IATF 16949 summary, page 2

Chapter 7: Support

The company must identify and supply the vital resources to build, enforce, and improve the quality management system. 

The persons employed in the company must be qualified for the effective implementation of the quality management system. 

Infrastructures are essential to accomplish conformity of the products and services to this international standard.

For the design of layout sites, the company should:

  • Optimize material course
  • Handling of the materials
  • Control of non-compliant products
  • Enable a good flow of products

In all processes, efficiency must be held to enable methods to be developed and implemented properly.

A suitable environment for activities comprises:

  • Social (Neutrality, calm)
  • Psychological (Less stress, protection of emotions, friendly)
  • Physical (Temperature, heat, light, hygiene, noise)

A production site must be clean, in order, and preserved.

The monitoring and measuring procedures should produce valid, verified, and reliable data. 

Proper documented information for these results should be retained. 

The company must execute statistical studies after control, measurement, and testing system to analyze the variations of the outcomes. 

These statistical studies must align with the cited manuals given in this standard.

Tracking of measurements are necessary to present trust relating to the validity of the company’s product and services.

Measuring apparatus must be:

  • Calibrated and verified
  • Identified to determine the status
  • Safe from changes and damages

It is important for the company to save all records regarding calibrations and tests of measuring and testing instruments. 

The following details must be present in these records:

  • Alterations about technical capacity
  • Values not mentioned in the specifications section
  • Results of the test with necessary details
  • Alerted the customer about the nature of the product
  • State of compliance to the standard
  • Software validation and verification of the product
  • Calibration and maintenance settings

An internal laboratory is necessary for the company. 

It can execute control services, tests and calibrations. 

It has specific technical requirements such as the relevance of the procedures performed in the laboratory.

The company may utilize an external laboratory to perform check and testing services. 

Utilizing such is subject to a confirmation by a governmental authority. 

The external laboratory must be accredited by ISO/IEC 17025 or any equivalent national certifications.

All members of the company must have sufficient intelligence to fully carry out operations to attain standard conformity.

The company must be prepared for ways to access and gain new discovered knowledge in case of additional needs or trends. 

The company must hire persons competent to complete the tasks. These persons should have certain training and education.

Throughout this process, documented information must be established and preserved.

If necessary, the company may grant on-the-job training to all members, especially those assigned with new or changed equipment or responsibilities. 

The details for this training should be proportionate to its complexity.

The minimum skills for quality management auditors are as follows:

  • Understanding of the automotive sector process and risk approach
  • Understanding of the client requirements
  • Understanding of the audit’s basic tools
  • Understanding of the ways to prepare an excellent audit report

Additional tasks and skills for internal auditors:

  • As defined by the company, perform a certain amount of yearly audits
  • Preservation of knowledge of relevant requirements based on internal and external changes

Second-party auditor should have basic understanding and knowledge of the following:

  • Process approach
  • Specific requirements such as ISO 9001 and IATF 16949
  • Manufacturing process to be audited
  • Audit core tools
  • Conduct of a perfect audit

All persons employed under the company should recognize the company’s quality policy and objectives and consequences of nonconformity to the standard.

All staff should assist in obtaining, upholding, and improving product quality to satisfy the clients. 

To obtain this, the company should perform motivating actions such as promotions. 

It is important for the company to determine all forms of internal and external communications.

A quality management system shall have documented information both required by the standard and determined by the company as essential. 

A quality manual is part of the quality management system and should integrate the following:

  • Scope of the quality management system
  • Processes, sequences, and relations
  • Sources
  • A paperwork that displays that client demands are taken into account

Upon update and review of a documented information, it should have proper identification, description, format, and approval.

Documented information should be available, suitable for use, and adequately protected.

To control the documented information, the company must address:

  • Delivery, access, retrieval and use
  • Storage
  • Changes in control
  • Retention and disposition

The control for the documented information must assemble legal, regulatory, internal and customer requirements. 

These records must be preserved throughout active production and use.

There should be a process to review, distribute, and enforce customer technical requirements. This review should be completed within ten working days.

Along with this review, company records should be updated.

Chapter 8: Operation

The company must perform the following set of actions to fulfill the requirements of this standard:

  • Identify the product and services requirements
  • Building criteria for both the processes and their acceptance levels
  • Determining the resources
  • Enforcing command on the processes
  • Retaining necessary document information

Actions relating to the product:

  • Verification
  • Validation
  • Monitoring
  • Measurement
  • Control tests and system checks

It is important for the company to assure the customers that the products and services are of excellent quality.

The customer and the company must preserve the communication throughout the entire production process to guarantee the fulfillment of the requirements.

Communicated may be through a computer language or format demanded by the customer.

The company must ensure that the requirements are well described and applicable to the standard and deemed necessary to them.

The defined requirements must involve recycling, environmental effects, and company characteristics.

The company must execute a review before committing to the customer. This is to double check if it can supply the products and services demanded by the customer.

The company must store the documents stating the exceptions for the requirements as accepted by the customer.

Feasibility research for any new product technology or manufacturing should be validated through production tests, benchmark studies or any other methods.

Results of the review and analysis, and new requirements should be recorded as part of the documented information of the company. 

Changes to the requirements should be noted in the documented information. Relevant persons should be made aware of these changes. 

The company must produce, apply, and preserve a proper design and development process.

The design and development process is part of the documented information of the company.

The following should be considered when planning the design and development process:

  • Nature, duration, and complexity of the activities
  • Required processes
  • Verification and validation methods
  • Tasks
  • Resources
  • Command interfaces
  • Involvement of customers and users
  • Control level

All interested parties of the company and its supply chain should know all the stages of the design and development process.