ISO / TS 16949:2009 – Automobile Industry Quality Management System Standard

TS 16949 Implementation Process

• Management Commitment and Support
• TS 16949 Audit/Assessment (Gap Analysis).
• Development of an Implementation Plan.
• Provide Awareness Training to all employees.
• Allocate Resources that will be necessary to develop and implement the system
• Prepare Quality System Documentation - Tier 1, 2, 3 documents (Quality Manual, Quality System Procedures, Work Instructions and Quality Records/Forms).
• Determine Training Needs of Employees - Job and Employee Skill Matrix (ie. overview of new system, internal auditing, problem solving, teamwork, etc...).
• Implement the New System.
• Conduct Internal Audits.
• Take Corrective Actions, if necessary.
• Re-Audit/Follow-up, if necessary.
• Registrar Audit Preparation/Training
• Registration Application.
• Registration Audit.
• Registration Certificate Issued.
• Maintain, Improve and Innovate the System.

TS 16949 Frequently Asked Questions

What is ISO/TS16949:2009?

ISO/TS 16949:2009 is an ISO Technical Specification, which integrates existing American and Europ ean automotive quality management systems standards within the global automotive industry, with the aim of eliminating the need for multiple certifications to satisfy multiple customer requirements.

Using ISO 9001:2000 as its foundation, ISO/TS 16949:2009 specifies the quality management system (QMS) requirements for the design & development, production, installation and servicing of automotive related products. In addition, there are customer specific requirements that are required by individual IATF subscribing vehicle manufacturers.

In the past a variety of standards were in use by various automotive companies around the world. ISO/TS 16949 is designed to eventually replace all of these standards as the single worldwide automotive sector QMS standard. Previous standards include the following:

• QS 9000 (Ford, General Motors, Daimler Chrysler)
• EAQF 94 (PSA Peugeot, Citroën, Renault, FIEV)
• VDA 6 (Audi, BMW, VW, Daimler Chrysler)
• AVSQ ‘94 (Fiat Auto, IVECO)

Who authored ISO/TS16949:2009?

ISO/TS 16949:2009 was developed by the International Automotive Task Force (IATF), in conjunction with the International Organization for Standardization (ISO).

The IATF consists of an international group of vehicle manufacturers - BMW Group, DaimlerChrysler, Fiat, Ford Motor Company, General Motors Corporation, PSA Peugeot-Citroen, Renault and Volkswagen - plus national trade associations - AIAG (America), VDA (Germany), SMMT (UK), ANFIA (Italy) and FIEV (France).

While the Japanese vehicle manufacturers association, JAMA, were also involved in the development of ISO/TS 16949:2009, they do not formally subscribe to the TS 16949 document as yet or require it of their supply chain.

What are the deadlines set by automotive OEM’s for TS 16949:2009 certification?

Organizations supplying these OEM’s must obtain TS 16949 certification by the following dates:
Dec 14, 2006 Ford Motor Company Dec
14, 2006 General Motors
July 1, 2006 Daimler/Chrysler
July 1, 2006 Renault
July 1, 2006 PSA - Peugeot Citroen
July 1, 2006 Visteon

What is the format of ISO/TS16949:2009?

TS 16949:2009 is built upon all of the requirements, principles and concepts included in ISO 9001:2000, and goes further in specifying supplemental requirements that are specific to the automotive sector.
The TS 16949 specific clauses may:

• Include new requirements over and above ISO 9001 requirements
• Supplement or expand on the existing ISO 9001 requirement
• Call for prescriptive ways to address ISO or TS requirements

These automotive sector requirements also refer to automotive core tools (reference documents) such as the Advanced Quality Planning (eg. APQP), Part Approval Process (eg. PPAP), Measurement Systems Analysis (MSA), FMEA and SPC. Customer specific requirements are required by individual IATF subscribing customers and are provided separately on their respective websites and on trade association websites representing them (e.g., IAOB).

Who does ISO/TS16949:2009 apply to?

TS 16949 is applicable to the following types of automotive supply chain products and facilities:

1. Cars, trucks (light, medium and heavy), buses, motorcycles.
2. Supplier ‘sites’ providing value-added parts, components, products , sub-assemblies and services up the supply chain to the OEM. TS 16949 requirements may be applied to any site in the supply chain by its customer
3. Supply chain facilities or ‘sites’ that manufacture production materials; production and service parts; assemblies; or provide (value-added) finishing services such as heat treating, welding, painting; etc., for the automotive OEM’s subscribing to this standard.
4. This means that all Tier 1 suppliers providing such products or services directly to IATF subscribing automotive OEM’s must get TS 16949 certification and they in turn may flow TS 16949 conformity or certification requirements down to Tier 2 suppliers and so on. The flow down to tier 2 or 3 has now become more the norm than the exception.

Who/what is excluded from TS 16949:2009

TS 16949 cannot be applied to the following products or organizations:

• The supply chain for agricultural, off-highway (mining, forestry, construction, etc.) vehicles.
• Automotive after-market service parts made to original IATF subscribing OEM specifications, but not procured and released through them.
• Manufacturers of tooling; production equipment; jigs; fixtures; molds; etc used by the auto industry.
• Remanufactured automobile parts.
• Distribution centers; warehousers; parts packagers; logistics support; and sequencers.
• Support functions (non-manufacturing, whether on-site or off), cannot obtain stand- alone TS 16949 certification. They must be audited and included with the certification of the manufacturing site they support.

Who is authorized to carry out certification of organizations to TS 1949:2009?

The IATF has developed its own unique and proprietary processes and requirements for registering organizations to TS 16949, as well as for Certification Bodies (CB) and CB auditors. Subscribing IATF automotive OEM companies will only recognize and accept a TS 16949 certification which has been conducted using the prescribed registration process (ask your CB for these rules), and conducted by CB’s that have been qualified and contracted by the IATF or its regional offices such as the IAOB in Detroit.

Certification to TS 16949 by an IATF qualified registrar is required before such a certificate can show the IATF mark and indicate IATF recognition. The IATF require all qualified CB’s to assure that TS16949:2009 (TS-2) registrants meet the following applicability requirements:

• The organization seeking TS 16949 certification must meet the TS 16949 definition of supplier applicability. See applicability above.
• Any tier may be certified if it has a direct customer (or potential customer) that requires either compliance or 3rd party registration to TS16949 and
• Evidence of being a potential supplier to a customer requiring TS16949 could include an RFQ issued to it, or the supplier being on the bid list of the TS16949 IATF subscribing customer.

What should you do if do not qualify for TS 16949 certification?

Those organizations that do not qualify for IATF recognized registration to ISO/TS16949 , or which supply parts and services to a TS16949 registered organization, are encouraged to maintain ISO9001:2000 or ISO 17025 certification as the case may apply.

How do I obtain TS 16949 publications and find an IATF qualified certification Body?

A complete and updated list of qualified Certification Bodies may be found on the IAOB Web site at www.iaob.org . You will also be able to purchase all the required publications for TS 16949 at this site. Please read our article on “Tips on choosing a Certification Body”, before you make your selection.

What are the benefits of implementing an effective QMS based on the TS 16949:2009 standard?

Benefits include:
External

• Improves OEM customer confidence and satisfaction in your organizations QMS capability and consistency in delivering conforming products and services.
• Improves conformity to quality requirements
• Increases competitive edge and automotive supply market share

Internal

• Improves business efficiency and productivity
• Reduces organizational waste, inefficiencies, and defects
• Facilitates continual improvement in business processes and customer satisfaction Improves process consistency and stability
• Provides basis for training programs to improve competence and consistency of personnel performance
• Improves employee motivation and participation through improved communication, interaction and involvement
• Contributes to provision of objective evidence that facilitates the assessment of system controls and effectiveness

What are TS 16949:2009 requirements?

The requirements cover a wide range of topics, including:

• Your organization’s top management commitment to quality, its customer focus,
• Adequacy of its resources, employee competence,
• Process management (for production, service delivery and relevant administrative and support processes), quality planning, product design, review of incoming orders, purchasing, monitoring and measurement of its processes and products, calibration of measuring equipment,
• Processes to resolve customer complaints, corrective/preventive actions and a requirement to drive continual improvement of the QMS.
• Last, there is a requirement to monitor customer perceptions about the quality of the goods and services it provides.

TS 16949:2009 does not specify requirements for your products or services; these are specified by your customer. It specifies requirements for your quality management system. An effective QMS will reap the benefit of providing/improving your ability to consistently meet customers product and other requirements.

For an complete and in-depth coverage of the TS 16949:2009 standard, please review our free eBook “understanding TS 16949:2009”. This book provides clause by clause explanation of TS requirements. It is an excellent guide for automotive QMS development, maintenance or improvement.

Can an organization exclude any clauses from the scope of its QMS registration?

You must begin with the premise that all requirements of TS 16949 are generic and applicable to your QMS. The only permitted exclusion to TS 16949 is from clause 7.3, for product design and development, if your organization is not responsible to any automotive OEM for design and development activity. If you not clear whether you are design responsible, contact your customer and get clarification in writing. You must include manufacturing process design and development in the scope of your QMS

How can an organization go about implementing TS 16949:2009?

The following is an overview of the key steps:

1. Get a copy of TS 16949:2009 and core tools reference documents
   Familiarize yourself with the requirements and determine if certification to this standard makes good business sense for your organization.
2. Educate yourself
   Start with reading our free eBook Understanding ISO/TS 16949:2009. The more you read, the more informed you will be in making choices and developing your TS 16949 QMS. You will find much of this right here on this web-site.
   
   Next, look into training courses available to gain deeper insight into the requirements and core tools for system development, implementation and auditing. Call us and we will discuss and arrange the appropriate course for your needs.
3. Review consultant options
   Experienced and expert consultants can fast track your TS 16949 QMS program development and implementation with realistic and effective strategies and solutions in a cost effective and timely manner. We have the expertise to assist you. Call us for a no-obligation discussion of your needs.
4. Do a 'Gap Assessment'
   A gap assessment is an audit of your current management system practices, controls and documentation, to determine the extent to which it conforms to those required by the TS 16949 standard. While a trained in-house quality practitioner can do this, it is best done by an consultant (ex CB auditor), with the experience of hundreds of such audits. The audit findings are presented in an audit report along with recommendations to address the gaps. The Gap Assessment is the starting point for planning your management system development.
5. Planning - strategy, resources and project
   The adoption of an TS 16949 QMS is a strategic decision for the organization. It is vital that your top management provides leadership, resources, involvement and support. In addition, you need to assemble a team to develop and implement your QMS. You also need to plan your implementation steps, time line, responsibilities and resources needed.
6. Determine training needs
   Your implementation team will need training in TS 16949 and other reference documents. There are a wide range of courses, workshops, and seminars available designed to meet these needs. We provide a number of these training courses. Call us for more information.
7. Develop a TS 16949 QMS manual
   Your QMS manual should describe the QMS policies and operations of your company. Through the manual, you will provide an accurate description of the organization and the best practice adopted to consistently satisfy customer expectations.
8. Develop your processes and needed documentation
   Define and document as needed the processes of your organization, and the best practice for effective planning, operation and control of these processes.
9. Implement your QMS
   Work to your implementation project plan. Communication and training are key to a successful implementation. Monitor progress and get management support to overcome hurdles along the way.
10. Consider a pre-assessment
    Consider having a preliminary evaluation of the QMS documentation and implementation by a Consultant or certification body. The purpose of this is to identify areas of non-conformity and allow you to correct these areas before you begin the formal certification process.
11. Select a certification body
    Your business relationship with the certification body will be in place for many years, as your certification has to be maintained. Read our article on “Tips on selecting a Certification Body” before you select your CB.

How do the latest rules on the Certification audit process affect your organization?

If you are currently pursuing TS 16949:2009 certification, then the IATF 2nd edition (published in 2004 and referred to as TS-2) Rules for achieving IATF recognized TS 16949 certification specifies the following audit process for your organization: The initial certification audit will be conducted in two stages:
Stage 1: Readiness Review - You must have a QMS and provide the CB audit team the following information for review on site:

1. Descriptions of processes showing the sequence and interactions, key indicators, and performance trends for the past 12 months
2. Evidence that all requirements of TS-2 are addressed by your organization
3. Quality Manual (level 1 and 2)
4. Internal audits and management review from past 12 months (must include a full cycle of internal audits (QMS, Manufacturing, Product) to TS-2 using the process approach.
5. List of qualified internal auditors and how they were qualified
6. List of customer specific requirements
7. Customer satisfaction and complaint status, including customer reports and scorecards This review will typically last 1-2 days. Based on the Readiness Review, the CB audit team determines the appropriate scope of the audit; readiness for the stage 2 site audit and develops the audit plan for stage 2.

Stage 2: Site Audit - Initial certification audits must be conducted according to the following:

1. Must be performed on-site within 90 days from stage 1 readiness acceptance
2. Use the automotive Process Approach (Checklist use not permitted)
3. Audit all processes for the initial assessment
4. Within the process, audit all clauses.
5. All process sequences and interactions must be appropriately addressed
6. Review effectiveness of implementation and practice, related to planned and achieved quality performance.
7. For the initial registration audit, remote supporting functions must be audited prior to the manufacturing site.

Post Stage 2 Audit - At the end of the site audit, the CB team conduct the final presentation and provide a draft report that includes as a minimum;

1. Description of all non conformities. All nonconformities must be recorded and shall NOT be closed during the audit
2. Audit team recommendation to the certification committee
3. Issue final report within 15 working days from the closing meeting
4. The audit Team may require a follow up visit to verify the effective implementation of the corrective actions

Additional information

The contract between the CB and your organization must agree that:

1. The organization shall notify the CB of any material changes, legal, commercial, organizational status or ownership
2. Organization cannot refuse an IATF witness audit
3. Access authorization for the IATF and their representatives
4. Authorization to provide the final report to the IATF
5. Only use of the IATF logo is as displayed on the certificate issued by the IATF qualified CB
6. If an organization is placed on Suspension (replaces Probation), the date of suspension is the date of the concern, not the date of notification. The CB is required to verify on site the effective implementation of the C/A before removing the Suspension.
7. If the CB withdraws the certificate, the organization must return the certificate and send out written notice that it is no longer certified, to its customers that require certification.

This is just an overview of the key rules governing the IATF prescribed TS 16949 certification audit process. For more information, contact your CB or obtain a copy of the - Automotive Certification Scheme for ISO/TS 16949:2009, Rules for achieving IATF recognition, 2nd Edition for ISO/TS 16949:2009, 2004, 2nd Printing. Effective December 15, 2004 at www.iaob.org http://www.iaob.org

There are many other contractual factors governing your relationship with your CB. Did you know that we can help you negotiate the most optimal financial and contractual terms with your CB? Most organizations leave thousands of dollars on the table without even knowing it. Give us a call for details.

Will the Process-based Approach be much different for the automotive sector?

Yes! The IATF has mandated an automotive process-based approach to QMS development and implementation, with a greater emphasis on meeting customer's needs. Organizations must clearly stress the important elements of Customer Oriented Processes (COP's), including:

• Process ownership, process definition, customer-focused process objectives, controls, linkages and interaction
• Process monitoring and feedback for process improvement
• Process effectiveness in meeting customer requirements, process efficiency and key performance indicators for the business

Process effectiveness and efficiency for product realization and support processes must be reviewed by top management. This also includes a more focused effort to tie process performance to customer requirements and expectations.

Are there specific competency or training requirements for an organization’s internal auditors?

Personnel performing QMS audits or manufacturing process audits must have adequate training on -

1. the requirements of the TS 16949 standard; training on the automotive process to auditing;
2. audit practices and audit experience as defined by ISO 19011 and IATF guidance;
3. QMS processes and their interaction;
4. customer requirements and applicable regulatory requirements.

Personnel performing product audits must have training on -

1. production and delivery processes; audit practices and techniques;
2. product specific customer requirements and applicable regulatory requirements.
3. specific auditors do not necessarily need training on the requirements of the TS 16949 Standard.

Organizations applying for TS 16949 certification must use a process-based approach to internal auditing. Check out some of our articles on the process based approach. Some OEM’s have mandated that internal auditors meet specific competency requirements. Check out these criteria at www.iaob.org(especially suppliers to Ford).