Introduction
ISO/TS 16949:2009 is a technical specification, that defines the requirements of
quality management systems for the automotive sector (automotive-related products, parts, etc.), in terms of design, production,
installation and service. The official designation of the specification is: "Quality management systems -- Particular requirements for the application of ISO 9001:2008 for automotive production and relevant service
part organizations".
The goal of this technical specification is to extend
ISO 9001:2008 with automotive specific requirements.
By developing and maintaining an ISO/TS 16949 conform quality management system, the organization is able to sustain continuous improvement, to prevent defects, to decrease risks and waste, to reduce deviations and
variation, and to indirectly reduce the number of quality incidents and unexpected
quality cost ("it’s always cheaper to be wrong on paper,
instead of being wrong during the manufacturing"). In addition, the clear intention of the makers (IATF and ISO) was to cascade the specification through the automotive supply chain.
The technical specification is in close conjunction with the ISO 9001:2008 standard, as it includes it completely (the boxed text contains the original ISO 9001:2008 text,
while the automotive-specific requirements are outside the boxes). This means the structure of the specification is the same as the structure of the ISO 9001:2008 standard. The specification has been created
by the
International Automotive Task Force (IATF), and the
ISO Technical Committee ISO/TC 176, responsible for quality management and quality assurance. The specification has already
been superseded by the new
IATF 16949:2016 automotive quality standard.
Revision and modification of the specification is performed by IATF, representing its members:
Source: qMindset.com; iatfglobaloversight.org; ISO.org
Key Features
The ISO/TS 16949:2009 technical specification can be applied to sites of the organization, instead of the whole parent company (example: all manufacturing sites of a tier 1
company must separately prove their conformance to the specification). Manufacturing sites can be certified, supporting functions (e.g. a development center) do not receive stand-alone certifications.
It holds the same structure as the parent ISO standard, so it contains the same aspects of the quality management related requirements, extended by automotive-specific
information:
- Terms and definition for the automotive industry.
- Quality Management System (e.g. general requirements, documentation, Quality Manual, control of documents, etc.).
- Management responsibility (e.g. management commitment, customer focus, Quality Policy, Quality Planning and -review, etc.).
- Resource management (e.g. provisioning, human resources, etc.).
- Product realization (e.g. planning, design and development, customer communication, control of measuring equipment, etc.).
- Measurement, analysis and improvement (e.g. monitoring customer satisfaction, internal audits, process- and product monitoring, control of non-conforming product, improvements, corrective- and preventive
actions, etc.).
One of the first difference compared to the parent standard is the listing of automotive references, some major elements of the list are:
- Control Plan
- Design responsible organization
- Error proofing
- Laboratory, and laboratory scope
- Maintenance categories
- Site and remote locations
- Special characteristics, etc.
Although the basis of ISO/TS 16949:2009 is the ISO 9001:2008 standard, several key elements and regulations are stricter. Depending on the function, automotive products and
services can have safety, governmental and functional regulations, and this fact itself brings and demands harder, and more precise requirements, compared to many other business sectors where ISO 9001:2008 is
enough.
To be ISO/TS 16949:2009 conform, the organization must extend its operation on top of the ISO 9001:2008 requirements. Without attempting to be fully comprehensive:
- It must be assured to maintain a process that ensures the frequent revision and implementation of specifications and the change of these specifications (change management). The control of these documents
and databases must be conform to customer-, legal- and regulatory requirements.
- In order to keep the product realization process efficient, the top management must review it frequently, analysing trends and the effectiveness of continual improvement (with evidences, and the results
of achieving / not achieving the quality objectives, valid and potential field-failures, risks, with special focus on customer satisfaction). Additionally the top management must create a business plan
that contains quality objectives and actions, based on the quality policy of the organization (management commitment and process approach).
- Product specific special characteristics (whether coming from the customer or regulations) must be controlled, monitored, documented and designated. All related sub-processes to be foregone by
risk analysis and feasibility study during the contracting process (at the very beginning of the quality planning). Special
characteristics shall be designated in DFMEA, PFMEA,
Control Plans, drawings, work instructions and visual aids.
- FMEA and Control Plan creation and revision is mandatory, such as the usage of knowledge and experience from previous projects, including risk analysis, set of reliability data, and information from
design validation, error proofing and failure elimination. Various sections of the development phase have to be defined, monitored and
reported to the review team (management).
- The approval of the manufacturing process has to be performed based on customer requirements. The customer defines what standard / specification it accepts.
- Nominated associates have the right to stop production and delivery in order to solve quality issues. In addition, assigned associates has to act as customer representatives, to keep customer
requirements (e.g. preventive and corrective actions, quality objectives, special characteristics, etc.). The top management must be informed properly about non-conform products and
problem solving.
- All employees on all levels of the organization must not only be trained to perform the given activity (that affects quality), but the organization must maintain a defined process that identifies
additional training and qualification needs to increase the competence of associates. In addition the organization must use specified processes to motivate employees.
- Resources must be allocated in case of incidents, by having contingency plans (both quality and volume related, e.g. high number of field returns, personnel shortage, outsider events, etc.).
- The organization shall develop the quality of its sub-suppliers in a systematic frame, in order to make them reach the conformity to ISO 9001:2008 and ISO/TS 16949:2009. A major part of
supplier development is the monitoring of supplier performance with feedback to the suppliers (rate of conform products, number of quality
incidents, etc.). In addition the organization has to assure the conformity of incoming products by various methods (such as
incoming inspection or testing, analysis of statistical data, audits, etc.).
- Tooling and equipment management process must be planned, and has to contain preventive maintenance according to production schedule. All customer-owned tools and equipment must be marked to assure
permanent transparency.
- All measuring and test equipment must be identified and calibrated. Only calibrated tools and gauges are allowed to be used in serial production.
- The organization shall maintain a comprehensive auditing system, including system audit, manufacturing process audit,
product audit. The whole activity must be planned and scheduled.
- The handling of non-conformities is one of the most crucial point on the automotive industry. The organization must block all non-conform products, and the rework activities (if applicable) must be
controlled such as the serial production. According to the TS, those products that are only suspect (unidentified) must be classified as non-conform products. The customer must be informed about the delivery
of non-conform products (or products that were produced with non-conform process), and the customer has the only right to give concession or permission for these products. It is mandatory to mark, label the
packaging of all affected products, or the products themselves. For the effectiveness of the problem solving process, the non-conform parts must be analysed, even if the deviation was detected in the plant.
- The organization shall maintain a systematic problem solving process, including root cause identification and the
definition of effective counter-measures and actions (both corrective and preventive).
Identified solutions have to be applied in a wider range (including similar processes, products) to prevent recurrence.
Source: qMindset.com; ISO.org
Hints
Designing and producing quality products is a top-down matter. It is always the management and the owners, who decide to spend effort, money and time on quality. Without the
commitment of the management it is impossible to sustain the manufacturing of quality products in the long-term..
Quality mindset and motivation supports quality in the most effective way. Inform your associates about the consequences of non-conform products, and how important their
activity is to achieve quality objectives. In many times it can increase quality mindset and awareness throughout the entire organization. In addition, many associates get motivated if they know their work
is part of a prestige / quality product. Visualizing this can support the enhancement of mindset (e.g. pictures, images, posters, etc.), and it should be part of trainings.
It is a general misunderstanding, that ISO/TS 16949 defines quality requirements. ISO/TS defines the requirements of quality management system, but not the quality requirements
of the product or service itself. More simply:
- Requirements of the quality management systems are defined by ISO/TS 16949.
Example 1: "We started the creation of an FMEA and Control Plan, as it is mandatory in the automotive business, and has to be part of the quality management system".
Example 2: "Our organization maintains a comprehensive audit system, including scheduled process-, product- and system audits."
- Quality requirements of a product or service are part of the contract or specification, defined by the manufacturer (based on the customer's needs). These requirements are objectives, what were obligated by
the company and must be fulfilled to reach customer satisfaction.
Example 1: "The specification of our alloy wheels demands minimum 180HV (Vickers hardness)."
Example 2: "The warranty time of the latest model has been increased to 7 years (or 100.000 km)."
Always ask if your quality system fulfils its purpose. Many organizations (usually the bigger ones) create policies, and rules that are only paperwork instead of leading to
efficient actions. The final goal is always the same, and simple: to create and to deliver quality products, that meet or even exceed the requirements of your customer.
You shouldn’t forget, the parent company is responsible for the outsourced processes, and the quality level of its sub-suppliers. Even if your customer specifies the source
of equipment, tooling or raw material (customer-designated source), you are still responsible for its quality.
Source: qMindset.com; ISO.org
Summary
- ISO/TS 16949:2009 is a technical specification, what defines the requirements of quality management systems for the automotive sector.
- ISO/TS 16949:2009 is not part of the ISO 9000 family, but it is in close conjunction with the ISO 9001:2008 standard.
- The technical specification was created by the International Automotive Task Force (IATF), and the ISO Technical Committee ISO/TC 176.
- The goal of this technical specification is to extend ISO 9001:2008 with automotive specific requirements.
- There are several quality management system requirements (risk management, safety relevant characteristics, etc.), that are more strict, compared to many other various business sectors.
- By developing and maintaining an ISO/TS 16949 conform quality management system, the company or organization is able to sustain continuous improvement, to prevent defects, to decrease risks and waste,
to reduce deviations and variation, and to indirectly reduce the number of quality incidents and unexpected quality cost.
Source: qMindset.com; ISO.org
