The 7 Major Components of IATF 16949

 

IATF 16949:2016 defines the quality management system requirements for the design and development, production and, when relevant, the assembly, installation and services of automotive-related products including products with embedded software. The focus of this automotive standard is the development of a QMS that provides for continual improvement, emphasizing defect prevention and the reduction of waste in the supply chain. Combined with applicable Customer Specific Requirements, IATF 16949 is also fully aligned with the structure and requirements of ISO 9001:2015.
The standard is divided into ten sections – the first three are introductory, with the remaining seven containing the requirements for the Quality Management System. Below is a brief summary of Sections 4-10:

Section 4: Context of the Organization

The organization determines its context in terms of the QMS, including interested parties and their needs and expectations. It also defines the requirements for determining the scope of the QMS, as well as general QMS requirements.

Section 5: Leadership

Top management is required to demonstrate leadership and commitment to the QMS, along with defining corporate responsibility and the quality policy. The top management must also assign process owners along with other roles and responsibilities.

Section 6: Planning

The planning section defines requirements for addressing risks and opportunities and the requirements for risk analysis. This clause also includes requirements for preventive actions, contingency plans, and quality objectives and plans to achieve them.

Section 7: Support

This section covers requirements for supporting processes and resources. It defines requirements for people, infrastructure, work environment, monitoring and measuring resources, organizational knowledge, auditor competence, awareness, communication, and documented information.

Section 8: Operation

The product requirements deal with all aspects of the planning and creation of the product or service. This section includes requirements on planning, product requirements review, design, purchasing, creating the product or service, and controlling the equipment used to monitor and measure the product or service. IATF 16949 allows for requirements in clause 8.3, regarding design and development of products, to be excluded if they are not applicable to the company.

Section 9: Performance Evaluation

This section includes requirements for monitoring the effectiveness of the QMS – assessing customer satisfaction, internal audits, monitoring and measurement of manufacturing processes, and management review.

Section 10: Improvement

The last section focuses on continual improvement of the QMS, including requirements for nonconformities and corrective actions, problem solving, and error-proofing processes.


These sections are based on a Plan-Do-Check-Act cycle, which uses these elements to implement change within the processes of the organization in order to drive and maintain improvements within the processes.

IATF 16949 is a standard that benefits businesses large and small. The experts at simpleQuE can help your business achieve this standard, ensuring your business cost savings and efficiencies.

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What You Need To Know About ISO 45001

Worldwide over 6300 people die each day from work-related accidents or diseases – nearly 2.3million every year.  ISO is developing a new standard, ISO 45001, Occupational health and safety management systems – Requirements, to provide a framework to improve employee safety, reduce workplace risks and create better, safer working conditions, all over the world. ISO 45001 is targeted to be published in the first quarter of 2018 and will replace OHSAS 18001. Current users of OHSAS 18001 will need to update their systems according to the requirements of the new international health and safety standard within a three year transition period that will commence after ISO 45001 is published.

 

IATF Transition Update from IAOB

Cherie Reiche of the International Automotive Oversight Board (IAOB) shared the following IATF 16949 transition update at several registrar conferences.  As of April 30th 2017:

  • 68,332 sites are ISO/TS 16949 or IATF 16949 certified worldwide
  • 181 audits were completed to IATF 16949 (0.3% upgraded)
    • To date the total NCs issued = 975 (avg 5.4 findings per audit)
      • Major NCs = 133 (16% of the findings are major)
      • Minor NCs = 842

A summary of the highest incidence of NCs (major/minor) by section is represented in the chart below.  It’s interesting to note that Customer Specific Requirements and Quality Management System Audit had the largest number of major NCs, while most minor NCs were written on Contingency and Control Plans.

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The History of AS9100

Once again, the IAQGs AS9100 standard has undergone a new revision. The latest version of this standard adds requirements for product safety, counterfeit parts, formal processes for operational risks, awareness, and ethics and human factors. Read more about the journey this pivotal standard has taken over the years.
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Don’t forget, June 15, 2018 is the final transition audit deadline for the new AS9100 standard. Learn more by viewing our transition timeline.

ISO 9001 Myths and Their Reality

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ISO 9001 is the world’s most used management system standard, existing for almost 30 years, it tends to fall into the gap where many people have heard about it, but not many fully understand what the standard involves. As a result, there are common myths about ISO 9001 that simpleQuE can help to clarify.

Is it complicated and difficult to implement?
In most cases, no. SimpleQuE was one of the first consulting companies in the world to become ISO 9001:2015 certified, so we know what it takes to transition to the new standard. It is possible to simplify ISO implementation, transition, training and maintenance, by integrating simple solutions that fit into your company’s culture.  This can be done with a gap audit checklist to identify where you’re already in compliance and more effectively target only those areas that need work.

Isn’t ISO 9001 an outdated model?
While it is true that ISO 9001 has been around since 1987, it has evolved through several revisions to match the changing needs of business. Today there is instant access to information, higher expectations from customers, more complex supply chains and a globally competitive economy.  ISO 9001:2015 takes all of these factors into account.

Isn’t ISO 9001 a standard that only benefits big corporations?
This is not the case. ISO 9001 is intended to be a set of requirements that can be used by any company, of any size, in any industry. The requirements are written as a set of best practices needed to control all the processes of a business system – no matter what the company does. The standard is designed to be flexible; the focus is on improving quality and customer satisfaction, which every organization can benefit from including:

  • More efficient use of resources and improved financial performance,
  • Improved risk management and protection of people and the environment, and
  • Increased capability to deliver consistent and improved services and products, thereby increasing value to customers and all other stakeholders.

Will everything have to be monitored and measured?
Processes do have to be monitored and measured to ensure that they are performing as designed, however, the standard allows a company to consider the impact that a process has on product/service conformity and the effectiveness of the Quality Management System (QMS) when determining what to monitor or measure and the method to be adopted.  A good QMS will help with monitoring performance and driving improvement.

Is ISO 9001 is the sole responsibility of the quality manager or department?
This couldn’t be farther from the truth, since the requirements cover every aspect of the business – from planning through delivery and post-delivery of your product or service.

Doesn’t ISO 9001 cost a lot to implement?
The question of cost will depend on the size and complexity of the organization and the competency of the personnel. Basic implementation pricing should be competitive and reasonable, depending if the work is done internally or through an external consulting service. The overall outcome of these activities should be to reduce costs through improvements and increase revenues through satisfied customers. Your return on investment should be well above the costs. Note that ISO certification is a separate additional cost.

SimpleQue can customize consulting for your organization and provide simple solutions while clearing up any misconceptions about ISO 9001 and how it can benefit your organization. Contact us today to find out more information and how simpleQue can help!

The AS9100:2016 Transition Timeline

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Certified companies to AS9100C will need to upgrade to AS9100D from when their certification body can begin issuing certificates (sometime late in 2016) through June 14, 2018. This should typically coincide with a scheduled surveillance or recertification audit. A special audit can also be scheduled and paid for. You should plan your upgrade based on this transition timing window and when your audit cycle falls.