News on the standard IATF 16949 version 2016 - Quality management system requirements for automotive production organizations

13/10/2023

The international standard IATF 16949 has been published beginning of October 2016. You can buy it in paper format from the English site SMMT for the sum of £ 28,86 (32,39 euros) transport included without being obliged to become a member.

This quality management system standard for the automotive sector is published by the International Automotive Task Force (IATF) and replaces the ISO / TS 16949 technical specification of 2009. The ISO / TS 16949 version 2009 certification will be valid until 14 September 2018. Companies may perform a certification audit in accordance with IATF 16949 from 01/01/2017.

The full title of the standard is "Quality management system requirements for automotive production and relevant service parts organizations".

The standard is based on ISO 9001 version 2015 but is completely separate because it does not contain any ISO 9001 requirements (whenever the requirements are the same there is a reference to the ISO 9001 requirements). The IATF 16949 standard includes specific automotive requirements and tools.

The pillars of IATF 16949 standard are:

continual improvement
prevention of defects
reduction of variations
elimination of waste

News on ISO 9001 version 2015

Requirements of ISO 9001 version 2015

Requirements of IATF 16949 version 2016

See also the quiz "IATF 16949 version 2016 requirements".

The online course T 16v16 IATF 16949 version 2016 readiness and its free demo without registration

The online course T 36v16 IATF 16949 version 2016 internal audit and its free demo without registration

The training package T 66v16 IATF 16949 version 2016 readiness and internal audit

1. The clauses are 10 according to the high level structure:

Scope
Normative references
Terms and definitions
Context of the organization (P)
Leadership (P, D, C, A)
Planning (P)
Support (D)
Operation (D)
Performance evaluation (C)
Improvement (A)

2. Some differences with ISO 9001:

No requirements or text of clauses of ISO 9001 v 2015 are cited

The term risk appears 59 times in the automotive requirements (it appears 50 times in the requirements ISO 9001 v 2015)

The term top management is emphasized many times (it appears 21 times, in the ISO 9001 it is used 16 times)

Preventive actions are not abandoned (sub-clause 6.1.2.2)

The quality manual reappears ((sub-clause 7.5.1.1)

The FMEA (as a method of risk analysis) is unavoidable (cited 23 times)

Appendix B contains a list of references mostly automobile specific

Appearance of new terms, definitions and expressions (compared to the technical specification ISO / TS 16949 v 2009):

accessory part
advanced product quality planning (APQP)
aftermarket part
anti-bribery policy
authorisation
challenge (master) part
cost of poor quality
customer complaints
customer requirements
customer specific requirements
design for assembly (DFA)
design for manufacturing (DFM)
design for manufacturing and assembly (DFMA)
design for six sigma (DFSS)
escalation process
ethics escalation policy ("whistle-blowing policy")
fault tree analysis
management of guarantees
manufacturing feasibility
manufacturing services
multi-disciplinary approach
no trouble found (NTF)
outsourced process
periodic overhaul
product
product safety
production shutdown
reaction plan
remote location
service parts
special status
support function
total productive maintenance (TPM)
trade-off curves
trade-off process

3.New clauses and sub-clauses compared to ISO 9001 (when it is not a supplement and in bold when it is new compared to ISO/TS 16949 V 2009) :

3.1 Terms and definitions for the automotive industry
4.3.2 Customer-specific requirements
4.4.1.1 Conformance of products and processes
4.4.1.2 Product safety
5.1.1.1 Corporate responsibility
5.1.1.2 Process effectiveness and efficiency
5.1.1.3 Process owner
5.3.2 Responsibility and authority for product requirements and corrective actions
6.1.2.1 Risks analysis
6.1.2.2 Preventive actions
6.1.2.3 Contigency plans
7.1.3.1 Plant, facility, and equipment planning
7.1.5.1.1 Measurement system analysis
7.1.5.2.1 Calibration/verification records
7.1.5.3 Laboratory requirements
7.2.2 Competence - on-the-job training
7.2.3 Internal auditor competency
7.2.4 Second-party auditor competency
7.3.2 Employee motivation and empowerment
7.5.1.1 Quality management system documentation
7.5.3.2.1 record retention
7.5.3.2.2 Engineering specifications
8.1.2 Confidentiality
8.2.3.1.2 Customer-designated special characteristics
8.2.3.1.3 Organization manufacturing feasibility
8.3.2.2 Product design skills
8.3.2.3 Development of products with embedded software
8.3.3.1 Product design input
8.3.3.2 Manufacturing process design input
8.3.3.3 Special characteristics
8.3.4.1 Monitoring
8.3.4.2 Design and development validation
8.3.4.3 Prototype programme
8.3.4.4 Product approval process
8.3.5.2 Manufacturing process design output
8.4.1.2 Supplier selection process
8.4.1.3 Customer-directed sources (also known as "Directed-buy")
8.4.2.2 Statutory and regulatory requirements
8.4.2.3 Supplier quality management system development
8.4.2.3.1 Automotive product-related software or automotive products with embedded software
8.4.2.4 Supplier monitoring
8.4.2.4.1 Second-party audits
8.4.2.5 Supplier development
8.5.1.1 Control plan
8.5.1.2 Standardised work - operator instructions and visual standards
8.5.1.3 Verification of job set-ups
8.5.1.4 Verification after shutdown
8.5.1.5 Total productive maintenance
8.5.1.6 Management of production tooling and manufacturing, test, inspection tooling and equipment
8.5.1.7 Production scheduling
8.5.5.1 Feedback of information from service
8.5.5.2 Service agreement with customer
8.5.6.1.1 temporary change of process controls
8.6.2 Layout inspection and functional testing
8.6.3 Appearance items
8.6.4 Verification and acceptance of conformity of externally provided products and services
8.6.5 Statutory and regulatory conformity
8.6.6 Acceptance criteria
8.7.1.1 Customer authorization for concession
8.7.1.2 Control of nonconforming product - customer-specified process
8.7.1.3 Control of suspect product
8.7.1.4 Control of reworked product
8.7.1.5 Control of repaired product
8.7.1.6 Customer notification
8.7.1.7 Nonconforming product disposition
9.1.1.1 Monitoring and measurement of manufacturing processes
9.1.1.2 Identification of statistical tools
9.1.1.3 Application of statistical concepts
9.1.3.1 Prioritization
9.2.2.1 Internal audit programme
9.2.2.2 Quality management system audit
9.2.2.3 Manufacturing process audit
9.2.2.4 product audit
10.2.3 Problem solving
10.2.4 Error-proofing
10.2.5 Warranty management systems
10.2.6 Customer complaints and field failure test analysis
Annex A - Control plan

4. MUCH MORE documented INFORMATION (to maintain and to retain) rEQUIRED (in bold AUTOMOBILE REQUIREMENTS)

maintain documented information (procedures, documented processes, documented system, document plans, communication process)
- scope (§ 4.3)
- product safety (§ 4.4.1.2)
- processes (§ 4.4.2 a)
- quality policy (§ 5.2.2 a)
- quality objectives (§ 6.2.1)
- calibration/verification management (§ 7.1.5.2.1)
- personnel competence (§ 7.2.1)
- internal auditor competency (§ 7.2.3)
- employee empowerment (§ 7.3.2)
- quality manual (§ 7.5.1.1 b)
- engineering specifications (§ 7.5.3.2.2)
- operational control (§ 8.1)
- design and development (§ 8.3.1.1)
- supplier selection (§ 8.4.1.2)
- outsourced processes (§ 8.4.2.1)
- purchasing statutory and regulatory requirements (§ 8.4.2.2)
- supplier performance ( § 8.4.2.4)
- job set-ups (§ 8.5.1.3)
- total productive maintenance (§ 8.5.1.5)
- identification and traceability (§ 8.5.2.1)
- feedback (§ 8.5.5.1)
- control of changes (§ 8.5.6.1)
- temporary change of process controls (§ 8.5.6.1.1)
- reworked product (§ 8.7.1.4)
- repairs (§ 8.7.1.5)
- nonconforming product disposition (§ 8.7.1.7)
- internal audit (§ 9.2.2.1)
- problem solving (§ 10.2.3)
- error-proofing (§ 10.2.4)
- continual improvement (§ 10.3.1)
retain documented information (records)
- justification of exclusion (§ 4.3.1)
- product safety (§ 4.4.1.2)
- processes (§ 4.4.2 b)
- customer requirements (§ 5.3.1)
- results of risk analysis (§ 6.1.2.1)
- contingency plans (§ 6.1.2.3)
- inspection resources adequacy (§ 7.1.5.1)
- acceptance of alternative methods and analysis (§ 7.1.5.1.1)
- calibration (§ 7.1.5.2)
- calibration and verification (§ 7.1.5.2.1)
- internal laboratory activities (§ 7.1.5.3.1)
- personnel competence (§ 7.2)
- list of qualified internal auditors (§ 7.2.3)
- training to achieve competency (§ 7.2.3)
- awareness of personnel (§ 7.3.1)
- quality manual (§ 7.51.1)
- of external origin (§ 7.5.3.2)
- date of change implemented in production (§§ 7.5.3.2.2 and 9.1.1.1)
- conformity of products and services (§ 8.1)
- accepted concessions (§ 8.2.3.1.1)
- special characteristics (§ 8.2.3.1.2)
- results of review of product and service requirements (§ 8.2.3.2)
- design and development inputs (§ 8.3.3)
- expected results, reviews, design and development verifications and validations (§ 8.3.4)
- product approval (§ 8.3.4.4)
- design and development outputs (§ 8.3.5)
- design and development changes (§ 8.3.6)
- activities and actions of evaluation of suppliers (§ 8.4.1)
- auto-evaluation of suppliers (§ 8.4.2.3.1)
- second-party audit results (§ 8.4.2.4.1)
- characteristics of products and services, related activities and results to obtain (§ 8.5.1)
- control plan (§ 8.5.1.1)
- rules for operator safety (§ 8.5.1.2)
- process and product approval (§ 8.5.1.3)
- traceability response (§ 8.5.2.1)
- product and service traceability (§ 8.5.2)
- status of customer property (§ 8.5.3)
- results of control of changes (§ 8.5.6)
- change verifications and validations (§ 8.5.6.1)
- list of alternate process control methods (§ 8.5.6.1.1)
- restart verification (§ 8.5.6.1.1)
- release of products and services (§ 8.6)
- customer concession (§ 8.7.1.1)
- product rework (§ 8.7.1.4)
- product repair (§ 8.7.1.5)
- customer notification of nonconforming shipment (§ 8.7.1.6)
- treatment of nonconforming products and services (§ 8.7.2)
- inspection results (§ 9.1.1)
- significant process events (§ 9.1.1.1)
- dates of process changes (§ 9.1.1.1)
- audit programme and audit results (§ 9.2.2)
- management review outputs (§ 9.3.3)
- action plan (§ 9.3.3.1)
- nonconformities, actions and results (§ 10.2.2)
- testing of error-proofing devices (§ 10.2.4)

5. The term process is used 202 times in clauses 1 to 10

Listed processes:

manufacturing, §§ 4.3.1, 4.4.1.1, 6.1.2.3, 7.1.4, 7.1.5.2.1 i, 7.2.3, 7.2.4, 8.2.2.1, 8.2.3.1.3, 8.3.1.1, 8.3.2.1 b, d, 8.3.3.2, 8.3.3.3 b, 8.3.4.3, 8.3.4.4, 8.3.5.2, 8.3.5.2 n, 8.5.1, 8.5.1.1, 8.5.1.1 g, 8.5.6.1, 8.7.1.1, 9.1.1.1, 9.1.2.1, 9.2.2.1, 9.2.2.3
management of product-safety, § 4.4.1.2
FMEA, §§ 4.4.1.2 f, 7.2.3, 7.2.4 d, 8.3.5.2 g, 8.5.1.1, 9.1.1.1, 9.1.1.2, 9.2.2.3, 9.3.2.1 j, 10.2.3 f, 10.2.4
escalation, § 4.4.1.2 h
flow of information, § 4.4.1.2 h
product-safety, § 4.4.1.2 i
product realization, §§ 5.1.1.2, 7.5.3.2.2
support, § 5.1.1.2
not conform to requirements, § 5.3.2 b
to lessen the impact of negative effects of risk, § 6.1.2.2
externally provided, § 6.1.2.3 c
notification, § 6.1.2.3 d
managing calibration/verification records, § 7.1.5.2.1
identification of training needs, § 7.2.1
verify internal audit competency, § 7.2.3
manufacturing auditor, §§ 7.2.3, 10.3.1 b
automotive approach, §§ 7.2.3, 7.2.4, 8.4.2.4.1
to motivate employees, § 7.3.2
outsourced, § 7.5.1.1
review, distribution, and implementation of customer standards/specifications, § 7.5.3.2.2
production part approval, note of § 7.5.3.2.2
design and development, § 8.3.1.1
quality assurance of products, § 8.3.2.3
software development, § 8.3.2.3
to identify special characteristics, 8.3.3.3
product approval, § 8.3.4.4
product validation, 8.3.4.4
trade-off, note, § 8.3.5.1
select suppliers, § 8.4.1.2
change management, § 8.4.1.2
logistics, § 8.4.1.2
to identify outsourced processes, § 8.4.2.1
to ensure that purchased products, processes and services meet applicable statutory and regulatory requirements, § 8.4.2.2
software quality assurance, § 8.4.2.3.1
supplier's software development, § 8.4.2.3.1
to evaluate supplier performance, § 8.4.2.4
second-party audit, § 8.4.2.4.1
statistically unstable or not statistically capable, § 8.5.1.1
TPM, § 8.5.1.5
identification and traceability, § 8.5.2.1
for communication of information on service, § 8.5.5.1
to control and react to changes, § 8.5.6.1
control and use of alternate methods, § 8.5.6.1.1
to ensure the quality of externally provided processes, products and services§ 8.6.4
customer-specified, § 8.7.1.2
rework, § 8.7.1.4
approval of rework, § 8.7.1.4
repair, § 8.7.1.5
approval of repair, § 8.7.1.5
for disposition of nonconforming product, § 8.7.1.7
escalation, § 9.1.1.1 e
internal audit, § 9.2.2.1
problem solving, § 10.2.3
to determine the use of error-proofing methodologies, § 10.2.4
warranty management, § 10.2.5
continual improvement, § 10.3.1

6. Comments

The term "conformity to requirements" is a pleonasm because the definition of conformity is "fulfilment of a requirement" and so we obtain "fulfilment of a requirement to requirements"
The term section is used in the standard for the first time. The correct term is clause and sub-clause, cf. Directives ISO/CEI, Part 2, Rules for the structure and drafting of International Standards, p.8.
The term record reappears in clauses 7, 8, 9 and 10 and gets along with the term documented information to retain. Strange
The expression have to (maintain, define, dispose, keep up to date) a documented process (used 17 times) is a novelty and replaces a documented procedure or documented information to maintain. Very, very strange
The term conformance is used instead of conformity, strange (sub-clause 4.4.1.1)
The term legislative instead of statutory, strange, sub-clause 7.2.2
In sub-clause 8.3.2.1.1 the reference should be to 8.7.1 and 8.7.2 and not 8.2.3.1
The term waiver is used along with the term concession, sub-clauses 8.2.3.1.1 and 8.7.1.1
The term stakeholders is used along with interested parties, strange (sub-clause 8.3.2.1)
The expressions quality assurance (sub-clauses 8.3.2.3 and 8.4.2.3.1) and ensure the quality (§ 8.6.4) is going back to the past? Strange
The verb should is used 5 times in the text of the standard (sub-clauses 7.5.3.2.2, 8.2.3.1.3, 8.4.1.2, 8.4.2.3 and 8.5.6.1) and not in the notes, which is very strange for a standard!
The verb may is used twice in the standard (sub-clauses 7.1.5.1.1 and 7.1.5.3.2) and not in the notes, which is very strange for a standard!
The term supplier (used 46 times) gets along with external provider (used 31 times), which is very stange!
The term targets should be indicators, sub-clause 6.2.2.1 or objectives, sub-clauses 8.3.3.1 f), 8.3.3.2 b and 3.3.3.1
The verb shall is missing in the second sentence, sub-clause 8.3.2.1
The sub-clause 8.5.1.6 should be Management of production tooling and manufacturing, test and inspection equipment, sub-clause 8.5.1.6
The measurement results of design and development stages are missing in management review inputs (should be bullet point l), sub-clause 9.3.2.1
Error-proofing devices should be used instead of Error-proofing methodologies, sub-clause 10.2.4
No requirement for process mapping
No requirement for staff satisfaction, perception, valuation and recognition
No requirement on partner management
No requirement on listening to the market