The Automotive Quality Management System: ISO/TS 16949 brings a number of benefits to an organisation, among them are:
- Global recognition as a reputable supplier – certification is recognised and accepted throughout the automotive supply chain as an industry benchmark
- Customer satisfaction – through delivery of products that consistently meet customer requirements
- Reduced cost of compliance with customer specifications – through implementation of a single management system and reduced audit requirements
- Reduced operating costs – through continual improvement of processes and resulting operational efficiencies
- Improved stakeholder relationships – including staff, customers and suppliers
- Legal compliance – by understanding how statutory and regulatory requirements impact the organisation and its customers
- Improved risk management – through greater consistency and traceability of products and services
- Proven business credentials – through independent verification against recognised standards
- Ability to win more business – particularly where procurement specifications require certification as a condition to supply
ISO/TS 16949:2009, in conjunction with ISO 9001:2008, defines the quality management system requirements for the design and development, production and, when relevant, installation and service of automotive-related products. ISO/TS 16949:2009 is applicable to sites of the organisation where customer-specified parts, for production and/or service, are manufactured.
In the past car manufacturers requested that suppliers build and certify their quality management system according to the rules and regulations of their own country organisations such as SMMT (UK), VDA (Germany), AVSQ (Italy), AIAG (North America) and FIEV (France). So suppliers had to provide several different certificates to their customers. All these complexities increased the requirement for harmonisation.
ISO/TS 16949 Automotive Quality Management System was then issued as a sector specific quality management standard for the automotive industry. It was issued in an attempt to improve quality and assure the integrity of supplies to the industry. There have been significant improvements in all aspects of quality, delivery and overall efficiency throughout the supply chain since the introduction of ISO/TS 16949. It has also resulted in the reduction of the requirement for multiple audits of manufacturers.
This third edition of ISO/TS 16949 issued in 2009 cancels and replaces the second edition (ISO/TS 16949:2002), which has been technically amended according to ISO 9001:2008. ISO/TS 16949 was prepared by the International Automotive Task Force (IATF), with support from ISO/TC 176, Quality management and quality assurance.
The International Automotive Task Force (IATF) which includes nine major OEM’s as members is committed to ensuring that ISO/TS 16949 remains as the automotive quality systems standard for the future. ISO/TS 16949 applies to all organisations in the automotive supply chain that manufactures and / or adds value to parts for supply to the automotive industry. The ISO/TS 16949 standard is based on the structure of ISO 9001 and the specific requirements of the automotive quality standard. ISO/TS 16949:2009 aligns with ISO 9001:2008.
The Plan – Do – Check – Act (PDCA) cycle is the foundation of all ISO management system standards. The cycle ensures development, continuous improvement and control of the management system in question.
The PDCA cycle ensures constant monitoring of your organisation’s effectiveness. It consists of the following:
- Plan – establishing the architecture of your quality management system is covered in clause 4.1 of the standard where it requires the identification of the processes, their success criteria, the inter-relationship between processes and the system for checking your results
- Do – implementing the plans and using the quality management system
- Check – reviewing whether the results are satisfactory at appropriate intervals against the ISO 9001 requirements
- Act – improving the quality management system or acting on the challenges and issues found in the reviews
An organisation will probably already have an effective quality management system but it is most likely informal and not well documented. A more systematic approach to achieving organisation’s objectives is provided by ISO 9001. This should not result in excessive bureaucracy or paperwork and lack of flexibility. It should not be a financial burden either. The quality management systems should be viewed as an investment and the return on the investment is the previously mentioned benefits.
The PDCA cycle starts with management because they identify appropriate processes and relevant areas of focus.
An essential requirement for a practical system is an appropriate process and the key is starting with two processes which are Management and Operations. Next decide if sub-processes are required instead of working “bottom up”. An owner is required for every process who is responsible for the activities that relate to the success criteria of the process.
Planning and Review:
A quality manual and a number of documents outlining procedures are required before implementation in order to successfully plan your quality system. The areas of documentation are:
- Document control
- Records control
- Internal audits
- Non – conforming product
- Corrective action
- Preventative action
The fundamental direction of the QMS should be established by owners or managers of your organisation using the quality policy. When designing the Quality Policy there are several aspects that have to be thought through such as:
- Strategy – should follow from the Quality Policy and the business environment
- Process criteria – should be aligned to the strategy
- Customer focus – system processes have to be designed to ensure customer satisfaction
- Resources – human, technological and environmental resources have to be put in place. The QMS requires that each company establish a way that their staff are competent
The system has to be used to see that it works the way it was intended to. It will be necessary to use the procedures, forms, equipment and instructions in the way it was planned. This part of the process should be fairly easy to implement with the direction from your management and the assigned resources. It is important that the processes all along the supply chain should be planned and defined. This might include:
- Research and Development
Some of the steps might not apply to your organisation as ISO 9001 certification is designed for every type of organisation.
The results of the QMS should be reviewed at appropriate intervals. When the system is new the intervals will be short but can be longer once the QMS becomes mature. The reporting of results against the process success criteria should be done regularly and then be used by management to ensure that the business is on track. The records should be appropriately designed to facilitate prompt recording as well as the early detection of problems.
The management review is a key milestone in evaluating the QMS and it is a meeting which assesses whether the QMS has succeeded in meeting:
- Strategic objectives
- Process success criteria
- ISO 9001 requirements
A key metric that has to be reviewed is perceived customer satisfaction. Handling complaints is not enough as customers could just move their businesses to a competitor. Internal audits are probably the most important characteristic of a successful quality management system. If an organisation does not carry out internal audits it is likely that the organisation will have their certification revoked as their system is probably out of control.
Corrective action or preferably preventative action can be used to tackle challenges. Corrective actions must be recorded and preventative actions should be designed for recurring problems. The following questions should be asked as a checklist:
- Customer focus – Have you found out what the customer’s current and future need and expectations are at a strategic level?
- Quality policy – Does it really suit your organisation and reflect your customer’s expectations, your vision and mission – and the requirements of the standard?
- Objectives – Are all the objectives measurable and linked to both the processes and to the strategies?
- Plan the system – Have all the responsibilities been identified and communicated? Does everyone know what they need to do to contribute to the success of the business – and the QMS?
- Review at regular intervals – Are the results of the QMS being reviewed and compared against planned results? Is action being taken to improve areas where results are not quite as good as planned?
- Principles – management should review the 8 principles mentioned earlier and how well the system delivers against these.
In order to get certified for ISO 9001 Quality Management System there are a number of steps involved:
The first step involves the application for certification
This is where:
- An on-site analysis of your current system is conducted
- This will then be assessed against the standard
- A report is then prepared to highlight the gaps between your current system and the standard
The gap assessment is optional and is not required for the certification process.
Preliminary Assessment – Stage 1
Your documentation has to be inspected and various areas have to be reviewed including:
- The proposed scope of your registration
- The status of implementation of your management system
- The appropriate regulatory and legal requirements
- Your management policies and objectives
- Whether the system addresses the key areas of your business
- Your site-specific activities – top level process review
- Your key management elements, e.g. internal audits, reviews and complaints procedures
- Your readiness to move onto Stage 2 of the assessment, the Registration Assessment
There should be a period of several weeks between preliminary assessment and registration assessment so that any issues can be sorted in relation to the preliminary assessment. If there are major non-conformities a second preliminary assessment will have to be carried out.
Registration Assessment – Stage 2
This involves a full review of your management system in order to confirm that your management system is controlled. When the registration assessment is complete a notified body issues a detailed report along with the outcome which recommends registration or not. If any issues arise during the assessment you will be expected to submit an action plan which should describe what changes are to be made to the management system in order to reduce or eliminate the risk of the same issues occurring again.
Surveillance and Re-assessment
A notified body visits each company at least once a year to make sure the management system is being maintained and that it is achieving it’s expected outcomes. A part of the management system is reviewed in depth during each visit.
There is an expiry date on the certificate and the certificate expires every three years. Before the expiry date occurs a detailed assessment of the whole management system is undertaken to ensure every element of the system is performing satisfactorily and the results of the previous visits are taken into account.
During the registration period, changes are inevitable. In order to make sure the management system remains sound the notified body works with each registered organisation. Usually, change can be reviewed and assessed during routine surveillance visits. The notified body reserves the right to suspend or revoke certification in cases where change leads to the breakdown of the system.