2 Standards, definitions and books T 16

2.1 Standards
2.2 Definitions
2.3 Books

2.1 Standards

Quality standards and references

2.1

explications The ISO 9000 family of standards contains three core booklets (and one guideline):

ISO 9000 (2015): Quality management systems. Fundamentals and vocabulary
ISO 9001 (2015): Quality management systems. Requirements
ISO/TS 9002 (2016): Quality management systems - Guidelines for the application of ISO 9001:2015
ISO 9004 (2018): Quality management - Quality of an organization - Guidance to achieve sustained success

The ISO 9000 standards are compatible with the other management systemset of processes allowing objectives to be achieved (see also ISO 9000, 3.5.3) standards (common vocabulary, process approachmanagement by the processes to better satisfy customers, improve the effectiveness of all processes and increase global efficiency (see also ISO 9001, 03), customer satisfactiontop priority objective of every management system (see also ISO 9000, 3.9.2), continual improvementprocess allowing the improvement of the global performance of the organization (see also ISO 9000, 3.3.2)). An added standard is:

ISO 19011: "Guidelines for auditing management systems " (2018).

ISO 14001 (2015 – third edition) is the standard related to the environment: "Environmental management systems - requirements with guidance for use".

The new version of ISO/TS 16949 was published in October 2016 and has the title: IATF 16949 "Quality management system requirements for automotive production and relevant service parts organizations".

IATF is the acronym of the International Automotive Task Force.

Automotive standards were introduced in the 1990s (AVSQ = FIAT, VDA = BMW + VW + Daimler, Valéo ...):

1994: EAQF (PSA + Renault); QS 9000 (Chrysler + Ford + GM)
1998: QS 9000 version 3
1999: ISO / TS 16949 first version
2002: ISO / TS 16949 edition 2
2009: ISO / TS 16949 edition 3
2016: IATF 16949 first edition

The role of the International Automotive Task Force (IATF) has been critical to replacing existing benchmarks in different countries with a single technical specification, which has become a standard since October 2016 and marks a divorce with ISOInternational Organization for Standardization .

This allows a unique certification recognized worldwide for any company related to automotive production. The requirements of the IATF 16949 and the specific requirements of customers are the basis of any quality management systemset of processes allowing the achievement of the quality objectives (see also ISO 9000, 3.5.4) for automotive manufacturers.

The IATF 16949 standard, which appeared in October 2016, fully incorporates the high-level structure (the 10 articles of ISO 9001: 2015) without citing the text of ISO 9001 and adds specific requirementsexplicit or implicit need or expectation (see also ISO 9000, 3.6.4) for the automotive industry (105 paragraphs and a normative annex). Some of these requirementsexplicit or implicit need or expectation (see also ISO 9000, 3.6.4) are:

product safety
potential risk analysis (FMEA)
preventive actions
contingency plans
advanced product quality planning (APQP)
measurement systems analysis(MSA)
control of the laboratory
auditor competency (including second-party)
confidentiality
special characteristics
feasibility study
embedded software
product part approval process (PPAP)
total productive maintenance (TPM)
control of suspect, reworked and repaired product
statistical process control (SPC)
problem solving
error-proofing devices
control plan
lessons learned

explications For more information on some of these core tools you can consult the following manuals:

Statistical Process Control (SPC) - 2005, AIAG
Production Part Approval Process (PPAP) - 2006, AIAG
System reliability analysis techniques - Failure Mode and Effects Analysis (FMEA) - 2006, IEC
Advanced Product Quality Planning and Control Plan (APQP) - 2008, AIAG
Measurement Systems Analysis (MSA) - 2010, AIAG
Effective Error-Proofing – 2011, AIAG
The Cost of Poor Quality Guide – 2012, AIAG
FMEA for Tooling & Equipment (Machinery FMEA) – 2012, AIAG
Effective Problem Solving Practitioners Guide – 2018, AIAG
Service Production Part Approval Process - (PPAP Service) - 2014, AIAG
Failure Mode and Effects Analysis - FMEA Handbook – 2019, AIAG & VDA
Lessons learned – 2020, VDA
Process audit, volume 6, part 3 – 2023, VDA

Some documents of the IATF site in which one finds many answers:

IATF 16949:2016 – Frequently Asked Questions (FAQs)
IATF 16949:2016 – Sanctioned Interpretations
Rules for Achieving and Maintaining IATF Recognition IATF Rules 5 th Edition – Frequently Asked Questions
Rules for achieving and maintaining IATF Recognition IATF Rules 5 th Edition – Sanctioned Interpretations
Ford Motor Company Customer-Specific Requirements
General Motors IATF 16949 - Customer Specific Requirements

ISO 31000 (2018) "Risk management - Guidelines" establishes the principles and risk management process, risk assessment and risk treatment.

The standards of the ISO 10001 to ISO 10019 series are guidelines for quality management systemsset of processes allowing the achievement of the quality objectives (see also ISO 9000, 3.5.4) and will help you find many answers (cf. ISO 9001: 2015, Annex B).

All of these standards and many more can be ordered in electronic or paper form on the ISO site.

More than 28,000 standards (in English and other languages) are available for free on the Public.Resource.Org site.

The Oxebridge Q001 is a user-friendly, open source remix of ISO 9001:2015.

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2.2 Definitions

Terms and definitions related to quality

2.2

The beginning of wisdom is the definition of terms. Socrates

Specific qualityaptitude to fulfill requirements (see also ISO 9000, 3.6.2) terms:

Competence: personal skills, knowledge and experiences
Conformity: fulfillment of a specified requirement
Corrective action: action to eliminate the causes of nonconformity or any other undesirable event and to prevent their recurrence
Customer: anyone who receives a product
Customer satisfaction: top priority objective of every quality management system related to the satisfaction of customer requirements
Documented information: any support allowing the treatment of information
Effectiveness: capacity to realize planned activities with minimum effort
Efficiency: financial relationship between achieved results and used resources
External provider (supplier): an entity that provides a product
Indicator: value of a parameter, associated with an objective, allowing the objective measure of its effectiveness
Interested party: person, group or company affected by the impacts of an organization
Management system: set of processes allowing objectives to be achieved
Nonconformity: fnon-fulfillment of a specified requirement
Organization (company): a structure that satisfies a need
Process: activities that transform inputs into outputs
Product (or service): every result of a process or activity
Quality: aptitude to fulfill requirements
Quality management: activities allowing the control of an organization with regard to quality
Quality objective: related to quality, measurable goal that must be achieved
Requirement: explicit or implicit need or expectation
Risk: likelihood of occurrence of a threat or an opportunity
Top management: group or persons in charge of the company's control at the highest level

In the terminology of quality management systemsset of processes allowing the achievement of the quality objectives (see also ISO 9000, 3.5.4), do not confuse:

accident and incident
- an accident is an unexpected serious event
- an incident is an event that can lead to an accident
anomaly, defect, dysfunction, failure, nonconformity, reject and waste:
- anomaly is a deviation from what is expected
- defect is the non-fulfillment of a requirement related to an intended use
- dysfunction is a degraded function that can lead to a failure
- failure is when a function has become unfit
- nonconformity is the non-fulfillment of a requirement in production
- reject is a nonconforming product that will be destroyed
- waste is when there are added costs but no value
audit program and plan
- an audit program is the annual planning of the audits
- an audit plan is the description of the audit activities
audit, inspection, auditee and auditor
- an audit is the process of obtaining audit evidence
- an inspection is the conformity verification of a process and product
- an auditee is the one who is audited
- an auditor is the one who conducts the audit
control and optimize
- control is meeting the objectives
- optimize is searching for the best possible results
customer, external provider and subcontractor
- a customer receives a product
- an external provider provides a service or a product
- a subcontractor provides a product or service on which specific work is done
effectiveness and efficiency
- effectiveness is the level of achievement of planned results
- efficiency is the ratio between results and resources
follow-up and review
- follow-up is the verification of the obtained results of an action
- review is the analysis of the effectiveness in achieving objectives
inform and communicate
- to inform is to give someone meaningful data
- to communicate is to pass on a message, to listen to the reaction and discuss
objective and indicator
- an objective is a sought after commitment
- an indicator is the information on the difference between the pre-set objective and the achieved result
organization and enterprise, society, company
- organization is the term used by the ISO 9001 standard as the entity between the supplier and the customer
- an enterprise, society and company are examples of organizations
process, procedure, product, activity and task
- a process is how we satisfy the customer using people to achieve the objectives
- a procedure is the description of how we should conform to the rules
- a product is the result of a process
- an activity is a set of tasks
- a task is a sequence of simple operations

Remark 1: the use of ISO 9000, ISO 9001 and IATF 16949 definitions is recommended. The most important thing is to determinate a common and unequivocal vocabulary for everyone in the company.

Remark 2: the customer can also be the user, the beneficiary, the trigger, the ordering party or the consumer.

Remark 3: documented information is any information that we must maintain (procedure ) or retain (record )

For other definitions, comments, explanations and interpretations that you don’t find in this module and annex 06, you can consult: explications record