IATF 16949:2016 Overview 222

audits

A process that examines an organization's products, processes, and services to verify that they are meeting expected outputs. Audits include internal and external audits.

capability assessments

The ability of a product to meet an output that fulfills requirements. Capability assessments for software development are included in internal audits.

capacity planning

The process of determining the production capacity an organization needs to meet product demands. Capacity planning is included as input to management reviews.

contingency plans

A document that lists strategies for providing a continuity of supply in the event of key equipment failures. Contingency plans are periodically tested and reviewed by management.

continual improvement

Recurring actions taken to enhance performance. Continual improvement methods must be part of an organization's QMS.

control plan

A normative reference included in annex A of IATF 16949:2016. A control plan contains descriptions of the systems and processes required to manufacture a product.

corrective actions

A plan created to eliminate the cause of a nonconformity and to prevent recurrence. Corrective actions are required to be documented in an organization's problem-solving process.

CSRs

Customer-specific requirements. An organization's interpretation of a supplemental requirement required by a customer. CSRs are linked to various sections throughout IATF 16949:2016 and must appear in an organization's QMS.

customer requirements

A requirement specified by a customer pertaining to processes and products. Customer requirements are the actual requirements, whereas customer-specific requirements are an organization's interpretation of those requirements.

customer-specific requirements

CSR. An organization's interpretation of a supplemental requirement required by a customer. Customer-specific requirements are linked to various sections throughout IATF 16949:2016 and must appear in an organization's QMS.

documented information

Data or evidence required to be retained and controlled by an organization in order for its QMS to be effective. Documented information should be preserved in whatever format best serves the needs of an organization.

error detection

The discovery of mistakes after they have occurred. Error detection is not as effective as error prevention.

error prevention

The goal of refining product planning and processes to greatly reduce the occurrence of mistakes. Error prevention requirements are established in the Operation section of IATF 16949:2016.

error-proofing

A manufacturing process that prevents the manufacture of nonconforming products. Error-proofing methods must be included as documented information in an organization's QMS.

escalation policy

A process used to highlight or flag certain issues within an organization so that appropriate personnel can monitor responses. An escalation policy is required for IATF 16949:2016 certification.

IATF

International Automotive Task Force. A group of automotive manufacturers and their respective trade associations that seeks to improve product quality throughout the automotive supply chain. IATF members include automakers from the U.S. and Europe.

IATF 16949

A standard containing quality management system requirements for organizations that manufacture automotive parts and component systems for original equipment manufacturers. IATF 16949, which may also be referred to as the "automotive QMS standard" or "IATF 16949:2016," is supplemental to ISO 9001:2015.

IATF 16949:2016

A standard containing quality management system requirements for organizations that manufacture automotive parts and component systems for original equipment manufacturers. IATF 16949:2016, which may also be referred to as the "automotive QMS standard" or "IATF 16949," is supplemental to ISO 9001:2015.

internal auditor

An individual within an organization that examines the products, processes, and services within their own organization. Internal auditors are documented in the QMS.

internal audits

A documented process that a company conducts to examine their products, processes, and services. Internal audits are required for IATF 16949:2016 certification.

International Automotive Task Force

IATF. A group of automotive manufacturers and their respective trade associations that seeks to improve product quality throughout the automotive supply chain. International Automotive Task Force members include automakers from the U.S. and Europe.

International Organization for Standardization

ISO. A nongovernmental organization based in Switzerland that develops and establishes standards, rules, and guidelines designed to ensure that products, processes, and services are fit for their purposes. The International Organization for Standardization publishes standards for a broad range of industries.

ISO 9000:2015

A series of standards intended to guide an organization on the implementation and continual improvement of a QMS. ISO 9000:2015 contains general guidelines that may be referenced in other standards.

ISO 9001:2015

The core standard of the ISO 9000 series that contains the requirements an auditor uses to verify a company's conformity to a quality management system. ISO 9001:2015 is titled "Quality Management—Requirements" and contains material a company must follow when developing a QMS.

ISO/TS 16949:2009

A standard created by the IATF and the Technical Committee of the ISO that contains the quality management system requirements for producers of automotive parts and component systems. The ISO/TS 16949:2009 standard has been replaced by IATF 16949:2016.

key performance indicators

KPI. A measurable value that demonstrates an organization's effectiveness in achieving key objectives. Key performance indicators may be based off internal or external factors.

management reviews

An examination of an organization's processes, products, services, and overall functions conducted by the organization's top management. Management reviews should identify areas for improvement and areas where the QMS could benefit from changes.

manufacturing feasibility

An analysis of a proposed project to determine if it can be manufactured to meet customer requirements. Manufacturing feasibility includes examining estimated costs and available resources.

multidisciplinary team

A group consisting of internal members of an organization and external members, such as customer representatives and supplier representatives. A multidisciplinary team captures input from all interested parties.

nonconforming outputs

The result of a process that fails to meet a requirement. Nonconforming outputs may be monitored and controlled through continual improvement methods.

normative references

A statement in a standard that refers to a related document or standard that is necessary for certification. Normative references mean that, unless otherwise stated, the most recent version of the referenced document or standard should be followed.

organizational gap analysis

A procedure an organization performs to determine the steps needed to transition from its current state to its desired state. An organizational gap analysis helps a company identify the differences between ISO 9001:2015 and IATF 16949:2016.

original equipment manufacturers

OEM. A company that produces the parts and equipment that are assembled and installed during the construction of a new vehicle. An original equipment manufacturer is required to earn IATF 16949:2016 certification.

outputs

The result of an organization's product or service. Outputs depend on the process or product inputs.

outsourced

A product or process procured from an outside company. Outsourced processes must be documented in an organization's QMS.

PDCA

Plan-Do-Check-Act. A process approach cycle. The PDCA cycle is used when determining the processes to include in a quality management system.

preventive actions

A step taken to eliminate the cause of a potential nonconformity or some other undesirable situation. Preventive actions reduce the impact of negative risk.

process approach

A method of viewing all parts of a system as interrelated. A process approach generally follows a specific cycle.

process owners

A person in an organization who manages production processes and related outputs. Process owners are appointed by management during IS0 9001:2015 certification.

product realization

A process that an organization conducts to develop, manufacture, and deliver a finished good or service. Product realization requires a documented process.

prototype

A preliminary model of a product used to evaluate the performance of a design. The prototype production stage is included in a control plan.

prototype programs

A system in which a full-scale working model of a product is built and approved before production begins. Prototype program requirements are established in the Operation section of IATF 16949:2016.

QMS

Quality Management System. The objectives and processes designed to focus a company toward maintaining quality and meeting customer requirements. A QMS consists of written documents that address standards such as ISO 9001:2015.

quality assurance

A process performed when planning for product realization that focuses on proving that quality requirements will be fulfilled. Quality assurance processes must be applied to all products, including products with embedded software.

quality management system

QMS. The objectives and processes designed to focus a company toward maintaining quality and meeting customer requirements. A quality management system consists of written documents that address standards such as ISO 9001:2015.

quality manual

A document or series of documents in an organization's QMS that describes the products and processes that affect the QMS. An organization's quality manual must be maintained as documented information.

quality objectives

A measurable outcome toward which all employees of an organization work to fulfill. Quality objectives must meet customer requirements and must also be aligned with an organization's quality policy.

quality policy

A key document of a QMS that reflects an organization's commitment to quality and continual improvement. The quality policy is clearly posted in all facilities of an organization and periodically reviewed.

reaction plans

A document containing the expected actions an organization will take in the event that nonconforming events are detected during a stage in production. Reaction plans are included with a control plan.

remote location

A site that provides a valuable function that supports a manufacturing site or process for an organization. Remote locations, such as warehouses and engineering sites, perform nonproduction processes.

rework

An action taken on a nonconforming product or service to make it conform to requirements. Reworking a product may change some of its parts or processes.

risk analysis

A documented process that an organization uses to help plan for risks and opportunities. A risk analysis includes information pertaining to previous recalls, scrap, and rework.

risks

An effect of uncertainty. A risk can have positive or negative effects.

scrap

A nonconforming product that is not used for its originally intended use. Scrapped products are recycled or destroyed.

second-party auditor

An individual who conducts an external audit and has an interest in the organization. Second-party auditors may be a customer or someone auditing on the customer's behalf.

shall statements

A requirement that is stated in plain language and designed to guide conformance to a standard. The shall statements in IATF 16949:2016 include processes that require documentation and requirements listed in ISO 9001:2015.

special characteristics

A product feature or part of the manufacturing process that can affect safety or compliance with regulations, fit function, performance, or processing of a product. Requirements for special characteristics are established in the Operation section of IATF 16949:2016.

standard

An established policy regarding a particular practice or method throughout industries. Standards included in the ISO 9000 series are concerned with establishing and implementing quality management systems.

statistical process control

SPC. The use of statistics and control charts to measure key quality characteristics and control how the related process behaves. Statistical process control methods are used by automotive part makers to evaluate their processes.

statistical tools

A device that helps in collecting, summarizing, and analyzing numerical data. Statistical tools include statistical software that plots data on a chart.

supplemental requirements

A mandate in a standard that contains additional information or guidelines. Supplemental requirements in IATF 16949:2016 are in addition to the requirements in ISO 9001:2015.

supplier selection

The process of selecting a producer, distributor, retailer, or vendor of a product or service. The supplier selection process requires a second-party audit.

supply chain

A complex network of companies and suppliers that produce and distribute a product. A supply chain consists of a company, its suppliers, its distributors, and its customers.

third-party auditor

An individual outside an organization who objectively assesses the organization's quality management system. Third-party auditors are required to register with ISO 9000.

top management

A person or group of people responsible for directing and controlling an organization. Top management has the power to delegate authority and provide resources for an organization.

total productive maintenance

A system of maintaining and improving a production system through machines, equipment processes, and employees that add value to the organization. A total productive maintenance system is covered in the Operation section of IATF 16949:2016.

waiver

A document that a person or organization signs to give up the rights or responsibility for something. A waiver might be established for different areas of the supply chain.