IATF 16949 including ISO 9001 Summary, page 1

Introduction

Adopting a quality management system is a strategic choice for any organization.

It has certain benefits such as an increase in the group’s overall performance and supplies a fit foundation for sustainable development initiatives. 

This specific international standard covers both internal and external parties. 

This standard utilizes the Plan-Do-Check-Act (PDCA) and risk-based thinking approach. It allows the company to plan all the processes and actions.

It is important to incorporate various forms of progress besides correction and continual improvement such as breakthrough change, innovation, and re-organization.

The important quality management principles are:

  • Customer focus
  • Leadership
  • Engagement of people
  • Process approach
  • Improvement
  • Evidence-based decision making
  • Relationship management

This international standard employs a process approach to develop, enforce, and improve an organization’s quality management system and boosts customer pleasure by fulfilling customer’s demands. 

The process approach enables the company to control its relationships and dependencies of all the involved procedures. 

It involves a systematic and organized meaning of all the processes and their interactions to accomplish wanted results.

 PDCA can be described as follows:

  • Plan – establishing the system objectives, processes, and resources
  • Do – enforcing the plans
  • Check – track and measure the products and services and their processes
  • Act – perform necessary actions for improvement

The concept of risk-based thinking is necessary to accomplish effectiveness and efficiency in the organization. 

It is important to perform actions for both risks and chances to establish a basis for increasing effectiveness, to accomplish positive results and to avoid negative outcomes.

The International Organization for Standardization (ISO) developed this international standard to enable a company to practice the process approach by applying the PDCA cycle and risk-based thinking.

This standard’s framework coordinates with the other standard produced by ISO. 

This standard relates to:

  • ISO 9000 Quality Management Systems – Fundamentals and Vocabulary
  • ISO 9004 Managing for the Sustained Success of an Organization

Chapter 1: Scope

A complying company must exhibit its ability to always render products and services to the customers at the same time fulfilling international standard requirements. 

An effective appeal of the system such as processes aimed for progress ensures consumer pleasure. 

 This quality management system is for the automation industry, involving serial parts, spare accessories requested by the customer.

Chapter 2: Normative References

The sole reference for this standard is ISO 9000: Quality Management Systems – Fundamentals and Vocabulary, which was published last 2015.

The two documents both have appendices that would aid the company better comprehend these international standards.

Chapter 3: Terms and Definitions

For the purposes of this document, the terms and definitions supplied in ISO 9000:2015 apply.

Yet, important automotive words are defined as follows:

  • Anti-error device – A technique established to prevent the production of non-conforming products in manufacturing
  • Advanced Product Quality Planning (APQP)- A referenced approach that supports the development of a product to fulfill customer demands and requirements
  • Customer Specific Requirements (CSR) – The needs of the customers according to certain clauses in this standard
  • Design for Assembly (DFA) – Referring to the build process of a product
  • Design for Manufacturing (DFM) – The union of product scheme and its plan
  • Design for Manufacturing and Assembly (DFMA) – The addition of DFA and DFMA that aims to optimize the fabrication to reduce errors for a better performance
  • Design for Six Sigma (DFSS) – A systematic method aimed to devise products with a quality level of Six Sigma
  • Design Organization – A committee tasked to produce a new product or to update current products
  • Manufacturing Feasibility Study (MFS) – Analysis and review of a project proposal to test if a product is technically possible and satisfies the customer requirements.
  • Multidisciplinary Approach – A way of soliciting inputs from all interested parties that could affect a production process
  • No Fault Detected/ No Trouble Found (NTF)/ French DNR (Default not Reproduced) – A qualifier placed on a part during maintenance or repairs
  • Periodic Review – Steps adopted to avoid a major unforeseen failure
  • Product Safety – A Standard that the principal goal is to present no harm or threat to any customer
  • Response Plan – A bunch of actions that must be enforced in case of nonconforming events
  • Support Function – Activity outside remote site that proposes encouragement to other production areas from the same company
  • Total Productive Maintenance (TPM) in French (Maintenance Productive Table) – A progress report of construction integrity and preservation and quality systems 
  • Trade-off Process – A method for the creation of products and their performance characteristics

Chapter 4: Context of the Organization

The group must identify all external and internal issues about its purpose and mission that may affect the success of accomplishing the intended outcomes of the quality management system. 

The group must determine the interested parties and their specific requirements. 

The data from these parties must be reviewed and monitored.

If applicable, the group must apply all the requirements of this international standard within the context of its quality management system. 

The scope must incorporate the types of products and services the company has to offer.

Support functions must be within the scope of the quality management system. All data should be preserved and properly documented.

Customer specific requirements should be incorporated in the quality management system.

About processes, the group must perform the required actions:

  • Identify all inputs and outputs
  • Establish its consecutive order
  • Apply the methods and its criteria
  • Render all necessary resources
  • Divide tasks and duties
  • Acknowledge risks and chances
  • Test and execute changes
  • Improve the processes

The following should be part of the product and safety processes records:

  • Legal requirements relating to product safety
  • Customer alert
  • Special FMEA approved products
  • Product’s characteristics
  • Identification of manufacture controls
  • Monitoring plans and FMEA processes
  • Reaction schemes
  • Division of labor
  • Personnel trainings
  • Changes to products or processes
  • Assessment
  • Supply chain
  • Product tracking
  • Lessons discovered about errors

Documented information is essential to support the group’s methods and must be always preserved. 

Chapter 5: Leadership

To determine leadership and commitment, the top management must:

  • Owning liability
  • Assuring that quality policy and objectives are reached
  • Employing quality management system
  • Encouraging the use of PDCA and risk-based thinking
  • Guaranteeing the access of resources
  • Securing positive results
  • Supporting and directing the members
  • Conforming to the requirements
  • Fostering progress

The company should define and enforce rules and procedures relating to corporate responsibility and roles, such as anti-corruption policies.

It is important that processes are assessed and improved. 

The top management must be focused on delivering the needs and prospects of the customers.

The top management must develop, enforce, and preserve a quality policy that lays a structure to accomplish the company’s goals and objectives.

All members of the company must be aware of this quality policy.

The top management must assign, communicate, and grasp the tasks and duties for relevant roles. 

These roles must conform to this standard and must convey necessary results.

Management must guarantee:

  • Personnel assigned to a product has the control to block cargoes and correct quality problems
  • Non-compliant products should not be shipped to the customer and should be isolated instead
  • All members of the committee should be responsible and aware of the nature of their jobs

Chapter 6: Planning

When designing the quality management system, the company must involve all issues and requirements and identify all the possible risks and chances.

The company must address these risks and chances and plan essential actions about it. 

Actions performed must have a positive impact for the company. 

Risk analysis should involve at least product recalls and audits, customer returns and repairs, complaints, scrap and touch-ups.

The following will reduce the impact of negative results of the risk analysis:

  • Determining possible nonconformities and its causes
  • Assessing the need for efforts
  • Identifying and enforcing those efforts
  • Recording essential data
  • Monitoring the preventive efforts
  • Applying lessons learned from experience to avoid future mistakes

Contingency schemes should involve methods to validate and verify that the reproduced product still satisfies the customer’s requirements. 

The defined quality objectives must be:

  • Consistent with the policy
  • Measurable and monitored
  • Considers the requirements
  • Corresponds to customers’ demands
  • Communicated
  • Updated

Company’s quality objectives should fulfill customer requirements. 

These should be developed and preserved for appropriate processes and procedures. 

Changes may happen to the company’s quality management system. These changes should be exhibited in a planned manner.