages during design and development of products and processes Cf. sub-clause 9.3.2.1. Risks are included, where appropriate, related to quality, costs, development times and other measures
191 8.3.4.1 Report to the customer, when required, measurements of the product and process development activity, at specified stages The stages are specified by the customer or decided with his consent
  8.3.4.2
Design and development validation
 
192 8.3.4.2  Perform design and development validation in accordance with customer and applicable industry standards Including any applicable industry and governmental agency-issued regulatory standard
193 8.3.4.2 Plan and meet deadlines for design and development validation If possible, follow the schedule specified by the customer
194 8.3.4.2 Include in the validation evaluation of the interaction of the product with the system of the final customer's product Where contractually agreed with the customer, including embedded software, cf. sub-clause 8.3.2.3
 
8.3.4.3
Prototype program
up
195 8.3.4.3  Ensure a prototype program, when required by the customer Including a prototype control plan, cf. sub-clause 8.5.1.1
196 8.3.4.3 Use, whenever possible, the same external providers, tooling and manufacturing processes as will be used in production In order not to have surprises
197 8.3.4.3 Monitor all performance-testing activities for timely completion And for conformity
198 8.3.4.3  Include in the scope of the QMS, when services are outsourced, the type and extent of control of outsourced services Cf. sub-clause 8.4
 
 8.3.4.4
Product approval process
 
199 8.3.4.4 Establish, implement and maintain a product and manufacturing approval process conforming to customer requirements Verify the manufacturing process before product approval, review the effectiveness of the process
200 8.3.4.4 Approve externally provided products and services Prior to submission of part approval to the customer. Cf. sub-clause 8.4.3
201 8.3.4.4 Obtain documented product approval prior to shipment If required by the customer
202 8.3.4.4 Retain documented information of such approval Cf. sub-clause 7.5.3.1
  8.3.5 Design and development outputs
 
    See ISO 9001 v 2015 requirements  
 
8.3.5.1
Design and development outputs
supplemental
203 8.3.5.1 Express product design output against design input requirements In terms that can be verified and validated
204 8.3.5.1 a Include in the product design output the design risk analysis Such as FMEA and problems resolved through a compromise process
205 8.3.5.1 b Include in the product design output the reliability study results Cf. sub-clause 8.3.5.2 l
206 8.3.5.1 c Include in the product design output the product special characteristics Cf. sub-clause 8.3.3.3
207 8.3.5.1 d Include in the product design output the results of product design error-proofing Cf. sub-clause 10.2.4 and annex B. Such as DFSS (Design for Six Sigma), DFMA (Design for Manufacture and Assembly), FTA (Fault Tree Analysis)
208 8.3.5.1 e Include in the product design output the product definition Such as 3D models, technical data packages, product manufacturing information, GD&T (geometric dimensioning & tolerancing)
209 8.3.5.1 f Include in the product design output the 2D drawings Such as product manufacturing information, GD&T (geometric dimensioning & tolerancing)
210 8.3.5.1 g Include in the product design output the product design review results Which may be included as inputs to the management review, cf. Sub-clause 9.3.2.1
212 8.3.5.1 h Include in the product design output the diagnostic guidelines and repair instructions In order to realize diagnostics, repairs and replacements
213 8.3.5.1 i Include in the product design output the service part requirements Including instructions, methods, tooling
214 8.3.5.1 j Include in the product design output the packaging and labelling requirements All shipping information
 
 8.3.5.2
Manufacturing process design output
up
215 8.3.5.2 Document the manufacturing process design output  In order to verify these outputs against inputs
216 8.3.5.2 Verify the outputs against manufacturing process design input requirements Concerning manufacturing process design
217 8.3.5.2 a Include in the manufacturing process design output the specifications and drawings Necessary to manufacturing
218 8.3.5.2 b Include in the manufacturing process design output the special characteristics Cf. sub-clause 8.3.3.3
219 8.3.5.2 c Include in the manufacturing process design output the identification of process input variables Input variables that impact chracteristics
220 8.3.5.2 d Include in the manufacturing process design output the tooling and equipment for production and control Including capability studies of equipment and processes
221 8.3.5.2 e Include in the manufacturing process design output the manufacturing process flow charts and layout In order to show the links between product, process, tooling, raw material and inspection
222  8.3.5.2 f Include in the manufacturing process design output the capacity analysis Cf. sub-clause 8.2.3.1.3
223  8.3.5.2 g Include in the manufacturing process design output the manufacturing process FMEA Cf. sub-clause 8.5.1.1
224  8.3.5.2 h Include in the manufacturing process design output the maintenance Planning, instructions, cf. sub-clause 8.5.1.5
225  8.3.5.2 i Include in the manufacturing process design output the control plan Cf. annex A 
226  8.3.5.2 j Include in the manufacturing process design output the standardized work and work instructions And any other necessary manufacturing document
227  8.3.5.2 k Include in the manufacturing process design output the process approval acceptance criteria In order to validate the processes
227  8.3.5.2 l Include in the manufacturing process design output the production data Concerning quality, reliability, maintainability and measurability
228  8.3.5.2 m Include in the manufacturing process design output the results of error-proofing identification and verification As appropriate. Cf. sub-clause 10.2.4
229  8.3.5.2 n Include in the manufacturing process design output the cases of product and process nonconformities Such as feedback, methods of rapid detection and solving
 
 8.3.6
Design and development changes
 
    See ISO 9001 v 2015 requirements  
 
 8.3.6.1
Design and development changes
supplemental
230  8.3.6.1  Evaluate all design changes after initial product approval for potential impact on fit, form, function, performance or durability Including those proposed internally or by external providers
231  8.3.6.1  Validate and approve these changes prior to production implementation Taking into account customer requirements
232  8.3.6.1 Obtain customer documented approval or a documented concession prior to production implementation If required by the customer
233  8.3.6.1 Document the revision level of software and hardware for products with embedded software When changes are retained, cf. sub-clause 7.5.3.1
   8.4
External providers
 
   8.4.1
General
up
    See ISO 9001 v 2015 requirements  
 
 8.4.1.1
General
supplemental
234  8.4.1.1 Include in the definition of externally provided products, processes and services all products and services that affect customer requirements Such as sub-assembly, sorting, rework and calibration
 
 8.4.1.2
External provider selection process
 
235 8.4.1.2 Define a documented external provider selection process Cf. sub-clause 8.4.1 
236 8.4.1.2 a Include in the selection process an assessment of external providers Compared to product and supply conformity
237 8.4.1.2 b Include in the selection process the performance Compared to quality and delivery performance
238 8.4.1.2 c Include in the selection process an evaluation of the external provider QMS Cf. sub-clause 8.4.2.3 
239 8.4.1.2 d Include in the selection process multidisciplinary decision making As representatives of purchasing, quality and logistics departments
240 8.4.1.2 e Include in the selection process an assessment of software development capabilities Cf. sub-clause 8.4.2.3.1
241 8.4.1.2  Include in the external provider selection other criteria to consider such as volume of automotive business As quantity or as percentage
242 8.4.1.2  Include in the external provider selection other criteria to consider such as financial stability Historical and competitive analysis
243 8.4.1.2  Include in the external provider selection other criteria to consider such as purchased product, material or service complexity Be careful because sometimes some simple things are very difficult to achieve
244 8.4.1.2  Include in the external provider selection other criteria to consider such as required technology Concern the product or the process
245 8.4.1.2  Include in the external provider selection other criteria to consider such as adequacy of available resources Such as people, equipment and infrastructure
246 8.4.1.2  Include in the external provider selection other criteria to consider such as design and development capabilities Including project management
247 8.4.1.2  Include in the external provider selection other criteria to consider such as manufacturing capability Very important criterion
248  8.4.1.2  Include in the external provider selection other criteria to consider such as change management process Cf. sub-clause 8.5.6
249 8.4.1.2  Include in the external provider selection other criteria to consider such as business continuity planning Such as disaster preparedness or contingency planning
250 8.4.1.2  Include in the external provider selection other criteria to consider such as logistic process Management of normal and crisis situations
 251 8.4.1.2  Include in the external provider selection other criteria to consider such as customer service Management of nonconforming product and crisis situations
 
 8.4.1.3
Customer-directed sources
 
252  8.4.1.3 Purchase products, materials or services from customer-directed sources These are customer-designated (approved) external providers
253  8.4.1.3 Apply the requirements of sub-clause 8.4 unless otherwise agreed in the contract with the customer Cf. sub-clause 8.4
   8.4.2
Type and extent of control
up
    See ISO 9001 v 2015 requirements  
 
 8.4.2.1
Type and extent of control
supplemental
254 8.4.2.1 Define a documented process to identify outsourced processes Select the type and extent of inspections to verify conformity of products, processes and services provided by external providers
255 8.4.2.1 Include the criteria and actions to escalate or reduce the type and extent of controls Based on external provider performance and associated risks
 
8.4.2.2
Statutory and regulatory requirements
 
256 8.4.2.2  Document a process to ensure that purchased products, processes and services conform to the current applicable statutory and regulatory requirements in the country of customer receipt, shipment and destination Cf. sub-clause 7.5.3.1
257 8.4.2.2  Implement and maintain as defined by customer special controls for certain products with statutory and regulatory requirements  Including if these inspections are performed at external provider's premises
 
8.4.2.3
External provider QMS development
 
258 8.4.2.3 Require the external providers to develop, implement and improve an ISO 9001-certified QMS by following the sequence below And to explain that the ultimate objective is becoming IATF 16949 certified, unless otherwise authorized by the customer
259 8.4.2.3 a Apply conformity to ISO 9001 through second-party audits Cf. sub-clause 7.2.4
260 8.4.2.3 b Obtain certification to ISO 9001 through third-party audits Tis must be done by a certification body recognized IAF MLA (International Accreditation Forum Multilateral Recognition Arrangement)
261 8.4.2.3 c Apply certification to ISO 9001 completed by conformity to other customer-defined QMS requirements Such as requirements announced in the MAQMSR (Minimum Automotive Management System Requirements) or another equivalent standard
262 8.4.2.3 d  Obtain certification to ISO 9001 with conformity to IATF 16949 through second-party audits Cf. sub-clause 7.2.4
263 8.4.2.3 e Obtain certification to IATF 16949 through third-party audits This must be issued by an IATF-recognized certification body
 
 8.4.2.3.1
Automotive product-related software (embedded software)
 
264 8.4.2.3.1 Require the external providers of automotive product-related software or embedded software to implement and maintain a specific process In order to ensure product software quality
265  8.4.2.3.1 Utilize a software development assessment methodology In order to assess the external provider software development process
266  8.4.2.3.1 Require the external providers to retain documented information of their self-assessment capability to develop software Using prioritization based on risk and potential impact to the customer
 
 8.4.2.4
External provider monitoring
up
267 8.4.2.4 Identify a documented process and criteria to evaluate the performance of external providers And introduce improvement actions. Cf. sub-clause 7.5.3.1
268 8.4.2.4 Ensure conformity with internal and customer requirements for all that is provided by external providers Such as products, processes and services
269 8.4.2.4 a Monitor performance indicators of external providers such as conformity of delivered products Cf. sub-clause 8.4.1.1
270 8.4.2.4 b Monitor performance indicators of external providers such as customer disruptions at the receiving plant Including yard holds and stop ships
271 8.4.2.4 c Monitor performance indicators of external providers such as delivery schedule Quantity, quality, deadlines
272 8.4.2.4 d Monitor performance indicators of external providers such as number of occurrences of premium freight Such as abnormal deliveries (by taxi, by airplane, by helicopter)
273 8.4.2.4 e Include customer notifications for special status Root causes related to quality or delivery issues of external providers
274 8.4.2.4 f Include dealer returns, warranty Including field actions and recalls
 
8.4.2.4.1
Second-party audit
 
275 8.4.2.4.1 Include a second-party audit process In external provider's management. Cf. the IATF auditor guide and ISO 19011 
276 8.4.2.4.1 a Use second-party audits for risk assessment Related to the external provider
277 8.4.2.4.1 b Use second-party audits for external provider monitoring Regular monitoring of its performance
278 8.4.2.4.1 c Use second-party audits for development of external provider QMS Cf. sub-clause 8.4.2.3
279 8.4.2.4.1 d Use second-party audits for product audits Cf. sub-clause 9.2.2.4
280 8.4.2.4.1 e Use second-party audits for process audits Cf. sub-clause 9.2.2.3
281 8.4.2.4.1 Document the criteria for determining the need, type, frequency and scope of second-party audits Based on a risk analysis, the external provider's safety / regulatory performance and the level of development of its QMS
 282 8.4.2.4.1 Retain documented information of the second-party audit reports Cf. sub-clause 7.5.3.1
283 8.4.2.4.1 Adopt an approach consistent with the automotive process approach When the audit assesses the QMS of external providers
 
 8.4.2.5
External provider development
 
284 8.4.2.5 Determine the development actions for active external providers Including the priority, type, extent and timing of actions. Consider short and long term goals
285 8.4.2.5 a Take into account performance issues Cf. sub-clause 8.4.2.4
286 8.4.2.5 b Take into account second-party audit findings Cf. sub-clause 8.4.2.4.1
287  8.4.2.5 c Take into account third-party QMS certification status Cf. sub-clause 8.4.2.3
288  8.4.2.5 d Take into account risk analysis Cf. sub-clause 6.1.2.1 
289  8.4.2.5 Implement actions necessary to resolve open performance issues And seize opportunities for continual improvement
  8.4.3
Information for external providers
up
    See ISO 9001 v 2015 requirements  
 
8.4.3.1
Information for external providers
 supplemental
290 8.4.3.1 Pass down all applicable statutory and regulatory requirements and special product and process characteristics to external providers Cf. sub-clauses 8.4.2.2 and 8.3.3.3
291 8.4.3.1 Require the external providers to cascade all applicable requirements down the supply chain Concerning the points of manufacture
  8.5
Production and service provision
 
  8.5.1
 Control of production and service provision
 
    See ISO 9001 v 2015 requirements  
  8.5.1.1
Control plan
 
292 8.5.1.1 Develop control plans at all levels (system, subsystem, component and material including bulk materials) Cf. annex A
293 8.5.1.1 Use family control plans For bulk material and similar parts (using a common manufacturing process)
294 8.5.1.1 Develop control plans for pre-launch and production with information from the design risk analysis, process flow diagram and process risk analysis outputs Such as FMEA. Cf. sub-clause 8.3.2.1
295 8.5.1.1  Provide, if requested by the customer, data collected during execution of either the pre-launch or production control plans Cf. sub-clause 7.5.3.1
296 8.5.1.1 a Include in the control plan controls used for the manufacturing process control Including verification of job set-ups
297 8.5.1.1 b Include in the control plan first-off/last-off part validation As applicable
298 8.5.1.1 c Include in the control plan methods for monitoring of control In order to verify the special characteristics, cf. annex A
299 8.5.1.1 d Include in the control plan customer-required information If any
300 8.5.1.1 e Include in the control plan when initiating a specified reaction plan When nonconforming product is detected, the process becomes statistically unstable or not statistically capable. Cf. annex A
301 8.5.1.1 f Review and update control plans when the organization determines it has shipped nonconforming product to the customer Cf. sub-clause 8.7.1
302 8.5.1.1 g Review and update control plans when any change occurs Affecting product, manufacturing process, measurement, logistics, supply sources, production volume, or risks analysis. Cf. annex A
303 8.5.1.1 h Review and update control plans after a customer complaint and implementation of the associated corrective action Cf. sub-clause 10.2
304 8.5.1.1 i Review and update control plans at a set frequency Based on a risk analysis
305 8.5.1.1  Obtain customer approval after review of the control plan If required by the customer
   8.5.1.2
Standardized work - operator instructions and visual standards
up
306 8.5.1.2 a Ensure that standardized work documents are communicated to and understand by the employees Who are responsible for performing the work
307 8.5.1.2 b Ensure that standardized work documents are legible Cf. sub-clause 7.5.2
308 8.5.1.2 c Ensure that standardized work documents are presented in the language understood by those responsible to follow them Cf. sub-clause 7.5.2
309 8.5.1.2 d Ensure that standardized work documents are accessible At the designed work areas
310 8.5.1.2 Include in standardized work documents rules for operator safety Cf. sub-clause 7.1
 
8.5.1.3
Verification of job set-ups
 
311 8.5.1.3 a  Verify job set-ups It is the responsibility of the team leader, during initial start-up, modification of equipment or change of production family
312 8.5.1.3 b  Maintain documented information for job set-ups For set-up personnel. Cf. sub-clause 7.5.3.1
313 8.5.1.3 c  Use statistical methods of verification Where applicable. Cf. sub-clause 9.1.1.2 
314 8.5.1.3 d  Perform first-off/last-off  part validation, as applicable Where appropriate retain first-off parts and last-off parts for comparison. Cf. sub-clause 8.5.1.1 b
315 8.5.1.3 e Retain documented information of process and product approval Following set-up and first-off (last-off) part validation, cf. sub-clause 7.5.3.1 
 
8.5.1.4
Verification after shutdown
 
316 8.5.1.4  Define and implement the necessary actions to ensure product conformity After a production shutdown period. Lessons learned and best practices
 
8.5.1.5
Total productive maintenance
up
317 8.5.1.5 Develop, implement and maintain a documented total productive maintenance system For all manufacturing processes. Cf. annex B
318 8.5.1.5 a Identify the necessary process equipment In order to produce conforming product at the required volume
319 8.5.1.5 b Manage the availability of replacements parts For the necessary process equipment
320 8.5.1.5 c Provide necessary maintenance personnel For machine, equipment and facility maintenance
321 8.5.1.5 d Manage packaging and preservation of equipment, tooling and gauging Cf. sub-clause 8.5.4 
322 8.5.1.5 e Include applicable customer-specific requirements Cf. sub-clause 4.3.2 
323 8.5.1.5 f Determine documented maintenance objectives Such as OEE (Overall Equipment Effectiveness), MTBF (Mean Time Between Failure), MTTR ( Mean Time To Repair) and preventive maintenance compliance metrics
324 8.5.1.5 f Use performance to the maintenance objectives as input to management review Cf. sub-clause 9.3.2 
325 8.5.1.5 g Review maintenance plan and objectives Regularly
326 8.5.1.5 g Document corrective actions where objectives are not achieved Cf. sub-clause 10.2 
327 8.5.1.5 h Use preventive maintenance methods To avoid the causes of malfunctions. "A little prevention is better than a lot of healing." English proverb
328 8.5.1.5 i Use predictive maintenance methods To monitor periodically and plan actions. As applicable
329 8.5.1.5 j Include periodic overhaul In the maintenance plan
 
 8.5.1.6
Management of tooling and equipment
up
330 8.5.1.6 Provide resources for tool and gauge design, fabrication and verification activities For production and service materials and for bulk materials, as applicable
331 8.5.1.6 a Include maintenance and repair facilities and personnel in tooling management Cf. sub-clauses 7.1.2 and 7.1.4
332 8.5.1.6 b Include storage and recovery in tooling management Cf. sub-clause 7.1.3
333 8.5.1.6 c Include set-up in tooling management Cf. sub-clause 7.1.3
334 8.5.1.6 d Include tool-change programs in tooling management For perishable tools
335 8.5.1.6 e Include tool design modification documentation in tooling management Including engineering change level of the product
336 8.5.1.6 f Include tool modification in tooling management Including revision of documentation
337 8.5.1.6 g Include tool identification in tooling management Such as serial or asset number, its usage status (production, repair or disposal), ownership and location
338 8.5.1.6  Verify that customer-owned tools and equipment are permanently marked in a visible location In order to determine owneship and application of each item, cf. sub-clause 8.5.3 
339 8.5.1.6  Monitor these activities when they are outsourced Cf. sub-clause 8.4.1
 
 8.5.1.7
Production scheduling
 
340 8.5.1.7 Ensure that production is scheduled in order to meet customer orders Including just-in-time (JIT) production. Use lessons learned
341 8.5.1.7 Ensure that an information system permits access to production data At key stages of the process and is order driven
342 8.5.1.7 include relevant planning information during production scheduling Such as customer orders, delivery performance of external providers, capacity, shared loading, lead time, inventory level, preventive maintenance and calibration. In other words a robust feasibility review process regarding production scheduling
   8.5.2
Identification and traceability
up
    See ISO 9001 v 2015 requirements  
 
 8.5.2.1
Identification and traceability
supplemental
343 8.5.2.1 Identify clear start and stop points for product received by the customer with the help of traceability Product that may present a risk of nonconformity or safety, based on lessons learned
344 8.5.2.1 Implement identification and traceability processes Processes described in the requirements below
345 8.5.2.1 Conduct an analysis of internal, customer and regulatory traceability requirements Related to traceability applicable to automotive products
346 8.5.2.1 Develop and document traceability plans Based on the levels of risk or failure severity for employees, customers and consumers, cf. sub-clause 7.5.3.1 
347 8.5.2.1 Define traceability systems, processes and methods By product, process and manufacturing location
348 8.5.2.1 a Identify nonconforming or suspect product Cf. sub-clauses 8.7.1 and 8.7.1.3 
349 8.5.2.1 b Segregate nonconforming or suspect product Red boxes and "prison"
350 8.5.2.1 c Meet customer or regulatory response time requirements Concerning notification response
351 8.5.2.1 d Retain documented information in appropriate format In accordance with the reaction time constraints, cf. sub-clause 7.5.3.1
352 8.5.2.1 e Ensure serialized identification of individual products If specified by the customer or regulatory standards
353 8.5.2.1 f Extend identification and traceability requirements to products with safety / regulatory characteristics Concerning externally provided products
  8.5.3
Property belonging to customers or external providers
 
    See ISO 9001 v 2015 requirements  
  8.5.4
Preservation 
up
    See ISO 9001 v 2015 requirements  
 
8.5.4.1
Preservation 
 supplemental
354 8.5.4.1 Include in preservation identification, handling, control of contamination, packaging, storage, transmission or transport and protection Concerning production and service provision outputs
355 8.5.4.1  Apply preservation to materials and components from external or internal providers From the receipt, through processing until acceptance by the customer
356 8.5.4.1  Assess, at appropriate planned intervals, the condition of product in stock, the storage container and environment In order to detect any deterioration
357 8.5.4.1  Use an inventory management system to optimize inventory turns and ensure stock rotation Such as FIFO (first in, first out)
358 8.5.4.1  Ensure that obsolete product is identified and controlled in a manner similar to that of nonconforming product Cf. sub-clause 8.7.1
359 8.5.4.1  Comply with customer requirements Concerning preservation, packaging, labelling and shipping
  8.5.5
 Post-delivery activities
 
    See ISO 9001 v 2015 requirements  
 
8.5.5.1
Feedback of information from service
 
360 8.5.5.1  Establish, implement and maintain a post-delivery service communication process Cf. sub-clause 10.2.6
8.5.5.2
Service agreement with customer
 
361 8.5.5.2 a Verify that relevant service centers meet applicable requirements Internal, customer and regulatory requirements
362 8.5.5.2 b Verify the effectiveness of any special purpose tools or measurement equipment Cf. sub-clause 7.1.5.1
363 8.5.5.2 c Ensure that all service personnel are trained in applicable requirements  Cf. sub-clause 7.2
  8.5.6
Control of changes
up
    See ISO 9001 v 2015 requirements  
 
8.5.6.1
Control of changes
 supplemental
364  8.5.6.1 Establish a documented process to control and react to changes That can impact product realization
365  8.5.6.1  Assess the effects of any change Including those caused by the organization, the customer or any external provider
366 8.5.6.1 a Define verification and validation activities In order to ensure meeting customer requirements
367 8.5.6.1 b Validate changes before implementation Sequence to be observed without exception
368 8.5.6.1 c Document the evidence of related risk analysis Cf. sub-clauses 7.5.3.1 and 6.1.2.1
369 8.5.6.1 d Retain documented information of verification and validation Cf. sub-clause 7.5.3.1 
370 8.5.6.1  Require a production trial run for verification of changes including those performed at external providers Such as changes to part design, manufacturing location or manufacturing process. The aim is to validate the impact of of any change on the manufacturing process.
371 8.5.6.1 e Notify the customer of any planned product realization changes After the most recent product approval
372 8.5.6.1 f Obtain customer documented approval Prior to any implementation of the change
373 8.5.6.1 g Complete additional verification or identification requirements Such as production trial run and new product validation
 
 8.5.6.1.1
Temporary change of process controls
 
374 8.5.6.1.1 Identify, document and maintain a list of the process controls Such as inspection, measuring, test, error-proofing devices, primary process control and approved back-up or alternate methods
375 8.5.6.1.1 Document the process that manages the use of alternate control methods Use these methods after approval
376 8.5.6.1.1  Include in this process the internel approvals to be obtained Before implementation of the alternate control method. Based on risk analysis (FMEA)
377 8.5.6.1.1  Obtain approval from the customer before shipping product Inspect or test using the alternate method
378 8.5.6.1.1  Maintain and periodically review a list of approved alternate process control methods Methods that are referenced in the control plan, cf. sub-clause 8.5.1.1
379 8.5.6.1.1  Ensure that standardized work instructions are available for each alternate process control method Cf. sub-clause 7.5.3.1 
380 8.5.6.1.1  Review the operation of alternate process controls Such as daily quality focused audits
381 8.5.6.1.1  Verify implementation of standard work in order to return to the standard process as soon as possible As defined in the control plan. Such as daily leadership meetings
382 8.5.6.1.1  Define and document a restart period with verification that all features of the error-proofing device or process are effectively reinstated Cf. sub-clause 7.5.3.1
383 8.5.6.1.1  Implement traceability of all products produced while any alternate process control devices or processes are being used Such as verification and retention of first piece and last piece from every shift
  8.6
Release of products and services
up
    See ISO 9001 v 2015 requirements  
 
8.6.1
Release of products and services
 supplemental
384 8.6.1 Ensure that the planned arrangements to verify that the product and service requirements have been met encompass the control plan And are documented as specified in the control plan, cf. annex A. Conduct a regular control plan audit
385 8.6.1 Ensure that the planned arrangements for initial release of products and services encompass their approval Cf. sub-clauses 8.1.1 and 8.3.4.4 
386 8.6.1 Ensure that product or service approval is accomplished after changes following initial release Cf. sub-clause 8.5.6
 
8.6.2
Layout inspection and functional testing
 
387 8.6.2 Perform for each product a layout inspection and a functional verification  To applicable customer engineering material and performance standard. Cf. sub-clause 8.5.1.1. The frequency of layout inspection is determined by the customer
388 8.6.2 Ensure that results are available for customer review Cf. sub-clause 7.5.3.1 
 
8.6.3
Appearance items
 
389 8.6.3 a Provide, for appearance items, appropriate resources Including lighting for evaluation
390 8.6.3 b Provide, for appearance items, masters For color, grain, gloss, metallic brilliance, texture, distinctness of image and haptic technology (science of touching by applying forces, vibrations or motions to the user)
391 8.6.3 c Maintain and control appearance masters Including equipment evaluation
392 8.6.3 d Verify that personnel making appearance evaluations are competent  and qualified to do so Cf. sub-clause 7.2.2
 
8.6.4
Verification and acceptance of conformity of externally provided products and services
 
393 8.6.4 a Establish a process to ensure the quality of externally provided processes, products and services by processing statistical data Communicated by the external provider
394 8.6.4 b Establish a process to ensure the quality of externally provided processes, products and services by receiving inspection Such as sampling based on performance of provider
395 8.6.4 c Establish a process to ensure the quality of externally provided processes, products and services by second or third-party assessments or audits of external provider's sites Such as audits of external provider sites when coupled with documented information delivered conforming product
396 8.64 d Establish a process to ensure the quality of externally provided processes, products and services by part evaluation by a designated laboratory Cf. sub-clause 7.1.5.3
397 8.6.4 e Establish a process to ensure the quality of externally provided processes, products and services by another method agreed with the customer Such as specific external provider contract
 
8.6.5
Statutory and regulatory conformity
up
398  8.6.5 Confirm and be able to provide evidence that externally provided processes, products and services conform to the latest applicable statutory and regulatory requirements prior to release into production flow This for the country of origin and the country of destination, if the information is provided by the customer
 
8.6.6
Acceptance criteria
 
399  8.6.6 Define internal acceptance criteria When appropriate and required, approved by the customer
400  8.6.6 Use acceptance level at zero defects For attribute data sampling, cf. sub-clause 9.1.1.1
  8.7
Control of nonconforming outputs
 
8.7.1
 
 
    See ISO 9001 v 2015 requirements  
8.7.1.1
Customer authorization for concession
 
401 8.7.1.1 Obtain a customer concession prior to further processing whenever the product or process differs from those accepted Prior to further processing
402 8.7.1.1 Obtain customer authorization prior to further processing Prior to further processing for "use as is"  or rework
403 8.7.1.1  Communicate clearly to the customer reuse of sub-components In the request for concession (deviation permit)
404 8.7.1.1  Retain documented information of the expiration date or quantity authorized under concession Cf. sub-clause 7.5.3.1 
405 8.7.1.1  Ensure conformity with the original specifications when the authorization expires Conformity with the original (as before concession)
406 8.7.1.1  Identify properly material shipped under concession on each shipping container This identification applies also to purchased product
407 8.7.1.1  Approve any request from external provider Before submission to the customer
 
 8.7.1.2
Control of nonconforming product - customer-specified process
 
408   8.7.1.2 Comply with controls for nonconforming products According to customer requirements
 
 8.7.1.3
Control of suspected product
up
409  8.7.1.3 Ensure that product with unidentified or suspect status is classified and controlled as nonconforming product Cf. sub-clause 8.7.1
410  8.7.1.3 Ensure that the appropriate manufacturing personnel receive training for containment of suspect and nonconforming product  Cf. sub-clause 7.2.2 
 
8.7.1.4
Control of reworked product
 
411 8.7.1.4 Utilize risk analysis methodology (such as FMEA) to assess risks in the rework process Prior to a decision to rework the product
412 8.7.1.4 Obtain customer approval, if required Prior to commencing rework of the product
413 8.7.1.4 Establish a documented process for rework confirmation Cf. sub-clauses 7.5.3.1 and 8.5.1.1
414 8.7.1.4 Ensure accessibility and use of disassembly and rework instructions by the appropriate personnel Including re-inspection and traceability requirements, cf. sub-clauses 7.5.3.1 and 8.5.2
415 8.7.1.4 Retain documented information on the disposition of reworked product, quantity, date and applicable traceability information Cf. sub-clauses 7.5.3.1 and 8.5.2
 
8.7.1.5
Control of repaired product
 
416 8.7.1.5 Utilize risk analysis methodology (such as FMEA) to assess risks in the repair process Prior to a decision to repair the product
417 8.7.1.5 Obtain customer approval Before commencing repair of the product
418 8.7.1.5 Establish a documented process for repair confirmation In accordance with the control plan or other relevant documented information, cf. sub-clause 8.5.1.1
419 8.7.1.5 Ensure accessibility and use of disassembly and repair instructions by the appropriate personnel Including re-inspection and traceability requirements, cf. sub-clauses 7.5.3.1 and 8.5.2
420 8.7.1.5 Obtain a documented customer authorization for concession For the product to be repaired
421 8.7.1.5 Retain documented information on the disposition of repaired product, quantity, date and applicable traceability information Cf. sub-clauses 7.5.3.1 and 8.5.2
 
8.7.1.6
Customer notification
 
421 8.7.1.6 Notify immediately the customer in the event that nonconforming product has been shipped Cf. sub-clause 8.7.1
422 8.7.1.6 Follow the initial communication with detailed documentation of the event Such as 8 D report
 
8.7.1.7
Nonconforming product disposition
up
423 8.7.1.7 Establish a documented process for disposition of nonconforming product For product not subject to rework or repair
424 8.7.1.7 Verify that the product to be scrapped is rendered unusable For nonconforming product not subject to rework or repair
425 8.7.1.7 Do not divert nonconforming product to service or other use With out prior customer (written) approval
8.7.2
 
 
    See ISO 9001 v 2015 requirements  
  9
Performance evaluation
Check
  9.1
Monitoring, measurement, analysis and evaluation

  9.1.1
General
 
    See ISO 9001 v 2015 requirements  
 
9.1.1.1
Monitoring and measurement of manufacturing processes
 
426 9.1.1.1 Perform process studies on all new manufacturing processes In order to verify process capability and to provide additional data including those for special characteristics, cf. 8.3.3.3 
427 9.1.1.1 Maintain manufacturing process capability or performance results According to customer's part approval process requirements
428 9.1.1.1 a Verify the implementation of the process flow diagram, PFMEA and control plan in accordance with measurement techniques Cf. sub-clause 8.5.1.1
429 9.1.1.1 b Verify the implementation of the process flow diagram, PFMEA and control plan in accordance with sampling plans Cf. sub-clause 9.1.1.2
430 9.1.1.1 c Verify the implementation of the process flow diagram, PFMEA and control plan in accordance with acceptance criteria Cf. sub-clause 8.6.6
431 9.1.1.1 d Verify the implementation of the process flow diagram, PFMEA and control plan in accordance with measurement values Cf. sub-clause 8.6.2
432 9.1.1.1 e Verify the implementation of the process flow diagram, PFMEA and control plan in accordance with reaction plans and escalation process When acceptance criteria are not met, cf. sub-clause 8.6.6
433 9.1.1.1 Record and retain documented information on significant process events Such as tool change or machine repair, cf. sub-clause 7.5.3.1
434 9.1.1.1 Initiate a reaction plan indicated on the control plan When characteristics are either not statistically capable or are unstable, cf. sub-clause 8.5.1.1
435 9.1.1.1 Include in the reaction plans the containment of product And their 100 percent inspection, as appropriate
436 9.1.1.1 Develop and implement a corrective action plan to ensure that the process becomes stable and statistically capable With assigned responsibilities, specific actions and timing. Review all customer performance measures to reduce risk of failure to achieving objectives
437 9.1.1.1 Review the plans with and approved by the customer, when required Cf. sub-clause 10.2
438 9.1.1.1 Retain documented information of effective dates of process changes Cf. sub-clause 7.5.3.1 
 
9.1.1.2
Identification of statistical tools
 
439 9.1.1.2 Determine the appropriate use of statistical tools Cf. annex B 
440 9.1.1.2 Verify that appropriate statistical tools are included in the QMS Such as APQP, DFMEA (design or product FMEA) and PFMEA
 
9.1.1.3
Application of statistical concepts
 
441 9.1.1.3 Understand and use statistical concepts by employees involved in the collection, analysis and management of statistical data Such as variation, stability, process capability and the consequences of over-adjustment
  9.1.2
Customer satisfaction
up
    See ISO 9001 v 2015 requirements  
 
9.1.2.1
Customer satisfaction
supplemental
442 9.1.2.1 Monitor customer satisfaction through continual evaluation of internal and external performance indicators In order to ensure product and process conformity
443 9.1.2.1 Base performance indicators on objective evidence Cf. sub-clause 6.2.2.1 
444 9.1.2.1 a Include delivered part quality performance Cf. sub-clause 6.2.2.1 
445 9.1.2.1 b Include customer disruptions Cf. sub-clause 10.2.6
446 9.1.2.1 c Include field returns, recalls and warranty claims Cf. sub-clause 10.2.6
447 9.1.2.1 d Include delivery schedule performance Including premium freight
448 9.1.2.1 e Include special status notifications Notifications related to quality or delivery issues
449 9.1.2.1 Monitor the performance of manufacturing processes Such as requirements for product quality and process efficiency
450 9.1.2.1 Include in the monitoring the review of customer performance data Including online customer portals and scorecards, where provided. Cf. sub-clause 8.4.2.4 
  9.1.3
Analysis and evaluation
 
    See ISO 9001 v 2015 requirements  
 
9.1.3.1
Prioritization
 
451 9.1.3.1 Compare quality trends and operational performance with progress towards objectives and lead to action to support prioritization of actions In order to improve customer satisfaction. Cf. sub-clause 9.1.2.1. Prioritization of actions should be based on performance and risk management
  9.2
Internal audit
 
 
9.2.1 and 9.2.2
 
 
    See ISO 9001 v 2015 requirements  
 
9.2.2.1
Internal audit program
up
452 9.2.2.1 Establish a documented internal audit process Cf. sub-clause 7.5.3.1
453 9.2.2.1 Develop and implement an internal audit program that covers the entire QMS Such as QMS, manufacturing process and product audits
454 9.2.2.1 Establish the audit program prioritized upon risk, internal and external performance trends and process criticality And also process complexity
455 9.2.2.1 Include in the audit program software development capability assessments  When the organization is responsible for software development, cf. sub-clause 8.3.2.3
456 9.2.2.1 Review and, where appropriate, adjust the frequency of audits Based on occurrence of process changes, nonconformities and customer complaints
457 9.2.2.1 Review the effectiveness of the audit program As part of the management review. Cf. sub-clause 9.3
 
9.2.2.2
QMS audit
 
458 9.2.2.2 Audit all QMS processes over each three-year calendar period In order to veify conformity with the IATF 16949 standard
459 9.2.2.2 Sample customer-specific QMS requirements In order to verify their effective implementation, cf. sub-clause 4.3.2 
 
9.2.2.3
Manufacturing process audit
 
460 9.2.2.3 Audit all manufacturing processes over each three-year calendar period In order to determine their effectiveness and efficiency
461 9.2.2.3 Determine the approach to be used When the customer does not require a specific approach
462 9.2.2.3 Plan for each manufacturing process to audit all shifts assigned to this process Including the appropriate sampling of the shift handover
463 9.2.2.3 Include in the manufacturing process audit an audit of the implementation of the process risk analysis, control plan and associated documents Cf. sub-clauses 6.1.2.18.5.1.1 and 7.5.3.1  
 
9.2.2.4
Product audit
 
464 9.2.2.4 Audit products using customer-specific approaches to verify that requirements are met At appropriate stages of production and delivery
465 9.2.2.4 Define the approach to be used When the customer has not defined a specific approach
  9.3
Management review
 
  9.3.1
General
 
    See ISO 9001 v 2015 requirements  
 
9.3.1.1
Management review
supplemental
466 9.3.1.1 Conduct management review at least annually And by planning its date. A monitoring system can be used, with criteria that trigger special management review
467 9.3.1.1 Increase the frequency of management review Based on risks of nonconformity, the impact of changes, performance issues
  9.3.2
Management review inputs
up
    See ISO 9001 v 2015 requirements  
  9.3.2.1
Management review inputs
supplemental
468 9.3.2.1 a Include in the inputs of the management review the costs of poor quality Cf. sub-clause 8.7.1
469 9.3.2.1 b Include in the inputs of the management review the measures of process effectiveness Cf. sub-clause 5.1.1.2
470 9.3.2.1 c Include in the inputs of the management review the measures of process efficiency Cf. sub-clause 5.1.1.2
471 9.3.2.1 d Include in the inputs of the management review product conformity Cf. sub-clause 8.5.1
472 9.3.2.1 e Include in the inputs of the management review the assessments of manufacturing feasibility Following changes to existing operations and for new facilities or new product, cf. sub-clause 7.1.3.1
473 9.3.2.1 f Include in the inputs of the management review customer satisfaction Cf. sub-clause 9.1.2
474 9.3.2.1 g Include in the inputs of the management review of performance Against maintenance objectives
475 9.3.2.1 h Include in the inputs of the management review warranty performance Cf. sub-clause 10.2.5
476 9.3.2.1 i Include in the inputs of the management review review of customer scorecards Cf. sub-clause 8.4.2.4
477 9.3.2.1 j Include in the inputs of the management review identification of potential field failures Via risk analysis such as process FMEA
478 9.3.2.1 k Include in the inputs of the management review the actual field failures And their impact on safety or the environment
479 9.3.2.1 l Include in the inputs of the management review the measurement results of design and development At specified stages. Cf. sub-clause 8.3.4.1
  9.3.3
Management review outputs
 
    See ISO 9001 v 2015 requirements  
 
9.3.3.1
Management review outputs
supplemental 
479  9.3.3.1 Document and implement an action plan When customer performance objectives are not achieved. This will support the continual analysis of process performance and risk
  10
Improvement
Act)
  10.1
General
 
    See ISO 9001 v 2015 requirements  
  10.2
Nonconformity and corrective action
 
 
10.2.1 and 10.2.2
 
up
    See ISO 9001 v 2015 requirements  
 
10.2.3
Problem solving
 
480 10.2.3 Establish a documented process for problem solving Cf. sub-clauses 6.1.2.2 and 10.2.6
481 10.2.3 a Define approaches for various types and scale of problems Such as new product development, current manufacturing issues, field failures, audit findings
482 10.2.3 b Ensure containment, interim actions and related activities In order to control nonconforming products, cf. sub-clause 8.7
483 10.2.3 c Analyze root causes, methodology used and results Cf. sub-clause 10.2.1
484 10.2.3 d Implement systematic corrective actions Including consideration of the impact on similar processes and products, cf. sub-clause 10.2.1
485 10.2.3 e Verify the effectiveness of implemented corrective actions Cf. sub-clause 10.2.1 
486 10.2.3 f Review and, when necessary, update the appropriate documented information Such as PFMEA and control plan
487 10.2.3 Use specific customer-approved problem solving processes, tools or systems Such as 8 D report. Or obtain approval of the customer for other problem solving processes, tools or systems 
 
10.2.4
Error-proofing
 
488 10.2.4 Establish a documented process to determine the use of appropriate error-proofing methodologies Cf. sub-clause 7.5.3.1
489 10.2.4 Document details of the method used in the process risk analysis Such as PFMEA
490 10.2.4 Document test frequency in the control plan Cf. sub-clause 8.5.1.1 
491 10.2.4 Include the testing of error-proofing devices for failure Failures can be simulated or not
492 10.2.4 Retain documented information on testing Cf. sub-clause 7.5.3.1 
493 10.2.4 Identify, control, verify and calibrate (where feasible) challenge parts Cf. annex A, process control 
494 10.2.4 Develop a reaction plan for error-proofing device failures Cf. annex A, reaction plan and corrective action
 
10.2.5
Warranty management systems
 
495 10.2.5 Implement a warranty management process When the organization provides warranty for their products
496 10.2.5 Include in this process a method for warranty part analysis Including NTF (no trouble found)
497 10.2.5 Implement the required warranty management process When specified by the customer
  10.2.6
Customer complaints and field failure test analysis
 
498 10.2.6 Perform analysis on customer complaints and field failures and returns Including any returned parts
499 10.2.6 Initiate problem solving and corrective action In order to prevent problem recurrence
500 10.2.6 Include analysis of the interaction of embedded software within the system of the final customer's product When requested by the customer. Cf. sub-clause 8.3.2.3 
501  10.2.6 Communicate the results of testing and analysis to the customer And internally
 
10.3
Continual improvement
up
    See ISO 9001 v 2015 requirements  
 
10.3.1
Continual improvement
supplemental
502 10.3.1 Establish a documented process for continual improvement Only after the manufacturing process is under control. In order to seize opportunities for improvement
503 10.3.1 a Include in this process identification of the methodology used, objectives, measurement, effectiveness and documented information Cf. sub-clauses 5.1.16.2.2.1 and 7.5.3.1
504 10.3.1 b Include in this process a manufacturing process improvement action plan Based on the reduction of process variation and waste
505  10.3.1 c Include in this process risk analysis Such as FMEA
 
annex A
Control plan
 
 
A.1 
Phases of the control plan
up
506 A.1 Cover three distinct phases Prototype, pre-launch and production control plans
507 A.1 a Include in the prototype control plan a description of the dimensional measurements, material and performance tests Performed during building of the prototype
508 A.1 a Implement a prototype control plan If required by the customer
509 A.1 b Include in the pre-launch control plan a description of the dimensional measurements, material and performance tests Performed after prototype and before full production
510 A.1 c Include in the production control plan documentation of product and process characteristics, process controls, tests and measurement systems Performed during mass production
511 A.1 Establish a control plan at a part number level Or by family of similar parts resulting from a common process